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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00146211
Other study ID # AN01.01.0011
Secondary ID
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


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.
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