First of all we would like to thank all participants again for deciding to take part in this clinical trial – without your willingness to take part in clinical studies, nobody will know whether novel treatments for HD are of benefit or not.
We are committed to spread the results as soon as they become available. Amarin Neuroscience, the sponsor of the Ethyl-EPA (Miraxion) Study in Europe and of the TREND HD Study in North America announced on Tuesday, April 24th, 2007 by a press release the first results of both studies. Information can also be found on the HSG website http://www.huntington-study-group.org
and in dialogue with the study site personnel.
The studies were designed to find out whether treatment with Ethyl-EPA, related to omega-3 fatty acid commonly found in fish oil, improves the motor impairment in HD, in particular chorea. The main results of these studies are as follows: unfortunately, after six months of treatment, patients on Ethyl-EPA did not display less motor impairment than patients on placebo. In addition, a first look at other aspects of HD (e.g. overall function and cognition) did not suggest a major benefit of Ethyl-EPA treatment during the six months of observation. On the other hand, treatment with Ethyl-EPA did not result in serious unwanted effects and can be considered safe and well tolerated by people affected by HD.
Despite the disappointment that Ethyl-EPA did not work as hoped based
on a first study conducted in North America, one should keep in mind,
that the Ethyl-EPA trial in Europe and the TREND HD Study combined
represent one of the largest trials in HD patients and helped to
clarify the potential benefits of a novel treatment for HD in a clear
and unequivocal way. This gives reasons to expect that future trials in
HD using different compounds can be conducted successfully and with
conclusive results - hopefully though with a better outcome.
For participants in the open label extension phase:
Since you are participating in the open label extension phase of the
Ethyl-EPA Study you may wonder whether you should continue to take
Ethyl-EPA and first of all, since Ethyl-EPA can be regarded as safe and
well tolerated, we suggest that you consider continuing the open label
extension phase until the more detailed analysis has been completed. At
this point in time nobody knows whether treatment for more than six
months may have beneficial effects not seen in the 6 month study, thus
providing a reason to continue observations. Furthermore, there has not
been time as yet to explore why the results of the large study you have
been involved in and the TREND-HD study appear to be different to the
first smaller study. It is clear, however, that the ultimate decision
rests with you. We advise that you discuss this point with your Study
Site Investigator at the occasion of your next contact or visit to the