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A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)
NCT06285643 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG AAV2-GDNF gene therapy
- PROCEDURE control surgery
Study Locations (20)
California
- UCI Alpha Clinic (Neurology) — Irvine
- Loma Linda University (Neurology) — Loma Linda
- Loma Linda University (Surgical) — Loma Linda
- University of California San Francisco (Neurology) — San Francisco
- University of San Francisco (Surgical) — San Francisco
North Carolina
- University of North Carolina (Neurology) — Chapel Hill
- Duke Neurosurgery (Surgical) — Durham
- Duke University (Neurology) — Durham
Florida
- Parkinson's Disease and Movement Disorders Center of Boca Raton (Neurology) — Boca Raton
- Parkinson's Disease Treatment Center of Southwest Florida (Neurology) — Port Charlotte
Massachusetts
- Massachusetts General Hospital (Neurology) — Boston
- Massachusetts General Hospital (Surgical) — Boston
Michigan
- Michigan State University (Neurology) — East Lansing
- Quest Research Institute (Neurology) — Farmington Hills
Colorado
- CenExel Rocky Mountain Clinical Research (Neurology) — Englewood
District of Columbia
- Georgetown University (Neurology) — Washington D.C.
Georgia
- Emory University (Surgical) — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2024-06-11 |
| Est. Completion | 2028-08-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06285643
The ClinicalTrials.gov registry entry for NCT06285643 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 127 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AskBio, which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Parkinson Disease appearing as the primary indexed condition, and to 2 interventions — of which AAV2-GDNF gene therapy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06285643 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, North Carolina, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06285643 about?
NCT06285643 is a clinical study titled "A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)". 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.
What is the current status of trial NCT06285643?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 127 participants. The study started on 2024-06-11. Estimated completion is 2028-08-31.
What conditions does trial NCT06285643 study?
This clinical trial studies the following conditions: Parkinson Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06285643?
The interventions under investigation include: AAV2-GDNF gene therapy (DRUG), control surgery (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06285643?
This trial is sponsored by AskBio, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06285643 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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