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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: Clinical Trial Phase 2 study, sponsored by Clementia Pharmaceuticals.
NCT02521792 is a Phase 2 study that was terminated before completion, run by Clementia Pharmaceuticals. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary endpoint was the safety of palovarotene as assessed by the incidence of TEAEs (including those known to be associated with retinoids) and serious adverse event (SAEs) monitored throughout the treatment period. TEAEs were adverse events reported during treatment with palovarotene or within 6 weeks after the end of treatment. Day 1 was the first day that study drug was administered for a flare-up. The number of subjects experiencing at least one TEAE or treatment-emergent SAE are prese
Interventions
- DRUG Palovarotene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2015-12-07 |
| Est. Completion | 2016-08-04 |
| Phase | Phase 2 |
Why NCT02521792 stopped before completion
NCT02521792 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Palovarotene is the first listed.
NCT02521792 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02521792's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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