TREND-HD - A Trial of Ethyl-EPA (Miraxion™) in Treating Mild to Moderate Huntington's Disease
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This study is designed to determine the effect of 2 gram/day of ethyl-EPA on motor (movement) signs and symptoms of Huntington disease.
Condition or disease
Drug: Ethyl-EPA (Miraxion™)
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.
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.
Secondary Outcome Measures :
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.
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Layout table for eligibility information
Ages Eligible for Study:
35 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Clinical features of Huntington's disease (HD) and confirmatory family history of HD, and/or CAG repeat expansion greater than or equal to 36
Ambulatory, not requiring skilled nursing care (total functional capacity [TFC] greater than or equal to 7)
Chorea score of at least 2 in one extremity (UHDRS)
Maximal dystonia less than or equal to 2 and maximal bradykinesia less than or equal to 2
35 years of age or older of either gender
Must be on stable dosages of non-competitive NMDA receptor antagonists, and/or antiepileptic medications for 60 days prior to baseline
Females of child-bearing potential must use adequate birth control
History of established diagnosis of tardive dyskinesia
Clinical evidence of unstable medical or psychiatric illness
Clinically significant active and unstable psychotic disease (hallucinations or delusions)
Major depression (Beck Depression Inventory [BDI]-II Score greater than 20) at Screening Visit
Suicidal ideation (BDI-II item 9 greater than or equal to 2) at Screening Visit
History of clinically significant substance abuse within 12 months of Baseline Visit
Participation in other drug studies within 60 days prior to Baseline Visit
Previous participation in any investigational study of ethyl-EPA (Miraxion™)
Use of aspirin at daily dosage greater than 325 mg/day