The Movement Disorder Society

MDS Abstract of the 16th International Congress of Parkinson's Disease and Movement Disorders, Volume 27,
June 2012 Abstract Supplement

Movement Disorders 2012
Dublin, Ireland June 17-21, 2012.


A phase III clinical trial of coenzyme Q10 (QE3) in early Parkinson's disease: Parkinson Study Group QE3 Investigators

Beal,  M.F.

Objective:

The Phase III QE3 study examined whether CoQ10 could slow disease progression in early PD.

Background:

Coenzyme Q10 (CoQ10), an antioxidant that supports mitochondrial function, has been shown in preclinical Parkinson's disease (PD) models to reduce loss of dopamine neurons, and was safe and well-tolerated in early phase studies.

Methods:

The study was a randomized, placebo-controlled, double-blind trial. Participants with early untreated PD (diagnosis within 5 years) were randomized equally to placebo, 1200 mg/d, or 2400mg/d of CoQ10; all subjects also received vitamin E 1200 IU/d. Participants were followed for 16 months or to disability requiring dopaminergic treatment, whichever occurred first. The primary outcome was the change in total UPDRS score (Parts I-III), from baseline to final visit.

Results:

600 participants from 67 sites (US and Canada) were enrolled. Treatment groups were well-balanced on baseline demographic and clinical variables. The treatments were well-tolerated and no safety concerns were identified. An independent monitoring board evaluated a planned interim analysis of the primary outcome from the first 300 participants in April 2011. This analysis revealed that a pre-specified futility threshold had been reached, and prompted the early conclusion of the trial. The adjusted mean changes (worsening) in total UPDRS from baseline to final visit were 8.3 pts (placebo), 9.9 pts (1200mg/d CoQ10), 10.0 pts (2400mg/d CoQ10), p=NS.

Conclusions:

Our analyses confirm that CoQ10 was safe and well tolerated in this population, but give no evidence of a benefit of CoQ10 in early PD. Further analyses of the complete study data are underway.

Keywords :

Mitochondria,Neuroprotective agents,Oxidative stress,Vitamin E

To cite this abstract, please use the following information:
Beal, M.F.; A phase III clinical trial of coenzyme Q10 (QE3) in early Parkinson's disease: Parkinson Study Group QE3 Investigators [abstract]. Movement Disorders 2012;27 Suppl 1 :346