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	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	EUCTR2011-001692-39-DE (EUCTR)		08/06/2011	A study to evaluate the safety and tolerability of the combination of an antidepressive therapy with oral fingolimod in the treatment of relapsing remitting multiple sclerosis patients with mild to moderate depression	A 21-week, multicenter, open label study to evaluate the safety and tolerability profile of the combination of a SSRI or SNRI antidepressive therapy with oral fingolimod in the treatment of RRMS patients with mild to moderate depression	Multiple SclerosisDepression MedDRA version: 14.1;Level: PT;Classification code 10012378;Term: Depression;System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 14.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Gilenya Product Name: Gilenya Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Venlafaxin Hexal Product Name: Venlafaxin Hexal Other descriptive name: VENLAFAXINE HYDROCHLORIDE Trade Name: Fluoxetin Hexal Product Name: Fluoxetin Hexal INN or Proposed INN: FLUOXETINE HYDROCHLORIDE Trade Name: Venlafaxin Hexal Product Name: Venlafaxin Hexal Other descriptive name: VENLAFAXINE HYDROCHLORIDE Trade Name: Fluoxetin Hexal Product Name: Fluoxetin Hexal INN or Proposed INN: FLUOXETINE HYDROCHLORIDE Trade Name: Gilenya Product Name: Gilenya Other descriptive name: FINGOLIMOD HYDROCHLORIDE	Novartis Pharma GmbH	NULL	Not Recruiting			Female: yes Male: yes			Germany

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

EUCTR2011-001692-39-DE
(EUCTR)

08/06/2011

A study to evaluate the safety and tolerability of the combination of an antidepressive therapy with oral fingolimod in the treatment of relapsing remitting multiple sclerosis patients with mild to moderate depression

A 21-week, multicenter, open label study to evaluate the safety and tolerability profile of the combination of a SSRI or SNRI antidepressive therapy with oral fingolimod in the treatment of RRMS patients with mild to moderate depression

Multiple SclerosisDepression
MedDRA version: 14.1;Level: PT;Classification code 10012378;Term: Depression;System Organ Class: 10037175 - Psychiatric disorders
MedDRA version: 14.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Gilenya
Product Name: Gilenya
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Venlafaxin Hexal
Product Name: Venlafaxin Hexal
Other descriptive name: VENLAFAXINE HYDROCHLORIDE
Trade Name: Fluoxetin Hexal
Product Name: Fluoxetin Hexal
INN or Proposed INN: FLUOXETINE HYDROCHLORIDE
Trade Name: Venlafaxin Hexal
Product Name: Venlafaxin Hexal
Other descriptive name: VENLAFAXINE HYDROCHLORIDE
Trade Name: Fluoxetin Hexal
Product Name: Fluoxetin Hexal
INN or Proposed INN: FLUOXETINE HYDROCHLORIDE
Trade Name: Gilenya
Product Name: Gilenya
Other descriptive name: FINGOLIMOD HYDROCHLORIDE

Novartis Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Germany