Trials / Active Not Recruiting
Active Not RecruitingNCT05894343
Long-term Follow-up of Glutamic Acid Decarboxylase (GAD) Gene Transfer in Parkinson's Disease
Long-term Follow-up of Glutamic Acid Decarboxylase Gene Transfer to the Subthalamic Nuclei in Participants With Parkinson's Disease
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- MeiraGTx, LLC · Industry
- Sex
- All
- Age
- 25 Years – 86 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate the long-term safety of AAV-GAD delivered bilaterally to the subthalamic nuclei (STN) in participants with Parkinson's disease.
Detailed description
The duration of individual participation in this study will be approximately 54 months for participants who received AAV-GAD in Study MGT-GAD-025 and approximately 60 months for participants who received sham surgery in Study MGT-GAD-025.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | AAV-GAD | Bilateral infusion of AAV-GAD |
Timeline
- Start date
- 2023-05-19
- Primary completion
- 2029-10-01
- Completion
- 2029-10-01
- First posted
- 2023-06-08
- Last updated
- 2025-08-17
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05894343. Inclusion in this directory is not an endorsement.