TREND-HD - A Trial of Ethyl-EPA (Miraxion™) in Treating Mild to Moderate Huntington's Disease
- Conditions
- Huntington Disease
- Registration Number
- NCT00146211
- Lead Sponsor
- Amarin Neuroscience Ltd
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (40)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Mayo Clinic Arizona
🇺🇸Scottsdale, Arizona, United States
University of California San Diego
🇺🇸La Jolla, California, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
University of California Davis
🇺🇸Sacramento, California, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Colorado Neurological Institute
🇺🇸Englewood, Colorado, United States
Institute of Neurodegenerative Disorders
🇺🇸New Haven, Connecticut, United States
University of Florida
🇺🇸Gainesville, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
Scroll for more (30 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States