At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 107 enrolled
Drug / intervention
Palovarotenedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP)
In Brief
A Phase 3 clinical trial evaluating Palovarotene for Fibrodysplasia Ossificans Progressiva. Completed, enrolled 107 participants across 16 sites in 11 countries.
Detailed Summary
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by heterotopic ossification (HO) often associated with painful, recurrent episodes of soft tissue swelling (flare-ups) that lead to ankyloses of major joints with cumulative and irreversible loss of movement and disability.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibrodysplasia Ossificans Progressiva
CountriesArgentina, Australia, Brazil, Canada, France, Italy, Japan, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedOct 2017
Enrollment StartNov 2017
Primary CompletionJan 2020
Study CompletionSep 2022
TodayJul 2026
First PostedOct 18, 2017
Enrollment StartNov 30, 2017
Primary CompletionJan 24, 2020
Study CompletionSep 7, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.7 years ago
Interventions
Palovarotenedrug
Palovarotene was taken orally once daily at approximately the same time each day following a meal.