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A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)
Sponsor: AskBio Inc
Summary
The objective of this randomized, surgically controlled, double-blinded, Phase 2 study is to evaluate the safety and efficacy of AAV2-GDNF delivered to the putamen in subjects with moderate Parkinson's Disease.
Official title: A Phase 2, Randomized, Double-blind, Sham Surgery-controlled Study of the Efficacy and Safety of Intraputaminal AAV2-GDNF in the Treatment of Adults With Moderate Stage Parkinson's Disease
Key Details
Gender
All
Age Range
45 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
127
Start Date
2024-06-11
Completion Date
2028-08-31
Last Updated
2025-12-08
Healthy Volunteers
No
Conditions
Interventions
AAV2-GDNF gene therapy
Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose
control surgery
Bilateral partial burr/twist holes without dural penetration
Locations (39)
UCI Alpha Clinic (Neurology)
Irvine, California, United States
Loma Linda University (Neurology)
Loma Linda, California, United States
Loma Linda University (Surgical)
Loma Linda, California, United States
University of California San Francisco (Neurology)
San Francisco, California, United States
University of San Francisco (Surgical)
San Francisco, California, United States
CenExel Rocky Mountain Clinical Research (Neurology)
Englewood, Colorado, United States
Georgetown University (Neurology)
Washington D.C., District of Columbia, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton (Neurology)
Boca Raton, Florida, United States
Parkinson's Disease Treatment Center of Southwest Florida (Neurology)
Port Charlotte, Florida, United States
Emory University (Surgical)
Atlanta, Georgia, United States
Rush University Medical Center (Neurology)
Chicago, Illinois, United States
University of Kansas Medical Center (Neurology)
Kansas City, Kansas, United States
Massachusetts General Hospital (Neurology)
Boston, Massachusetts, United States
Massachusetts General Hospital (Surgical)
Boston, Massachusetts, United States
Michigan State University (Neurology)
East Lansing, Michigan, United States
Quest Research Institute (Neurology)
Farmington Hills, Michigan, United States
Cleveland Clinic Lou Ruvo (Neurology)
Las Vegas, Nevada, United States
University of North Carolina (Neurology)
Chapel Hill, North Carolina, United States
Duke Neurosurgery (Surgical)
Durham, North Carolina, United States
Duke University (Neurology)
Durham, North Carolina, United States
Ohio State University (Surgical)
Columbus, Ohio, United States
University of Pennsylvania (Neurology)
Philadelphia, Pennsylvania, United States
Vanderbilt University (Neurology)
Nashville, Tennessee, United States
Houston Methodist (Neurology)
Houston, Texas, United States
Houston Methodist (Surgical)
Houston, Texas, United States
EvergreenHealth Research Department (Neurology)
Kirkland, Washington, United States
University of Wisconsin (Neurology)
Madison, Wisconsin, United States
Charité - Universitätsmedizin Berlin (Surgical)
Berlin, Germany
Philipps-Universität Marburg (Neurology)
Marburg, Germany
Universitätsklinikum Tübingen (Neurology)
Tübingen, Germany
Universitätsklinikum Tübingen (Surgical)
Tübingen, Germany
Universitätsklinikum Würzburg (Neurology)
Würzburg, Germany
Copernicus Podmiot Leczniczy, Szpital św. Wojciecha (Neurology)
Gdansk, Poland
Specjalistyczna Praktyka Lekarska Prof. Grzegorz Opala (Neurology)
Katowice, Poland
Mazowiecki Szpital Bródnowski (Neurology)
Warsaw, Poland
Mazowiecki Szpital Bródnowski (Surgical)
Warsaw, Poland
Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orłowskiego CMKP (Neurology)
Warsaw, Poland
North Bristol NHS Trust - Southmead Hospital (Neurology)
Bristol, United Kingdom
University Hospital of Wales (Surgical)
Cardiff, United Kingdom