Phase 2Active, not recruiting
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
- Sponsor
- AskBio Inc (Industry)
- Enrolment
- 127 planned
- Conditions
- Parkinson Disease
- Interventions
- AAV2-GDNF gene therapy; control surgery
- Ages
- adults, older adults
- Registry
- NCT06285643
From the registry
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 outcomes
- Change from baseline to Month 18 on PD Motor Diary