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

Study Overview
=================
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.

Official Title
-----------------
A Multicenter, Double Blind, Randomized, Parallel Group, Placebo-Controlled Trial of Ethyl-EPA (Miraxion™) in Subjects With Mild to Moderate Huntington's Disease

Conditions
-----------------
Huntington Disease

Intervention / Treatment
-----------------
* Drug: Ethyl-EPA (Miraxion™)


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ethyl-EPA (Miraxion™)|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trial, ethyl-EPA, Miraxion™, treating, mild, moderate, Huntington's