Long-term Follow-up of Glutamic Acid Decarboxylase (GAD) Gene Transfer in Parkinson's Disease
NCT ID: NCT05894343
Last Updated: 2025-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
13 participants
INTERVENTIONAL
2023-05-19
2029-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Follow-up group
Participants who were randomized to immediate treatment in Study MGT-GAD-025 will transition directly to a long-term follow-up schedule to complete an additional 54 months of follow-up. All study participants are to be followed for 60 months after vector administration.
No interventions assigned to this group
Active treatment group
Participants who were randomized to sham surgery in Study MGT-GAD-025 will transition to an active treatment schedule, including open-label bilateral treatment, upon confirmation of continued eligibility. Upon completion of the treatment period, participants will enter the long-term follow-up schedule to complete a total of 60 months of follow-up.
AAV-GAD
Bilateral infusion of AAV-GAD
Interventions
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AAV-GAD
Bilateral infusion of AAV-GAD
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
25 Years
86 Years
ALL
No
Sponsors
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MeiraGTx, LLC
INDUSTRY
Responsible Party
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Locations
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Yale University
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
Countries
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Other Identifiers
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MGT-GAD-026
Identifier Type: -
Identifier Source: org_study_id
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