Trial record 2 of 3 for:    neurologix

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
  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

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Neurologix, Inc.
ClinicalTrials.gov Identifier: NCT01301573     History of Changes
Other Study ID Numbers: GAD-LTFU
Study First Received: February 18, 2011
Last Updated: February 20, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 11, 2014