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NCT06285643PHASE2Recruiting

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

AskBio Inc

Start Date

6/11/2024

Completion Date

8/31/2028

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 Criteria

Age Range: 45 years to 75 years

Inclusion Criteria: Age 1. Male and female adults 45-75 years of age inclusive, at the time of signing of informed consent Type of Subject and Disease Characteristics 2. Diagnosed with Parkinson's disease in the past 4-10 years (inclusive) as defined by the following: 1. Presence of bradykinesia PLUS any of the following: * Rigidity * Rest tremor * Postural instability 2. Presence of motor fluctuations as measured by the PD Motor Diary 3. Stable anti-parkinsonian medication regimen for \>/= 4 weeks prior to screening 4. Must demonstrate responsiveness to levodopa therapy Exclusion Criteria: * Known history or current evidence of medical, genetic, or neurological conditions that may provide an alternative to idiopathic PD diagnosis * Presence or history of significant vascular and/or cardiovascular disease * Presence of significant cognitive impairment, poorly controlled depression/anxiety * Presence or history of psychosis or impulse control disorder * History of malignancy other than treated cutaneous squamous or basal cell carcinomas * Presence of clinically relevant conditions that could compromise surgical suitability and/or subject safety * Contraindication to magnetic resonance imaging and/or use gadolinium-based contrast agents * Prior history of brain surgery including, but no limited: DBS, pallidotomy focused ultrasound thalamotomy, or other experimental neurosurgical procedure * Chronic immunosuppressive therapy

Interventions

DRUG

AAV2-GDNF gene therapy

PROCEDURE

control surgery

Interested in This Trial?

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Conditions

Parkinson Disease

Locations

Mayo Clinic

Phoenix, Arizona 85054

United States

UCI Alpha Clinic (Neurology)

Irvine, California 92697

United States

Loma Linda University (Neurology)

Loma Linda, California 92354

United States

Loma Linda University (Surgical)

Loma Linda, California 92354

United States

University of California San Francisco (Neurology)

San Francisco, California 94143

United States

University of San Francisco (Surgical)

San Francisco, California 94143

United States

CenExel Rocky Mountain Clinical Research (Neurology)

Englewood, Colorado 80113

United States

Georgetown University (Neurology)

Washington D.C., District of Columbia 20057

United States

Parkinson's Disease and Movement Disorders Center of Boca Raton (Neurology)

Boca Raton, Florida 33486

United States

University of Florida

Gainesville, Florida 32608

United States

University of Miami

Miami, Florida 33125

United States

Orlando Health Neuroscience Institute

Orlando, Florida 32806

United States

Parkinson's Disease Treatment Center of Southwest Florida (Neurology)

Port Charlotte, Florida 33980

United States

Emory University (Surgical)

Atlanta, Georgia 30322

United States

Rush University Medical Center (Neurology)

Chicago, Illinois 60612

United States

University of Kansas Medical Center (Neurology)

Kansas City, Kansas 66103

United States

Massachusetts General Hospital (Neurology)

Boston, Massachusetts 02114

United States

Massachusetts General Hospital (Surgical)

Boston, Massachusetts 02114

United States

Michigan State University (Neurology)

East Lansing, Michigan 48824

United States

Quest Research Institute (Neurology)

Farmington Hills, Michigan 48334

United States

Cleveland Clinic Lou Ruvo (Neurology)

Las Vegas, Nevada 89106

United States

Columbia University

New York, New York 10032

United States

University of North Carolina (Neurology)

Chapel Hill, North Carolina 27514

United States

Duke Neurosurgery (Surgical)

Durham, North Carolina 27705

United States

Duke University (Neurology)

Durham, North Carolina 27710

United States

Ohio State University (Surgical)

Columbus, Ohio 43210

United States

University of Pennsylvania (Neurology)

Philadelphia, Pennsylvania 19104

United States

Vanderbilt University (Neurology)

Nashville, Tennessee 37232

United States

Texas Movement Disorder Specialists

Georgetown, Texas 78628

United States

Houston Methodist (Neurology)

Houston, Texas 77030

United States

Houston Methodist (Surgical)

Houston, Texas 77030

United States

University of Utah

Salt Lake City, Utah 84132

United States

EvergreenHealth Research Department (Neurology)

Kirkland, Washington 98034

United States

University of Wisconsin (Neurology)

Madison, Wisconsin 53705

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