Clinical trial NCT00146211: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Huntington Disease
Keywords: Trial
ethyl-EPA
Miraxion™
treating
mild
moderate
Huntington's
Lead sponsor: Amarin Neuroscience Ltd
Sponsor class: INDUSTRY
Collaborators: name: Huntington Study Group
First posted: 2005-09-07
Enrollment: 300
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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 outcomes:
measure: 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.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Sacramento
country: United States
facility: University of California Davis
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Englewood
country: United States
facility: Colorado Neurological Institute
state: Colorado
city: New Haven
country: United States
facility: Institute of Neurodegenerative Disorders
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas
state: Kansas
city: Wichita
country: United States
facility: Hereditary Neurological Disease Centre
state: Kansas
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Boston University
state: Massachusetts
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Manhasset
country: United States
facility: North Shore-LIJ Health System
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Columbus
country: United States
facility: Ohio State University Parkinson's Center
state: Ohio
city: Hershey
country: United States
facility: Penn State Milton & Hershey Medical College
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Memphis
country: United States
facility: University of Tennessee-Memphis
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Glenrose Rehab Hospital
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: London
country: Canada
facility: University of British Columbia
state: Ontario
city: Markham
country: Canada
facility: The Centre for Addiction and Mental Health
state: Ontario
city: Montreal
country: Canada
facility: Hotel-Dieu Hospital-CHUM
state: Quebec
Study officials:
affiliation: Huntington Study Group/University of Rochester
name: Ira Shoulson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Huntington Study Group/Johns Hopkins University School of Medicine
name: Christopher Ross, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Huntington Study Group/University of British Columbia
name: Blair Leavitt, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.