Safety and Efficacy of CERE-120 in Subjects With Parkinson's Disease

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Idiopathic Parkinson's Disease

In brief

The purpose of this study was to evaluate the safety and potential benefits of CERE-120 in the treatment of Parkinson's disease.

Key facts

Study ID

NCT00985517

Run by

Sangamo Therapeutics

People needed

57

Starts

2009-10-29

Expected to finish

2017-11-16

Last updated by the study team

2020-04-16

Who can join

Age: 35 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Stanford School of Medicine — Palo Alto, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Emory University — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Beth Israel Medical Center — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Mount Sinai Medical Center — New York, New York, United States
• Duke University — Durham, North Carolina, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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