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TerminatedNCT01301573Updated Feb 22, 2012

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

An observational study in Parkinson's Disease, sponsored by Neurologix, Inc.. Terminated at 6 sites in United States. Open to participants aged 30 Years to 90 Years. Per ClinicalTrials.gov, last updated 2012-02-22.

Sponsored by Neurologix, Inc. · Observational

Why this study was terminated
Due to financial reasons
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
30 Years to 90 Years
Sex
All
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Study 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.

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Conditions studied

  • Parkinson's Disease

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In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's planned enrollment of 40 is below the median of 96 across 1,057 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Neurologix, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 90 Years
Sexes eligible
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.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)

Groups and cohorts

  • 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

Interventions

  • BiologicalrAAV-GAD
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Study locations

6 sites
  • 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
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01301573
Lead sponsor
Neurologix, Inc.
Responsible party
Sponsor
First posted
Feb 23, 2011
Start date
Jan 2011
Last update
Feb 22, 2012
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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