Huntington Study Group and the European Huntington’s Disease Network Announce Preliminary Results of Two Phase III Studies of Ethyl-EPA (Miraxion) for the Treatment of Huntington Disease
Rochester, New York and
Ulm, Germany – April 25, 2007
The Huntington Study Group (HSG) and the European Huntington’s Disease Network (EHDN) announce the preliminary results of two phase III studies of Ethyl-EPA (Miraxion), an omega-3 fatty acid, for people with Huntington´s Disease. These clinical trials were conducted in North America by the HSG, and in Europe by EHDN.
Neither study showed a statistically significant differences in the
pre-specified primary or secondary endpoints between patients receiving
ethyl-EPA (one gram twice daily) or placebo for 6 months.
Huntington disease (HD) is an inherited disease affecting the brain
that usually begins between the ages of 30 to 50, and includes motor,
cognitive and behavioral symptoms and signs. About 30,000 people living
in North America and approximately 38,000 people in Europe are directly
affected by HD, and more than 300,000 people are
immediately at risk for having inherited the altered gene that causes
the disease. While there are medications to help relieve some disease
symptoms, there are no treatments to slow the progression of this fatal
Ethyl-EPA is an omega-3 fatty acid commonly found in fish oil. Research
physicians at 41 North American sites of the HSG
evaluated 316 research participants in the 6-month TREND-HD study. The primary
outcome measure was Total Motor Score-4 (TMS-4), a subset of the
Unified Huntington Disease Rating Scale, designed to assess the degree
of motor impairment in people with Huntington disease. There was no
significant benefit of ethyl-EPA on the TMS-4 nor were there any significant safety concerns.
In the European study, research physicians in 27 sites of the EHDN evaluated 290 research participants in a
6-month study. The primary outcome was also the TMS-4. No significant
benefit of ethyl-EPA on the TMS-4 was found nor was there evidence in
the preliminary analysis of any major safety concern. In both studies,
ethyl-EPA appeared to be well-tolerated.
Ira Shoulson, the HSG Principal Investigator said 'We are disappointed
by the preliminary results of these studies but need to examine the
findings in more detail. We are grateful for the commitment of our
research participants, and are proud of the high-quality data obtained
in the trials. We remain committed to investigating experimental
treatments that will make a difference in the lives of those affected
by Huntington disease.'
Bernhard Landwehrmeyer, the EHDN Principal Investigator said 'The
Ethyl-EPA trials in North America and Europe combined enrolled the
largest number of research participants in any Huntington disease
therapeutic trial to date and provided clear and unequivocal answers,
although not the answers we hoped for. We are disappointed that no
novel treatment option for patients affected with Huntington disease
emerged from these large studies. Clearly there is a need for further
analysis to understand why the results obtained differed from those of
an earlier smaller study. EHDN will continue to support and conduct
clinical studies and research projects that clarify conclusively what
treatments benefit people affected by Huntington disease.'
In the coming weeks and months, the HSG and EHDN will conduct
additional in-depth analyses and disseminate these results to research
participants, investigators, the HD community, and the scientific
The Huntington Study Group
is a non-profit cooperative group of Huntington’s disease experts from
medical centers in the United States, Canada, Europe and Australia who
are dedicated to improving treatment for persons affected by
Huntington’s disease. For more information, please visit our website.
The European Huntington’s Disease Network
is an independent, non-profit network of clinicians, scientists and
family members that aims to advance knowledge of Huntington's disease
("HD"). The EHDN supports scientific and clinical efforts to develop
and test therapeutic interventions that will improve the quality of
life of people with HD. EHDN serves as a platform for clinicians,
scientists and organizations for families affected by HD to collaborate
in support of preclinical and clinical research on HD.
For further information, please contact:
For HSG Ira Shoulson, MD Leslie Briner University of Rochester Phone: +1 585 273 4147