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

Stopped early

Conditions studied: Parkinson's Disease

In brief

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.

Key facts

Study ID

NCT01301573

Run by

Neurologix, Inc.

People needed

40

Starts

2011-01-01

Last updated by the study team

2012-02-22

Who can join

Age: 30 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participated in a clinical trial where they received AAV-GAD
• Able to give informed consent to participate in the study

You may not qualify if…

• 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

Where it is running

• Stanford University — Stanford, California, United States
• University of Colorado — Aurora, Colorado, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Henry Ford Health Systems — Southfield, Michigan, United States
• Wake Forest University Health Science Center — Winston-Salem, North Carolina, United States
• The Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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