Loading clinical trials...
Loading clinical trials...
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
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.
The planned length of participation in the study for each participant was approximately 7 months, including a screening period of up to 40 days, randomization, surgery, and a follow-up period of 26 weeks.
Age
25 - 85 years
Sex
ALL
Healthy Volunteers
No
Yale University - Yale New Haven Hospital
New Haven, Connecticut, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States
Weill Cornell Medicine
New York, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
West Virginia University
Morgantown, West Virginia, United States
Start Date
October 5, 2022
Primary Completion Date
September 6, 2024
Completion Date
September 6, 2024
Last Updated
September 5, 2025
14
ACTUAL participants
AAV-GAD Low Dose
GENETIC
AAV-GAD High Dose
GENETIC
Sham Surgery
PROCEDURE
Lead Sponsor
MeiraGTx, LLC
NCT02119611
NCT07310264
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07216976