EHDN.
Methods | 144‐week double‐blind, unbalanced parallel study (treatment:placebo ‐ 2:1). Method of randomisation: computer generated stratification by centre. Results presented for each arm of the trial. Intention‐to‐treat and per‐protocol data analysis. Location: 44 centres (Europe). | |
Participants | 537 patients with 158 drop‐outs. 271 male and 266 female patients. Mean age of participants: 45,5±9.7 years. Mean duration of disease: 5,5±4.4 years. Inclusion criteria: adult (25‐65 years old), genetically established HD, independently ambulatory with a TFC‐UHDRS≥8, total motor score‐UHDRS≥5, monitor compliance, caregiver to witness consent. Exclusion criteria: comorbid or co‐medication that would interfere study results, pregnancy, breast‐feeding, inadequate contraception, prior exposure to riluzole, contraindication to riluzole, serum markers of hepatic function>2xULN (alanine aminotransferase, aspartate aminotransferase and bilirubin) and anti‐choreic medication within 1 month of baseline visit. | |
Interventions | Oral Riluzole 100 mg/day (357 patients) and placebo ‐ identical pills ‐ (180 patients). No titration. | |
Outcomes | Primary: composite score of TMS‐UHDRS and TFC‐UHDRS. Secondary:
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Notes | Negative for efficacy measures. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |