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NCT05603312
A Double-blind Study to Evaluate the Safety of Glutamic Acid Decarboxylase Gene Transfer in Parkinson's Participants
Conditions: Parkinson Disease
Sex: All
Ages: 25 Years – 85 Years
Phase: PHASE1, PHASE2
Enrollment: 12
Sponsor: MeiraGTx, LLC
Location: United States
Summary
The objective of this clinical trial is 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.
Eligibility Criteria
Inclusion Criteria:Confirmed Parkinson's DiseaseLevodopa responsiveness for at least 12 monthsUPDRS Part 3 score of ≥25 points in the "off" stateExclusion Criteria:Past history of brain surgery to treat Parkinson's DiseaseAny history of cerebral insult or central nervous system infectionAtypical Parkinson's DiseaseFocal or lateralized neurologic deficitsEvidence of significant medical or psychiatric disordersCognitive impairment as defined by Montreal Cognitive Assessment (MoCA)≤20Beck Depression Inventory-II score of ≥ 20
Source: ClinicalTrials.gov (NCT05603312). StuddyBuddy aggregates publicly available trial information.
