Status:
TERMINATED
Study of AAV-GAD Gene Transfer Into the Subthalamic Nucleus for Parkinson's Disease
Lead Sponsor:
Neurologix, Inc.
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the safety and efficacy of AAV-GAD gene transfer into the subthalamic nucleus (STN) region of the brain. This study involves the treatment of subjects with me...
Eligibility Criteria
Inclusion
- Idiopathic Parkinson's disease
- Duration of disease for at least 5 years
- Levodopa responsiveness for at least 12 months
- UPDRS Part 3 score ≥ 25 or more in "off" state
Exclusion
- Past history of brain surgery for PD
- Beck Depression Inventory Score ≥ 20
- Any history of cerebral insult or central nervous system infection
- Cognitive impairment score \< 130 on the Mattis Dementia Rating Scale
- Focal neurological deficits
- Evidence of significant medical or psychiatric disorders
- Secondary Parkinsonism
- Atypical Parkinson's disease
- History of substance abuse
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00643890
Start Date
August 1 2008
Last Update
February 22 2012
Active Locations (7)
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1
Stanford University
Stanford, California, United States, 94305-5401
2
University of Colorado
Aurora, Colorado, United States, 80045
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
Henry Ford Health Systems - Franklin Pointe Medical
Southfield, Michigan, United States, 48034