Clementia

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MOVE Clinical Trial 

Phase III

In October 2016, pharmaceutical company Clementia announced the top-line results of its phase II study of palovarotene. The drug has shown positive trends in reducing bone formation and the pain and severity of flare-ups in those with FOP. Although these trends were not found to be statistically significant, this is still positive news. Showing that something is statistically significant is a challenge for all trials of rare diseases, where the number of participants (40 in this trial) makes it harder to prove significant trends. Clementia then extended its phase 2 study of palovarotene to test new dosing regimens and recruited 20 new trial participants. 

The phase II program is now complete. Data collected from this program supported the U.S. Food & Drug Administration (FDA) designation of palovarotene as Breakthrough Therapy. This is granted when preliminary clinical evidence suggests that the drug may demonstrate substantial improvemt over other available therapies. 

In December 2017, the first FOP patient was enrolled onto Clementia's Phase III MOVE Trial. Clementia are currently recruiting approximately 80 individuals to take part in the phase III trial, which is a global, open-label (no placebo) trial. Trials will be conducted internationally, with proposed sites located in countries such as France, Germany, USA, and the UK. 

Clinical Trial Overview 
Study  Drug  Phase  Duration  Enrollement Age Method Dosing
 MOVE  Palovarotene  Phase III  24-months 4-years-old and above Oral (Pill) Daily

More details regarding UK trial sites will be posted here as soon as they are available. 

Click here to visit Clementia's official site to find out more information and have some of your common FAQs answered before you, or someone you know, decides to commit to the trial.

For an in-depth overview, click here.

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