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.

Clinical Trials Survey

Who We Are

Learn more about our clincial trials team

Clinical Trials Team

Learn More

For more details on all of our clinical trials visit the SOM Clinical Trial Database or ClinicalTrials.gov

Frequently Asked Questions

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.

COVID Updates

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

Stanford Alzheimer's Disease Research Center (ADRC)

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
Research coordinator: Christina Wyss-Coray
CWyssCoray@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

Autonomic Disorders Multiple System Atrophy, REM sleep disorder, autonomic failure

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

Epilepsy

Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval Study (EPAS)
PI: Kevin Graber, MD
NCT03900468
Study Status: Enrolling Soon
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

Double-Blind, Randomized, Two Period Crossover Comparison of the Cognitive and Behavioral Effects of Eslicarbazepine Acetate and Carbamazepine in Healthy Adults
PI: Kimford Meador, MD
NCT02912364
Study Status: Closed to Enrollment
Research Coordinator: Jordan Seliger
Contact: jseliger@stanford.edu

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 Soon
Research Coordinator: Jordan Seliger
Contact: jseliger@stanford.edu

Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Adjunctive Therapy in Subjects with Partial Onset Seizures with or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic Seizures (E2007-G000-410)
PI: Babak Razavi
NCT03288129
Study Status: Closed to Enrollment
Research Coordinator: Christine Lin
Contact: cblin@stanford.edu

RNS® System Post-Approval Study in Epilepsy Clinical Investigational Plan (CIP)
PI: Babak Razavi
NCT02403843
Study Status: Enrolling
Research Coordinator: Jordan Seliger, Christine Lin
Contact: jseliger@stanford.edu or cblin@stanford.edu

ENGAGE-E-001: A Double-Blind, Placebo-Controlled, Inpatient, Dose-Ranging Eficacy Study of Staccato Alprazolam (STAP-001) in Subjects With Epilepsy With a Predictable Seizure Pattern (StATES)
PI: Jessica Walter
NCT03478982
Study Status: Closed to Enrollment
Research Coordinator: Jordan Seliger
Contact: jseliger@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

Headache

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

Memory Disorders Alzheimer’s disease, Mild Cognitive Impairment

Active, recruiting:

Sponsor: Digital Biomarker
Intervention: None/Observational
Indication: Healthy Controls/MCI/Mild AD
PI: Sharon Sha, MD
Contact: Viktoriya Bourakova, viktoriya.bourakova@stanford.edu

Sponsor: Eisai/NIH (AHEAD3-45)
Intervention: BAN2401 (monoclonal antibody binding to amyloid)
Indication: Cognitively Unimpaired
Clinicaltrials.gov identifier: NCT04468659
PI: Sharon Sha, MD
Contact: Anthony Velasquez, anthgv@stanford.edu, and Amanda Ng, amandang@stanford.edu

Sponsor: Alzheimer's Disease Cooperative Study (PeaceAD Study)
Intervention: Prazosin
Indication: Probable or possible AD and disruptive agitation
Clinicaltrials.gov identifier: NCT03710642
PI: Victor Henderson, MD and Sharon Sha, MD
Contact: Amanda Ng, amandang@stanford.edu

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 APOE₄Homozygotes 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 APOE₄Homozygotes
Clinicaltrials.gov identifier: NCT02565511
PI: Sharon Sha, MD
Contact: Amanda Ng, amandang@stanford.edu

Movement Disorders Parkinson’s disease, Huntington’s disease, Multiple System Atrophy, Spinocerebellar Ataxia

PARKINSON'S DISEASE

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

Neuroimmunology Multiple Sclerosis

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

Neurogenetics

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

Neuromuscular

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

Neuro-Oncology (Adult)

Newly Diagnosed Glioma

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
Co-PI: Reena Thomas
Clinicaltrials.gov#: NCT03746080

Recurrent High Grade Glioma

ONC201 in Adults With Recurrent H3 K27M-mutant Glioma
PI: Reena Thomas
ClinicalTrials.gov#: NCT03295396

TTAC-0001 Phase II Trial With Recurrent Glioblastoma Progressed on Bevacizumab
PI: Seema Nagpal
ClinicalTrials.gov#: NCT03856099

