Emalex Biosciences, a US-based company that was created by Paragon Biosciences to develop new treatments for central nervous system disorders, announced on Wednesday that it has dosed its first subject in its phase three clinical trial assessing ecopipam to treat Tourette Syndrome.
Participants in the trial receive ecopipam for 12 weeks in the open-label phase of the study. Those with at least a 25% reduction in the Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) at both week 8 and 12 will be randomised to continue on ecopipam or placebo in the double-blind phase of the study until they relapse, up to an additional 12 weeks. Efficacy will be assessed as the difference in time-to-relapse between groups.
Amanda Talty, Tourette Association of America president and CEO, said, 'Tourette Syndrome is a serious condition for which there is significant unmet need. Currently, the two classes of medicines commonly used to treat Tourette can have a number of concerning side effects. We are happy to see the progress of additional studies being conducted to test new treatment alternatives for our community.'
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