Status:
COMPLETED
TREND-HD - A Trial of Ethyl-EPA (Miraxion™) in Treating Mild to Moderate Huntington's Disease
Lead Sponsor:
Amarin Neuroscience Ltd
Collaborating Sponsors:
Huntington Study Group
Conditions:
Huntington Disease
Eligibility:
All Genders
35+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00146211
Start Date
September 1 2005
End Date
July 1 2007
Last Update
December 27 2007
Active Locations (41)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States
2
Mayo Clinic Arizona
Scottsdale, Arizona, United States
3
University of California San Diego
La Jolla, California, United States
4
UCLA Medical Center
Los Angeles, California, United States