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

This study has been terminated.
(Due to financial reasons)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01301573
First Posted: February 23, 2011
Last Update Posted: February 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Neurologix, Inc.
  Purpose
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.

Condition Intervention
Parkinson's Disease Biological: rAAV-GAD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Neurologix, Inc.:

Estimated Enrollment: 40
Study Start Date: January 2011
Groups/Cohorts Assigned Interventions
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.
Biological: rAAV-GAD

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Parkinson's disease patients who participated in a clinical trial in which they received AAV-GAD gene transfer.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01301573


Locations
United States, California
Stanford University
Stanford, California, United States, 94305-5401
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 0211
United States, Michigan
Henry Ford Health Systems
Southfield, Michigan, United States, 48034
United States, North Carolina
Wake Forest University Health Science Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Neurologix, Inc.
  More Information

Responsible Party: Neurologix, Inc.
ClinicalTrials.gov Identifier: NCT01301573     History of Changes
Other Study ID Numbers: GAD-LTFU
First Submitted: February 18, 2011
First Posted: February 23, 2011
Last Update Posted: February 22, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases