Long Term Follow-Up Study for rAAV-GAD Treated Subjects
This study has been terminated.
(Due to financial reasons)
Sponsor:
Neurologix, Inc.
Information provided by (Responsible Party):
Neurologix, Inc.
ClinicalTrials.gov Identifier:
NCT01301573
First received: February 18, 2011
Last updated: February 20, 2012
Last verified: February 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Parkinson's Disease |
Biological: rAAV-GAD |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
Resource links provided by NLM:
Further study details as provided by Neurologix, Inc.:
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2011 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
rAAV-GAD Treated Subjects
rAAV-GAD treated subjects who are being observed for long-term effects of the gene therapy product which they received from participating in a previous clinical study.
|
Biological: rAAV-GAD |
Eligibility| Ages Eligible for Study: | 30 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Parkinson's disease patients who participated in a clinical trial in which they received AAV-GAD gene transfer.
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301573
Locations
| United States, California | |
| Stanford University | |
| Stanford, California, United States, 94305-5401 | |
| United States, Colorado | |
| University of Colorado | |
| Aurora, Colorado, United States, 80045 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 0211 | |
| United States, Michigan | |
| Henry Ford Health Systems | |
| Southfield, Michigan, United States, 48034 | |
| United States, North Carolina | |
| Wake Forest University Health Science Center | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| The Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
Sponsors and Collaborators
Neurologix, Inc.
More Information
No publications provided
| Responsible Party: | Neurologix, Inc. |
| ClinicalTrials.gov Identifier: | NCT01301573 History of Changes |
| Other Study ID Numbers: | GAD-LTFU |
| Study First Received: | February 18, 2011 |
| Last Updated: | February 20, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on May 23, 2013