Status:
COMPLETED
Safety and Efficacy of CERE-120 in Subjects With Parkinson's Disease
Lead Sponsor:
Sangamo Therapeutics
Conditions:
Idiopathic Parkinson's Disease
Eligibility:
All Genders
35-70 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study was to evaluate the safety and potential benefits of CERE-120 in the treatment of Parkinson's disease.
Detailed Description
CERE-120 is an experimental drug that consists of an adeno-associated virus (AAV) that was engineered to carry the human gene for neurturin, a neurotrophic (growth) factor. Similar to other growth fac...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 29 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2017
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00985517
Start Date
October 29 2009
End Date
November 16 2017
Last Update
April 16 2020
Active Locations (11)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States
2
Stanford School of Medicine
Palo Alto, California, United States
3
University of California, San Francisco
San Francisco, California, United States
4
Emory University
Atlanta, Georgia, United States