Neurology & Neurological Sciences Clinical Trials
How to Participate
Sign up here to be added to a registry for clinical trials. This survey will ask you questions about yourself and contact information that takes about 10 minutes.
Learn More
For more details on all of our clinical trials visit the SOM Clinical Trial Database or ClinicalTrials.gov
What is a clinical trial?
- Clinical trials are research studies that explore whether a medical strategy, treatment or device is safe and effective for people. Before people are given a new intervention (drug, device, or treatment), it is carefully studied in the laboratory or in animals. Studies with the most promising results are then moved into clinical trials with people. Clinical trials are used to evaluate new and better ways to treat, prevent, detect, diagnose, and manage symptoms of diseases.
Why Participate?
- By participating in clinical research, you help medical science by providing valuable information about treatments and prevention of disease. Most treatments we use today are the result of past clinical trials. One way to gain access to promising new interventions is to participate in a clinical trial while also helping science.
Eligibility
- Researchers follow clinical trials guidelines when deciding who can participate in a study. These guidelines are called Inclusion/Exclusion Criteria. These criteria are based on factors such as age, gender, the type and stage of a disease, treatment history, and other medical conditions. Trial coordinators can provide additional information about individual trials.
What are the benefits and risks of participating in a clinical trial?
- By being in a clinical trial you help advance medicine and help future patients. You may also have access to promising treatments by joining a clinical trial. However, all clinical trials have risks. There may be side effects or other risks, which may or may not be worse than those from regular care. The intervention (drug, device, treatment) may not work for you, even if it helps others and you may get a placebo. Joining a research trial may be more burdensome due to more frequent visits. However, more visits may give you more attention and monitoring which you would not normally get by your regular doctor.
Are the research staff vaccinated against Covid-19?
- Yes. All staff are compliant with mandates set forth by the state and Stanford University unless the staff have a valid exception
Are research staff wearing protective equipment?
- Yes. All research staff are required to wear masks and may have additional requirements based upon each building protocol. All buildings for clinical care such as our Stanford Neuroscience Health Center (SNHC) have requirements for Health Screening, physical distancing, and masks.
Are there safety protocols required due to the Covid-19 pandemic?
- Yes. Stanford University has safety requirement protocols and some buildings locations have additional protocols as mandated by Stanford Healthcare.
Are there safety protocols for visitors arriving to buildings?
- Yes. There are requirements for masks for all visitors. There may be additional requirements based upon Stanford University, county, and state mandates. All research participants are required be tested for covid-19 within 72 hours of arriving to a University building or are required to be vaccinated against covid-19. All visitors are required to answer health screenings before arriving. This may be subject to change according to local and state mandates.
Clinical Trials
Healthy Brain Aging Study
This is a longitudinal study enrolling individuals with Alzheimer’s disease, Mild Cognitive Impairment, Lewy Body Dementia, Parkinson’s disease, Parkinson’s disease with dementia and healthy volunteers. It is funded by the National Institute of Health and is part of the Alzheimer’s Disease Research Center (ADRC). This study will collect data including medical history, family history and medication. There will be questionnaires to be filled out, cognitive testing and PET/MRI of the brain. This study will follow participants over time.
Status: Active recruiting
PI: Victor Henderson, MD
Status: Open, enrollment ongoing
Contact: Isabelle Yi - isabelleyi@stanfordhealthcare.org
(650) 721-2409
Pacific Udall Center
Sponsor: NIH/NINDS Morris K. Udall Center of Excellence for Parkinson's Disease Research
PI: Tom Montine, MD, PhD
Study status: Open, Enrollment ongoing
Research coordinator: Maria-Lucia Campos
udallcenter@stanford.edu
650-721-5274
Natural History Study of Synucleinopathies
PI: Mitchell Miglis, MD
Study Status: Open to enrollment
Research Coordinator: Ruba Shaik or Jordan Seliger
Contact: rubas@stanford.edu or jseliger@stanford.edu
A Phase 3, 4-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure
PI: Dong-In Sinn, MD
NCT03750552
Study Status: Open to enrollment
Research Coordinator: Ruba Shaik or Jordan Seliger
Contact: rubas@stanford.edu or jseliger@stanford.edu
A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD˗9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure
PI: Dong-In Sinn, MD
NCT03829657
Study Status: Open to enrollment
Research Coordinator: Ruba Shaik or Jordan Seliger
Contact: rubas@stanford.edu or jseliger@stanford.edu
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of BHV-3241 in Subjects With Multiple System Atrophy
PI: Mitchell Miglis, MD
NCT03952806
Study Status: Closed to enrollment
Research Coordinator: Ruba Shaik or Jordan Seliger
Contact: rubas@stanford.edu or jseliger@stanford.edu
A First-in-human Study of Inhibitory Interneurons (NRTX-1001) in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (MTLE)
PI: Kevin Graber, MD
NCT05135091
Study Status: Enrolling
Research Coordinator: Jordan Seliger
Contact: jseliger@stanford.edu
RNS System Responsive Thalamic Stimulation for Primary Generalized Seizures Study (NAUTILUS Study)
NCT05147571
Study Status: Enrolling Soon
Research Coordinator: Jordan Seliger
Contact: jseliger@stanford.edu
Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval Study (EPAS)
PI: Kevin Graber, MD
NCT03900468
Study Status: Enrolling
Research Coordinator: Jordan Seliger
Contact: jseliger@stanford.edu
Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD)
PI: Kimford Meador, MD
NCT01730170
Study Status: Closed to Enrollment
Research Coordinator: Jordan Seliger
Contact: jseliger@stanford.edu
Electrophysiological Biomarkers of Consciousness in Patients with Epilepsy and Patients with Psychogenic Non-Epileptic Spells
PI: Kimford Meador, MD
Study Status: Enrolling
Research Coordinator: Jordan Seliger
Contact: jseliger@stanford.edu
Electroencephalographic Biomarkers of Neuro-Cognitive Function
PI: Kimford Meador, MD
Study Status: Enrolling
Research Coordinator: Jordan Seliger
Contact: jseliger@stanford.edu
Using Artificial Intelligence to Choose the Optimal Antiepileptic Drug
Protocol ID : 46059
PI: Robert S. Fisher, MD, PhD
Status: Enrolling subjects
Transcranial Direct Current Stimulation to Treat Epilepsy
Protocol ID : 47711
