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RECRUITING
NCT06285643
PHASE2

A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)

Sponsor: AskBio Inc

View on ClinicalTrials.gov

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

Interventions

DRUG

AAV2-GDNF gene therapy

Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose

PROCEDURE

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