Randomized controlled trial of ethyl-eicosapentaenoic acid in Huntington disease: the TREND-HD study
Huntington Study Group TREND-HD Investigators
Archives of neurology · 77 citas
Etiquetas de revisión
Financiación no declaradaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2008-12-01 · Arch Neurol · vol. 65 · número 12 · págs. 1582–9
- Editorial
- American Medical Association
- Citado
- 50 citas · más que el 77% de estudios similares · 1.3× el promedio de su campo
- Referencias
- 0 trabajos
- Acceso
- De pago
- Áreas de investigación
- Genetic Neurodegenerative Diseases · Fatty Acid Research and Health · Parkinson's Disease Mechanisms and Treatments
- Palabras clave
- Huntington's disease, omega-3 fatty acids, motor symptoms, Unified Huntington's Disease Rating Scale, CAG repeat expansion, open-label extension, dietary supplementation
- MeSH
- humans, huntington disease, eicosapentaenoic acid, treatment outcome, severity of illness index, analysis of variance, follow-up studies, double-blind method, neuropsychological tests, trinucleotide repeat expansion, adult, middle aged, canada, united states, female, male
1 autor
- Huntington Study Group TREND-HD Investigators · autor de correspondencia
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
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