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	EUCTR2013-001055-12-IT (EUCTR)	28/05/2015	03/06/2013	Study to evaluate the efficacy of cetirizine in the treatment of Flu-like syndrome (FLS) in patients with multiple sclerosis treated with interferoneß.	Flu-like syndrome Inhibition Giving anti-histaminic Therapy. Randomized cross-over, single-center, randomized, placebo-controlled, double-blind study to evaluate the efficacy of cetirizine on Flu-like syndrome (FLS) in patients with multiple sclerosis treated with interferoneß. - FLU-LIGHT	Patients with relapsing remitting multiple sclerosis (RRMS) treated with interferoneß, suffering from flu-like syndrome (FLS). MedDRA version: 16.0;Level: PT;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: Cetirizina Mylan Generics Product Name: Cetirizina Mylan Generics INN or Proposed INN: Cetirizina Other descriptive name: CETIRIZINE HYDROCHLORIDE	Biogen Idec Italia S.r.l.	NULL	Not Recruiting			Female: yes Male: yes			Italy
2	NCT00240032 (ClinicalTrials.gov)	October 2004	13/10/2005	A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Taking an Antihistamine (Zyrtec®) or Placebo Prior to Daily Injections of Copaxone®.	A Double-Blind, Randomized, Placebo Controlled Study of An Oral Antihistamine on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone® Using Autoject® 2 for Glass Syringe.	Multiple Sclerosis	Drug: glatiramer acetate injection with oral cetirizine hydrochloride;Drug: glatiramer acetate with placebo	Teva Pharmaceutical Industries	NULL	Completed	18 Years	N/A	Both	80	Phase 4	United States

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

EUCTR2013-001055-12-IT
(EUCTR)

28/05/2015

03/06/2013

Study to evaluate the efficacy of cetirizine in the treatment of Flu-like syndrome (FLS) in patients with multiple sclerosis treated with interferoneß.

Flu-like syndrome Inhibition Giving anti-histaminic Therapy. Randomized cross-over, single-center, randomized, placebo-controlled, double-blind study to evaluate the efficacy of cetirizine on Flu-like syndrome (FLS) in patients with multiple sclerosis treated with interferoneß. - FLU-LIGHT

Patients with relapsing remitting multiple sclerosis (RRMS) treated with interferoneß, suffering from flu-like syndrome (FLS).
MedDRA version: 16.0;Level: PT;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: Cetirizina Mylan Generics
Product Name: Cetirizina Mylan Generics
INN or Proposed INN: Cetirizina
Other descriptive name: CETIRIZINE HYDROCHLORIDE

Biogen Idec Italia S.r.l.

NULL

Not Recruiting

Female: yes
Male: yes

Italy

NCT00240032
(ClinicalTrials.gov)

October 2004

13/10/2005

A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Taking an Antihistamine (Zyrtec®) or Placebo Prior to Daily Injections of Copaxone®.

A Double-Blind, Randomized, Placebo Controlled Study of An Oral Antihistamine on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone® Using Autoject® 2 for Glass Syringe.

Multiple Sclerosis

Drug: glatiramer acetate injection with oral cetirizine hydrochloride;Drug: glatiramer acetate with placebo

Teva Pharmaceutical Industries

NULL

Completed

18 Years

N/A

Both

Phase 4

United States