A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)
Recruiting now · Phase 2
Conditions studied: Parkinson Disease
In brief
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.
Key facts
- Study ID
- NCT06285643
- Run by
- AskBio Inc
- People needed
- 127
- Starts
- 2024-06-11
- Expected to finish
- 2028-08-31
- Last updated by the study team
- 2026-06-29
Who can join
Age: 45 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age
- Male and female adults 45-75 years of age inclusive, at the time of signing of informed consent Type of Subject and Disease Characteristics
- Diagnosed with Parkinson's disease in the past 4-10 years (inclusive) as defined by the following:
- Presence of bradykinesia PLUS any of the following:
- Rigidity
- Rest tremor
- Postural instability
- Presence of motor fluctuations as measured by the PD Motor Diary
- Stable anti-parkinsonian medication regimen for >/= 4 weeks prior to screening
- Must demonstrate responsiveness to levodopa therapy
You may not qualify if…
- 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
Where it is running
- University of California San Francisco (Neurology) — San Francisco, California, United States (enrolling)
- Orlando Health Neuroscience Institute — Orlando, Florida, United States (enrolling)
- EvergreenHealth Research Department (Neurology) — Kirkland, Washington, United States (enrolling)
- University of Wisconsin (Neurology) — Madison, Wisconsin, United States (enrolling)
- Parkinson's Disease Treatment Center of Southwest Florida (Neurology) — Port Charlotte, Florida, United States (enrolling)
- Philipps-Universität Marburg (Neurology) — Marburg, Germany (enrolling)
- Universitätsklinikum Tübingen (Neurology) — Tübingen, Germany (enrolling)
- Loma Linda University (Neurology) — Loma Linda, California, United States (enrolling)
- Universitätsklinikum Würzburg (Neurology) — Würzburg, Germany (enrolling)
- Copernicus Podmiot Leczniczy, Szpital św. Wojciecha (Neurology) — Gdansk, Poland (enrolling)
- Specjalistyczna Praktyka Lekarska Prof. Grzegorz Opala (Neurology) — Katowice, Poland (enrolling)
- Mazowiecki Szpital Bródnowski (Neurology) — Warsaw, Poland (enrolling)
- Rush University Medical Center (Neurology) — Chicago, Illinois, United States (enrolling)
- Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orłowskiego CMKP (Neurology) — Warsaw, Poland (enrolling)
- North Bristol NHS Trust - Southmead Hospital (Neurology) — Bristol, United Kingdom (enrolling)
- University of Kansas Medical Center (Neurology) — Kansas City, Kansas, United States (enrolling)
- Massachusetts General Hospital (Neurology) — Boston, Massachusetts, United States (enrolling)
- CenExel Rocky Mountain Clinical Research (Neurology) — Englewood, Colorado, United States (enrolling)
- Michigan State University (Neurology) — East Lansing, Michigan, United States (enrolling)
- Quest Research Institute (Neurology) — Farmington Hills, Michigan, United States (enrolling)
- Cleveland Clinic Lou Ruvo (Neurology) — Las Vegas, Nevada, United States (enrolling)
- Columbia University — New York, New York, United States (enrolling)
- University of North Carolina (Neurology) — Chapel Hill, North Carolina, United States (enrolling)
- Georgetown University (Neurology) — Washington D.C., District of Columbia, United States (enrolling)
- Duke University (Neurology) — Durham, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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