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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)
NCT06089616 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Study Locations (5)
Other
- Edmonton Clinic Health Academy (ECHA)- University of Alberta — Edmonton
- Bone Research and Education Centre — Oakville
- University Health Network (UHN) - Toronto General — Toronto
California
- The Regents of the University of California — San Francisco
Pennsylvania
- The Trustees of the University of Pennsylvania, Office of Clinical Research-Legal Services, Perelman School of Medicine — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-12-05 |
| Est. Completion | 2035-12-05 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06089616
The ClinicalTrials.gov registry entry for NCT06089616 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ipsen, which has 205 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Fibrodysplasia Ossificans Progressiva appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06089616 reports 5 study locations spanning 3 distinct geographic areas — top geographies include Other, California, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06089616 about?
NCT06089616 is a clinical study titled "A Study to Document and to Further Describe Long-term Safety and Effectiveness of Palovarotene in Participants With Fibrodysplasia Ossificans Progressiva (FOP)". 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 painf...
What is the current status of trial NCT06089616?
This trial is currently recruiting. The enrollment target is 100 participants. The study started on 2024-12-05. Estimated completion is 2035-12-05.
What conditions does trial NCT06089616 study?
This clinical trial studies the following conditions: Fibrodysplasia Ossificans Progressiva. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT06089616?
This trial is sponsored by Ipsen, which has 205 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06089616 being conducted?
This trial has 5 study locations across California, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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