TREND-HD - A Trial of Ethyl-EPA (Miraxion™) in Treating Mild to Moderate Huntington's Disease
NCT ID: NCT00146211
Last Updated: 2007-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2005-09-30
2007-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ethyl-EPA (Miraxion™)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
35 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Huntington Study Group
NETWORK
Amarin Neuroscience Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
University of Rochester
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ira Shoulson, MD
Role: PRINCIPAL_INVESTIGATOR
Huntington Study Group/University of Rochester
Christopher Ross, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Huntington Study Group/Johns Hopkins University School of Medicine
Blair Leavitt, MD
Role: PRINCIPAL_INVESTIGATOR
Huntington Study Group/University of British Columbia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
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
Colorado Neurological Institute
Englewood, Colorado, United States
Institute of Neurodegenerative Disorders
New Haven, Connecticut, United States
University of Florida
Gainesville, Florida, United States
University of Miami
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas
Kansas City, Kansas, United States
Hereditary Neurological Disease Centre
Wichita, Kansas, United States
Johns Hopkins University
Baltimore, Maryland, United States
Boston University
Boston, Massachusetts, United States
Massachusetts General Hospital
Charlestown, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
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
Ohio State University Parkinson's Center
Columbus, Ohio, United States
Penn State Milton & Hershey Medical College
Hershey, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Tennessee-Memphis
Memphis, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
University of Calgary
Calgary, Alberta, Canada
University of Alberta Glenrose Rehab Hospital
Edmonton, Alberta, Canada
University of British Columbia
Vancouver, British Columbia, Canada
University of British Columbia
London, Ontario, Canada
The Centre for Addiction and Mental Health
Markham, Ontario, Canada
Hotel-Dieu Hospital-CHUM
Montreal, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AN01.01.0011
Identifier Type: -
Identifier Source: org_study_id