| Methods |
52‐week double‐blind, parallel study. Method of randomisation: stratified by blocks of four.
Results presented for each arm of the trial.
Intention‐to‐treat and per‐protocol data analysis.
Location: 6 centres (USA and Canada). |
| Participants |
135 patients with 14 drop‐outs. 68 male and 67 female patients completed the trial.
Mean age of participants: 49,5±9,1 years.
Mean duration of disease: no data.
Inclusion criteria: symptomatic HD genetically confirmed or with family history of HD. Functional stage I/II. Independence scale score of 50 ‐ 90. Available caregiver between 30 and 70 years of age.
Exclusion criteria: depot neuroleptics. |
| Interventions |
Oral Ethyl‐EPA 2g/day (67 patients) and placebo ‐ identical pills (68 patients). No titration. |
| Outcomes |
Primary: TMS‐4 score (UHDRS) at 12 months.
Secondary:
Change in TMS‐UHDRS. Change in TMS‐4 score (motor‐UHDRS) at 6 months. Change in UHDRS (cognitive, behavioral, functional scales). Change in Rockland Simpson Dysknesia Score.
|
| Notes |
Negative for efficacy measures. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
