Phase 2
Completed N=14
A Double-blind Study to Evaluate the Safety of Glutamic Acid Decarboxylase Gene Transfer in Parkinson's Participants
Source: ClinicalTrials.gov NCT05603312 ↗Enrolled (actual)
14
Serious AEs
21.4%
Results posted
Sep 2025
Primary outcomePrimary: Incidence of Adverse Events Related to the Treatment — 0; 1; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events Related to the Treatment |
0; 1; 0 | — |
| PRIMARY Incidence of Serious Adverse Events Related to the Treatment |
0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed Parkinson's Disease
- Levodopa responsiveness for at least 12 months
- UPDRS Part 3 score of ≥25 points in the "off" state
Exclusion Criteria
- History of brain surgery to treat Parkinson's Disease
- Any history of cerebral insult or central nervous system infection
- Atypical Parkinson's Disease
- Focal or lateralized neurologic deficits
- Evidence of significant medical or psychiatric disorders
- Cognitive impairment as defined by the Montreal Cognitive Assessment (MoCA) ≤ 20
- Beck Depression Inventory-II score of ≥ 20
Data sourced from ClinicalTrials.gov (NCT05603312). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.