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CompletedNCT00146211Updated Dec 27, 2007

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

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

Phase
Phase 3
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
35 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Huntington Disease

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Keywords

  • Trial
  • ethyl-EPA
  • Miraxion™
  • treating
  • mild
  • moderate
  • Huntington's
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In context

Huntington Disease

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 →

Lead sponsor

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.

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Who can participate

Ages eligible
35 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
300 participants (actual)

Interventions

  • DrugEthyl-EPA (Miraxion™)
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What researchers measure

Primary outcomes

  1. 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. 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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Study locations

41 sites
  • University of Alabama at Birmingham
    Birmingham, Alabama, United States
  • Mayo Clinic Arizona
    Scottsdale, Arizona, United States
  • University of California San Diego
    La Jolla, California, United States
  • UCLA Medical Center
    Los Angeles, California, United States
  • University of California Davis
    Sacramento, California, United States
  • University of California San Francisco
    San Francisco, California, United States
  • Colorado Neurological Institute
    Englewood, Colorado, United States
  • Institute of Neurodegenerative Disorders
    New Haven, Connecticut, United States
  • University of Florida
    Gainesville, Florida, United States
  • University of Miami
    Miami, Florida, United States
  • University of South Florida
    Tampa, Florida, United States
  • Emory University
    Atlanta, Georgia, United States
  • Medical College of Georgia
    Augusta, Georgia, United States
  • Rush University Medical Center
    Chicago, Illinois, United States
  • University of Chicago
    Chicago, Illinois, United States
  • Indiana University
    Indianapolis, Indiana, United States
  • University of Iowa
    Iowa City, Iowa, United States
  • University of Kansas
    Kansas City, Kansas, United States
  • Hereditary Neurological Disease Centre
    Wichita, Kansas, United States
  • Johns Hopkins University
    Baltimore, Maryland, United States
  • Boston University
    Boston, Massachusetts, United States
  • Massachusetts General Hospital
    Charlestown, Massachusetts, United States
  • University of Michigan
    Ann Arbor, Michigan, United States
  • Washington University School of Medicine
    St. Louis, Missouri, United States
  • Albany Medical College
    Albany, New York, United States
  • North Shore-LIJ Health System
    Manhasset, New York, United States
  • Columbia University Medical Center
    New York, New York, United States
  • University of Rochester
    Rochester, New York, United States
  • Ohio State University Parkinson's Center
    Columbus, Ohio, United States
  • Penn State Milton & Hershey Medical College
    Hershey, Pennsylvania, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania, United States
  • University of Pittsburgh
    Pittsburgh, Pennsylvania, United States
  • University of Tennessee-Memphis
    Memphis, Tennessee, United States
  • Baylor College of Medicine
    Houston, Texas, United States
  • University of Virginia
    Charlottesville, Virginia, United States
  • University of Calgary
    Calgary, Alberta, Canada
  • University of Alberta Glenrose Rehab Hospital
    Edmonton, Alberta, Canada
  • University of British Columbia
    Vancouver, British Columbia, Canada
  • University of British Columbia
    London, Ontario, Canada
  • The Centre for Addiction and Mental Health
    Markham, Ontario, Canada
  • Hotel-Dieu Hospital-CHUM
    Montreal, Quebec, Canada
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References and documents

Publications

  • Huntington 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. Erratum In: Arch Neurol. 2009 Mar;66(3):305. PubMed 19064745 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00146211
Lead sponsor
Amarin Neuroscience Ltd
Collaborators
Huntington Study Group
First posted
Sep 7, 2005
Start date
Sep 2005
Primary completion
Aug 2007
Completion
Jul 2007
Last update
Dec 27, 2007

Study contacts

Ira Shoulson, MD
principal investigator · Huntington Study Group/University of Rochester
Christopher Ross, MD, PhD
principal investigator · Huntington Study Group/Johns Hopkins University School of Medicine
Blair Leavitt, MD
principal investigator · Huntington Study Group/University of British Columbia
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.

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