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

NCT00146211 | Completed Phase 3

• 1 other identifier: AN01.01.0011
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 41

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.

Conditions

Huntington Disease

Keywords

Trial; ethyl-EPA; Miraxion™; treating; mild; moderate; Huntington's

Outcome Measures

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.

Interventions

Ethyl-EPA (Miraxion™) DRUG

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amarin Neuroscience Ltd: lead
• Huntington Study Group: collaborator

Study Sites (41)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Location

Mayo Clinic Arizona

Scottsdale, Arizona, United States

Location

University of California San Diego

La Jolla, California, United States

Location

UCLA Medical Center

Los Angeles, California, United States

Location

University of California Davis

Sacramento, California, United States

Location

University of California San Francisco

San Francisco, California, United States

Location

Colorado Neurological Institute

Englewood, Colorado, United States

Location

Institute of Neurodegenerative Disorders

New Haven, Connecticut, United States

Location

University of Florida

Gainesville, Florida, United States

Location

University of Miami

Miami, Florida, United States

Location

University of South Florida

Tampa, Florida, United States

Location

Emory University

Atlanta, Georgia, United States

Location

Medical College of Georgia

Augusta, Georgia, United States

Location

Rush University Medical Center

Chicago, Illinois, United States

Location

University of Chicago

Chicago, Illinois, United States

Location

Indiana University

Indianapolis, Indiana, United States

Location

University of Iowa

Iowa City, Iowa, United States

Location

University of Kansas

Kansas City, Kansas, United States

Location

Hereditary Neurological Disease Centre

Wichita, Kansas, United States

Location

Johns Hopkins University

Baltimore, Maryland, United States

Location

Boston University

Boston, Massachusetts, United States

Location

Massachusetts General Hospital

Charlestown, Massachusetts, United States

Location

University of Michigan

Ann Arbor, Michigan, United States

Location

Washington University School of Medicine

St Louis, Missouri, United States

Location

Albany Medical College

Albany, New York, United States

Location

North Shore-LIJ Health System

Manhasset, New York, United States

Location

Columbia University Medical Center

New York, New York, United States

Location

University of Rochester

Rochester, New York, United States

Location

Ohio State University Parkinson's Center

Columbus, Ohio, United States

Location

Penn State Milton & Hershey Medical College

Hershey, Pennsylvania, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Location

University of Tennessee-Memphis

Memphis, Tennessee, United States

Location

Baylor College of Medicine

Houston, Texas, United States

Location

University of Virginia

Charlottesville, Virginia, United States

Location

University of Calgary

Calgary, Alberta, Canada

Location

University of Alberta Glenrose Rehab Hospital

Edmonton, Alberta, Canada

Location

University of British Columbia

Vancouver, British Columbia, Canada

Location

University of British Columbia

London, Ontario, Canada

Location

The Centre for Addiction and Mental Health

Markham, Ontario, Canada

Location

Hotel-Dieu Hospital-CHUM

Montreal, Quebec, Canada

Location

Related Publications (1)

• 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.

  PMID: 19064745 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Huntington Disease; Lymphoma, Follicular

Interventions

eicosapentaenoic acid ethyl ester; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 7, 2005
• Study Start: September 1, 2005
• Primary Completion: August 1, 2007
• Study Completion: July 1, 2007
• Last Updated: December 27, 2007

Record last verified: 2007-12

Locations

CA (6); US (35)