PI: Robert S. Fisher, MD, PhD
Status: Enrolling subjects
Focused ultrasound to treat epilepsy (EP001)
Protocol ID : 55981
PI: Robert S. Fisher, MD, PhD
Status: Enrolling subjects
AI-Guided 3D Video Analysis for Seizure Detection
Protocol ID : 53035
PI: Robert S. Fisher, MD, PhD
Status: Pending loosening of COVID travel requirements
Cognitive Effects of Vinpocetine in Patients with Epilepsy
PI: Kimford Meador, MD
NCT02011971
Study Status: Closed to Enrollment
Research Coordinator: Jordan Seliger
Contact: jseliger@stanford.edu
Effects of Titration Rate on Cognitive and Behavioral Side Effects of Perampanel
PI: Kimford Meador, MD
NCT# Pending
Study Status: Enrolling
Research Coordinator: Jordan Seliger
Contact: jseliger@stanford.edu
RNS® System Post-Approval Study in Epilepsy Clinical Investigational Plan (CIP)
PI: Babak Razavi
NCT02403843
Study Status: Closed to enrollment
Research Coordinator: Jordan Seliger, Ruba Shaik
Contact: jseliger@stanford.edu or rubas@stanford.edu
Personal Impact of Epilepsy Scale (PIES): Determining the Minimally Important Change
Protocol ID : 43107
PI: Robert S. Fisher, MD, PhD
Status: Closed, in data analysis phase
Interventional, randomized, double-blind, parallel-group, placebo-controlled delayed-start study to evaluate the efficacy and safety of eptinezumab in patients with episodic Cluster Headache (Alleviate)
PI: Nada Hindiyeh, MD
NCT04688775
Study Status: Enrolling
Research Coordinator: Stephanie Tran
Contact: trans@stanford.edu
Sunstar: The Stanford Neuroscience Headache Biorepository
PI: Robert Cowan, MD, FAAN
NCT03231241
Study Status: Enrolling
Research Coordinator: Bharati Sanjanwala
Contact: bharatis@stanford.edu
Sphenopalatine Ganglion Stimulation for the Treatment of Chronic Cluster Headache
PI: Meredith Barad, MD
NCT02168764
Study Status: Closed to Enrollment
Research Coordinator: Stephanie Tran
Contact: trans@stanford.edu
Diagnostic comparison of an online questionnaire versus a semi-structured interview for the diagnosis of primary headache disorders, using ICHD 3 as the Gold Standard
PI: Robert Cowan, MD, FAAN
NCT03304886
Study Status: Closed to Enrollment
Research Coordinator: Bharati Sanjanwala
Contact: bharatis@stanford.edu
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel- Group Study to Evaluate the Efficacy, Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants with Episodic Migraine (ADVANCE)
PI: Nada Hindiyeh, MD
NCT03777059
Study Status: Closed to Enrollment
Research Coordinator: Stephanie Tran
Contact: trans@stanford.edu
A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens (Intravenous/Subcutaneous and Subcutaneous) of TEV-48125 Versus Placebo for the Prevention of Epidosic Cluster Headache
PI: Nada Hindiyeh, MD
NCT02945046
Study Status: Closed to Enrollment
Research Coordinator: Stephanie Tran
Contact: trans@stanford.edu
A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens (Intravenous/Subcutaneous and Subcutaneous) of TEV-48125 Versus Placebo for the Prevention of Chronic Cluster Headache
PI: Nada Hindiyeh, MD
NCT02964338
Study Status: Closed to Enrollment
Research Coordinator: Stephanie Tran
Contact: trans@stanford.edu
A Multicenter, Double-Blind, Double-Dummy Study to Explore the Long-Term Safety of TEV-48125 for the Prevention of Cluster Headache
PI: Nada Hindiyeh, MD
NCT03107052
Study Status: Closed to Enrollment
Research Coordinator: Stephanie Tran
Contact: trans@stanford.edu
A Randomized, Multicenter, Double-Blind, Parallel, Sham-Controlled Study of Non-Invasive Vagus Nerve Stimulation (NVNS) for the Prevention of Migraines. (PREMIUM II)
PI: Nada Hindiyeh, MD
NCT03716505
Study Status: Closed to enrollment
Research Coordinator: Stephanie Tran
Contact: trans@stanford.edu
A Phase 3b Multicenter, SIngle-arm, Open-label Safety Study of Ly2951742 (Galcanezumab) in Patients with Episodic or Chronic Cluster Headache
PI: Nada Hindiyeh, MD
NCT02797951
Study Status: Closed to Enrollment
Research Coordinator: Stephanie Tran
Contact: trans@stanford.edu
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients with Episodic Cluster Headache
PI: Nada Hindiyeh, MD
NCT02397473
Study Status: Closed to Enrollment
Research Coordinator: Stephanie Tran
Contact: trans@stanford.edu
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 with a Long-Term Open-Label Extension in Patients with Chronic Cluster Headache
PI: Nada Hindiyeh, MD
NCT02438826
Study Status: Closed to Enrollment
Research Coordinator: Stephanie Tran
Contact: trans@stanford.edu
A 12-Month Prospective, Randomized, Interventional, Global, Multi-Center, Active-Controlled Study Comparing Sustained Benefit of Two Treatment Paradigms (Erenumab GM vs. Oral Prophylactics) in Adult Episodic Migraine Patients (CAMG334A2401)
PI: Nada Hindiyeh, MD
NCT03927144
Study Status: Closed to enrollment
Research Coordinator: Stephanie Tran
Contact: trans@stanford.edu
A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Single Doses of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine
PI: Nada Hindiyeh, MD
NCT03901482
Study Status: Closed to enrollment
Research Coordinator: Stephanie Tran
Contact: trans@stanford.edu
A Parallel Group Double-Blind Randomized PlaceboControlled Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Subjects Experiencing an Acute Attack of Migraine
PI: Nada Hindiyeh, MD
NCT04152083
Study Status: Closed to Enrollment
Research Coordinator: Stephanie Tran
Contact: trans@stanford.edu
Randomized, Double-Blind, Multi-Center, Parallel-Group Comparison of the Efficacy and Safety of the C213 (Zolmitriptan Microneedle System) to Placebo for the Acute Treatment of Cluster Headaches
PI: Nada Hindiyeh, MD
NCT04066023
Study Status: Closed to enrollment
Research Coordinator: Stephanie Tran
Contact: trans@stanford.edu
A PHASE 3, MULTICENTER, OPEN-LABEL 40-WEEK EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF ORAL ATOGEPANT FOR THE PREVENTION OF MIGRAINE IN PARTICIPANTS WITH EPISODIC MIGRAINE
PI: Nada Hindiyeh, MD
NCT03777059
Study Status: Closed to Enrollment
Research Coordinator: Stephanie Tran
Contact: trans@stanford.edu
A Long-Term, Open-Label Safety Study to Evaluate the Safety of M207 (Intracutaneous Microneedle System) in the Acute Treatment of Migraine
PI: Nada Hindiyeh, MD
NCT03282227
Study Status: Closed to Enrollment
Research Coordinator: Stephanie Tran
Contact: trans@stanford.edu
Active, recruiting:
Sponsor: Indiana University and NIA (LEADS)
Intervention: N/A - Observational
Indication: Early onset Alzheimer's Disease (EOAD), Early onset non-Alzheimer's Disease (EO-nonAD), and cognitively normal (CN)
Brief Summary: A non-randomized, natural history, non-treatment study designed to look at disease progression in individuals with early onset cognitive impairment. Clinical, cognitive, imaging, biomarker, and genetic characteristics will be assessed across three cohorts: (1) early onset Alzheimer's Disease (EOAD) participants, (2) early onset non-Alzheimer's Disease (EO-nonAD) participants, and (3) cognitively normal (CN) control participants.
