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An Open-Label Extension Study of Palovarotene Treatment in Fibrodysplasia Ossificans Progressiva (FOP)

NCT02279095 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2025-02-19

Study results available
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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.

Conditions

Interventions

DRUG

Palovarotene dose level 1

Palovarotene was taken orally once daily at approximately the same time each day.

DRUG

Palovarotene dose level 2

Palovarotene will be taken orally once daily at approximately the same time each day.

DRUG

Palovarotene dose level 3

Palovarotene will be taken orally once daily at approximately the same time each day.

DRUG

Palovarotene dose level 4

Palovarotene will be taken orally once daily at approximately the same time each day.

Sponsors & Collaborators

  • Clementia Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-09
Primary Completion
2022-09-20
Completion
2022-09-20
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • France
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02279095 on ClinicalTrials.gov