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NCT05603312 · ClinicalTrials.gov registry record · Phase 1
A Double-blind Study to Evaluate the Safety of Glutamic Acid Decarboxylase Gene Transfer in Parkinson's Participants
A Phase 1 study, sponsored by MeiraGTx.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT05603312: Completed Phase 1 study, sponsored by MeiraGTx.
NCT05603312 is a Phase 1 study that has completed, run by MeiraGTx. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05603312, a Phase 1 study, has completed, sponsored by MeiraGTx.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The primary outcome measure is the safety of treatment with AAV-GAD, assessed by the absence of IMP-related treatment-emergent adverse events.
Interventions
- PROCEDURE Sham Surgery
- GENETIC AAV-GAD Low Dose
- GENETIC AAV-GAD High Dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2022-10-05 |
| Est. Completion | 2024-09-06 |
| Phase | Phase 1 |
What the finished NCT05603312 record still lists
NCT05603312 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 3 interventions - of which Sham Surgery is the first listed.
NCT05603312 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05603312 about?
NCT05603312 is a clinical study titled "A Double-blind Study to Evaluate the Safety of Glutamic Acid Decarboxylase Gene Transfer in Parkinson's Participants". 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.
What is the current status of trial NCT05603312?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2022-10-05. Estimated completion is 2024-09-06.
What interventions are being tested in trial NCT05603312?
The interventions under investigation include: Sham Surgery (PROCEDURE), AAV-GAD Low Dose (GENETIC), AAV-GAD High Dose (GENETIC).
Who is sponsoring clinical trial NCT05603312?
This trial is sponsored by MeiraGTx, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05603312's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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