Palovarotene (DrugBank: Palovarotene)
1 disease| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 272 | Fibrodysplasia ossificans progressiva | 14 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2017-002541-29-NL (EUCTR) | 16/07/2018 | 06/02/2018 | 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 Inc | NULL | NA | 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 | |||
| 2 | EUCTR2017-002541-29-GB (EUCTR) | 14/12/2017 | 11/09/2017 | 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 Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 107 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Canada;Argentina;Brazil;Australia;Germany;Netherlands;Japan;Sweden | |||
| 3 | EUCTR2017-002541-29-SE (EUCTR) | 05/12/2017 | 20/09/2017 | 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 Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 107 | Phase 3 | United States;Spain;United Kingdom;Italy;France;Canada;Argentina;Brazil;Australia;Germany;Netherlands;Japan;Sweden | |||
| 4 | NCT03312634 (ClinicalTrials.gov) | November 28, 2017 | 9/10/2017 | An Efficacy and Safety Study of Palovarotene for the Treatment of FOP | A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP) | Fibrodysplasia Ossificans Progressiva | Drug: Palovarotene | Clementia Pharmaceuticals Inc. | NULL | Active, not recruiting | 4 Years | N/A | All | 110 | Phase 3 | United States;Argentina;Australia;Brazil;Canada;France;Italy;Japan;Spain;Sweden;United Kingdom |
| 5 | EUCTR2017-002541-29-ES (EUCTR) | 14/11/2017 | 28/09/2017 | 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] | Product Name: PALOVAROTENE INN or Proposed INN: PALOVAROTENE Other descriptive name: PALOVAROTENE | Clementia Pharmaceuticals Inc | NULL | Authorised-recruitment may be ongoing or finished | 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 | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT02979769 (ClinicalTrials.gov) | November 28, 2016 | 23/11/2016 | An Open-Label Extension Study of Palovarotene to Prevent Heterotopic Ossification in FOP Subjects in France | 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 | Clementia Pharmaceuticals Inc. | NULL | Active, not recruiting | 6 Years | 65 Years | All | 9 | Phase 2 | France |
| 7 | NCT02521792 (ClinicalTrials.gov) | December 7, 2015 | 6/8/2015 | 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. | NULL | Terminated | 6 Years | 65 Years | All | 6 | Phase 2 | United States;France;United Kingdom |
| 8 | EUCTR2014-002496-28-GB (EUCTR) | 13/11/2015 | 04/09/2015 | Extension 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | United States;Argentina;Australia;United Kingdom | ||
| 9 | EUCTR2014-001453-17-GB (EUCTR) | 07/07/2015 | 25/02/2015 | The 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. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United States;Argentina;United Kingdom | ||
| 10 | NCT02279095 (ClinicalTrials.gov) | October 27, 2014 | 26/10/2014 | 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. | NULL | Active, not recruiting | 6 Years | 65 Years | All | 54 | Phase 2 | United States;Argentina;Australia;France;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT02190747 (ClinicalTrials.gov) | July 2014 | 13/7/2014 | 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. | NULL | Completed | 6 Years | N/A | All | 40 | Phase 2 | United States;France;United Kingdom |
| 12 | EUCTR2017-002541-29-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 Inc | NULL | NA | 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 | ||||
| 13 | EUCTR2017-002541-29-DE (EUCTR) | 29/09/2017 | 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] | 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 Inc | NULL | Not Recruiting | 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 | |||
| 14 | EUCTR2016-002526-36-FR (EUCTR) | 04/07/2016 | 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] | Clementia Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 17 | Phase 2 | France |