TREND-HD - A Trial of Ethyl-EPA (Miraxion™) in Treating Mild to Moderate Huntington's Disease
TREND-HD - A Trial of Ethyl-EPA (Miraxion™) in Treating Mild to Moderate Huntington's Disease
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.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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

 -  Pregnant/lactating women

 -  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

 -  Exclusionary Drugs (within 6 months Baseline Visit): Depot neuroleptics

 -  Exclusionary Drugs (within 60 days Baseline Visit): Omega-3 supplementation,
 tetrabenazine or reserpine, high dose and/or variable dose oral anti-psychotic
 medications, steroid (other than topical), selenium supplements greater than 55
 mcg/day, lithium, benzodiazepines (except for low dose), anticoagulants