CARE‐HD.
Methods | 120‐week double‐blind, four‐arm parallel study. Method of randomisation: computer generated stratification by investigator. Results presented for each arm of the trial. Intention‐to‐treat data analysis. Location: 25 centres (USA). | |
Participants | 347 patients, 37 drop‐outs. 176 male and 171 female patients completed the trial. Mean age of participants: 47.9±10,5 years. Mean duration of disease: 4,9±3,1 years. Inclusion criteria: HD (genetically established or positive family history) TFC‐UHDRS≥7, disease stage I or II. Exclusion criteria: Coenzyme Q10 use in previous 3 months, unstable medical or psychiatric disease. | |
Interventions | Coenzyme Q10, 300‐600mg/day (87 patients), remacemide, 400‐600mg/day (86 patients) or Coenzyme Q10+remacemide , 300‐600mg/day+400‐600mg/day (87 patients) and placebo ‐ identical pills (87 patients). No titration. | |
Outcomes | Primary: deteriorarion in TFC‐UHDRS. Secondary:
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Notes | Negative for efficacy measures. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |