DDrare: Database of Drug Development for Rare Diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
272	進行性骨化性線維異形成症	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-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
13	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
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

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

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

Female: yes
Male: yes

Phase 3

United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Brazil;Australia;South Africa;Netherlands;Germany;Japan;Sweden

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

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

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

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

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

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

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

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

Phase 2

France

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

Phase 2

United States;France;United Kingdom

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

Phase 2

United States;Argentina;Australia;United Kingdom

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

Phase 2

United States;Argentina;United Kingdom

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

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

NCT02190747
(ClinicalTrials.gov)

July 2014

13/7/2014

An Efficacy and Safety Study of Palovarotene to Treat Preosseous Flare-ups in FOP Subjects

Fibrodysplasia Ossificans Progressiva

Drug: Palovarotene;Drug: Placebo

Clementia Pharmaceuticals Inc.

NULL

Completed

6 Years

N/A

All

Phase 2

United States;France;United Kingdom

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

Phase 3

United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Brazil;Australia;South Africa;Netherlands;Germany;Japan;Sweden

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

Clementia Pharmaceuticals Inc

NULL

Female: yes
Male: yes

Phase 3

United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Brazil;Australia;South Africa;Netherlands;Germany;Japan;Sweden

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

Phase 2

France