Trial record 1 of 1 for:    NCT00146211
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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
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
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 San Diego
La Jolla, California, United States
UCLA Medical Center
Los Angeles, California, United States
University of California Davis
Sacramento, 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
University of Kansas
Kansas City, Kansas, United States
Hereditary Neurological Disease Centre
Wichita, 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
Albany Medical College
Albany, New York, United States
North Shore-LIJ Health System
Manhasset, New York, United States
Columbia University Medical Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
United States, Ohio
Ohio State University Parkinson's Center
Columbus, Ohio, United States
United States, Pennsylvania
Penn State Milton & Hershey Medical College
Hershey, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, 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:
No publications provided by Amarin Neuroscience Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ira Shoulson, MD/Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT00146211     History of Changes
Other Study ID Numbers: AN01.01.0011
Study First Received: September 2, 2005
Last Updated: December 24, 2007
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:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Chorea
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Dyskinesias
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Mental Disorders
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on October 23, 2014