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A Study to Document and to Further Describe Long-term Safety and Effectiveness of Palovarotene in Participants With Fibrodysplasia Ossificans Progressiva (FOP)

Study acronym: FOPal
StatusRecruiting
PhaseNot specified
SponsorIpsen
Started
View on ClinicalTrials.gov ↗

Record History

  1. Secondary endpoints: details revised at 11 of 29 entries Eligibility criteria expanded, about 5 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 5 words
  2. Re-verified, no change to tracked fieldsv27
  3. Site details revised at 1 of 5 sitesv26
  4. 2 versions Re-verified since Apr 29, 2026, no change to tracked fieldsv24-v25
  5. Site details revised at 2 of 5 sitesv23
Show 21 earlier versionsHide 21 earlier versions
  1. Re-verified, no change to tracked fieldsv22
  2. Site details revised at 3 of 5 sitesv21
  3. 3 versions Re-verified since Oct 29, 2025, no change to tracked fieldsv18-v20
  4. Primary completion date: Dec 31, 2033 to Dec 5, 2035 Enrollment target: 70 to 100 · Study sites: 3 to 5 · Completion date: Jan 31, 2034 to Dec 5, 2035 · 1 morev17 Show 4 more changesShow less
    • Enrollment target: 70 to 100
    • Study sites: 3 to 5
    • Completion date: Jan 31, 2034 to Dec 5, 2035
    • Secondary endpoints: 26 to 29

    See this version in full on ClinicalTrials.gov ↗

  5. 7 versions Re-verified since Jan 31, 2025, no change to tracked fieldsv10-v16
  6. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Dec 31, 2035 to Dec 31, 2033 · Study sites: 0 to 3 · Completion date: Dec 31, 2035 to Jan 31, 2034 · 1 morev9 Show 4 more changesShow less
    • Primary completion date: Dec 31, 2035 to Dec 31, 2033
    • Study sites: 0 to 3
    • Completion date: Dec 31, 2035 to Jan 31, 2034
    • Start date changed from estimate of Dec 31, 2024 to Dec 5, 2024
  7. Re-verified, no change to tracked fieldsv8
  8. Primary completion date: Dec 31, 2033 to Dec 31, 2035 Start date: Sep 30, 2024 to Dec 31, 2024 · Completion date: Jan 31, 2034 to Dec 31, 2035v7 Show 2 more changesShow less
    • Start date: Sep 30, 2024 to Dec 31, 2024
    • Completion date: Jan 31, 2034 to Dec 31, 2035
  9. Start date: Jul 15, 2024 to Sep 30, 2024v6
  10. Start date: Apr 15, 2024 to Jul 15, 2024v5
  11. Primary completion date: Dec 2033 to Dec 31, 2033 Completion date: Jan 2034 to Jan 31, 2034v4 Show 1 more changeShow less
    • Completion date: Jan 2034 to Jan 31, 2034
  12. Start date: Mar 2024 to Apr 15, 2024v3
  13. Start date: Jan 2024 to Mar 2024v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Ipsen
46 trials monitored
See 4 trials at risk
The participants in this registry study will have fibrodysplasia ossificans progressiva (FOP). FOP is an ultra-rare, severely disabling disease characterized by new bone formation in areas of the body where bone is not normally present (heterotopic ossification (HO)). HO is often preceded by painful, recurrent episodes of soft tissue swelling (flare-ups). This registry study will take place in countries where the treatment, known as palovarotene, has been approved for use. Participants will either be treated with palovarotene (i.e already be receiving palovarotene as prescribed by their treating physician according to locally approved product information) or untreated with palovarotene. The main aim of this registry study will be to collect and assess real-world safety data on children and adult participants with FOP treated with palovarotene. This registry study will also describe the effectiveness of palovarotene in exposed participants, including the effect on everyday activities and physical performance. In addition, this registry study aims to descriptively compare key safety outcomes (i.e. flare-up episodes, growth outcomes, and bone fractures) between participants exposed and unexposed to palovarotene.
Trial Details
NCT Number NCT06089616
Lead Sponsor Ipsen
Conditions Fibrodysplasia Ossificans Progressiva
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov