NINDS Parkinson's Disease Neuroprotection Trial of CoQ10 and GPI 1485
The goal of this study is to assess the impact of CoQ10 and GPI 1485 on the progression of Parkinson's disease, in order to determine whether it is reasonable to proceed with further study of either of these agents.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Multi-center, Double-blind, Pilot Study of CoQ10 and GPI 1485 in Subjects With Early Untreated Parkinson's Disease|
|Study Start Date:||January 2004|
|Study Completion Date:||September 2005|
|Primary Completion Date:||September 2005 (Final data collection date for primary outcome measure)|
Parkinson's disease (PD) affects nearly a million Americans, a number that will increase over the coming decades as the population ages. While available medical therapies are usually effective for controlling symptoms in the initial years following diagnosis, higher doses of multiple agents are required over time, with increasing side effects and incomplete control of symptoms. Although these treatments can dramatically improve the lives of patients with PD initially, they do not address the underlying causes of the disease or the inevitable disease progression.
This multi-center, randomized, double-blind trial will involve 42 trial centers in the United States and Canada, and enroll 195 people with PD. The primary objective of this neuroprotection trial is to identify agents capable of slowing the progression of PD. In the trial, investigators will assess the impact of CoQ10, an antioxidant, and GPI 1485, a novel immunophilin compound, on the progression of PD and determine if it is futile or non-futile to proceed with further study of these agents.
In this study, subjects with early, untreated PD will be equally randomized into one of the three study arms: 1.) the group that receives active CoQ10 and placebo instead of GPI 1485; 2.) the group that receives active GPI 1485 and placebo instead of CoQ10; or 3.) the group that receives placebo instead of CoQ10 and GPI 1485. Subjects will remain on the blinded study drug for 12 months.
|United States, New York|
|University of Rochester Medical Center|
|Rochester, New York, United States, 14620|
|Principal Investigator:||Karl Kieburtz, MD, MPH||University of Rochester|
|Principal Investigator:||Barbara Tilley, Ph.D.||Medical University of South Carolina|