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
13	多発性硬化症／視神経脊髄炎	2

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	EUCTR2010-021978-11-IT (EUCTR)	14/12/2011	02/03/2012	A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis - 101MS326	Multiple Sclerosis MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: TYSABRI*IV 1FL 300MG 15ML INN or Proposed INN: NA Other descriptive name: NA	BIOGEN IDEC LTD	NULL	Not Recruiting			Female: yes Male: yes	856		United States;Finland;Spain;Ireland;Russian Federation;Italy;United Kingdom;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Sweden
2	EUCTR2010-024000-10-IT (EUCTR)	26/10/2011	27/12/2011	A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis	A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis	Relapsing-Remitting Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: TYSABRIIV 1FL 300MG 15ML Trade Name: TYSABRIIV 1FL 300MG 15ML	BIOGEN IDEC LTD	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	Spain;Belgium;Germany;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

EUCTR2010-021978-11-IT
(EUCTR)

14/12/2011

02/03/2012

A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis - 101MS326

Multiple Sclerosis
MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: TYSABRI*IV 1FL 300MG 15ML
INN or Proposed INN: NA
Other descriptive name: NA

BIOGEN IDEC LTD

NULL

Not Recruiting

Female: yes
Male: yes

856

United States;Finland;Spain;Ireland;Russian Federation;Italy;United Kingdom;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Sweden

EUCTR2010-024000-10-IT
(EUCTR)

26/10/2011

27/12/2011

A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis

Relapsing-Remitting Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: TYSABRI*IV 1FL 300MG 15ML
Trade Name: TYSABRI*IV 1FL 300MG 15ML

BIOGEN IDEC LTD

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

Spain;Belgium;Germany;Italy