Clinicaltrials.gov identifier: NCT03507257
PI: Sharon Sha, MD
Contact: Amanda Ng - amandang@stanford.edu - (650) 485-9560
Sponsor: Janssen Research & Development (Autonomy Study)
Intervention: JNJ-63733657 (monoclonal anti-tau antibody)
Indication: mild cognitive impairment and mild AD
Age: 55-80 years old
Brief Summary: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of JNJ-63733657, an Anti-tau Monoclonal Antibody, in Participants with Early Alzheimer’s Disease
Clinicaltrials.gov identifier: NCT04619420
PI: Sharon Sha, MD
Contact: Viktoriya Bourakova - viktoriya.bourakova@stanford.edu - (650) 709-9041
Sponsor: Eisai and NIH (AHEAD 3-45 Study)
Intervention: BAN2401 (monoclonal antibody binding to amyloid)
Indication: Pre-clinical AD
Brief Summary: A Placebo-Controlled, Double-Blind, Parallel-Treatment Arm, 216 Week Study to Evaluate Efficacy and Safety of Treatment With BAN2401 in Subjects With Preclinical Alzheimer’s Disease and Elevated Amyloid (A45 Trial) and in Subjects With Early Preclinical Alzheimer’s Disease and Intermediate Amyloid (A3 Trial)
Clinicaltrials.gov identifier: NCT04468659
PI: Sharon Sha, MD
Contact: https://studypages.com/s/the-ahead-study-440395/
Active, not recruiting:
Sponsor: Eli Lilly (Trailblazer Study)
Intervention: Donanemab (monoclonal antibody binding to amyloid)
Protocol NCT#: NCT04437511
PI: Sharon Sha, MD
Coordinator: Amanda Ng, amandang@stanford.edu
Sponsor: Eisai (Clarity AD)
Intervention: BAN2401 (monoclonal antibody binding to amyloid)
Indication: MCI/Mild AD
Clinicaltrials.gov identifier: NCT03887455
PI: Sharon Sha, MD
Contact: Viktoriya Bourakova, viktoriya.bourakova@stanford.edu
Sponsor: Cortexyme (Gain Study)
Intervention: COR388 (Gingipain inhibitor)
Indication: Mild to Moderate AD
Clinicaltrials.gov identifier: NCT03823404
PI: Sharon Sha, MD
Contact: Amanda Ng, amandang@stanford.edu
Sponsor: Biogen (Embark Study)
Intervention: Aducanumab (Monoclonal antibody binding to amyloid)
Indication: MCI/Mild AD (Recruiting by invitation only: participants who were previously enrolled in aducanumab trials)
Clinicaltrials.gov identifier: NCT04241068
PI: Sharon Sha, MD
Contact: Anthony Velasquez, anthgv@stanford.edu
Completing, not recruiting:
Sponsor: Biogen (Tango Study)
Intervention: BIIB092 (Monoclonal antibody binding to tau)
Indication: MCI/Mild AD
Clinicaltrials.gov identifier: NCT03352557
PI: Sharon Sha, MD
Contact: Viktoriya Bourakova, viktoriya.bourakova@stanford.edu
Sponsor: Genentech (Tauriel Study)
Intervention: RO7105705 (Monoclonal antibody binding to tau)
Indication: MCI/Mild AD
Clinicaltrials.gov identifier: NCT03289143
PI: Sharon Sha, MD
Contact: Jenn Gaudioso, jenn.gaudioso@stanford.edu
Sponsor: Genentech (Lauriet Study)
Intervention: RO7105705 (Monoclonal antibody binding to tau)
Indication: Moderate AD
Clinicaltrials.gov identifier: NCT03828747
PI: Sharon Sha, MD
Contact: Jenn Gaudioso, jenn.gaudioso@stanford.edu
Sponsor: Novartis (Generations II Study)
Intervention: CNP520 (Active BACE-1 Inhibitor)
Target Population: Cognitively Unimpaired APOE4 Homozygotes or Amyloid Positive Heterozygotes
Clinicaltrials.gov identifier: NCT03131453
PI: Sharon Sha, MD
Contact: Amanda Ng, amandang@stanford.edu
Sponsor: Novartis (Generations I Study)
Intervention: CAD106 (Induces Active Antibody without activating Aβ-reactive T cells) and CNP520 (BACE-1 Inhibitor)
Target Population: Cognitively Unimpaired APOE4 Homozygotes
Clinicaltrials.gov identifier: NCT02565511
PI: Sharon Sha, MD
Contact: Amanda Ng, amandang@stanford.edu
PARKINSON'S DISEASE
The Role of the Gut Microbiome in Parkinson’s Disease
Studies
show that the gut microbiome in Parkinson’s patients is different from
the gut microbiome in healthy individuals. What is not clear, however,
is how these differences impact one’s risk for developing Parkinson’s
Disease or how the different microbiome in Parkinson’s patients impacts
disease course. Additionally, in Parkinson’s patients there is chronic
systemic inflammation due to excessive immune activity, and the gut
microbiome is known to impact immune functioning. Therefore, in this
study we examine whether the differences in the microbiome of
Parkinson’s patients are associated with increased inflammatory markers
in the blood, and whether the differences in microbiome impact immune
cell activation. Through this study, we hope to better understand the
mechanism by which the microbiome in Parkinson’s patients may be
contributing to the disease. In the future, these findings could be used
to develop disease treatments that target the microbiome. We are
recruiting individuals who have been diagnosed by a neurologist with
Parkinson’s Disease and healthy individuals from the same house.
Participation entails answering an online questionnaire and giving small
amounts of blood and stool. Each participant will receive a gift card
for their involvement.
PI: Bianca Palushaj, MD
Co-PI: Ami S. Bhatt, MD, PhD
Study status: Open, enrollment ongoing
Research Coordinators: Meena Chakraborty, Erin Brooks, Gabriella Green
Contact: mchakra@stanford.edu, efbrooks@stanford.edu, gzmg1@stanford.edu
Vibrotactile Coordinated Reset: A Non-invasive Treatment for Parkinson's Disease
Purpose: The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on motor ability within Parkinson's patients. vCR will be administered with a device called the VT Brain Glove. VCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as levodopa and or deep brain stimulation. This study will include a dedicated sham that will aid in understanding true treatment effects from vCR.
Sponsor: Stanford University, Synergic Medical Technologies, Inc.
PI: Peter Tass, MD, PhD
Co-PI: Leila Montaser Kouhsari, MD, PhD
Study status: Open, enrollment ongoing
Research Coordinator: Jessica Kalinova Yankulova
Contact: parkinsonsvcr@stanford.edu
Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) (NCT04547712)
Sponsor: Medtronic, Inc.
Purpose: The purpose of the study is to demonstrate the safety and effectiveness of adaptive DBS (aDBS) for Parkinson’s disease.
PI: Helen Bronte-Stewart, MD, MS
Study status: Open, enrollment ongoing
Research coordinator: Emilia Lambert
emilial@stanford.edu
(650) 723-6709
Blood biomarkers study in REM sleep behavior disorder (RBD)
Purpose: studying neuroinflammation and immune protective factors in patients with RBD
PI: Emmanuel H. During, MD
Co-PI: Emmanuel Mignot, MD, PhD
Study status: Open, enrollment ongoing
Research Coordinator: Ana Cahuas
acahuas@stanford.edu 650 721 5489
Home diagnosis of REM sleep behavior disorder (RBD) using wearable sleep trackers
Purpose: developing a machine learning method to diagnose RBD in the home environment with wrist-worn actigraphy
PI: Emmanuel H. During, MD
Study status: Open, enrollment ongoing
Research Coordinator: Ana Cahuas
acahuas@stanford.edu 650 721 5489
U19 North American Prodromal Synucleinopathy (NAPS) consortium
Purpose: Neuroprotection trial planning in REM sleep behavior disorder (RBD)
PI: Emmanuel H. During, MD
Study status: Open, enrollment ongoing
Research Coordinator: Vincent Nguyen
vnguyen9@stanford.edu
Sodium Oxybate in Refractory REM Sleep Behavior Disorder: A Randomized Controlled Study
Purpose: This study evaluates the efficacy of sodium oxybate in individuals with and without Parkinson’s disease who act out their dreams (REM Sleep Behavior Disorder, known as “RBD”) and do not respond to usual therapies.
PI: Emmanuel H. During, MD
Co-PI: Mitchell Miglis, MD
Study status: Open, enrollment ongoing
Research Coordinator: Ana Cahuas
acahuas@stanford.edu 650 721 5489
Pacific Udall Center
Sponsor: NIH/NINDS Morris K. Udall Center of Excellence for Parkinson's Disease Research
PI: Tom Montine, MD, PhD
Study status: Open, Enrollment ongoing
Research coordinator: Maria-Lucia Campos
udallcenter@stanford.edu (650) 721-5351
Healthy Brain Aging Study
Sponsor: NIH/NIA
PI:Victor Henderson, MD and Tony Wyss-Coray, PhD
Study Status: Open, enrollment ongoing
Research coordinator: Christina Wyss-Coray
ADRCstanford@stanford.edu (650) 721-2409
Bilateral Closed Loop Deep Brain Stimulation for Freezing of Gait using Neural and Kinematic Feedback (NCT04043403)
Sponsor(s): NIH/NINDS, BRAIN Initiative
Purpose: This study aims to investigate the safety and feasibility of adaptive deep brain stimulation for impaired gait and freezing of gait in Parkinson’s disease, driven by subject-specific neural or behavioral control variables, and in response to medication.
