Neurologix Initiates Recruitment for Phase ll Parkinson’s Disease Trial
News Aug 25, 2008
Neurologix, Inc. has announced that it has received Institutional Review Board approvals to begin recruiting and enrolling participants for its Phase 2 clinical trial of the company’s gene transfer approach to the treatment of advanced Parkinson’s disease.
The study is designed to evaluate the safety and efficacy of a novel non-dopaminergic approach for reestablishing motor function in Parkinson’s patients who are sub-optimally responsive to drug therapies.
The randomized, double-blind, sham-procedure controlled trial will involve up to 10 leading academic research centers across the United States, with the first sites being Massachusetts General Hospital and Wake Forest University Health Sciences.
Neurologix expects to enroll a total of 40 study participants in the trial. Twenty participants will receive an infusion of the gene-based treatment bilaterally via a catheter temporarily placed in each subthalamic nucleus (STN) by stereotactic surgery. The other 20 participants will receive sterile saline solution into a partial thickness burr hole made into the skull, with no brain infusion.
Study participants will be assessed for treatment effects by standardized Parkinson’s disease ratings at multiple time points post-procedure. The primary endpoint for the study will be a clinical assessment of motor function at 6 months using the Unified Parkinson’s Disease Rating Scale (UPDRS).
All participants in the study will also be monitored for safety for 12 months following the gene transfer procedure. If the primary endpoint is met following the analysis of 6 month data, then the sham-control participants will be offered the opportunity to crossover into an open label study of the Neurologix gene transfer therapy if they continue to meet all entry, medical and surgical criteria.
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