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NCT02279095 · ClinicalTrials.gov registry record · Phase 2
An Open-Label Extension Study of Palovarotene Treatment in Fibrodysplasia Ossificans Progressiva (FOP)
A Phase 2 study, sponsored by Clementia Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
NCT02279095 is a Phase 2 study that has completed, run by Clementia Pharmaceuticals. The registered enrollment target is 58 participants.
The verdict
NCT02279095, a Phase 2 study, has completed, sponsored by Clementia Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
Study Summary
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by heterotopic ossification (HO), i.e., abnormal bone formation, often associated with painful, recurrent episodes of soft tissue swelling (flare-ups). Lesions begin in early childhood and lead to progressive ankyloses of major joints with resultant loss of movement. In this study, the ability of different palovarotene dosing regimens to prevent the formation of new HO will be evaluated in adult and pediatric participants with FOP.
Interventions
- DRUG Palovarotene dose level 1
- DRUG Palovarotene dose level 2
- DRUG Palovarotene dose level 3
- DRUG Palovarotene dose level 4
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2014-10-09 |
| Est. Completion | 2022-09-20 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02279095
The ClinicalTrials.gov registry entry for NCT02279095 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 58 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 4 interventions - of which Palovarotene dose level 1 is the first listed.
NCT02279095 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02279095 about?
NCT02279095 is a clinical study titled "An Open-Label Extension Study of Palovarotene Treatment in Fibrodysplasia Ossificans Progressiva (FOP)". Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by heterotopic ossification (HO), i.e., abnormal bone formation, often associated with painful, recurrent episodes of soft tissue swelling (flare-ups). Lesions begin in early childhood and lead to progres...
What is the current status of trial NCT02279095?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2014-10-09. Estimated completion is 2022-09-20.
What interventions are being tested in trial NCT02279095?
The interventions under investigation include: Palovarotene dose level 1 (DRUG), Palovarotene dose level 2 (DRUG), Palovarotene dose level 3 (DRUG), Palovarotene dose level 4 (DRUG).
Who is sponsoring clinical trial NCT02279095?
This trial is sponsored by Clementia Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
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