PI: Helen Bronte-Stewart, MD, MS
Study status: Open, enrollment ongoing
Research coordinator: Sudeep Aditham
sudeepa@stanford.edu (650) 723-6709
The Natural History of Synucleinopathies
PI: Mitchell Miglis, MD
Study status: Open, enrollment by invitation only
Research coordinator: Jordan Seliger
jseliger@gmail.com
ATYPICAL PARKINSONISM (MSA, PSP, CBD, DLB)
M-STAR
Sponsor: Biohaven
Site PI: Mitchell Miglis, MD
Study status: Closed for enrollment
Research coordinator: Ruba Shaik
rubas@stanford.edu 650-546-1436
HUNTINGTON’S DISEASE
Generation HD
Clinical Trials Protocol#: NCT03761849
Sponsor: Roche
Site PI: Jacinda Sampson, MD, PhD
Study status: Enrollment Closed, trial ongoing
Research coordinator: Stephanie Tran
trans@stanford.edu
Upcoming Movement Clinical Trials
PARKINSON’S DISEASE
ADX48621 for the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease
Clinical Trials Protocol#: NCT01336088
Sponsor: Addex Pharmaceuticals
Study status: Pending, open to enrollment Fall/Winter 2020
Research coordinator: Lila Perrone
perronel@stanford.edu
Open-Label Study With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease Psychosis
Clinical Trials Protocol#: NCT04292223
Sponsor: Acadia
Site PI: Sharon Sha, MD, MS
Study status: Pending, open to enrollment Fall/Winter 2020
Research coordinator: Lila Perrone
perronel@stanford.edu
BOOST3 – Brain Oxygen Optimization in Severe TBI Phase 3
BOOST3 is a study to learn if either of two strategies for monitoring and treating patients with traumatic brain injury (TBI) in the intensive care unit (ICU) is more likely to help them get better. More information: https://med.stanford.edu/neurology/divisions/neurocriticalcare/clinical-trials/boost3.html
Protocol ID: 49130
PI: Karen G. Hirsch, MD
Study Coordinator: Elizabeth Osborn
Status: RECRUITING
CHARM - Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 for Severe Cerebral Edema following Large Hemispheric Infarction.
The purpose of this study is to evaluate the safety and effectiveness of the study drug, Intravenous BIIB093 (Glibenclamide), in improving functional outcome in subjects with large strokes. NCT02864953
Protocol ID: 46054
PI: Chitra Venkatasubramanian, MBBS, MD
Status: RECRUITING
CERIBELL Stroke Study
The primary objective of this study is to acquire EEG data in suspected stroke patients, immediately following diagnostic brain imaging to detect potential EEG signals that differ among emergent large vessel occlusion stroke (ELVO), intracranial hemorrhage (ICH), and non-stroke patients (stroke mimics).
Protocol ID: 47822
PI: Anna Finley Caulfield, MD
Status: RECRUITING
ICECAP - Influence of Cooling duration on Efficacy in Cardiac Arrest Patients
The purpose of this study is to determine if increasing durations of induced hypothermia are associated with an increasing rate of good neurological outcomes and to identify the optimal duration of induced hypothermia for neuroprotection in comatose survivors of cardiac arrest.
NCT04217551
Protocol ID: 56493
PI: Karen Hirsch, MD
Status: RECRUITING
PRECICECAP - PREcision Care In Cardiac ArrEst -ICECAP
In partnership with the ICECAP trial, this project will use novel data-driven approaches to collect high resolution monitoring data from patients in the critical care unit and will use that multi-parametric data to develop newly defined patient sub-groups with differing clinical trajectories and responses to therapies.
Protocol ID: 58318
PI: Karen Hirsch, MD
Status: RECRUITING
Project BIG: The Stanford Brain Immune Gut Research Initiative
Status: Active, Enrolling
PI: Jeffrey Dunn, MD
Research Coordinators: Anna Tomczak and Julia Sumera
Contact: atomc96@stanford.edu, jsumera@stanford.edu
North American Registry for Care and Research in Multiple Sclerosis (NARCRMS) Study
PI: Jeffrey Dunn, MD
Study Status: Active, Enrolling
Research Coordinator: Anna Tomczak
Contact: atomc96@stanford.edu
A Phase IIIB Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple Sclerosis (BN42082)
PI: Lucas Kipp, MD
NCT04544436
Study Status: Active, Enrolling
Research Coordinator: Julia Sumera and Anna Tomczak
Contact: jsumera@stanford.edu, atomc96@stanford.edu
A Phase IIIB Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis (BN42083)
PI: Lucas Kipp, MD
NCT04548999
Study Status: Active, Enrolling
Research Coordinator: Julia Sumera and Anna Tomczak
Contact: jsumera@stanford.edu, atomc96@stanford.edu
A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Teriflunomide in Adult Patients with Relapsing Multiple Sclerosis (GN42272)
PI: Lucas Kipp, MD
NCT04586023
Study Status: Active, Enrolling
Research Coordinator: Julia Sumera and Anna Tomczak
Contact: jsumera@stanford.edu, atomc96@stanford.edu
A Randomized, Double-blind, Double-dummy, Parallel-group Study to Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif ®) in Patients with Relapsing Multiple Sclerosis
PI: Jeffrey Dunn, MD
NCT01412333
Study Status: Closed to Enrollment
Research Coordinator: Yamuna Joseph
Multicenter, Randomized, Double-Blind, Parallel-Group Extension to Study AC-058B201 to Investigate the Long-Term Safety, Tolerability, and Efficacy of 10, 20, and 40 mg/day ACT-128800, an Oral S1P1 Receptor Agonist, in Patients with Relapsing-Remitting Multiple Sclerosis
PI: Jeffrey Dunn, MD
NCT01093326
Study Status: Closed to Enrollment
Research Coordinator: Yamuna Joseph
An open-label, multicenter, biomarker study to explore the mechanism of action of ocrelizumab and B-cell biology in patients with relapsing multiple sclerosis
PI: Christopher Lock, MD
NCT02688985
Study Status: Closed to Enrollment
Research Coordinator: Yamuna Joseph
A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Subjects with Relapsing-Remitting Multiple Sclerosis Switching from Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment (101MS329)
PI: Lucas Kipp, MD
NCT03689972
Study Status: Closed to Enrollment
Research Coordinator: Julia Sumera
A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Safety and Efficacy of Elezanumab when Added to Standard of Care in Progressive Forms of Multiple Sclerosis (M14-397)
PI: Christopher Lock, MD
NCT03737812
Study Status: Closed to Enrollment
Research Coordinator: Julia Sumera
A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Safety and Efficacy of Elezanumab when Added to Standard of Care in Relapsing Forms of Multiple Sclerosis (M18-918)
PI: Christopher Lock, MD
NCT03737851
Study Status: Closed to Enrollment
Research Coordinator: Julia Sumera
1A Phase 2, Open-label, Multicenter study to evaluate the safety and efficacy of repeated administration of NurOwn® (Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors; MSC-NTF cells) in participants with Progressive Multiple Sclerosis (MS) (BCT-101-US)
PI: Christopher Lock, MD
NCT03799718
Study Status: Study Closed
A Multicenter, Randomized, Double Blind, Placebo Controlled Parallel Group, Pilot Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects With Relapsing-Remitting Multiple Sclerosis (MNK14274069)
PI: Christopher Lock, MD
NCT03126760
Study Status: Study Closed
A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis
PI: Christopher Lock, MD
NCT02792218
Study Status: Study Closed
A Phase 3, Randomized, Multi-center, Double-blinded, Active-controlled Study to Assess the Efficacy and Safety/Tolerability of Ublituximab (TG-1101; UTX) as Compared to Teriflunomide in Subjects With Relapsing Multiple Sclerosis (RMS) (ULTIMATE 1)
PI: Christopher Lock, MD
NCT03277261
Study Status: Study Closed
Upcoming Clinical Trials:
A Multicenter Randomized Controlled Trial of Best Available Therapy versus Autologous Hematopoietic Stem Cell Transplant for Treatment-Resistant Relapsing Multiple Sclerosis (BEAT-MS-ITN077AI)
PI: Jeffrey Dunn, MD
Research Coordinator: Yamuna Joseph
Contact: yamuna@stanford.edu
A Phase 1, Double-blind, Placebo-controlled Dose-expansion Study with an Open-label Extension to Evaluate the Safety and Efficacy of ATA188 in Subjects with Progressive Multiple Sclerosis (ATA188) )
PI: Lawrence Steinman, MD
Research Coordinator: Anna Tomczak
Contact: atomc96@stanford.edu
A Phase 3B, multicenter, open-label study to evaluate the immune response to, and the safety of, vaccines in participants with relapsing forms of multiple sclerosis who receive oral ozanimod compared to non-pegylated interferon-β or no disease modifying therapy
PI: Jeffrey Dunn, MD
CorEvitas SPHERES (Synergy of Prospective Health & Experimental Research for Emerging Solutions) Registry for Neuromyelitis Optica Spectrum Disorder (NMOSD)
PI: May Han, MD
An open-label, multicenter study to evaluate the efficacy and safety of satralizumab in patients with early stage Neuromyelitis Optica Spectrum Disorder (NMOSD)
PI: May Han, MD
A phase 4, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy of ocrelizumab in patients with radiologically isolated syndrome
PI: Christopher Lock, MD
A Randomized, Double-blind, Placebo-controlled, Multinational, Multicenter study with open-label treatment extension to assess the effect of Min-102 on the progression of adrenomyeloneuropathy in male patients with x-linked adrenoleukodystrophy
PI: Jacinda Sampson, MD
NCT03231878
Study Status: Closed to Enrollment
Research Coordinator: Lila Perrone
Contact: Perronel@stanford.edu
Development and Validation for the Adult Test of Neuromuscular Disorders (ATEND), a Functional Motor Outcome Measure
Protocol ID: 58208
NCT: NA
PI: Dr. John W. Day
Study coordinator: Whitney Tang, whitneyt@stanford.edu, 650-475-6580
Purpose: This is a multi-center, prospective, observational study aimed to develop and validate a wheelchair based functional motor outcome measure for chronic, weak, non-ambulatory individuals diagnosed with a neuromuscular disease.
