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

Sponsor:	Amarin Neuroscience Ltd
Collaborator:	Huntington Study Group
Information provided by:	Amarin Neuroscience Ltd
ClinicalTrials.gov Identifier:	NCT00146211

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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:

Genetics Home Reference related topics: chorea-acanthocytosis familial paroxysmal nonkinesigenic dyskinesia Huntington disease McLeod neuroacanthocytosis syndrome

MedlinePlus related topics: Huntington's Disease

U.S. FDA Resources

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

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

Show 41 Study Locations

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:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Amarin Neuroscience Ltd

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	University of Rochester ( Ira Shoulson, MD/Principal Investigator )
Study ID Numbers:	AN01.01.0011
Study First Received:	September 2, 2005
Last Updated:	December 24, 2007
ClinicalTrials.gov Identifier:	NCT00146211 History of Changes
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:

Basal Ganglia Diseases
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Dyskinesias
Cognition Disorders
Chorea

Delirium, Dementia, Amnestic, Cognitive Disorders
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Mental Disorders
Movement Disorders
Dementia
Huntington Disease

ClinicalTrials.gov processed this record on February 08, 2010