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

Tracking Information

First Received Date ^ICMJE

September 2, 2005

Last Updated Date

December 24, 2007

Start Date ^ICMJE

September 2005

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

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.

Change History

Complete list of historical versions of study NCT00146211 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Multicenter, Double Blind, Randomized, Parallel Group, Placebo-Controlled Trial of Ethyl-EPA (Miraxion™) in Subjects With Mild to Moderate Huntington's Disease

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Huntington Disease

Intervention ^ICMJE

Drug: Ethyl-EPA (Miraxion™)

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

300

Completion Date

July 2007

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

35 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00146211

Responsible Party

Ira Shoulson, MD/Principal Investigator, University of Rochester

Study ID Numbers ^ICMJE

AN01.01.0011

Study Sponsor ^ICMJE

Amarin Neuroscience Ltd

Collaborators ^ICMJE

Huntington Study Group

Investigators ^ICMJE

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

Information Provided By

Amarin Neuroscience Ltd

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP