RecruitingPhase 2NCT06285643

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

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

Sponsor

AskBio Inc

Enrollment

127 participants

Start Date

Jun 11, 2024

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease

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.

Eligibility

Min Age: 45 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a gene therapy called AAV2-GDNF, which delivers a growth factor directly into the brain to try to slow or improve symptoms of moderate Parkinson's disease. **You may be eligible if...** - You are between 45 and 75 years old - You were diagnosed with Parkinson's disease 4 to 10 years ago - You experience motor fluctuations (times when your medication wears off and symptoms return) - Your Parkinson's symptoms respond to levodopa (a standard Parkinson's medication) - Your medication regimen has been stable for at least 4 weeks **You may NOT be eligible if...** - There is reason to think your movement disorder is caused by something other than Parkinson's disease - You have a history of brain surgery, brain tumors, or other neurological conditions - You are taking medications that could interfere with the gene therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAAV2-GDNF gene therapy

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

PROCEDUREcontrol 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

View Full Details on ClinicalTrials.gov

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NCT06285643

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