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

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amarin Neuroscience Ltd
• Collaborator: Huntington Study Group
• Treatments: Eicosapentaenoic acid ethyl ester

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