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

This study has been completed.
Sponsor:
Collaborator:
Huntington Study Group
Information provided by:
Amarin Neuroscience Ltd
ClinicalTrials.gov Identifier:
NCT00146211
First received: September 2, 2005
Last updated: December 24, 2007
Last verified: December 2007
History of Changes

September 2, 2005
December 24, 2007
September 2005
August 2007   (final data collection date for primary outcome 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.
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.
Complete list of historical versions of study NCT00146211 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
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

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Huntington Disease
Drug: Ethyl-EPA (Miraxion™)
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
July 2007
August 2007   (final data collection date for primary outcome measure)

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
Both
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00146211
AN01.01.0011
Not Provided
Ira Shoulson, MD/Principal Investigator, University of Rochester
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
Amarin Neuroscience Ltd
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP