Randomized controlled trial of ethyl-eicosapentaenoic acid in Huntington disease: the TREND-HD study.

Abstract

OBJECTIVE:

To determine whether ethyl-eicosapentaenoic acid (ethyl-EPA), an omega-3 fatty acid, improves the motor features of Huntington disease.

DESIGN:

Six-month multicenter, randomized, double-blind, placebo-controlled trial followed by a 6-month open-label phase without disclosing initial treatment assignments.

SETTING:

Forty-one research sites in the United States and Canada.

PATIENTS:

Three hundred sixteen adults with Huntington disease, enriched for a population with shorter trinucleotide (cytosine-adenine-guanine) repeat length expansions.

INTERVENTIONS:

Random assignment to placebo or ethyl-EPA, 1 g twice a day, followed by open-label treatment with ethyl-EPA.

MAIN OUTCOME MEASURES:

Six-month change in the Total Motor Score 4 component of the Unified Huntington's Disease Rating Scale analyzed for all research participants and those with shorter cytosine-adenine-guanine repeat length expansions (<45).

RESULTS:

At 6 months, the Total Motor Score 4 point change for patients receiving ethyl-EPA did not differ from that for those receiving placebo. No differences were found in measures of function, cognition, or global impression. Before public disclosure of the 6-month placebo-controlled results, 192 individuals completed the open-label phase. The Total Motor Score 4 change did not worsen for those who received active treatment for 12 continuous months compared with those who received active treatment for only 6 months (2.0-point worsening; P=.02).

CONCLUSION:

Ethyl-EPA was not beneficial in patients with Huntington disease during 6 months of placebo-controlled evaluation. Clinical Trial Registry clinicaltrials.gov Identifier: NCT00146211.

• Authors: Huntington Study Group TREND-HD Investigators
• Journal: Archives of neurology (Arch Neurol) Vol. 65 Issue 12 Pg. 1582-9 (Dec 2008) ISSN: 1538-3687 [Electronic] United States
• PMID: 19064745 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• eicosapentaenoic acid ethyl ester
• Eicosapentaenoic Acid

Topics

• Adult
• Analysis of Variance
• Canada
• Double-Blind Method
• Eicosapentaenoic Acid (analogs & derivatives, therapeutic use)
• Female
• Follow-Up Studies
• Humans
• Huntington Disease (drug therapy, genetics, physiopathology)
• Male
• Middle Aged
• Neuropsychological Tests
• Severity of Illness Index
• Treatment Outcome
• Trinucleotide Repeat Expansion (genetics)
• United States