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

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:
  • TMS‐UHDRS.

  • TFC‐UHDRS.

  • UHDRS items: chorea score, cognitive, behavioral, functional, independence and global clinical impression subscales.

  • Beck Depression inventory.

Notes Negative for efficacy measures.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Low risk A ‐ Adequate