Trials / Recruiting
RecruitingNCT06285643
A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)
A Phase 2, Randomized, Double-blind, Sham Surgery-controlled Study of the Efficacy and Safety of Intraputaminal AAV2-GDNF in the Treatment of Adults With Moderate Stage Parkinson's Disease
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 127 (estimated)
- Sponsor
- AskBio Inc · Industry
- Sex
- All
- Age
- 45 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AAV2-GDNF gene therapy | Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose |
| PROCEDURE | control surgery | Bilateral partial burr/twist holes without dural penetration |
Timeline
- Start date
- 2024-06-11
- Primary completion
- 2028-08-31
- Completion
- 2028-08-31
- First posted
- 2024-02-29
- Last updated
- 2025-12-08
Locations
39 sites across 4 countries: United States, Germany, Poland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06285643. Inclusion in this directory is not an endorsement.