1. A randomized, double-blind, placebo-controlled trial of coenzyme Q10 in Huntington disease
- Author
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McGarry, Andrew, McDermott, Michael, Kieburtz, Karl, de Blieck, Elisabeth A, Beal, Flint, Marder, Karen, Ross, Christopher, Shoulson, Ira, Gilbert, Peter, Mallonee, William M, Guttman, Mark, Wojcieszek, Joanne, Kumar, Rajeev, LeDoux, Mark S, Jenkins, Mary, Rosas, H Diana, Nance, Martha, Biglan, Kevin, Como, Peter, Dubinsky, Richard M, Shannon, Kathleen M, O'Suilleabhain, Padraig, Chou, Kelvin, Walker, Francis, Martin, Wayne, Wheelock, Vicki L, McCusker, Elizabeth, Jankovic, Joseph, Singer, Carlos, Sanchez-Ramos, Juan, Scott, Burton, Suchowersky, Oksana, Factor, Stewart A, Higgins, Donald S, Molho, Eric, Revilla, Fredy, Caviness, John N, Friedman, Joseph H, Perlmutter, Joel S, Feigin, Andrew, Anderson, Karen, Rodriguez, Ramon, McFarland, Nikolaus R, Margolis, Russell L, Farbman, Eric S, Raymond, Lynn A, Suski, Valerie, Kostyk, Sandra, Colcher, Amy, Seeberger, Lauren, Epping, Eric, Esmail, Sherali, Diaz, Nancy, Fung, Wai Lun Alan, Diamond, Alan, Frank, Samuel, Hanna, Philip, Hermanowicz, Neal, Dure, Leon S, Cudkowicz, Merit, and Huntington Study Group 2CARE Investigators and Coordinators
- Subjects
0301 basic medicine ,Male ,Huntington's Disease ,Ubiquinone ,International Cooperation ,Placebo-controlled study ,Disease ,Neurodegenerative ,law.invention ,chemistry.chemical_compound ,0302 clinical medicine ,Randomized controlled trial ,law ,Medicine ,Vitamins ,Middle Aged ,Huntington Disease ,Treatment Outcome ,6.1 Pharmaceuticals ,Female ,Cognitive Sciences ,Adult ,medicine.medical_specialty ,Canada ,Clinical Trials and Supportive Activities ,Clinical Sciences ,Placebo ,03 medical and health sciences ,Rare Diseases ,Double-Blind Method ,Clinical Research ,Internal medicine ,Humans ,Proportional Hazards Models ,Retrospective Studies ,Nutrition ,Coenzyme Q10 ,Neurology & Neurosurgery ,business.industry ,Proportional hazards model ,Australia ,Neurosciences ,Evaluation of treatments and therapeutic interventions ,Retrospective cohort study ,Huntington Study Group 2CARE Investigators and Coordinators ,Interim analysis ,United States ,Brain Disorders ,030104 developmental biology ,chemistry ,Neurology (clinical) ,business ,030217 neurology & neurosurgery - Abstract
Objective:To test the hypothesis that chronic treatment of early-stage Huntington disease (HD) with high-dose coenzyme Q10 (CoQ) will slow the progressive functional decline of HD.Methods:We performed a multicenter randomized, double-blind, placebo-controlled trial. Patients with early-stage HD (n = 609) were enrolled at 48 sites in the United States, Canada, and Australia from 2008 to 2012. Patients were randomized to receive either CoQ 2,400 mg/d or matching placebo, then followed for 60 months. The primary outcome variable was the change from baseline to month 60 in Total Functional Capacity score (for patients who survived) combined with time to death (for patients who died) analyzed using a joint-rank analysis approach.Results:An interim analysis for futility revealed a conditional power of Conclusions:These data do not justify use of CoQ as a treatment to slow functional decline in HD.ClinicalTrials.gov identifier:NCT00608881.Classification of evidence:This article provides Class I evidence that CoQ does not slow the progressive functional decline of patients with HD.
- Published
- 2017