Status: Active
An Open-label Extension Study for Patients with Spinal Muscular Atrophy who Previously Participated in Investigational Studies of ISIS 396443
Protocol ID: 36172
NCT02594124
Sponsor: Ionis Pharmaceuticals, Inc.
PI: Dr. John W. Day
Study coordinator: Shirley Paulose, spaulose@stanford.edu, 650-725-4341
Purpose: To evaluate the long-term safety and tolerability, and to examine the cerebrospinal fluid pharmacokinetics of ISIS 396443 administered intrathecally to patients with SMA who previously participated in investigational studies of ISIS 396443.
Status: Active, but closed to enrollment.
Defining and Managing the Neuropsychological Abnormalities of Myotonic Dystrophy (CHRI protocol on DM)
Protocol ID: 28486
NCT02269865
PI: Dr. John W. Day
Study coordinator: Mitchell Reddan, mreddan@stanford.edu, 650-725-4341
Sponsor: Childrens’ Health Research Institute/investigator initiated
Purpose: To clarify mechanisms that underlie cognitive and behavioral changes in DM, some of which may also be involved in more common childhood behavioral abnormalities
Status: Recruitment paused
Clinical and Genetic Characterization of Myotonic Dystrophy
Protocol ID: 22947
NCT: NA
PI: Dr. John W. Day
Study coordinator: Mitchell Reddan, mreddan@stanford.edu, 650-725-4341
Sponsor: NIH/investigator initiated
Purpose: This is an umbrella protocol for Myotonic Dystrophy to study various aspects of the disease including sleep abnormalities.
Status: Recruiting
Inherited Neuropathies Consortium
Protocol ID: 23094
NCT01193088
PI: Dr. John W. Day
Study coordinator: Shirley Paulose, spaulose@stanford.edu, , 650-725-4341
Sponsor: NIH and Muscular Dystrophy Association
Purpose: to learn more information about the way that Charcot Marie Tooth disease (CMT) progresses over time, and also looking for new genetic types of CMT and looking to see if there are things in the DNA that may change the presentation of the condition by making it better or worse
Status: Recruiting
Subject Database and Specimen Repository for Neuromuscular and Neurodegenerative Disorders
Protocol ID: 23888
NCT: NA
PI: Dr. John W. Day
Study coordinator: Mitchell Reddan, mreddan@stanford.edu, 650-725-4341
Sponsor: investigator initiated
Purpose: This is a study that involves collecting clinical information of subjects (patients with any neurological condition or their close family member) and tissue samples to develop a subject database and tissue bank, which will be of great value in helping the investigators learn more about various related neurological conditions. This also includes a Biobank.
Status: Recruiting
Compassionate Distribution Treatment Protocol: Treatment of Lambert-Eaton Syndrome with 3,4-Diaminopyridine
Protocol ID: 33296
NCT: NA
PI: Dr. John W. Day
Study coordinator: Shirley Paulose, spaulose@stanford.edu, 650-725-4341
Sponsor: Jacobus Pharmaceuticals
Purpose: To provide access to 3,4-diaminopyridine (3,4-DAP), a drug which has been demonstrated to be effective in treating the weakness associated with Lambert-Eaton Myasthenic Syndrome (LEMS) but is currently not approved by the FDA for use in the United States. This study is for one patient only and to provide the medication on a compassionate use basis.
Status: Active, NOT Recruiting
An Open-Label, Expanded Access Protocol for Firdapse® (Amifampridine Phosphate; 3,4-Diaminopyridine Phosphate) Treatment in Patients with Lambert-Eaton Myasthenic Syndrome (LEMS), Congenital Myasthenic Syndromes (CMS) and Downbeat Nystagmus
Protocol ID: 36811
NCT02189720
PI: Dr. Yuen So
Sponsor: Catalyst Pharmaceuticals
Study coordinator: Lesly Welsh, lwelsh@stanford.edu, 650-725-4341
Purpose:To provide patients with LEMS/CMS/downbeat nystagmus access to amifampridine phosphate therapy until the product becomes commercially available.
Status: Active, enrollment open by invitation only
Tissue Banking of Blood, Spinal Fluid or Skin Biopsy for the Research of Neurological Diseases
Protocol ID: 16472
NCT: NA
PI: Dr. Yuen So
Study coordinator: Shirley Paulose, spaulose@stanford.edu, 650-725-4341
Sponsor: investigator initiated
Purpose: To collect blood, spinal fluid, or skin biopsy specimen to create a tissue bank for current or future neuroscience research, which would help to learn more about various neurological conditions.
Status: Recruiting
Clinical Study of Spinal Muscular Atrophy (PNCR/iSMAC SMA study)
Protocol ID: 31140
NCT00443066
PI: Dr. John W. Day
Study coordinators: Monica Sangco, msangco@stanford.edu and Katharine Hagerman, khagerma@stanford.edu, 650-725-4341
Sponsor: Columbia University, Collaborator: Spinal Muscular Atrophy Foundation
Purpose: To study the natural history of Spinal Muscular Atrophy to help with clinical trials in future.
Status: Recruiting in clinic
The Rare Disease Registry Program
Protocol ID: 12372
Sponsor: Genzyme Corporation/Sanofi
PI: Dr. Gregory Enns, Co-I: Dr. John W. Day
Study coordinator: Lesly Welsh, lwelsh@stanford.edu, 650-725-4341
Purpose: To collect information on the subjects with rare diseases like Pompe Disease and other lysosomal storage disorders longitudinally.
Status: Recruiting
WN40226 A Multi-Site, Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RO07239361 (BMS-986089) in Ambulatory Boys with Duchenne Muscular Dystrophy.
Protocol ID: 35232
NCT02515669
Sponsor: Bristol-Myers Squibb
PI: Dr. John W. Day
Study coordinator: Tia Nguyen, tinguyen@stanford.edu, 650-725-4341
Purpose: To study the safety, tolerability and pharmacokinetics of the study medication, BMS-986089, in Duchenne muscular dystrophy
Status: Active, Closed to enrollment.
Collection of Confirmed DMD Positive and Presumptive Negative Newborn Screening DBS Specimens
Protocol ID: 36312
NCT: NA
Sponsor: Parent Project Muscular Dystrophy
PI: Dr. John W. Day
Study coordinated by Senior Genetic Counselor, Carly Siskind, csiskind@stanfordhealthcare.org, 650-725-4341
Purpose: The purpose of this study is to help develop and validate a kit for future newborn screening for Duchenne muscular dystrophy.
Status: Recruiting
CReATe/ Phenotype, Genotype and Biomarkers in Amyotrophic Lateral Sclerosis and Related Disorders
Protocol: 40338
NCT02327845
Sponsor: NINDS/NIH (sub award through University of Miami)
PI: Dr. Yuen So
Coordinator: Mitchell Reddan, mreddan@stanford.edu, 650-725-4341
Purpose: to learn more about Amyotrophic Lateral Sclerosis and some related disorders
Status: Recruiting
A Double-Blind, Placebo-Controlled, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of SRP-4045 n SRP-4053 in Patients With Duchenne Muscular Dystrophy (ESSENCE)
Protocol: 38263
NCT02500381
Sponsor: Sarepta Therapeutics, Inc.
