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

A Multicenter, Double Blind, Randomized, Parallel Group, Placebo-Controlled Trial of Ethyl-EPA (Miraxion™) in Subjects With Mild to Moderate Huntington's Disease

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00146211

Enrollment

300

Registered

2005-09-07

Start date

2005-09-30

Completion date

2007-07-31

Last updated

2007-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Huntington Disease

Keywords

Trial, ethyl-EPA, Miraxion™, treating, mild, moderate, Huntington's

Brief summary

This study is designed to determine the effect of 2 gram/day of ethyl-EPA on motor (movement) signs and symptoms of Huntington disease.

Detailed description

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.

Interventions

DRUGEthyl-EPA (Miraxion™)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

35 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026