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

Completed · Phase 3

Conditions studied: Huntington Disease

In brief

This study is designed to determine the effect of 2 gram/day of ethyl-EPA on motor (movement) signs and symptoms of Huntington disease.

Key facts

Study ID

NCT00146211

Run by

Amarin Neuroscience Ltd

People needed

300

Starts

2005-09-01

Expected to finish

2007-07-01

Last updated by the study team

2007-12-27

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• University of South Florida — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Medical College of Georgia — Augusta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Kansas — Kansas City, Kansas, United States
• Hereditary Neurological Disease Centre — Wichita, Kansas, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Boston University — Boston, Massachusetts, United States
• Massachusetts General Hospital — Charlestown, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Albany Medical College — Albany, New York, United States

Full record on ClinicalTrials.gov

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