Recurrent Low Grade Glioma

Study of AG-881 in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)
PI: Seema Nagpal
Clinicaltrials.gov#: NCT04164901

CNS Diagnostic Imaging

Phase I/II, Open-Label Study Evaluating the Efficacy and Pharmacokinetics of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Neoplasms during Neurosurgical Procedure
PI: Gordon Li
Clinicaltrials.gov#: NCT03510208

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
Clinicaltrials.gov#: NCT03539731

A Pilot Study to Assess Lactate and Bicarbonate Detection Within Malignant Brain Tumors Using [1-13C]-Pyruvate DNP Magnetic Resonance Spectroscopy (MRS)
PI: Lawrence Recht
Clinicaltrials.gov#: NCT03565367

Neuro-Oncology (Pediatric)

New Diagnoses

PBTC-047: Phase 1 Trial of Panobinostat in Children with Diffuse Intrinsic Pontine Glioma

ACNS1422: A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients

ACNS1721: A Phase 2 Study of Veliparib and Local Irradiation, Followed by Maintenance Veliparib and Temozolomide, in patients with Newly Diagnosed High-Grade Glioma (HGG) without H3 K27M or BRAFV600E Mutations

SJATRT: Phase 2 Study of Alisterib 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

SJMB12: A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma

Recurrent/Refractory Diseases

PBTC-029B: Phase I and Phase II of AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma

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

PBTC-048: Feasibility Trial of Optune for Children with Recurrent or Progressive Supratentorial High-Grade Glioma and Ependymoma

PBTC-049: A Phase I Study of Savolitinib in Recurrent, Progressive or Refractory Primary CNS Tumors

PBTC-050: A Phase I and Surgical Study of Ribociclib and Everolimus (RAD001) in Children with Recurrent or Refractory Malignant Brain Tumors

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

POE16-01: A Phase I/II Study of Neratinib in Pediatric Patients with Relapsed/ Refractory Solid Tumors or Hematologic Malignancies

ADVL1622: Phase 2 Trial of XL184 (Cabozantinib) an Oral Small-Molecule Inhibitor of Multiple Kinases, in Children and Young Adults with Refractory Sarcomas, Wilms Tumor, and Other Rare Tumors

APEC1621: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)

Ancillary Studies

APEC14B1: The Project: Everychild Protocol: A Registry, Eligibility, Screening, Biology, and Outcome Study

ALTE07C1: Neuropsychological, Social, Emotional and Behavioral Outcomes in Children with Cancer

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

UCSC Treehouse: California Initiative to Advance Precision Medicine: California Kids Cancer Comparison, and Treehouse Childhood Cancer Initiative

Stroke

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. For more information, please see http://emed.stanford.edu/boost3.html.
Protocol ID: 49130
PI: James Quinn, MD
Status: RECRUITING

Blood Transcriptome of Transient Ischemic Attack (TIA STAR)
This study will examine gene expression in the blood of patients with Transient Ischemic Attack (TIA) / minor strokes compared to various types of control subjects. The purpose of this study is to learn whether there are changes in molecules in blood, called RNA, after TIA / minor stroke.
Protocol ID: 37711
PI: Paul George, MD, PhD
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, MD
Status: RECRUITING

Efficacy, Safety and Tolerability of BAF312 Compared to Placebo in Patients With Intracerebral Hemorrhage (ICH).
This is a randomized, placebo-controlled, subject- and investigator-blinded trial of BAF312 in intracerebral hemorrhage (ICH) patients to study efficacy, safety, and tolerability. BAF312 is a drug that could potentially limit brain inflammation after ICH, and thereby improve neurological outcome for hemorrhagic stroke patients.
NCT03338998
Protocol ID: 43744
PI: Chitra Venkatasubramanian, MD
STATUS: RECRUITING

INTREPID - Impact of Fever Prevention in Brain Injured Patients
This study will assess the impact of fever prevention on fever burden and short- and long-term neurologic outcomes in brain injured patients. Half of the subjects will undergo fever prevention using a targeted temperature management system and half of the subjects will be treated for fever should it develop.
NCT02996266
Protocol ID: 43136
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
Status: RECRUITING

