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

NCT00643890 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2012-02-22

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Neurologix, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00643890 on ClinicalTrials.gov