Study Stopped
Due to financial reasons
Long Term Follow-Up Study for rAAV-GAD Treated Subjects
1 other identifier
observational
40
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 18, 2011
CompletedFirst Posted
Study publicly available on registry
February 23, 2011
CompletedFebruary 22, 2012
February 1, 2012
February 18, 2011
February 20, 2012
Conditions
Study Arms (1)
rAAV-GAD Treated Subjects
rAAV-GAD treated subjects who are being observed for long-term effects of the gene therapy product which they received from participating in a previous clinical study.
Interventions
Eligibility Criteria
Parkinson's disease patients who participated in a clinical trial in which they received AAV-GAD gene transfer.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neurologix, Inc.lead
Study Sites (6)
Stanford University
Stanford, California, 94305-5401, United States
University of Colorado
Aurora, Colorado, 80045, United States
Massachusetts General Hospital
Boston, Massachusetts, 0211, United States
Henry Ford Health Systems
Southfield, Michigan, 48034, United States
Wake Forest University Health Science Center
Winston-Salem, North Carolina, 27157, United States
The Ohio State University
Columbus, Ohio, 43210, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2011
First Posted
February 23, 2011
Study Start
January 1, 2011
Last Updated
February 22, 2012
Record last verified: 2012-02