A Phase 3 interventional study of Ethyl-EPA (Miraxion™) in Huntington Disease, sponsored by Amarin Neuroscience Ltd. Completed at 41 sites in 2 countries. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2007-12-27.
Sponsored by Amarin Neuroscience Ltd · Phase 3, Interventional, and Treatment
This study is designed to determine the effect of 2 gram/day of ethyl-EPA on motor (movement) signs and symptoms of Huntington disease.
Multi-center, double blind, placebo-controlled study with parallel groups of outpatients with early, symptomatic Huntington's disease. Participants will be randomized to receive 1 gram twice daily (2 gram/day total daily dose) of active study drug or placebo. The 6-month placebo-controlled phased will be followed by a subsequent 6-month open-label extension phase with all subjects receiving 1 gram twice daily (2 grams/day total daily dose) of active study drug.
285 studies on the registry are indexed under Huntington Disease; 49 are open to participants now.
This study's enrollment of 300 is above the median of 40 across 203 interventional studies indexed under Huntington Disease.
Browse Huntington Disease studies →This is the only study on the registry with Amarin Neuroscience Ltd as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
To compare with placebo the effect of ethyl-EPA on the Total Motor Score-4 component (TMS) of the Unified Huntington's Disease Rating Scale (UHDRS) over a 6-month period of observation.
To compare with placebo the effect of ethyl-EPA over a 6-month period of observation on, 1) Chorea (UHDRS Total Motor Score Scale); 2) Total Motor Score component (TMS) of the UHDRS; and, 3) Clinical Global Impression (CGI) score.
This study is completed, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.