NCT05603312CompletedPhase 1/2
A Double-blind Study to Evaluate the Safety of Glutamic Acid Decarboxylase Gene Transfer in Parkinson's Participants
A Randomized, Double-Blind, Sham-Controlled Study to Evaluate the Safety and Tolerability of Glutamic Acid Decarboxylase Gene Transfer to the Subthalamic Nuclei in Participants With Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 5 Sept 2025
Brief summary (registry, in English)
The objective of this clinical trial was to evaluate the safety and tolerability of adeno-associated virus (AAV)-mediated delivery of glutamic acid decarboxylase (GAD) gene transfer into the subthalamic nuclei (STN) of participants with Parkinson's Disease.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 12 Oct 2022
- Start date
- 5 Oct 2022
- Primary completion date
- 6 Sept 2024
- Lead sponsor
- MeiraGTx, LLC
- Diseases
- Parkinson disease
- NCT number
- NCT05603312
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 14
- From 5 Oct 2022 to the primary completion date, 6 Sept 2024
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of brain surgery to treat Parkinson's Disease
- Any history of cerebral insult or central nervous system infection
- Atypical Parkinson's Disease
- Evidence of significant medical or psychiatric disorders
- Cognitive impairment as defined by the Montreal Cognitive Assessment (MoCA) ≤ 20
Other
- Focal or lateralized neurologic deficits
- Beck Depression Inventory-II score of ≥ 20
Who the study is looking for
- Confirmed Parkinson's Disease
- Levodopa responsiveness for at least 12 months
- UPDRS Part 3 score of ≥25 points in the "off" state
Age in the registry: 25 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West Virginia University Coordinator of this site? Confirm its status | Morgantown | United States | Unknown status |
| Yale University - Yale New Haven Hospital Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Weill Cornell Medicine Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Henry Ford West Bloomfield Hospital Coordinator of this site? Confirm its status | West Bloomfield | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.