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

Huntington Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00146211
• Other study ID #: AN01.01.0011
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2005
• Last updated: December 24, 2007
• Start date: September 2005
• Est. completion date: July 2007

Study information

• Verified date: December 2007
• Source: Amarin Neuroscience Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Huntington Disease

Intervention

Drug:
• Ethyl-EPA (Miraxion™)

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	University of Alberta Glenrose Rehab Hospital	Edmonton	Alberta
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	University of British Columbia	Vancouver	British Columbia
United States	Albany Medical College	Albany	New York
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Medical College of Georgia	Augusta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Boston University	Boston	Massachusetts
United States	Massachusetts General Hospital	Charlestown	Massachusetts
United States	University of Virginia	Charlottesville	Virginia
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Ohio State University Parkinson's Center	Columbus	Ohio
United States	Colorado Neurological Institute	Englewood	Colorado
United States	University of Florida	Gainesville	Florida
United States	Penn State Milton & Hershey Medical College	Hershey	Pennsylvania
United States	Baylor College of Medicine	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	University of Kansas	Kansas City	Kansas
United States	University of California San Diego	La Jolla	California
United States	UCLA Medical Center	Los Angeles	California
United States	North Shore-LIJ Health System	Manhasset	New York
United States	University of Tennessee-Memphis	Memphis	Tennessee
United States	University of Miami	Miami	Florida
United States	Institute of Neurodegenerative Disorders	New Haven	Connecticut
United States	Columbia University Medical Center	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Rochester	Rochester	New York
United States	University of California Davis	Sacramento	California
United States	University of California San Francisco	San Francisco	California
United States	Mayo Clinic Arizona	Scottsdale	Arizona
United States	Washington University School of Medicine	St. Louis	Missouri
United States	University of South Florida	Tampa	Florida
United States	Hereditary Neurological Disease Centre	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Amarin Neuroscience Ltd	Huntington Study Group

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.

External Links

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