Safety Study of Subthalamic Nucleus Gene Therapy for Parkinson's Disease
Completed · Phase 1
Conditions studied: Parkinson's Disease
In brief
The purpose of this study is to determine the safety of using a modified virus to transfer a gene called GAD into a region of the brain called the subthalamic nucleus in patients with advanced Parkinson's disease. The overall goal of this approach is to ultimately normalize the flow of information in several brain regions responsible for movement, to ultimately improve function in patients with this disorder. The current study is primarily designed to evaluate the safety of this approach, but patients are also being monitored for possible signs of effectiveness as well.
Key facts
- Study ID
- NCT00195143
- Run by
- Neurologix, Inc.
- People needed
- 12
- Starts
- 2003-08-01
- Expected to finish
- 2005-08-01
- Last updated by the study team
- 2008-03-27
Who can join
Age: 25 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Duration of disease: Greater than 5 years
- Idiopathic Parkinson's disease
- Parkinson's medication stable for 3 months
- Absence of dementia
- Hoehn and Yahr rating: 3 or greater and/or UPDRS: 30 or more in "off" state and/or Complications of l-dopa therapy limiting effective use
You may not qualify if…
- Poor candidate for any surgery
- Significant dementia
- Secondary parkinsonism
- Severe autonomic symptoms
- Atypical Parkinson's disease
- History of substance abuse
Where it is running
- North Shore University Hospital — Manhasset, New York, United States
Full record on ClinicalTrials.gov
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