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

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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05894343

Enrollment

Registered

2023-06-08

Start date

2023-05-19

Completion date

2029-10-01

Last updated

2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Brief 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.

Detailed 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.

Interventions

GENETICAAV-GAD

Bilateral infusion of AAV-GAD

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Participants will be assigned to the follow-up or active treatment group based on the group to which they were randomized in Study MGT-GAD-025.

Eligibility

Sex/Gender

ALL

Age

25 Years to 86 Years

Healthy volunteers

Inclusion criteria

* Previously enrolled in Study MGT-GAD-025.

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame
Number of participants with study drug-related adverse events and serious adverse events	From study start until Month 60 post treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026