Status:
COMPLETED
Safety Study of Subthalamic Nucleus Gene Therapy for Parkinson's Disease
Lead Sponsor:
Neurologix, Inc.
Collaborating Sponsors:
Weill Medical College of Cornell University
North Shore University Hospital
Conditions:
Parkinson's Disease
Eligibility:
All Genders
25-75 years
Phase:
PHASE1
Brief Summary
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 Parkins...
Detailed Description
This study involves treatment of patients with medically refractory Parkinson's disease (PD) with gene therapy. The patients are chosen from a population of patients who would normally be candidates f...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Poor candidate for any surgery
- Significant dementia
- Secondary parkinsonism
- Severe autonomic symptoms
- Atypical Parkinson's disease
- History of substance abuse
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00195143
Start Date
August 1 2003
End Date
August 1 2005
Last Update
March 27 2008
Active Locations (1)
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1
North Shore University Hospital
Manhasset, New York, United States, 11030