A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)
Condition(s) studied
Investigational drug(s) / intervention(s)
AAV2-GDNF gene therapy: Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose
control surgery: Bilateral partial burr/twist holes without dural penetration
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.
Eligibility
Primary outcome measure(s)
- Change from baseline to Month 18 on PD Motor Diary — 18 months
Normalized Good ON time per Hauser Diary
Trial sites (46)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | |
| UCI Alpha Clinic (Neurology) | Irvine | California | |
| Loma Linda University (Neurology) | Loma Linda | California | |
| Loma Linda University (Surgical) | Loma Linda | California | |
| University of California San Francisco (Neurology) | San Francisco | California | |
| University of San Francisco (Surgical) | San Francisco | California | |
| CenExel Rocky Mountain Clinical Research (Neurology) | Englewood | Colorado | |
| Georgetown University (Neurology) | Washington D.C. | District of Columbia | |
| Parkinson's Disease and Movement Disorders Center of Boca Raton (Neurology) | Boca Raton | Florida | |
| University of Florida | Gainesville | Florida | |
| University of Miami | Miami | Florida | |
| Orlando Health Neuroscience Institute | Orlando | Florida | |
| Parkinson's Disease Treatment Center of Southwest Florida (Neurology) | Port Charlotte | Florida | |
| Emory University (Surgical) | Atlanta | Georgia | |
| Rush University Medical Center (Neurology) | Chicago | Illinois | |
| University of Kansas Medical Center (Neurology) | Kansas City | Kansas | |
| Massachusetts General Hospital (Neurology) | Boston | Massachusetts | |
| Massachusetts General Hospital (Surgical) | Boston | Massachusetts | |
| Michigan State University (Neurology) | East Lansing | Michigan | |
| Quest Research Institute (Neurology) | Farmington Hills | Michigan | |
| Cleveland Clinic Lou Ruvo (Neurology) | Las Vegas | Nevada | |
| Columbia University | New York | New York | |
| University of North Carolina (Neurology) | Chapel Hill | North Carolina | |
| Duke Neurosurgery (Surgical) | Durham | North Carolina | |
| Duke University (Neurology) | Durham | North Carolina | |
| Ohio State University (Surgical) | Columbus | Ohio | |
| University of Pennsylvania (Neurology) | Philadelphia | Pennsylvania | |
| Vanderbilt University (Neurology) | Nashville | Tennessee | |
| Texas Movement Disorder Specialists | Georgetown | Texas | |
| Houston Methodist (Neurology) | Houston | Texas | |
| Houston Methodist (Surgical) | Houston | Texas | |
| University of Utah | Salt Lake City | Utah | |
| EvergreenHealth Research Department (Neurology) | Kirkland | Washington | |
| University of Wisconsin (Neurology) | Madison | Wisconsin | |
| Charité - Universitätsmedizin Berlin (Surgical) | Berlin | Germany | |
| Philipps-Universität Marburg (Neurology) | Marburg | Germany | |
| Universitätsklinikum Tübingen (Neurology) | Tübingen | Germany | |
| Universitätsklinikum Tübingen (Surgical) | Tübingen | Germany | |
| Universitätsklinikum Würzburg (Neurology) | Würzburg | Germany | |
| Copernicus Podmiot Leczniczy, Szpital św. Wojciecha (Neurology) | Gdansk | Poland |
+ 6 more sites — see the full list on the official registry below.
More AskBio Inc trials in Germany
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06285643 on ClinicalTrials.gov ↗ ← All trials in Germany