CERE-120 (AAV2-Neurturin)
Parkinson’s Disease Study
Summary
The purpose of this Phase 2b study is to evaluate the safety and potential benefits of CERE-120 for Parkinson's disease. CERE-120 is an experimental drug that has been safely tested in over 60 people with Parkinson's disease. It employs a vector to transfer the gene that makes neurturin directly into brain cells most affected by Parkinson's disease. Neurturin is a neurotrophic factor shown in laboratory experiments to restore damaged dopamine cells and protect them from further degeneration.
Approximately fifty two people with PD will participate in this study. Once enrolled, half will undergo surgery to receive CERE-120 and the other half will undergo a placebo surgery where no medication will be injected. Participants in the study will be carefully followed by a team of experts, at no cost.
Who Can Enroll in the Study
Inclusion Criteria
- Males and females, ages 35-70 years old
- PD diagnosis with bilateral symptoms
- Robust response to medicines containing levodopa such as Sinemet, Stalevo, etc.
- Medically fit to undergo neurosurgery
Exclusion Criteria
- Secondary parkinsonism (including MSA and PSP
- Other significant neurological disorders
- Prior DBS or other neurosurgical treatment for PD
- Previous gene therapy
- Significant psychiatric disorders
- Cancer within the past three years
(except for basal cell carcinoma)
No Longer Recruiting Subjects
List of Participating Centers
ALABAMA
University of Alabama, Birmingham
Contact: Jeff Worrell
Phone: (205) 996-4034
Email: jworrell@uab.edu
CALIFORNIA
Stanford School of Medicine
Contact: Sandra Dunn
Phone: (650) 724-8278
Email: sandradunn@stanford.edu
University of Calif., San Francisco
Contact: Robin Taylor
Phone: (415) 353-1555
Email: robin.taylor@ucsf.edu
GEORGIA
Emory University
Contact: Becky McMurray
Phone: (404) 728-6427
Email: rmcmurr@emory.edu
ILLINOIS
Rush University Medical Center
Contact: Jean Jaglin
Phone: (312) 942-5003
Email: n/a
NEW YORK
Beth Israel Medical Center
Contact: Sara A. Lewis, MPH, CIP
Phone: (212) 844-6571
Email: salewis@chpnet.org
Columbia University Medical Center
Contact: Linda Winfield
Phone: (212) 305-0549
Email: lmw4@mail.cumc.columbia.edu
Mount Sinai Medical Center
Contact: Joan Bratton
Phone: (212) 241-0279
Email: joan.bratton@mssm.edu
NORTH CAROLINA
Duke University
Contact: Lisa Gauger
Phone: (919) 668-1538
Email: lisa.gauger@duke.edu
PENNSYLVANIA
University Pennsylvania
Contact: Heather Maccarone
Phone: (215) 829-7181
Email: heather.maccarone@pahosp.com
TEXAS
Baylor College of Medicine
Contact: Tahari Griffin
Phone: (713) 798-8655
Email: tgriffin@bcm.edu