DIACOMIT ( DrugBank: - )


1 disease
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

140. ドラベ症候群


臨床試験数 : 116 薬物数 : 65 - (DrugBank : 17) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 64
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-JapicCTI-205180
29/11/201225/02/2020Post-marketing surveillance of DIACOMITCapsule, Powder for Oral SuspensionPost-marketing surveillance of DIACOMIT (Capsule: 250 mg or 500 mg, Powder for Oral Suspension: 250 mg or 500 mg) Dravet SyndromeIntervention 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.NULLrecruitingBOTH300NAJapan
2EUCTR2007-001784-30-FR
(EUCTR)
19/07/200701/06/2007Population 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. AntiepilepticTrade Name: DIACOMIT
Product Name: DIACOMIT
Trade Name: DIACOMIT
Product Name: DIACOMIT
BIOCODEXNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France