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

February 20, 2012 updated by: Neurologix, Inc.
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305-5401
        • Stanford University
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
    • Massachusetts
      • Boston, Massachusetts, United States, 0211
        • Massachusetts General Hospital
    • Michigan
      • Southfield, Michigan, United States, 48034
        • Henry Ford Health Systems
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Science Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurologix, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Study Registration Dates

First Submitted

February 18, 2011

First Submitted That Met QC Criteria

February 18, 2011

First Posted (ESTIMATE)

February 23, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 22, 2012

Last Update Submitted That Met QC Criteria

February 20, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAD-LTFU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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