Kaufmann 2009.
Methods | Two‐stage, adaptive‐design, randomized, placebo‐controlled, double‐blind |
Participants | United States Stage 1: N = 105 (CoQ10 1800 mg: 35, CoQ10 2700 mg: 35, placebo: 35) Stage 1: mean age 59.4 years (CoQ10 1800 mg), 56.1 years (CoQ10 2700 mg) Stage 1: gender distribution, male (%): 71.4% (CoQ10 1800 mg), 42.9% (CoQ10 2700 mg) Stage 1: family history of ALS not reported in published manuscript Stage 2: N = 150 (75 CoQ10 2700 mg (including 35 who received CoQ10 2700 mg in stage 1) and 75 placebo (including 35 who received placebo in stage 1)) Stage 2: mean age 56.5 years (CoQ10), 57.4 years (placebo) Stage 2: gender distribution, male (%): 53.3% (CoQ10), 61.3% (placebo) Stage 2: family history of ALS not reported in published manuscript |
Interventions | Coenzyme Q10 Stage 1: 1800 mg/day, 2700 mg/day Stage 2: 2700 mg/day |
Outcomes | Primary: decline in the ALSFRS‐R |
Notes | Funded by the National Institute of Neurological Disorders and Stroke |