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

December 24, 2007 updated by: Amarin Neuroscience Ltd

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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.

Secondary Outcome Measures

Outcome 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amarin Neuroscience Ltd

Collaborators

Huntington Study Group

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (Estimate)

September 7, 2005

Study Record Updates

Last Update Posted (Estimate)

December 27, 2007

Last Update Submitted That Met QC Criteria

December 24, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN01.01.0011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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