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

A

Amarin

Status and phase

Completed
Phase 3

Conditions

Huntington Disease

Treatments

Drug: Ethyl-EPA (Miraxion™)

Study type

Interventional

Funder types

NETWORK
Industry

Identifiers

NCT00146211
AN01.01.0011

Details and patient eligibility

About

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

Full 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.

Enrollment

300 patients

Sex

All

Ages

35+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

41

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Data sourced from clinicaltrials.gov

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