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

This study has been terminated.
(Due to financial reasons)
Sponsor:
Information provided by (Responsible Party):
Neurologix, Inc.
ClinicalTrials.gov Identifier:
NCT01301573
First received: February 18, 2011
Last updated: February 20, 2012
Last verified: February 2012

February 18, 2011
February 20, 2012
January 2011
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Complete list of historical versions of study NCT01301573 on ClinicalTrials.gov Archive Site
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Long Term Follow-Up Study for rAAV-GAD Treated Subjects
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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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Parkinson's disease patients who participated in a clinical trial in which they received AAV-GAD gene transfer.

Parkinson's Disease
Biological: rAAV-GAD
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.
Intervention: Biological: rAAV-GAD
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
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Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Both
30 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01301573
GAD-LTFU
Not Provided
Neurologix, Inc.
Neurologix, Inc.
Not Provided
Not Provided
Neurologix, Inc.
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP