Parkinson's Disease Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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