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
11	重症筋無力症	1

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	EUCTR2019-003383-47-IT (EUCTR)	12/08/2020	25/09/2020	A Study to Investigate the Safety, Tolerability, and Efficacy of TAK-079 in Participants With Generalized Myasthenia Gravis	A Phase 2, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Generalized Myasthenia Gravis - -	Generalized Myasthenia Gravis MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: TAK-079 Product Code: [TAK-079, TSF-021, TSF79] INN or Proposed INN: TAK-079 Other descriptive name: TAK-079 Product Name: metilprdnisolone Product Code: [-] INN or Proposed INN: METILPREDNISOLONE Other descriptive name: methylprednisolone Product Name: difenidramina Product Code: [NA] INN or Proposed INN: DIFENIDRAMINA CLORIDRATO Other descriptive name: diphenhydramine hydrochloride Product Name: paracetamolo Product Code: [acetominofene] INN or Proposed INN: PARACETAMOLO Other descriptive name: acetaminophen	MILLENNIUM PHARMACEUTICALS, INC.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	36	Phase 2	United States;Serbia;Canada;Spain;Poland;Italy

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

EUCTR2019-003383-47-IT
(EUCTR)

12/08/2020

25/09/2020

A Study to Investigate the Safety, Tolerability, and Efficacy of TAK-079 in Participants With Generalized Myasthenia Gravis

A Phase 2, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Generalized Myasthenia Gravis - -

Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: TAK-079
Product Code: [TAK-079, TSF-021, TSF79]
INN or Proposed INN: TAK-079
Other descriptive name: TAK-079
Product Name: metilprdnisolone
Product Code: [-]
INN or Proposed INN: METILPREDNISOLONE
Other descriptive name: methylprednisolone
Product Name: difenidramina
Product Code: [NA]
INN or Proposed INN: DIFENIDRAMINA CLORIDRATO
Other descriptive name: diphenhydramine hydrochloride
Product Name: paracetamolo
Product Code: [acetominofene]
INN or Proposed INN: PARACETAMOLO
Other descriptive name: acetaminophen

MILLENNIUM PHARMACEUTICALS, INC.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Serbia;Canada;Spain;Poland;Italy