drugset

drugset / Trial / NCT00243932

Clinical Trial of High Dose CoQ10 in ALS

NCT00243932 ↗

Phase 2 Completed 185 enrolled Columbia University National Institute of Neurological Disorders and Stroke (NINDS) · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine the efficacy and preferred dose of CoQ10 in individuals with ALS for a possible future phase III study.

Timeline

Start: 2005-04
Primary completion: 2008-03
Completion: 2008-03

Outcome

Missed primary endpoint

registry analysis (unspecified test); 2700mg CoQ10 vs Placebo; p = 0.14; futility (non-superiority) NCT00243932 ↗

paper In Stage 2, the pre-specified primary null hypothesis that this dose is superior to placebo was not rejected. PMID 19743457 ↗

Publications

Results Kaufmann P, Thompson JL, Levy G, Buchsbaum R, Shefner J, Krivickas LS, Katz J, Rollins Y, Barohn RJ, Jackson CE, Tiryaki E, Lomen-Hoerth C, Armon C, Tandan R, Rudnicki SA, Rezania K, Sufit R, Pestronk A, Novella SP, Heiman-Patterson T, Kasarskis EJ, Pioro EP, Montes J, Arbing R, Vecchio D, Barsdorf A, Mitsumoto H, Levin B; QALS Study Group. Phase II trial of CoQ10 for ALS finds insufficient evidence to justify phase III. Ann Neurol. 2009 Aug;66(2):235-44. doi: 10.1002/ana.21743.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Coenzyme Q10	Other / unclassified	1800 mg	Oral
Subject	Coenzyme Q10	Other / unclassified	2700 mg	Oral

Indications