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NCT06285643 · ClinicalTrials.gov registry record · Phase 2
A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)
A Phase 2 study of Parkinson Disease, sponsored by AskBio.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 127
- Enrollment target
- 20
- Study locations
NCT06285643: Recruiting Phase 2 study of Parkinson Disease, sponsored by AskBio.
NCT06285643 is a Phase 2 study of Parkinson Disease that is actively recruiting participants, run by AskBio. The registered enrollment target is 127 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06285643, a Phase 2 study of Parkinson Disease, is actively recruiting participants, sponsored by AskBio.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 127 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Normalized Good ON time per Hauser Diary
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 |
What NCT06285643 shows while recruiting
NCT06285643 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (98% lower).
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.
NCT06285643 names 20 study sites across 11 states, led by California, North Carolina, Florida.
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.
What interventions are being tested in trial NCT06285643?
The interventions under investigation include: AAV2-GDNF gene therapy (DRUG), control surgery (PROCEDURE).
Who is sponsoring clinical trial NCT06285643?
This trial is sponsored by AskBio, which has 8 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Parkinson Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06285643's enrollment target sits among peer trials
127 66th of 297 higher than 231 of 297 other Parkinson Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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