272. Fibrodysplasia ossificans progressiva
[
9 clinical trials,
7 drugs（DrugBank:
2 drugs),
8 target genes / 42 target pathways ]
Searched query = "Fibrodysplasia ossificans progressiva"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03188666 | February 26, 2018 | 23 April 2019 | A Study to Examine the Safety, Tolerability and Effects on Abnormal Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva | A Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effects on Heterotopic Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva | Fibrodysplasia Ossificans Progressiva | Drug: REGN2477;Drug: Matching placebo | Regeneron Pharmaceuticals | Not recruiting | 18 Years | 60 Years | All | 44 | Phase 2 | United States;Colombia;Italy;Netherlands;United Kingdom | |
| 2 | EUCTR2017-002541-29-ES | 14/11/2017 | 19 February 2018 | A clinical trial to evaluate the Efficacy and Safety of Oral Palovarotene as a treatment for Fibrodysplasia Ossificans Progressiva (FOP) | A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP) - MOVE Trial | Fibrodysplasia Ossificans Progressiva (FOP) MedDRA version: 20.0 Level: PT Classification code 10068715 Term: Fibrodysplasia ossificans progressiva System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: PALOVAROTENE Pharmaceutical Form: Capsule, hard INN or Proposed INN: PALOVAROTENE CAS Number: 410528-02-8 Other descriptive name: PALOVAROTENE Concentration unit: mg milligram(s) Concentration type: range Concentration number: 1-10 | Clementia Pharmaceuticals Inc | Authorised | Female: yes Male: yes | 80 | Phase 3 | Sweden;Japan;Germany;Netherlands;South Africa;Australia;Brazil;Argentina;Canada;France;Italy;United Kingdom;Russian Federation;Spain;United States | |||
| 3 | EUCTR2017-002541-29-FR | 28 February 2019 | A clinical trial to evaluate the Efficacy and Safety of Oral Palovarotene as a treatment for Fibrodysplasia Ossificans Progressiva (FOP) | A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP) - MOVE Trial | Fibrodysplasia Ossificans Progressiva (FOP) MedDRA version: 20.0 Level: PT Classification code 10068715 Term: Fibrodysplasia ossificans progressiva System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: PALOVAROTENE Pharmaceutical Form: Capsule, hard INN or Proposed INN: PALOVAROTENE CAS Number: 410528-02-8 Other descriptive name: PALOVAROTENE Concentration unit: mg milligram(s) Concentration type: range Concentration number: 1-10 | Clementia Pharmaceuticals Inc | Not Available | Female: yes Male: yes | 80 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Brazil;Australia;South Africa;Netherlands;Germany;Japan;Sweden | ||||
| 4 | NCT02979769 | November 2016 | 11 February 2019 | An Open-Label Extension Study of Palovarotene to Prevent Heterotopic Ossification in FOP Subjects in France | A Phase 2, Open-Label, Efficacy and Safety Study of an RAR? Specific Agonist (Palovarotene) to Prevent Heterotopic Ossification in Subjects With Fibrodysplasia Ossificans Progressiva (FOP) | Fibrodysplasia Ossificans Progressiva | Drug: Palovarotene dose level 1;Drug: Palovarotene dose level 2 | Clementia Pharmaceuticals Inc. | Not recruiting | 6 Years | 65 Years | All | 17 | Phase 2 | France | |
| 5 | NCT02521792 | January 2016 | 4 November 2019 | In-Home Evaluation of Episodic Administration of Palovarotene in Fibrodysplasia Ossificans Progressiva (FOP) Subjects | A Phase 2, In-Home, Safety and Efficacy Evaluation of Episodic Administration of Open-Label Palovarotene in Subjects With Fibrodysplasia Ossificans Progressiva (FOP) | Fibrodysplasia Ossificans Progressiva | Drug: Palovarotene | Clementia Pharmaceuticals Inc. | Not recruiting | 6 Years | 65 Years | All | 40 | Phase 2 | United States;France;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2016-002526-36-FR | 28 February 2019 | Study of an Investigational Drug, Palovarotene, in the prevention of Preosseous Flare-ups in Subjects with Fibrodysplasia Ossificans Progressiva (FOP) | A Phase 2, Open-Label, Efficacy and Safety Study of an RAR?-Specific Agonist (Palovarotene) to Prevent Heterotopic Ossification in Subjects with Fibrodysplasia Ossificans Progressiva (FOP) | Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) and abnormal heterotopic ossification (HO) in muscles, tendons, and ligaments. Lesions begin in early childhood and lead to progressive ankyloses of major joints with resultant loss of movement. Prognosis is poor and median life expectancy is 40 years. MedDRA version: 19.0 Level: PT Classification code 10068715 Term: Fibrodysplasia ossificans progressiva System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Palovarotene Product Code: Palovarotene Pharmaceutical Form: Capsule, hard INN or Proposed INN: Palovarotene CAS Number: 410528-02-8 Other descriptive name: Palovarotene Concentration unit: mg milligram(s) Concentration type: range Concentration number: 2.5-10 | Clementia Pharmaceuticals Inc. | Not Recruiting | Female: yes Male: yes | 17 | Phase 2 | France | ||||
| 7 | NCT02279095 | October 2014 | 11 February 2019 | An Open-Label Extension Study of Palovarotene Treatment in FOP | A Phase 2, Open-Label Extension, Efficacy and Safety Study of a RAR? Specific Agonist (Palovarotene) in the Treatment of Preosseous Flare-ups in Subjects With Fibrodysplasia Ossificans Progressiva (FOP) | Fibrodysplasia Ossificans Progressiva | Drug: Palovarotene dose level 1;Drug: Palovarotene dose level 2;Drug: Palovarotene dose level 3;Drug: Palovarotene dose level 4 | Clementia Pharmaceuticals Inc. | Not recruiting | 6 Years | 65 Years | All | 58 | Phase 2 | United States;Argentina;Australia;France;United Kingdom | |
| 8 | NCT02190747 | July 2014 | 16 December 2017 | An Efficacy and Safety Study of Palovarotene to Treat Preosseous Flare-ups in FOP Subjects | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of a RAR?-Specific Agonist (Palovarotene) in the Treatment of Preosseous Flare-ups in Subjects With Fibrodysplasia Ossificans Progressiva (FOP) | Fibrodysplasia Ossificans Progressiva | Drug: Palovarotene;Drug: Placebo | Clementia Pharmaceuticals Inc. | Not recruiting | 6 Years | N/A | All | 40 | Phase 2 | United States;France;United Kingdom | |
| 9 | JPRN-UMIN000019348 | 2010/07/01 | 2 April 2019 | Approved calcium channel blocker in the treatment of fibrodysplasia ossificans progressiva (FOP) | fibrodysplasia ossificans progressiva | oral administration of perhexiline maleate for one year | Nagoya University Graduate School of Medicine | Not Recruiting | 15years-old | 65years-old | Male and Female | 5 | Phase 1,2 | Japan |