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DESCRIPTION A Phase III, multicenter, single treatment arm study evaluating the safety and efficacy of palovarotene for the treatment of FOP.
ELIGIBILITY CRITERIA Participants must:

  • Be clinically diagnosed with FOP, ages of 4 and above
  • Have the R206H mutation (genetic testing available)
  • Reside in one of the countries where a clinical site is located, due to regulatory requirements (please see clinicaltrials.gov for an updated list of sites)
  • Have been flare-up free the 4 weeks before enrolling
  • Can undergo all study procedures, including low-dose whole-body CT (WBCT) scans
  • Meet all other enrollment criteria (please see clinicaltrials.gov)
DESIGN We intend to enroll 80 participants. All participants will take palovarotene daily for 24 months, with increased dosing in the event of a flare up.

  • Chronic treatment: All participants will receive 5 mg of palovarotene once daily for 24 months.
  • Flare-up treatment: In the event of a flare-up, participants will receive 20 mg palovarotene once daily for 4 weeks, followed 10 mg palovarotene once daily for 8 weeks, (which may be extended by the investigator until the flare-up has resolved).
  • All dosing will be weight-adjusted for those under the age of 18 years who have not reached skeletal maturity.
  • No placebo will be administered.

Participants are required to visit the clinical site at enrollment, and at months 6, 12, 18 and  24 during which they will undergo WBCT scans and other assessments. Safety assessments will be performed at months 3, 9, 15 and 21 at the participant’s home.

CLINICALTRIALS.GOV IDENTIFIER: NCT03312634
TRIAL ID NUMBER  PVO-1A-301
CONTACT CLEMENTIA To contact Clementia for more information on the MOVE study, please click here.