PI: Dr. John W. Day
Coordinator: Monica Sangco, msangco@stanford.edu 650-725-4341
Purpose: To evaluate the efficacy of SRP-4045 and SRP-4053 compared to placebo in Duchenne muscular dystrophy (DMD) patients with out-of-frame deletion mutations amenable to skipping exon 45 and exon 53 respectively.
Status: Active, Closed to recruitment
Phase I, Open-Label, Dose Comparison Study of AVXS-101 for Sitting but Non-ambulatory Patients with Spinal Muscular Atrophy
Protocol: 38893
NCT03381729
Sponsor: Avexis Pharmaceuticals, Inc.
PI: Dr. John W. Day
Coordinator: Carolyn McLaughlin Savage, cmcsavage@stanford.edu 650-725-4341
Purpose: It is a gene therapy study to compare doses of the investigational product for a group of subjects with Spinal Muscular Atrophy
Status: Open for recruitment.
A Two Part Seamless, Open-Label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of R07034067 in Infants With Type 1 Spinal Muscular Atrophy (Firefish)
Protocol: 40452
NCT02913482
Sponsor: Roche Pharmaceuticals, Inc.
PI: Dr. John W. Day
Coordinator: Lesly Welsh, lwelsh@stanford.edu, 650-725-4341
Purpose: it is to assess an investigational product for spinal muscular atrophy Type 1
Status: Active, but closed to enrollment
AVXS-101-CL-303: Phase 3, Open-Label, Single-Arm, Single-Dose Gene Replacement Therapy Clinical Trial for Patients with Spinal Muscular Atrophy Type 1 with One or Two SMN 2 CopiesPhase I, Open-Label, Dose Comparison Study of AVXS-101 by Intravenous Infusion (STRIVE) GENE TRANSFER.
Protocol: 40902
NCT03306277
Sponsor: Avexis Pharmaceuticals, Inc.
PI: Dr. John W. Day
Coordinator: Carolyn McLaughlin Savage, cmcsavage@stanford.edu 650-725-4341
Purpose: It is a gene therapy study in subjects with Spinal Muscular Atrophy Type 1.
Status: Will be open for recruitment soon.
WN40227 A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of RO7239361 (BMS-986089) in Ambulatory Boys with Duchenne Muscular Dystrophy
Protocol: 40357
NCT03039686
Sponsor: Roche Pharmaceuticals
PI: Dr. John W. Day
Coordinator: Tia Nguyen, tinguyen@stanford.edu, 650-725-4341
Purpose: An anti-myostatin compound is tried in subjects with any type of Duchenne Muscular Dystrophy.
Status: Will be recruiting soon.
CY 5022/ a Phase 2, Multi-Center, Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of CK-2127107 in Patients with Amyotrophic Lateral Sclerosis
Protocol: 41454
NCT03160898
Sponsor: Cytokinetics, Inc.
PI: Dr. Yuen So
Coordinator: Tia Nguyen, tnguyen@stanford.edu, 650-725-4341
Purpose: This study is mainly to assess the improvement in respiratory function in patients with Amyotrophic Lateral Sclerosis
Status: Will be open soon for recruitment
Compassionate Distribution Treatment Protocol: Treatment of Lambert-Eaton Syndrome and Congenital Myasthenic Syndromes with 3,4 Diaminopyridine
Protocol: 39538
NCT: NA
Sponsor: Jacobus Pharmaceuticals, Inc.
PI: Dr. Carolina Tesi Rocha
Coordinator: Lesly Welsh, 650-725-4341, lwelsh@stanford.edu
Purpose: This protocol is specifically for a child with congenital myasthenia syndrome to treat the muscle weakness.
Status: Active, but not recruiting.
A Phase 3 Randomized, Multicenter, Multinational, Double-Blinded Study Comparing the Efficacy and Safety of Repeated Biweekly Infusions of NeoGAA (GZ402666) and Alglucosidase Alfa in Treatment-Naïve Patients with Late Onset Pompe Disease
Protocol ID: 38164
NCT02782741
Sponsor: Sanofi Genzyme
PI: Dr. John W. Day
Coordinator: Monica Sangco, msangco@stanford.edu, 650-725-4341
Purpose: To study the possible risks, efficacy, and pharmacokinetics of the study drug when compared to Lumizyme which is available now commercially to treat Pompe Disease.
Status: Open to recruitment.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Ataluren in Patients with Nonsense Mutation Duchenne Muscular Dystrophy and Open-Label Extension
Protocol ID: 42313
NCT03179631
Sponsor: PTC Therapeutics
PI: Dr. John W. Day
Coordinator: Monica Sangco, msangco@stanford.edu, 650-725-4341
Purpose: to characterize the long-term effects of ataluren-mediated dystrophin restoration on disease progression.
Status: Open for recruitment.
Collection of Confirmed SMA, XLA, and SCID Positive Newborn Screening Dried Blood Spot Specimens
Protocol: 45467
NCT:NA
Sponsor: Perkin Elmer
PI: Dr. John W. Day
Coordinator: Managed in clinic by senior genetic counsellor Carly Siskind, csiskind@stanfordhealthcare.org, 650-725-4341
Purpose: to develop a newborn SMA screening kit.
Status: Open by invitation only
Individual Patient Expanded Access Protocol for the Treatment of a Single Patient with Late-Onset Tay Sachs.
Protocol: 46346
NCT: NA
PI: Dr. Yuen So
Coordinator: Tia Nguyen, tinguyen@stanford.edu, 650-725-4341
Purpose: To evaluate the safety, tolerability, and feasibility of administration of RT001 in a single subject with Late Onset Tay Sachs.
Status: Closed for enrollment, but active.
A Two Part Seamless Multi-center Randomized Placebo-Controlled, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7034067 in Type 2 and 3 Spinal Muscular Atrophy Patients (SUNFISH Trial)
Protocol: 44102
NCT02908685
PI: Dr. John W. Day
Coordinator: Lesly Welsh, lwelsh@stanford.edu, 650-725-4341
Purpose: to assess the safety and tolerability, efficacy, pharmacokinetics and pharmacodynamics of RO7034067 in pediatric and adults patients with SMA Type 2 and 3.
