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 272. 進行性骨化性線維異形成症 [臨床試験数:9,薬物数:7(DrugBank:2),標的遺伝子数:4,標的パスウェイ数:4] 

Searched query = "Fibrodysplasia ossificans progressiva"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03188666February 26, 201823 April 2019A Study to Examine the Safety, Tolerability and Effects on Abnormal Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans ProgressivaA Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effects on Heterotopic Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans ProgressivaFibrodysplasia Ossificans ProgressivaDrug: REGN2477;Drug: Matching placeboRegeneron PharmaceuticalsNot recruiting18 Years60 YearsAll44Phase 2United States;Colombia;Italy;Netherlands;United Kingdom
2EUCTR2017-002541-29-ES14/11/201719 February 2018A 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 TrialFibrodysplasia 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 IncAuthorisedFemale: yes
Male: yes
80Phase 3Sweden;Japan;Germany;Netherlands;South Africa;Australia;Brazil;Argentina;Canada;France;Italy;United Kingdom;Russian Federation;Spain;United States
3EUCTR2017-002541-29-FR28 February 2019A 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 TrialFibrodysplasia 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 IncNot Available Female: yes
Male: yes
80Phase 3United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Brazil;Australia;South Africa;Netherlands;Germany;Japan;Sweden
4NCT02979769November 201611 February 2019An Open-Label Extension Study of Palovarotene to Prevent Heterotopic Ossification in FOP Subjects in FranceA 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 ProgressivaDrug: Palovarotene dose level 1;Drug: Palovarotene dose level 2Clementia Pharmaceuticals Inc.Not recruiting6 Years65 YearsAll17Phase 2France
5NCT02521792January 20164 November 2019In-Home Evaluation of Episodic Administration of Palovarotene in Fibrodysplasia Ossificans Progressiva (FOP) SubjectsA Phase 2, In-Home, Safety and Efficacy Evaluation of Episodic Administration of Open-Label Palovarotene in Subjects With Fibrodysplasia Ossificans Progressiva (FOP)Fibrodysplasia Ossificans ProgressivaDrug: PalovaroteneClementia Pharmaceuticals Inc.Not recruiting6 Years65 YearsAll40Phase 2United States;France;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2016-002526-36-FR28 February 2019Study 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
17Phase 2France
7NCT02279095October 201411 February 2019An Open-Label Extension Study of Palovarotene Treatment in FOPA 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 ProgressivaDrug: Palovarotene dose level 1;Drug: Palovarotene dose level 2;Drug: Palovarotene dose level 3;Drug: Palovarotene dose level 4Clementia Pharmaceuticals Inc.Not recruiting6 Years65 YearsAll58Phase 2United States;Argentina;Australia;France;United Kingdom
8NCT02190747July 201416 December 2017An Efficacy and Safety Study of Palovarotene to Treat Preosseous Flare-ups in FOP SubjectsA 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 ProgressivaDrug: Palovarotene;Drug: PlaceboClementia Pharmaceuticals Inc.Not recruiting6 YearsN/AAll40Phase 2United States;France;United Kingdom
9JPRN-UMIN0000193482010/07/012 April 2019Approved calcium channel blocker in the treatment of fibrodysplasia ossificans progressiva (FOP)fibrodysplasia ossificans progressivaoral administration of perhexiline maleate for one yearNagoya University Graduate School of MedicineNot Recruiting15years-old65years-oldMale and Female5Phase 1,2Japan

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