At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 14 enrolled
Drug / intervention
AAV-GAD Low Dose +2 moregenetic
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating AAV-GAD Low Dose, AAV-GAD High Dose, and 1 other intervention for Parkinson's Disease. Completed, enrolled 14 participants across 6 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2023202420252026
Enrollment StartOct 2022
First PostedNov 2022
Primary CompletionSep 2024
TodayJul 2026
First PostedNov 2, 2022
Enrollment StartOct 5, 2022
Primary CompletionSep 6, 2024
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 3.7 years ago
Interventions
AAV-GAD Low Dosegenetic
Bilateral infusion of AAV-GAD low dose
AAV-GAD High Dosegenetic
Bilateral infusion of AAV-GAD high dose
Sham Surgeryprocedure
Sham infusion