Status: Active, closed to recruitment
Newly Diagnosed Glioma
A Phase I Study of Tumor Treating Fields with 5-Day Hypofractionated Stereotactic Radiosurgery and Concurrent and Maintenance Temozolomide in Newly Diagnosed Glioblastoma
PI: Scott Soltys, MD
ClinicalTrials.gov#: NCT04474353
A Follow-Up Study to Add Whole Brain Radiotherapy (WBRT) to Standard Temozolomide Chemo-Radiotherapy in Newly Diagnosed Glioblastoma (GBM) Treated with 4 Weeks of Continuous Infusion Plerixafor
PI: Lawrence Recht, MD
ClinicalTrials.gov#: NCT03746080
A Phase II Study of BPM31510 with Vitamin K1 in Subjects with Newly Diagnosed Glioblastoma (GB)
PI: Seema Nagpal, MD
ClinicalTrials.gov#: NCT04752813
Pivotal, Randomized, Open-label Study of Optune (Tumor Treating Fields) Concomitant with RT & TMZ for the Treatment of Newly Diagnosed GBM (EF-32)
PI: Seema Nagpal, MD
ClinicalTrials.gov#: NCT04471844
Recurrent High Grade Glioma
Phase I Clinical Trial of Locoregionally (LR) Delivered Autologous B7-H3 Chimeric Antigen Receptor T Cells (B7-H3CART) in Adults with Recurrent Glioblastoma Multiforme (GBM)
PI: Reena Thomas, MD PhD
ClinicalTrials.gov#: NCT05474378
BRAF V600 Mutations
A Phase I, First-In-Human, Multicenter, Open-Label Study of ABM-1310, Administered Orally in Adult Patients with Advanced Solid Tumors
PI: Seema Nagpal, MD
ClinicalTrials.gov#: NCT04190628
NTRK-Fusion Positive
A Phase I/II Study of PBI-200 in Subjects with NTRK-Fusion-Positive Advanced or Metastatic Solid Tumors
PI: Seema Nagpal, MD
ClinicalTrials.gov#: NCT04901806
Primary CNS Lymphoma
An Open-Label Phase II Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Tirabrutinib in Patients with Primary Central Nervous System Lymphoma (PCNSL)
PI: Neel Gupta, MD
ClinicalTrials.gov#: NCT04947319
CNS Diagnostic Imaging
A Phase I Study of [18F]DASA-23 as a PET Tracer for Evaluating Pyruvate Kinase M2 (PKM2) Expression in Healthy Volunteers and in Patients with Intracranial Tumors
PI: Guido Davidzon, MD SM
ClinicalTrials.gov#: NCT03539731
Brain Metastases
Study Assessing QBS72S For Treating Brain Metastases of Triple Negative Breast CancerPI: Melanie Hayden Gephart, MD
ClinicalTrials.gov#: NCT05305365
LGG
Newly Diagnosed
ACNS1831: A Phase 3 Randomized Study of Selumetinib (IND #77782) Versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG)
Diagnosis: Low-Grade Glioma (LGG)
ACNS1833: A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine Versus Selumetinib (NSC# 748727, IND# 77782) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) Not Associated with BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)
Diagnosis: Low-Grade Glioma (LGG)
Relapse/Refractory
PBTC-055: Phase I/II Trial of Dabrafenib, Trametinib, and Hydroxychloroquine (HCQ) for BRAF V600E-Mutant or Trametinib and HCQ for BRAF Fusion/Duplication Positive or NF1-Associated Recurrent or Progressive Gliomas in Children and Young Adults
Diagnosis: LGG/HGG & LGG with NF1
ACNS1931: A Phase 3 Study of Selumetinib (NSC# 748727) or Selumetinib in Combination With Vinblastine for Non-NF1, Non-TSC Patients With Recurrent or Progressive Low-Grade Gliomas (LGGs) Lacking BRAFV600E or IDH1 Mutations
Diagnosis: LGG lacking BRAFV600E or IDH1 Mutations
DIPG
Newly Diagnosed
GD2 CAR-T: Phase 1 Clinical Trial of Autologous GD2 Chimeric Antigen Receptor (CAR) T cells (GD2CART) for Diffuse Intrinsic Pontine Gliomas (DIPG) and Spinal Diffuse Midline Glioma (DMG)
Diagnosis: Diffuse Intrinsic Pontine Glioma (DIPG) and Spinal Cord Diffuse Midline Glioma (DMG) that is H3K27 mutated
PBTC-051: Phase I Study to Evaluate the Safety and Tolerability of the CD40 Agonistic Monoclonal Antibody APX005M in Pediatric Subjects with Recurrent/Refractory Brain Tumors and Newly Diagnosed Brain Stem Glioma
Diagnosis: Stratum 2 newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG)
Relapse/Refractory
PBTC-049: A Phase I Study of Savolitinib in Recurrent, Progressive or Refractory Primary CNS Tumors
Diagnosis: Medulloblastoma, DIPG, and HGG
HGG
Newly Diagnosed
ACNS1723: A Phase 2 Study of Dabrafenib (NSC# 763760) With Trametinib (NSC# 763093) After Local Irradiation in Newly-Diagnosed BRAF V600-Mutant High-Grade Glioma (HGG)
Diagnosis: BRAF V600-Mutant HGG
Relapse/Refractory
PBTC048: A Feasibility Trial of Optune for Children with Recurrent or Progressive Supratentorial High-Grade Glioma and Ependymoma
Diagnosis: Supratentorial HGG
PBTC-045: A Safety and Preliminary Efficacy trial of MK-3475 (pembrolizumab; anti-PD-1) in children with recurrent, progressive or refractory high-grade gliomas (HGG), DIPGs and hypermutated brain tumors
Diagnosis: Stratum B- histologically confirmed diagnosis of a non-brainstem high-grade glioma (NB-HGG) that is recurrent, progressive or refractory following therapy which included radiotherapy. Spinal primary disease is eligible
PBTC-049: A Phase I Study of Savolitinib in Recurrent, Progressive or Refractory Primary CNS Tumors
Diagnosis: Medulloblastoma, DIPG, and HGG
PBTC-055: Phase I/II Trial of Dabrafenib, Trametinib, and Hydroxychloroquine (HCQ) for BRAF V600E-Mutant or Trametinib and HCQ for BRAF Fusion/Duplication Positive or NF1-Associated Recurrent or Progressive Gliomas in Children and Young Adults
Diagnosis: LGG/HGG & LGG with NF1
Ependymoma
Newly Diagnosed
There are currently no open trials
Relapse/Refractory
PBTC-045: A Safety and Preliminary Efficacy trial of MK-3475 (pembrolizumab; anti-PD-1) in children with recurrent, progressive or refractory high-grade gliomas (HGG), DIPGs and hypermutated brain tumors
Diagnosis: Stratum D-Patients must have a histologically confirmed diagnosis of ependymoma that is recurrent, progressive or refractory following therapy which included radiotherapy.
PBTC048: A Feasibility Trial of Optune for Children with Recurrent or Progressive Supratentorial High-Grade Glioma and Ependymoma
Diagnosis: Supratentorial ependymoma
MEDULLOBLASTOMA
Newly Diagnosed
ACNS1422: A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients
Diagnosis: Medulloblastoma
Relapse/ Refractory
PBTC-045: A Safety and Preliminary Efficacy trial of MK-3475 (pembrolizumab; anti-PD-1) in children with recurrent, progressive or refractory high-grade gliomas (HGG), DIPGs and hypermutated brain tumors
Diagnosis: Stratum E- Patients must have a histologically confirmed diagnosis of medulloblastoma that is recurrent, progressive or refractory following therapy which included radiotherapy.
PBTC-049: A Phase I Study of Savolitinib in Recurrent, Progressive or Refractory Primary CNS Tumors
Diagnosis: Medulloblastoma, DIPG, and HGG
PBTC-053: A Pediatric Brain Tumor Consortium Phase I/ II and Surgical Study of CX-4945 in Patients with Recurrent SHH Medulloblastoma
Diagnosis: Medulloblastoma
ATRT
Newly Diagnosed
SJATRT: Phase 2 Study of Alisertib as a single agent in Recurrent or Progressive Central Nervous System (CNS) Atypical Teratoid Rhabdoid Tumors (ATRT) and Extra-CNS Malignant Rhabdoid Tumors (MRT) and in Combination Therapy in Newly Diagnoses ATRT
Diagnosis: Atypical Teratoid Rhabdoid Tumors (ATRT)
Relapse/Refractory
PBTC-051: Phase I Study to Evaluate the Safety and Tolerability of the CD40 Agonistic Monoclonal Antibody APX005M in Pediatric Subjects with Recurrent/Refractory Brain Tumors and Newly Diagnosed Brain Stem Glioma
Diagnosis: Stratum I Recurrent or Refractory Primary Malignant CNS tumor patients
Neurofibromatosis-1 (NF1)
Newly Diagnosed
ACNS1831- A Phase 3 Randomized Study of Selumetinib (IND # 77782) versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG)
Diagnosis: NF1 associated LGG
Relapse/Refractory
PBTC-055: Phase I/II Trial of Dabrafenib, Trametinib, and Hydroxychloroquine (HCQ) for BRAF V600E-Mutant or Trametinib and HCQ for BRAF Fusion/Duplication Positive or NF1-Associated Recurrent or Progressive Gliomas in Children and Young Adults
Diagnosis: LGG/HGG & LGG with NF1
Other
NF1-OPG Natural History Study: Developing Evidence-Based Criteria for Initiating Treatment for Neurofibromatosis Type 1 Associated Optic Pathway Glioma/CTF 004: The Collection of Blood Samples from Patients with NF1 for Research Purposes
Diagnosis: Optic pathway glioma
OTHER & MOLECULAR BASED THERAPIES
Cellectar: An Open-Label, Dose Escalation, Efficacy, and Safety Study of CLR 131 in Children, Adolescents, and Young Adults With Select Solid Tumors, Lymphoma, and Malignant Brain Tumors
Diagnosis: Previously confirmed (histologically or cytologically) pediatric solid tumor (e.g., neuroblastoma, sarcoma), lymphoma (including Hodgkin's lymphoma), or malignant brain tumors that are clinically or radiographically suspected to be relapsed, refractory, or recurrent for which there are no standard treatment options with curative potential
G042286: A Phase I/II, Open-Label, Multicenter, Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS Tumors for Whom Prior Treatment Has Proven to be Ineffective or for Whom There is No Satisfactory Treatment Available
Diagnosis: CNS or solid tumors harboring ALK gene fusions
LOXO RET: A Phase 1/2 Study of the Oral RET Inhibitor LOXO 292 in Pediatric Patients With Advanced RET-Altered Solid or Primary Central Nervous System Tumors
Diagnosis: Advanced or metastatic solid or primary CNS tumor which has failed standard of care therapies
POE16-01: A Phase I/II Study of Neratinib in Pediatric Patients with Relapsed/ Refractory Solid Tumors or Hematologic Malignancies
Diagnosis: Solid & Central Nervous System (CNS) Tumor, Lymphoma, or Leukemia-
ALTE07C1: Neuropsychological, Social, Emotional and Behavioral Outcomes in Children with Cancer
Diagnosis: Non-disease specific, nontreatment
APEC14B1: The Project: Everychild Protocol: A Registry, Eligibility, Screening, Biology, and Outcome Study
Diagnosis: Registry or eligibility arm
APEC1621: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)
Diagnosis: CNS diagnosis with specific mutation
- APEC1621A: Phase 2 study of LOXO-101 (Larotrectinib) in patients with tumors harboring NTRK fusions
- APEC1621D: Phase 2 study of LY3023414 in patients with solid tumors- temp closed
- APEC1621F: Phase 2 study of Ensartinib in patients with tumors harboring ALK or ROS1 genomic alterations
- APEC1621I: Phase 2 subprotocol of Palbociclib in Patients with Tumors Harboring Activating Alterations in Cell Cycle Genes
- APEC1621K: Phase 2 Subprotocol of AG-120 (Ivosidenib) in Patients with Tumors Harboring IDH1 Mutations
- APEC1621M: Phase 2 subprotocol of Tipifarnib in patients with tumors harboring HRAS genomic alterations
- APEC1621N: Phase 2 Subprotocol of LOXO-292 in Patients with Tumors Harboring RET Gene Alterations
FURTHER INFORMATION AND SUMMARIES FOR HEALTH CARE PROFESSIONALS
Pediatric Brain Tumor Consortium
CHARM - Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 for Severe Cerebral Edema following Large Hemispheric Infarction.
