Palovarotene    (DrugBank: Palovarotene)

1 disease
IDDisease name (Link within this page)Number of trials
272Fibrodysplasia ossificans progressiva14

272. Fibrodysplasia ossificans progressiva    [ 23 clinical trials,   21 drugs,   (DrugBank: 4 drugs),   10 drug target genes,   87 drug target pathways]
Searched query = "Fibrodysplasia ossificans progressiva", "FOP"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
14 / 23 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-002541-29-NL
(EUCTR)
16/07/201806/02/2018 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]
Clementia Pharmaceuticals IncNULLNA Female: yes
Male: yes
80Phase 3United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Brazil;Australia;South Africa;Netherlands;Germany;Japan;Sweden
2EUCTR2017-002541-29-GB
(EUCTR)
14/12/201711/09/2017 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]
Clementia Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
107Phase 3United States;Spain;United Kingdom;Italy;France;Canada;Argentina;Brazil;Australia;Germany;Netherlands;Japan;Sweden
3EUCTR2017-002541-29-SE
(EUCTR)
05/12/201720/09/2017 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]
Clementia Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
107Phase 3United States;Spain;United Kingdom;Italy;France;Canada;Argentina;Brazil;Australia;Germany;Netherlands;Japan;Sweden
4NCT03312634
(ClinicalTrials.gov)
November 28, 20179/10/2017An Efficacy and Safety Study of Palovarotene for the Treatment of FOPA Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP)Fibrodysplasia Ossificans ProgressivaDrug: PalovaroteneClementia Pharmaceuticals Inc.NULLActive, not recruiting4 YearsN/AAll110Phase 3United States;Argentina;Australia;Brazil;Canada;France;Italy;Japan;Spain;Sweden;United Kingdom
5EUCTR2017-002541-29-ES
(EUCTR)
14/11/201728/09/2017A 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
INN or Proposed INN: PALOVAROTENE
Other descriptive name: PALOVAROTENE
Clementia Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 3United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Brazil;Australia;South Africa;Netherlands;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT02979769
(ClinicalTrials.gov)
November 28, 201623/11/2016An Open-Label Extension Study of Palovarotene to Prevent Heterotopic Ossification in FOP Subjects in FranceA 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 2Clementia Pharmaceuticals Inc.NULLActive, not recruiting6 Years65 YearsAll9Phase 2France
7NCT02521792
(ClinicalTrials.gov)
December 7, 20156/8/2015In-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.NULLTerminated6 Years65 YearsAll6Phase 2United States;France;United Kingdom
8EUCTR2014-002496-28-GB
(EUCTR)
13/11/201504/09/2015Extension Study of an Investigational Drug, Palovarotene, in the Treatment of Preosseous Flare-ups in Subjects with Fibrodysplasia Ossificans Progressiva (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 (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: 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
Product Code: Palovarotene
INN or Proposed INN: Palovarotene
Other descriptive name: Palovarotene
Clementia Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2United States;Argentina;Australia;United Kingdom
9EUCTR2014-001453-17-GB
(EUCTR)
07/07/201525/02/2015The Study of an Investigational Drug, Palovarotene, in the Treatment of Preosseous Flare-ups in Subjects with Fibrodysplasia Ossificans Progressiva.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 (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: 18.0;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
INN or Proposed INN: PALOVAROTENE
Other descriptive name: PALOVAROTENE
Product Name: Palovarotene
Product Code: Palovarotene
INN or Proposed INN: PALOVAROTENE
Other descriptive name: PALOVAROTENE
Clementia Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
40Phase 2United States;Argentina;United Kingdom
10NCT02279095
(ClinicalTrials.gov)
October 27, 201426/10/2014An 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.NULLActive, not recruiting6 Years65 YearsAll54Phase 2United States;Argentina;Australia;France;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT02190747
(ClinicalTrials.gov)
July 201413/7/2014An 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.NULLCompleted6 YearsN/AAll40Phase 2United States;France;United Kingdom
12EUCTR2016-002526-36-FR
(EUCTR)
04/07/2016Study 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]
Clementia Pharmaceuticals Inc.NULLNot Recruiting Female: yes
Male: yes
17Phase 2France
13EUCTR2017-002541-29-FR
(EUCTR)
20/10/2017 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]
Clementia Pharmaceuticals IncNULLNA Female: yes
Male: yes
80Phase 3United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Brazil;Australia;South Africa;Netherlands;Germany;Japan;Sweden
14EUCTR2017-002541-29-DE
(EUCTR)
29/09/2017A 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 - 1mg
INN or Proposed INN: PALOVAROTENE
Other descriptive name: PALOVAROTENE
Product Name: PALOVAROTENE - 1.5mg
INN or Proposed INN: PALOVAROTENE
Other descriptive name: PALOVAROTENE
Product Name: PALOVAROTENE - 2 mg
INN or Proposed INN: PALOVAROTENE
Other descriptive name: PALOVAROTENE
Product Name: PALOVAROTENE - 2.5 mg
INN or Proposed INN: PALOVAROTENE
Other descriptive name: PALOVAROTENE
Product Name: PALOVAROTENE - 3 mg
INN or Proposed INN: PALOVAROTENE
Other descriptive name: PALOVAROTENE
Product Name: PALOVAROTENE - 4 mg
INN or Proposed INN: PALOVAROTENE
Other descriptive name: PALOVAROTENE
Product Name: PALOVAROTENE - 5 mg
INN or Proposed INN: PALOVAROTENE
Other descriptive name: PALOVAROTENE
Product Name: PALOVAROTENE - 10 mg
INN or Proposed INN: PALOVAROTENE
Other descriptive name: PALOVAROTENE
Clementia Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
80Phase 3United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Brazil;Australia;South Africa;Netherlands;Germany;Japan;Sweden