140. ドラベ症候群 Dorabe syndrome Clinical trials / Disease details

臨床試験数 : 104 / 薬物数 : 61 - (DrugBank : 14) / 標的遺伝子数 : 48 - 標的パスウェイ数 : 63

2 trials found

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