A randomized clinical trial of coenzyme Q10 and GPI-1485 in early Parkinson disease.

Published

Journal Article

OBJECTIVE: To determine if future studies of coenzyme Q(10) and GPI-1485 in Parkinson disease (PD) may be warranted. METHODS: We conducted a randomized, double-blind, calibrated futility clinical trial of coenzyme Q10 and GPI-1485 in early untreated PD using placebo data from the DATATOP study to establish the futility threshold. RESULTS: The primary outcome measure (change in total Unified Parkinson's Disease Rating Scale scores over 1 year) did not meet the prespecified criteria for futility for either agent. Secondary analyses using calibration controls and other more recent placebo data question the appropriateness of the predetermined definition of futility, and suggest that a more restrictive threshold may be needed. CONCLUSIONS: Coenzyme Q(10) and GPI-1485 may warrant further study in Parkinson disease, although the data are inconsistent. Additional factors (cost, availability of other agents, more recent data on placebo outcomes, other ongoing trials) should also be considered in the selection of agents for Phase III studies.

Full Text

Duke Authors

Cited Authors

  • NINDS NET-PD Investigators,

Published Date

  • January 2, 2007

Published In

Volume / Issue

  • 68 / 1

Start / End Page

  • 20 - 28

PubMed ID

  • 17200487

Pubmed Central ID

  • 17200487

Electronic International Standard Serial Number (EISSN)

  • 1526-632X

Digital Object Identifier (DOI)

  • 10.1212/01.wnl.0000250355.28474.8e

Language

  • eng

Conference Location

  • United States