AXIOMATIC-SSP: Oral Factor XIa Inhibitor for the Prevention of New Ischemic Stroke in Patients Receiving Aspirin and Clopidogrel Following Acute Ischemic Stroke or Transient Ischemic Attack (TIA)
The purpose of this study is to determine if an investigational study drug, BMS-986177, which inhibits factor XIa (one of the components in the clotting process) is safe and effective in preventing future strokes when given daily with antiplatelet medication (aspirin and clopidogrel) for 21 days, then from Day 22 with aspirin alone, for up to 90 days to subjects who recently experienced stroke or TIA due to blood clots.
NCT: NCT03766581
IRB: 48543
PI: Nirali Vora
Status: RECRUITING

RECOVERY STUDIES

Cerebral Spinal Fluid Study
Purpose: The Cerebral Spinal Fluid Study looks at the immune cells and proteins found in cerebral spinal fluid, which coats the site of the stroke. We are studying these immune cells and proteins to look for the presence of brain inflammation and to learn if the inflammation is related to memory loss after stroke. We aim to use this research to develop treatments that reduce brain inflammation and prevent memory loss in stroke survivors.
Eligibility: Participants without a history of back surgery and bleeding disorders and are not taking blood thinners or antiplatelet drugs (aside from aspirin).
Study Schedule: Participants will come to Stanford for a one time spinal fluid collection and then annually, for at least 3 years, for memory and thinking tests and a small blood draw.
Status: Enrollment on hold because of the COVID pandemic
PI: Marion Buckwalter, MD, PhD

StrokeCog
Purpose: StrokeCog observes the long-term effects of stroke on a person’s memory and thinking and whether immune responses play a role in changes to memory and thinking after stroke. We hope to use this research to see if there are immune therapies that can be developed to target memory and thinking problems after stroke.
Eligibility: Patients who’ve had a stroke within the past 6-12 months.
Study Schedule: Participants will come to Stanford annually, for at least 3 years, to undergo some memory and thinking tests and a small blood draw.
Status: Recruiting
PI: Maarten Lansberg, MD, PhD

vREHAB (Virtual Reality Glove for Hand and Arm Rehabilitation After Stroke)
Purpose: vREHAB examines whether the Neofect Smart Glove (a virtual reality biofeedback glove) is an effective, home-based rehabilitation tool for recovering stroke survivors. Participants use the smart glove to interact with a tablet pre-loaded with games and activities that are similar to standard therapy exercises and motions related to activities of daily living.
Eligibility: Patients who’ve have a stroke within the past 30 days.
Study Schedule: Participants will come to Stanford within 30 days of their stroke, and 6, 12, and 24 weeks after their first in-person visit (4 in-person visits in total).
Status: Enrollment on hold because of the COVID pandemic
PI: Maarten Lansberg, MD, PhD; Kara Flavin MD

STRONG (Genetic Variation, Stress, and Functional Outcomes After Stroke Rehabilitation)
Purpose: STRONG studies how genes and stress interact with rehabilitation therapy to affect recovery. There is wide variability in how well people recover after stroke while in rehab and we hope to better understand the biological factors causing this variability. With this research, we hope to better understand how people recover from stroke and to help individualize future rehabilitation care.
Eligibility: Patients who’ve had a stroke within the past 2-10 days.
Study Schedule: Participants will come to Stanford within 2-10 days of their stroke for a short in-person visit and 3, 6, and 12 months after their first visit.
Status: Enrollment Closed
PI: Maarten Lansberg, MD

The Rehab Glove study
Purpose: We have developed a wireless, computerized glove that stroke survivors with hand weakness and spasticity can wear during daily life. The Rehab Glove provides gentile, vibratory stimulation to your affected hand. No exercises are required. We hope that the Rehab Glove will reduce spasticity and improve hand function after stroke.
Eligibility: Patients who have suffered a stroke at least 6 months ago and who have spasticity in their hand (fingers that curl up or form a fist).
Study Schedule: Participants will come to Stanford every two weeks for four to eight months.
Status: Enrollment on hold because of the COVID pandemic
PI: Kara Flavin MD

Adult Clinical Trials

For questions about clinical trials please contact our clinical trials research coordinator Maria Coburn at 650-736-9551 or mcoburn@stanford.edu

Pediatric Clinical Trials

To find out the current status of any pediatric study please contact us at: Neuroonc@stanfordchildrens.org

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