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
140	ドラベ症候群	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	JPRN-JapicCTI-205180	29/11/2012	25/02/2020	Post-marketing surveillance of DIACOMITCapsule, Powder for Oral Suspension	Post-marketing surveillance of DIACOMIT (Capsule: 250 mg or 500 mg, Powder for Oral Suspension: 250 mg or 500 mg)	Dravet Syndrome	Intervention name : DIACOMIT (Stiripentol) INN of the intervention : stiripentol Dosage And administration of the intervention : Usually, for patients aged 1 year or older, 50 mg/kg of stiripentol per day is orally administered in divided doses two to three times a day during or immediately after a meal. Dosing starts at 20 mg/kg daily and is increased by 10 mg/kg at intervals of at least one week. However, for patients weighing 50 kg or more, start taking 1000 mg of stiripentol daily, and increase the dosage by 500 mg at intervals of one week or more. The maximum daily dose shall not exceed 50 mg/kg or 2500 mg, whichever is lower. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -	Meiji Seika Pharma Co., Ltd.	NULL	recruiting			BOTH	300	NA	Japan
2	EUCTR2007-001784-30-FR (EUCTR)	19/07/2007	01/06/2007	Population pharmacokinetic study in Dravet's syndrome patients treated with stiripentol, valproate and clobazam. Open pharmacokinetic multicenter study.	Population pharmacokinetic study in Dravet's syndrome patients treated with stiripentol, valproate and clobazam. Open pharmacokinetic multicenter study.	Antiepileptic	Trade Name: DIACOMIT Product Name: DIACOMIT Trade Name: DIACOMIT Product Name: DIACOMIT	BIOCODEX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			France

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

JPRN-JapicCTI-205180

29/11/2012

25/02/2020

Post-marketing surveillance of DIACOMITCapsule, Powder for Oral Suspension

Post-marketing surveillance of DIACOMIT (Capsule: 250 mg or 500 mg, Powder for Oral Suspension: 250 mg or 500 mg)

Dravet Syndrome

Intervention name : DIACOMIT (Stiripentol)
INN of the intervention : stiripentol
Dosage And administration of the intervention : Usually, for patients aged 1 year or older, 50 mg/kg of stiripentol per day is orally administered in divided doses two to three times a day during or immediately after a meal.
Dosing starts at 20 mg/kg daily and is increased by 10 mg/kg at intervals of at least one week.
However, for patients weighing 50 kg or more, start taking 1000 mg of stiripentol daily, and increase the dosage by 500 mg at intervals of one week or more.
The maximum daily dose shall not exceed 50 mg/kg or 2500 mg, whichever is lower.

Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -

Meiji Seika Pharma Co., Ltd.

NULL

recruiting

BOTH

300

Japan

EUCTR2007-001784-30-FR
(EUCTR)

19/07/2007

01/06/2007

Population pharmacokinetic study in Dravet's syndrome patients treated with stiripentol, valproate and clobazam. Open pharmacokinetic multicenter study.

Antiepileptic

Trade Name: DIACOMIT
Product Name: DIACOMIT
Trade Name: DIACOMIT
Product Name: DIACOMIT

BIOCODEX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

France