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New registry tracks Real-World safety of FOP drug palovarotene

NCT ID NCT06089616

Knowledge-focused Sponsor: Ipsen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 01, 2026 · Updated 4 times

Summary

This registry study follows about 100 people with FOP, a rare disease where soft tissue turns to bone. Some participants take palovarotene (an approved treatment), while others do not. Researchers will track side effects, flare-ups, and daily function over time to see how well the drug works in real life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
palovarotene
What this could lead to
If successful, this study could confirm that palovarotene is safe and helps manage FOP symptoms in the real world, supporting its continued use.
What could go wrong
This is an observational registry, not a controlled trial, so results may be less definitive. It only includes people already prescribed the drug, which may introduce bias.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Dec 2035

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adults and children with FOP who have been prescribed palovarotene, as per local label, by their treating physician for which informed consent has been obtained and maintained. Participants cannot be included if they are currently participating in a palovarotene clinical trial or an interventional clinical trial for FOP or if they have any contraindication for palovarotene (except for pregnant women who have previously received and discontinued palovarotene at any time during the pregnancy and who will be included for safety follow-up).

Ages

8 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria : * Adult or child with FOP who have been prescribed palovarotene (prior to and independently of the decision to enroll the patient in this registry study and as per local label) by their treating physician according to the locally approved product information; * Signed informed consent as per local regulations must be obtained and maintained. Consent/assent from the participant should be obtained as appropriate before any registry study data collection are conducted. If applicable, parents or legally authorized representatives must give signed informed consent. Exclusion Criteria : * Currently participating in a palovarotene clinical trial; * Currently participating in any interventional clinical trial for FOP; * Have any contraindication to palovarotene as per the locally approved label (except for pregnant women who have previously received and discontinued palovarotene at any time during the pregnancy and who will be included for safety follow-up).

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Conditions

The condition(s) this trial relates to.

fibrodysplasia ossificans progressiva myositis ossificans

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fibrodysplasia ossificans progressiva

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bone Research and Education Centre

    ACTIVE_NOT_RECRUITING

    Oakville, Canada

  • Edmonton Clinic Health Academy (ECHA)- University of Alberta

    RECRUITING

    Edmonton, Canada

  • The Regents of the University of California

    RECRUITING

    San Francisco, California, 94103, United States

  • The Trustees of the University of Pennsylvania, Office of Clinical Research-Legal Services, Perelman School of Medicine

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University Health Network (UHN) - Toronto General

    RECRUITING

    Toronto, Canada

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