Newron Pharmaceuticals announced last week the successful completion of patient enrollment in its Phase 2/3 trial of Sarizotan for the Treatment of Apneas in Rett Syndrome. The Company expects to report top line results from the trial in Q4 2019.
A very low rate of discontinuation due to adverse events or lack of efficacy was reported and approximately 90% of patients who completed the 6 month double-blind period continued in the long-term open-label extension study.
The 129 patient trial commenced in August 2016 and was held over 15 centres in United States, UK, Italy, India and Australia.
https://clinicaltrials.gov/ct2/show/NCT02790034?term=sarizotan&rank=1
https://www.news-medical.net/news/2...ion-of-patient-enrollment-in-STARS-study.aspx
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Ann: Plans for Phase 3 trial in Rett syndrome, page-51
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