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NCT02521792 · ClinicalTrials.gov registry record · Phase 2
In-Home Evaluation of Episodic Administration of Palovarotene in Fibrodysplasia Ossificans Progressiva (FOP) Subjects
A Phase 2 study, sponsored by Clementia Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT02521792 is a Phase 2 study that was terminated before completion, run by Clementia Pharmaceuticals. The registered enrollment target is 6 participants.
The verdict
NCT02521792, a Phase 2 study, was terminated before completion, sponsored by Clementia Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result in abnormal bone formation (heterotopic ossification or HO) in muscles, tendons, and ligaments. Flare-ups begin early in life and may occur spontaneously or after soft tissue trauma, vaccinations, or influenza infections. Recurrent flare-ups progressively restrict movement by locking joints leading to cumulative loss of function and disability. Mouse models of FOP have demonstrated the ability of retinoic acid receptor gamma (RARγ) agonists such as palovarotene to prevent HO following injury. This 36-month study will evaluate the long-term safety and efficacy of episodic treatment with palovarotene for flare-ups in FOP subjects who successfully complete two flare-up treatment periods (6 weeks duration) and two follow-up periods (6 weeks duration) in Study PVO-1A-202.
Interventions
- DRUG Palovarotene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2015-12-07 |
| Est. Completion | 2016-08-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02521792
The ClinicalTrials.gov registry entry for NCT02521792 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Clementia Pharmaceuticals, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Palovarotene is the first listed.
NCT02521792 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02521792 about?
NCT02521792 is a clinical study titled "In-Home Evaluation of Episodic Administration of Palovarotene in Fibrodysplasia Ossificans Progressiva (FOP) Subjects". Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result in abnormal bone formation (heterotopic ossification or HO) in muscles, tendons, and ligaments. Flare-ups begin early in life...
What is the current status of trial NCT02521792?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2015-12-07. Estimated completion is 2016-08-04.
What interventions are being tested in trial NCT02521792?
The interventions under investigation include: Palovarotene (DRUG).
Who is sponsoring clinical trial NCT02521792?
This trial is sponsored by Clementia Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
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