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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Follow-up group | No Intervention | 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 | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AAV-GAD | Genetic | Bilateral infusion of AAV-GAD |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06510 | United States | ||
| Henry Ford West Bloomfield Hospital |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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.
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| West Bloomfield |
| Michigan |
| 48322 |
| United States |
| Weill Cornell Medicine | New York | New York | 10021 | United States |
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |