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Phase 2Recruiting

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

Sponsored by AskBio Inc

About this study

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.

Where this study is enrolling (27)

  • Mayo Clinic

    Phoenix, Arizona

    I'm interested

  • University of California San Francisco (Neurology)

    San Francisco, California

    I'm interested

  • UCI Alpha Clinic (Neurology)

    Irvine, California

    I'm interested

  • Loma Linda University (Neurology)

    Loma Linda, California

    I'm interested

  • CenExel Rocky Mountain Clinical Research (Neurology)

    Englewood, Colorado

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Show all 27 locations

  • Georgetown University (Neurology)

    Washington D.C., District of Columbia

    I'm interested

  • Orlando Health Neuroscience Institute

    Orlando, Florida

    I'm interested

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

    Boca Raton, Florida

    I'm interested

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

    Port Charlotte, Florida

    I'm interested

  • University of Florida

    Gainesville, Florida

    I'm interested

  • University of Miami

    Miami, Florida

    I'm interested

  • Rush University Medical Center (Neurology)

    Chicago, Illinois

    I'm interested

  • University of Kansas Medical Center (Neurology)

    Kansas City, Kansas

    I'm interested

  • Massachusetts General Hospital (Neurology)

    Boston, Massachusetts

    I'm interested

  • Quest Research Institute (Neurology)

    Farmington Hills, Michigan

    I'm interested

  • Michigan State University (Neurology)

    East Lansing, Michigan

    I'm interested

  • Cleveland Clinic Lou Ruvo (Neurology)

    Las Vegas, Nevada

    I'm interested

  • Columbia University

    New York, New York

    I'm interested

  • University of North Carolina (Neurology)

    Chapel Hill, North Carolina

    I'm interested

  • Duke University (Neurology)

    Durham, North Carolina

    I'm interested

  • University of Pennsylvania (Neurology)

    Philadelphia, Pennsylvania

    I'm interested

  • Vanderbilt University (Neurology)

    Nashville, Tennessee

    I'm interested

  • Texas Movement Disorder Specialists

    Georgetown, Texas

    I'm interested

  • Houston Methodist (Neurology)

    Houston, Texas

    I'm interested

  • University of Utah

    Salt Lake City, Utah

    I'm interested

  • EvergreenHealth Research Department (Neurology)

    Kirkland, Washington

    I'm interested

  • University of Wisconsin (Neurology)

    Madison, Wisconsin

    I'm interested
Who can participate

Inclusion criteria

  • ✓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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.