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Safety and Efficacy of CERE-120 in Subjects With Parkinson's Disease
Not Recruiting
Trial ID: NCT00985517
Purpose
The purpose of this study was to evaluate the safety and potential benefits of CERE-120 in
the treatment of Parkinson's disease.
Official Title
A Phase 1/2 Trial Assessing the Safety and Efficacy of Bilateral Intraputaminal and Intranigral Administration of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) in Subjects With Idiopathic Parkinson's Disease
Eligibility
Inclusion Criteria:
- Males and females, ages 35 to 70 years old (inclusive)
- A diagnosis of idiopathic Parkinson's disease based on UK Brain Bank criteria,
including bradykinesia and at least 1 of the following PD features: resting tremor or
rigidity
- A Hoehn and Yahr score of no greater than 3 in the "off" condition at Screening
- A robust response to dopaminergic therapy as judged by the investigator based on the
UPDRS Part III: Motor Examination
- Experiencing motor complications despite adequate antiparkinsonian therapy
- A stable, optimized regimen of antiparkinsonian medications and stable parkinsonian
features for at least 6 weeks prior to Screening
- Subject is willing not to undergo DBS for at least 12 months after the study surgical
procedure (Phase 1 subjects) or while the study is blinded (Phase 2 subjects) and the
investigator believes that this is medically acceptable
- Medically fit to undergo the study surgical procedure as determined by medical
history, clinical and laboratory evaluations, and any other pre-surgical evaluations
that are standard at the institution where the subject will undergo surgery
- Physically and mentally capable of performing all protocol-specified assessments and
complying with the study visit schedule
- Subjects must be able to travel to study visits alone or able to identify a partner or
caregiver who agrees to accompany the subject to the study visits
- Females of childbearing potential must have a negative β-HCG pregnancy test at
Screening and again before surgery on Day 0
- All subjects, both male and female, must agree to practice adequate barrier method
contraception for at least 6 months after the surgical procedure
- Provides written informed consent to participate before any study-specific procedures
are conducted
Exclusion Criteria:
- Atypical or secondary parkinsonism, including, but not limited to, multiple system
atrophy (MSA) or progressive supranuclear palsy
- Any subject for whom participation in the study would pose a substantial safety risk
- Any condition that would compromise the ability of the subject to undergo study
procedures, including allergy to gadolinium
- Presence of any known brain abnormality that could interfere with the assessment of
safety or efficacy or represents a surgical risk to the subject
- Evidence of significant brain atrophy on the Baseline MRI
- History of any cancer other than basal or squamous cell skin cancer within the 3 years
prior to Screening
- Any chemotherapy, cytotoxic therapy, or immunotherapy (e.g., IL-2, IL-12, interferon)
within the 3 months prior to Screening
- Any prior treatment for PD with a procedure involving intracranial surgery or
implantation of a device (e.g. DBS, pallidotomy)
- Any prior treatment for a neurological or psychiatric disorders with a procedure
involving the implantation of a device (e.g. spinal cord stimulator, vagus nerve
stimulator)
- History of any prior gene transfer therapy
- Treatment with any investigational agent within the 3 months prior to Screening
- Anticipated need for antiplatelet agents or anticoagulation therapy, including gingko
biloba, during the 10 days prior to the projected surgery date
- Any vaccinations within the 30 days prior to the projected surgery date Note:
Vaccinations are not allowed for 30 days after the surgical procedure, unless deemed
necessary by the investigator for the subject's well-being
- Not likely to be available for the duration of the trial, likely to be noncompliant
with the protocol, or who are deemed unsuitable by the investigator for any other
reason
- Participation in a previous surgical treatment study for Parkinson's disease
Intervention(s):
biological: CERE-120: Adeno-Associated Virus Delivery of Neurturin
procedure: Sham Surgery
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sandra Dunn
6507248278