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

Primary Purpose

Huntington Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ethyl-EPA (Miraxion™)
Sponsored by
Amarin Neuroscience Ltd
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Huntington Disease focused on measuring Trial, ethyl-EPA, Miraxion™, treating, mild, moderate, Huntington's

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Mayo Clinic Arizona
  • University of California San Diego
  • UCLA Medical Center
  • University of California Davis
  • University of California San Francisco
  • Colorado Neurological Institute
  • Institute of Neurodegenerative Disorders
  • University of Florida
  • University of Miami
  • University of South Florida
  • Emory University
  • Medical College of Georgia
  • Rush University Medical Center
  • University of Chicago
  • Indiana University
  • University of Iowa
  • University of Kansas
  • Hereditary Neurological Disease Centre
  • Johns Hopkins University
  • Boston University
  • Massachusetts General Hospital
  • University of Michigan
  • Washington University School of Medicine
  • Albany Medical College
  • North Shore-LIJ Health System
  • Columbia University Medical Center
  • University of Rochester
  • Ohio State University Parkinson's Center
  • Penn State Milton & Hershey Medical College
  • University of Pennsylvania
  • University of Pittsburgh
  • University of Tennessee-Memphis
  • Baylor College of Medicine
  • University of Virginia
  • University of Calgary
  • University of Alberta Glenrose Rehab Hospital
  • University of British Columbia
  • University of British Columbia
  • The Centre for Addiction and Mental Health
  • Hotel-Dieu Hospital-CHUM

Outcomes

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.

Full Information

First Posted
September 2, 2005
Last Updated
December 24, 2007
Sponsor
Amarin Neuroscience Ltd
Collaborators
Huntington Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT00146211
Brief Title
TREND-HD - A Trial of Ethyl-EPA (Miraxion™) in Treating Mild to Moderate Huntington's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Amarin Neuroscience Ltd
Collaborators
Huntington Study Group

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington Disease
Keywords
Trial, ethyl-EPA, Miraxion™, treating, mild, moderate, Huntington's

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ethyl-EPA (Miraxion™)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ira Shoulson, MD
Organizational Affiliation
Huntington Study Group/University of Rochester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher Ross, MD, PhD
Organizational Affiliation
Huntington Study Group/Johns Hopkins University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Blair Leavitt, MD
Organizational Affiliation
Huntington Study Group/University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
Country
United States
Facility Name
University of California Davis
City
Sacramento
State/Province
California
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
Country
United States
Facility Name
Colorado Neurological Institute
City
Englewood
State/Province
Colorado
Country
United States
Facility Name
Institute of Neurodegenerative Disorders
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Medical College of Georgia
City
Augusta
State/Province
Georgia
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
Country
United States
Facility Name
University of Kansas
City
Kansas City
State/Province
Kansas
Country
United States
Facility Name
Hereditary Neurological Disease Centre
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Massachusetts General Hospital
City
Charlestown
State/Province
Massachusetts
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
Country
United States
Facility Name
North Shore-LIJ Health System
City
Manhasset
State/Province
New York
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
Country
United States
Facility Name
Ohio State University Parkinson's Center
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Penn State Milton & Hershey Medical College
City
Hershey
State/Province
Pennsylvania
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
University of Tennessee-Memphis
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
University of Alberta Glenrose Rehab Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
University of British Columbia
City
London
State/Province
Ontario
Country
Canada
Facility Name
The Centre for Addiction and Mental Health
City
Markham
State/Province
Ontario
Country
Canada
Facility Name
Hotel-Dieu Hospital-CHUM
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19064745
Citation
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. Erratum In: Arch Neurol. 2009 Mar;66(3):305.
Results Reference
derived
Links:
URL
http://www.Huntington-Study-Group.org
Description
Related Info

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

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