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Phase II Study (PVO-1A-201) Enrollment is Now Complete

DESCRIPTION Phase II, randomized, double-blind, placebo-controlled study evaluating the effect of different doses of palovarotene on new bone formation during and after a flare-up in people with FOP.
Efficacy and safety endpoints include imaging endpoints for new bone formation, clinical assessments of physical function and patient-reported outcomes
ELIGIBILITY CRITERIA
  • Age 6 or older
  • Experiencing a distinct flare-up of the shoulders, arms, hips or legs
  • Can start study medication within 7 days of flare-up onset
DESIGN
  • Up to 40 participants randomized to receive either palovarotene or placebo
  • 3:1 randomization ratio
  • 6 weeks of treatment, 6 weeks of follow-up
CLINICALTRIALS.GOV IDENTIFIER: NCT02190747
TRIAL ID NUMBER PVO-1A-201
Phase II Study Information (PDF)