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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00146211
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : December 27, 2007
Huntington Study Group
Information provided by:
Amarin Neuroscience Ltd

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.

Condition or disease Intervention/treatment Phase
Huntington Disease Drug: Ethyl-EPA (Miraxion™) Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multicenter, Double Blind, Randomized, Parallel Group, Placebo-Controlled Trial of Ethyl-EPA (Miraxion™) in Subjects With Mild to Moderate Huntington's Disease
Study Start Date : September 2005
Actual Primary Completion Date : August 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00146211

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The Centre for Addiction and Mental Health
Markham, Ontario, Canada
Canada, Quebec
Hotel-Dieu Hospital-CHUM
Montreal, Quebec, Canada
Sponsors and Collaborators
Amarin Neuroscience Ltd
Huntington Study Group
Principal Investigator: Ira Shoulson, MD Huntington Study Group/University of Rochester
Principal Investigator: Christopher Ross, MD, PhD Huntington Study Group/Johns Hopkins University School of Medicine
Principal Investigator: Blair Leavitt, MD Huntington Study Group/University of British Columbia

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ira Shoulson, MD/Principal Investigator, University of Rochester Identifier: NCT00146211     History of Changes
Other Study ID Numbers: AN01.01.0011
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: December 27, 2007
Last Verified: December 2007

Keywords provided by Amarin Neuroscience Ltd:

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders