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

Sponsor:	Amarin Neuroscience Ltd
Collaborator:	Huntington Study Group
Information provided by:	Amarin Neuroscience Ltd
ClinicalTrials.gov Identifier:	NCT00146211

Purpose

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	Intervention	Phase
Huntington Disease	Drug: Ethyl-EPA (Miraxion™)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: chorea-acanthocytosis familial paroxysmal nonkinesigenic dyskinesia Huntington disease McLeod neuroacanthocytosis syndrome

MedlinePlus related topics: Huntington's Disease Hurricanes

U.S. FDA Resources

Further study details as provided by Amarin Neuroscience Ltd:

Primary Outcome Measures:

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:

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.

Enrollment:	300
Study Start Date:	September 2005
Study Completion Date:	July 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	35 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146211

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Locations

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

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

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Amarin Neuroscience Ltd

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	University of Rochester ( Ira Shoulson, MD/Principal Investigator )
Study ID Numbers:	AN01.01.0011
Study First Received:	September 2, 2005
Last Updated:	December 24, 2007
ClinicalTrials.gov Identifier:	NCT00146211 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Amarin Neuroscience Ltd:

Trial
ethyl-EPA
Miraxion™
treating

mild
moderate
Huntington's

Additional relevant MeSH terms:

Basal Ganglia Diseases
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Dyskinesias
Cognition Disorders
Chorea

Delirium, Dementia, Amnestic, Cognitive Disorders
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Mental Disorders
Movement Disorders
Dementia
Huntington Disease

ClinicalTrials.gov processed this record on November 27, 2009