Parkinson's Disease Clinical Trial
| NCT number | NCT01301573 |
| Other study ID # | GAD-LTFU |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | February 18, 2011 |
| Last updated | February 20, 2012 |
| Start date | January 2011 |
| Verified date | February 2012 |
| Source | Neurologix, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Observational |
The purpose of this observational study is the long term follow-up of Parkinson's patients who participated in a clinical trial in which they received AAV-GAD gene transfer into the subthalamic nucleus (STN) region of the brain. Patients will be followed once a year for up to five (5) years. The study will monitor and evaluate the long term effects of AAV-GAD and provide long term safety information.
| Status | Terminated |
| Enrollment | 40 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 30 Years to 90 Years |
| Eligibility |
Inclusion Criteria: - Participated in a clinical trial where they received AAV-GAD - Able to give informed consent to participate in the study Exclusion Criteria: - Received Deep Brain Stimulation after receiving AAV-GAD - Received any experimental device in the brain after receiving AAV-GAD - Had any type of brain surgery after receiving AAV-GAD - Received any experimental therapy (drug or biologic) for Parkinson's disease or any other indication after receiving AAV-GAD |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Colorado | Aurora | Colorado |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | The Ohio State University | Columbus | Ohio |
| United States | Henry Ford Health Systems | Southfield | Michigan |
| United States | Stanford University | Stanford | California |
| United States | Wake Forest University Health Science Center | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Neurologix, Inc. |
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