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. 2009 Jul 8;2009(3):CD006455. doi: 10.1002/14651858.CD006455.pub2

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:
  • Change in TMS‐UHDRS.

  • Change in cognitive function (Stroop test, Hopkins Verbal Learning Test, Brief Test Attention, Conditional Associative Learning Test, Trailmaking test, Test for visuomotor speed).

  • Frequency and severity of individual adverse events, abnormal values or changes of laboratory tests and ECG results, changes from baseline to 30 months in laboratory test and vital signs.

Notes Negative for efficacy measures.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear