We were incredibly excited to share that TEMPO, the Harmony Biosciences phase three trial of Pitolisant in people with PWS, is coming to Australia. PWRFA has been working behind the scenes for months to make this trial happen and for years to build the overall clinical trial ecosystem in Australia.
TEMPO is a randomised, double blind, placebo-controlled trial, that will include an open-label extension phase. The TEMPO study will investigate the impact of Pitolisant on excessive daytime sleepiness and behaviour in PWS. The study seeks to recruit 134 people globally, with multiple trial sites located around Australia. To read more information about Harmony Biosciences and Pitolisant see here https://www.harmonybiosciences.com/science/.
We at PWRFA are incredibly grateful for this opportunity as trials within Australia are hard to procure due to our natural geographical isolation, our smaller population size and clinician workforce.
We will keep you up to date with all the latest information as it becomes more available.
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