Clinical trial · Interventional
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
NCT00146211CI-TRIAL-00001064completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is designed to determine the effect of 2 gram/day of ethyl-EPA on motor (movement) signs and symptoms of Huntington disease.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Huntington Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ethyl-EPA (Miraxion™) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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 outcomes (1)
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHuntington Study Group TREND-HD Investigators. Randomized controlled trial of ethyl-eicosapentaenoic acid in Huntington disease: the TREND-HD study. Arch Neurol. 2008 Dec;65(12):1582-9. doi: 10.1001/archneur.65.12.1582. PMID 19064745