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NCT05894343 Clinical Trial

Long-term Follow-up of Glutamic Acid Decarboxylase (GAD) Gene Transfer in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:
Long-term Follow-up of Glutamic Acid Decarboxylase Gene Transfer to the Subthalamic Nuclei in Participants With Parkinson's Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05894343
Other study ID # MGT-GAD-026
Secondary ID
Status Enrolling by invitation
Phase Phase 1/Phase 2
First received
Last updated
Start date May 19, 2023
Est. completion date May 2028

Study information
Verified date June 2023
Source MeiraGTx UK II Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to evaluate the long-term safety of AAV-GAD delivered bilaterally to the subthalamic nuclei (STN) in participants with Parkinson's disease.

Description:

The duration of individual participation in this study will be approximately 54 months for participants who received AAV-GAD in Study MGT-GAD-025 and approximately 60 months for participants who received sham surgery in Study MGT-GAD-025.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 14
Est. completion date May 2028
Est. primary completion date May 2028
Accepts healthy volunteers No
Gender All
Age group 25 Years to 86 Years
Eligibility Inclusion Criteria: - Previously enrolled in Study MGT-GAD-025. Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• AAV-GAD
Bilateral infusion of AAV-GAD

Locations
Country Name City State
United States West Virginia University Morgantown West Virginia
United States Columbia University Irving Medical Center New York New York
United States Weill Cornell Medicine New York New York
United States Thomas Jefferson University Philadelphia Pennsylvania
United States Henry Ford West Bloomfield Hospital West Bloomfield Michigan

Sponsors (1)
Lead Sponsor Collaborator
MeiraGTx, LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with study drug-related adverse events and serious adverse events From study start until Month 60 post treatment
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