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NCT01301573 Clinical Trial

Long Term Follow-Up Study for rAAV-GAD Treated Subjects

Parkinson's Disease Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data
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

Study information
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

Clinical Trial Summary

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.

Recruitment information / eligibility
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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Biological:
• rAAV-GAD

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
Neurologix, Inc.

Country where clinical trial is conducted

United States, 

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