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Safety Study of Subthalamic Nucleus Gene Therapy for Parkinson's Disease

NCT00195143 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2008-03-27

No results posted yet for this study

Summary

The purpose of this study is to determine the safety of using a modified virus to transfer a gene called GAD into a region of the brain called the subthalamic nucleus in patients with advanced Parkinson's disease. The overall goal of this approach is to ultimately normalize the flow of information in several brain regions responsible for movement, to ultimately improve function in patients with this disorder. The current study is primarily designed to evaluate the safety of this approach, but patients are also being monitored for possible signs of effectiveness as well.

Conditions

Interventions

GENETIC

Surgical infusion of AAV-GAD into the subthalamic nucleus

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    collaborator OTHER

  • North Shore University Hospital

    collaborator OTHER

  • Neurologix, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael G Kaplitt, MD PhD · Weill Medical College of Cornell University

  • Matthew J During, MD · Weill Medical College of Cornell University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2003-08-31
Completion
2005-08-31

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 NCT00195143 on ClinicalTrials.gov