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	EUCTR2010-023210-31-IT (EUCTR)	27/04/2012	12/03/2012	The aim of the study is to assess the efficacy and safety of intra - detrusor injections of Dysport versus placebo in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis	A PHASE IIA, MULTICENTRE, DOUBLE BLIND, SINGLE DOSE, PARALLEL GROUP, PLACEBO CONTROLLED, CLINICAL PILOT STUDY TO ASSESS THE EFFICACY AND SAFETY OF SINGLE DOSE, INTRA-DETRUSOR INJECTIONS OF 750 UNITS OF DYSPORT IN SUBJECTS SUFFERING FROM NEUROGENIC DETRUSOR OVERACTIVITY FOLLOWING SPINAL CORD INJURY OR MULTIPLE SCLEROSIS	NEUROGENIC DETRUSOR OVERACTIVITY MedDRA version: 14.1;Level: LLT;Classification code 10012547;Term: Detrusor hyperreflexia;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: DYSPORT*SC IM 2FL 500U INN or Proposed INN: BOTULINUM TOXIN TYPE A	IPSEN INNOVATION	NULL	Not Recruiting			Female: yes Male: yes	56	Phase 2A	Czech Republic;Lithuania;Austria;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

EUCTR2010-023210-31-IT
(EUCTR)

27/04/2012

12/03/2012

The aim of the study is to assess the efficacy and safety of intra - detrusor injections of Dysport versus placebo in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis

A PHASE IIA, MULTICENTRE, DOUBLE BLIND, SINGLE DOSE, PARALLEL GROUP, PLACEBO CONTROLLED, CLINICAL PILOT STUDY TO ASSESS THE EFFICACY AND SAFETY OF SINGLE DOSE, INTRA-DETRUSOR INJECTIONS OF 750 UNITS OF DYSPORT IN SUBJECTS SUFFERING FROM NEUROGENIC DETRUSOR OVERACTIVITY FOLLOWING SPINAL CORD INJURY OR MULTIPLE SCLEROSIS

NEUROGENIC DETRUSOR OVERACTIVITY
MedDRA version: 14.1;Level: LLT;Classification code 10012547;Term: Detrusor hyperreflexia;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: DYSPORT*SC IM 2FL 500U
INN or Proposed INN: BOTULINUM TOXIN TYPE A

IPSEN INNOVATION

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2A

Czech Republic;Lithuania;Austria;Germany;Italy