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Special Protocol Assessment for Miraxion in Huntington's Disease Cleared by FDA
Rick Stewart, Chief Executive Officer of Amarin, commented; "Reaching agreement with the FDA on the trial designs is a positive development for Amarin. This is a major milestone for the company and we look forward to immediate enrollment in the U.S. trial."
The U.S. and European trials will be multi-centre, randomized, double blind, placebo -controlled studies of Miraxion at 43 sites in the U.S. and up to 28 sites in Europe. The trials are expected to involve a total of up to 540 Huntington's disease patients with approximately 300 in the U.S. Phase III trial and approximately 240 in the European Phase III trial over a 6 month period. Patients in the U.S. trial will participate in a further 6-month extension period.
The Huntington Study Group (H.S.G.), based at the University of Rochester, will conduct the U.S. clinical trial on behalf of Amarin. The H.S.G. is a non-profit group of physicians and other health care providers from medical centers in the U.S., Canada, Europe and Australia, experienced in the care of Huntington's disease patients and dedicated to clinical research of Huntington's disease. The European clinical trial will be conducted in collaboration with EURO-HD and ICON, a leading contract research organization (CRO). EURO-HD is a non-profit group of physicians and other healthcare professionals dedicated to the research and care of Huntington's disease patients.
The primary endpoint of the trials will be to determine whether Miraxion taken 2 grams per day (1gram twice daily) results in clinically and statistically significant changes in the Total Motor Score-4 subscale of the Unified Huntington's Disease Rating Scale (UHDRS).
Source: Amarin Corporation