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Study of AAV-GAD Gene Transfer Into the Subthalamic Nucleus for Parkinson's Disease

This study has been terminated.
(Due to financial reasons)
Sponsor:
Information provided by (Responsible Party):
Neurologix, Inc.
ClinicalTrials.gov Identifier:
NCT00643890
First received: March 24, 2008
Last updated: February 20, 2012
Last verified: February 2012

March 24, 2008
February 20, 2012
August 2008
December 2010   (final data collection date for primary outcome measure)
Evaluate a change in UPDRS scores [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00643890 on ClinicalTrials.gov Archive Site
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Study of AAV-GAD Gene Transfer Into the Subthalamic Nucleus for Parkinson's Disease
Phase 2 Safety and Efficacy Study Evaluating Glutamic Acid Decarboxylase Gene Transfer to Subthalamic Nuclei in Subjects With Advanced Parkinson's Disease

The purpose of this study is to determine the safety and efficacy of AAV-GAD gene transfer into the subthalamic nucleus (STN) region of the brain. This study involves the treatment of subjects with medically refractory Parkinson's disease (PD). The gene transfer product, a disabled virus with a gene called GAD, will be infused into the STN bilaterally using stereotactic surgical techniques. The overall goal of this approach is to normalize the activity of the STN and reduce the motor symptoms of PD.

Because the change in UPDRS demonstrated a positive outcome, the sham surgery subjects from the blinded portion of the study will be invited to crossover into the Open-label Arm portion of the study. The Open-label Arm will further evaluate the safety and efficacy of AAV-GAD gene transfer into the subthalamic nucleus (STN) region of the brain.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson's Disease
Genetic: Bilateral surgical infusion of AAV-GAD into the subthalamic nucleus
One-time bilateral administration of rAAV-GAD at 1X10^12 vector genomes in 35 uL.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
44
Not Provided
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Idiopathic Parkinson's disease
  • Duration of disease for at least 5 years
  • Levodopa responsiveness for at least 12 months
  • UPDRS Part 3 score ≥ 25 or more in "off" state

Exclusion Criteria:

  • Past history of brain surgery for PD
  • Beck Depression Inventory Score ≥ 20
  • Any history of cerebral insult or central nervous system infection
  • Cognitive impairment score < 130 on the Mattis Dementia Rating Scale
  • Focal neurological deficits
  • Evidence of significant medical or psychiatric disorders
  • Secondary Parkinsonism
  • Atypical Parkinson's disease
  • History of substance abuse
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00643890
NRGX-GAD-02
Yes
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