The purpose of this study is to evaluate the safety and effectiveness of the study drug, Intravenous BIIB093 (Glibenclamide), in improving functional outcome in subjects with large strokes. NCT02864953
Protocol ID: 46054
PI: Chitra Venkatasubramanian, MD
Status: RECRUITING
ARCADIA - AtRial Cardiopathy and Antithrombotic Drugs Intervention After cryptogenic stroke
The purpose of this research study is to compare the effects (good and bad) of apixaban with the effects (good and bad) of aspirin in patients with unexplained strokes and atrial cardiopathy to see which is better at prevention of future strokes.
NCT03192215
Protocol ID: 45088
PI: Nirali Vora, MD
STATUS: RECRUITING
Crest 2 - Carotid Revascularization And Medical Management For Asymptomatic Carotid Stenosis Trial
The main purpose of the study is to find out if the incidence of stroke or death is different or the same between subjects that receive medical management alone compared to subjects that receive medical management in combination with carotid endarterectomy (CEA) or carotid artery stenting (CAS). The occurrence of stroke and death may be higher, lower, or the same between groups.
NCT: 02089217
Protocol ID: 41678
PI: Gary Steinberg, MD
STATUS: RECRUITING
TIMELESS: Tenecteplase in Stroke Patients Between 4.5 and 24 Hours
This study is testing a drug called tenecteplase. The purpose of this study is to compare the effects, good or bad, of tenecteplase versus placebo on patients with stroke symptoms who present within 4.5 to 24 hours after the onset of the stroke symptoms.
NCT: NCT03785678
IRB: 49467
PI: Neil Schwartz, MD, PhD
Status: RECRUITING
MASTERS 2 - MultiStem Administration for Stroke Treatment and Enhanced Recovery Study (Phase III, blinded, placebo controlled)
The purpose of this study is to compare the effects (good and bad) of an investigational human stem cell (the body’s master cells) product with placebo (no active ingredients) in patients who suffered a recent ischemic stroke.
NCT: NCT03545607
Protocol ID: 50889
PI: Neil Schwartz , MD, PhD
Study coordinator: Irina Eyngorn
Status: RECRUITING
PRECISE - Perfusion imaging to identify posterior circulation candidates for thrombectomy
The purpose of this research is to find out if advanced brain imaging can help identify which patients who have suffered an ischemic stroke (a blockage of blood flow) to the back of their brain are most likely to benefit from a procedure to remove the blood clot to restore the blood flow to the brain.
Protocol ID: Pro00053806
PI: Gregory Albers, MD
Study Coordinator: Irina Eyngorn
Status: RECRUITING
CRISP 2 - CT Perfusion to Predict Response to Recanalization in Ischemic Stroke Project
The purpose of this research is to analyze brain imaging data and clinical data to understand how stroke progresses through the brain.
Protocol ID: 56227
PI: Maarten Lansberg, MD, PhD
Study coordinator: Leonel Lugo
Status: RECRUITING
ARCADIA CSI - AtRial Cardiopathy and Antithrombotic Drugs Intervention After cryptogenic stroke (Cognition and Silent Infarcts)
This is a research study looking to compare the effects (good and bad) of two drugs -apixaban and aspirin- on memory, thinking, reasoning and understanding after stroke.
Protocol ID: 51535
PI: Nirali Vora, MD
Study coordinator: Madelleine Garcia
Status: RECRUITING
SATURN -Statins Use in Intracerebral Hemorrhage Patients
This research is being done to find out if it is better to continue or discontinue statin drugs (a type of cholesterol-lowering medication) in people who had a brain hemorrhage (bleeding in the brain) while taking such a statin drug. It will also examine if having certain genes (apolipoproteine E) influences the likelihood of getting a brain hemorrhage while taking a statin drug.
Protocol ID: 55536
PI: Chitra Venkatasubramanian, MD
Study coordinator: Madelleine Garcia
Status: RECRUITING
ASPIRE: Anticoagulation in ICH (intracerebral hemorrhage) Survivors for Stroke Prevention and Recovery
The purpose of this study is to compare the effects of a drug called apixaban with aspirin in patients with atrial fibrillation (irregular heart beating) and a recent brain hemorrhage (bleeding in the brain) to see which is better in preventing strokes and death.
NCT03907046
IRB #: 52983
PI: Chitra Venkatasubramanian, MD
Study coordinator: Madelleine Garcia
Status: RECRUITING
AirX BP Control Study Virtual BP Monitoring Pilot Study
The purpose of this study is to learn if individuals who had a stroke can use a home blood pressure monitoring system and a remote medical team to help get their blood pressure under control and reduce their risk of future strokes.
Protocol ID: 61821
PI: Lironn Kraler, MD
Study Coordiantor: Sarah Drobny
Status: RECRUITING
RECOVERY STUDIES
vREHAB - Virtual Reality Glove for Hand and Arm Rehabilitation After Stroke
The purpose of the study is to demonstrate (a) the feasibility of increasing the dose of rehabilitation in acute stroke patients with a “Smart Glove”, (b) the effect of the “Smart Glove” use on functional recovery, and (c) the effect of the “Smart Glove” use on quality of life.
Protocol ID: 46423
PI: Maarten Lansberg, MD, PhD
STATUS: RECRUITING
StrokeCog
The purpose of this research study is to understand the long-term effects of stroke on a person’s memory and thinking. To determine this, we will schedule stroke patients to come in on a yearly basis for memory testing and collection of a small amount of blood.
Protocol ID: 42089
PI: Maarten Lansberg, MD, PhD
STATUS: RECRUITING
Adult Clinical Trials
For questions about clinical trials please contact our clinical trials research coordinator Maria Coburn at mcoburn@stanford.edu
Pediatric Clinical Trials
To find out the current status of any pediatric study please contact us at: Neuroonc@stanfordchildrens.org