A Double-blind Study to Evaluate the Safety of Glutamic Acid Decarboxylase Gene Transfer in Parkinson's Participants

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Parkinson's Disease

In brief

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.

Key facts

Study ID

NCT05603312

Run by

MeiraGTx, LLC

People needed

14

Starts

2022-10-05

Expected to finish

2024-09-06

Last updated by the study team

2025-09-05

Who can join

Age: 25 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed Parkinson's Disease
• Levodopa responsiveness for at least 12 months
• UPDRS Part 3 score of ≥25 points in the "off" state

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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