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

MeiraGTx

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Parkinson's Disease

Treatments: Genetic: AAV-GAD

Study type: Interventional

Funder types: Industry

Identifiers

NCT05894343

MGT-GAD-026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 25 to 86 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previously enrolled in Study MGT-GAD-025.

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

13 participants in 2 patient groups

Follow-up group

No Intervention group

Description:

Participants who were randomized to immediate treatment in Study MGT-GAD-025 will transition directly to a long-term follow-up schedule to complete an additional 54 months of follow-up. All study participants are to be followed for 60 months after vector administration.

Active treatment group

Experimental group

Description:

Participants who were randomized to sham surgery in Study MGT-GAD-025 will transition to an active treatment schedule, including open-label bilateral treatment, upon confirmation of continued eligibility. Upon completion of the treatment period, participants will enter the long-term follow-up schedule to complete a total of 60 months of follow-up.

Treatment:

Genetic: AAV-GAD