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The TREND-HD Study

Huntington Study Group TREND-HD Investigators

Arch Neurol. 2008;65(12):1582-1589.

Objective  To determine whether ethyl-eicosapentaenoic acid (ethyl-EPA), an -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

Author Affiliations: The Huntington Study Group TREND-HD Investigators and their affiliations are listed here.
Steering Committee: E. R. Dorsey (medical monitor), I. Shoulson (principal investigator), B. Leavitt (coprincipal investigator), C. Ross (coprincipal investigator), C. A. Beck, E. A. de Blieck (project coordinator), J. T. Greenamyre, S. M. Hersch, K. Kieburtz, K. Marder, C. McCallum (project coordinator), C. Moskowitz, D. Oakes, A. Rosenblatt, A. Shinaman.
Participating Site Investigators/Coordinators: Columbia University Medical Center, New York, New York: S. Frucht, K. Marder, and C. Moskowitz. The Johns Hopkins University, Baltimore, Maryland: R. Margolis. University of California San Diego: J. Corey-Bloom. Massachusetts General Hospital, Charlestown: S. M. Hersch and L. Mook. Rush University Medical Center, Chicago, Illinois: K. Shannon and J. Jaglin. University of South Florida, Tampa: J. Sanchez-Ramos. University of Alabama, Birmingham: L. S. Dure. Centre for Movement Disorders, Markham, Ontario, Canada: M. Guttman. North Shore–Long Island Jewish Health System, Manhasset, New York: A. Feigin and B. Shannon. University of Maryland School of Medicine, Baltimore: K. E. Anderson. Washington University, St. Louis, Missouri: B. A. Racette. Albany Medical College, Albany, New York: D. Higgins. Colorado Neurological Institute, Englewood: P. Agarwal, L. Seeberger, and S. Montellano. Ohio State University, Columbus: S. Kostyk and A. Seward. Struthers Parkinson's Center, Golden Valley, Minnesota: M. Nance. University of British Columbia, Vancouver, Canada: L. A. Raymond and J. Decolongon. University of Calgary, Calgary, Alberta, Canada: O. Suchowersky. University of Iowa, Iowa City: L. Beglinger and H. Paulson. University of Rochester, Rochester, New York: P. Como, R. Barbano, and C. Zimmerman. Indiana University School of Medicine, Indianapolis: J. Wojcieszek. London Health Sciences Centre, London, Ontario, Canada: M. Jog and C. Horn. University of Pennsylvania, Philadelphia: A. Colcher. University of California San Francisco: M. D. Geschwind. University of Kansas Medical Center, Kansas City: R. M. Dubinsky. University of Alberta, Edmonton, Canada: W. Martin and M. Wieler. University of Tennessee Health Science Center, Memphis: M. S. LeDoux. University of Virginia, Charlottesville: M. B. Harrison. Medical College of Georgia, Augusta: J. C. Morgan and B. Dill. University of Miami, Miami, Florida: C. Singer and M. Quesada. University of Michigan, Ann Arbor: N. Kartha and K. Wernette. Boston University, Boston, Massachusetts: S. Frank. University of Florida, Gainesville: H. Fernandez. Institute for Neurodegenerative Disorders, New Haven, Connecticut: D. Jennings and T. Kelsey. Baylor College of Medicine, Houston, Texas: C. Hunter.
Biostatistics/Coordination Center: University of Rochester, Rochester, New York: C. Beck, K. Bourgeois, E. A. de Blieck, L. Deuel, C. McCallum, N. McMullen, D. Oakes, V. Ross, L. Rumfola, A. Watts, C. Weaver, and T. Winebrenner.
Safety Monitoring Committee: Banner Alzheimer's Disease Center, Phoenix, Arizona: P. N. Tariot (chair). University of Rochester, Rochester: A. Watts.
Non-Huntington Study Group Authors and Sponsors: Amarin Neuroscience, London, England, sponsor: A. Clarke, N. Mallard, and R. Stewart. Since completion of the study, Clarke and Stewart have left Amarin Neuroscience. Bridge Biomedical Research and Consulting, San Francisco, California, sponsor medical monitor: B. Strausser. Avanti Research, Foster City, California, sponsor project management: D. Scott.

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