A Double-blind Study to Evaluate the Safety of Glutamic Acid Decarboxylase Gene Transfer in Parkinson's Participants
NCT ID: NCT05603312
Last Updated: 2025-09-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
14 participants
INTERVENTIONAL
2022-10-05
2024-09-06
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
TRIPLE
Study Groups
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AAV-GAD Low Dose
Eligible participants received bilateral infusion of AAV-GAD low dose into the STN
AAV-GAD Low Dose
Bilateral infusion of AAV-GAD low dose
AAV-GAD High Dose
Eligible participants received bilateral infusion of AAV-GAD high dose into the STN
AAV-GAD High Dose
Bilateral infusion of AAV-GAD high dose
Sham Surgery
Eligible participants underwent a sham surgical procedure
Sham Surgery
Sham infusion
Interventions
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AAV-GAD Low Dose
Bilateral infusion of AAV-GAD low dose
AAV-GAD High Dose
Bilateral infusion of AAV-GAD high dose
Sham Surgery
Sham infusion
Eligibility Criteria
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Inclusion Criteria
* Levodopa responsiveness for at least 12 months
* UPDRS Part 3 score of ≥25 points in the "off" state
Exclusion Criteria
* 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
25 Years
85 Years
ALL
No
Sponsors
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MeiraGTx, LLC
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MGT-GAD-025
Identifier Type: -
Identifier Source: org_study_id
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