Stiripentol ( DrugBank: Stiripentol )


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15

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
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
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Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2016-000474-38-ES
(EUCTR)
31/05/201707/04/2017A Multicenter, Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 Oral Solution When Added to Standard of Care, Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to standar treatment in Children and Young Adults with Dravet SyndromeA Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults with Dravet Syndrome (Cohort 2) Dravet's syndrome
MedDRA version: 19.1;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Fenfluramine hydrochloride
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Product Name: Fenfluramine hydrochloride
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Product Name: Fenfluramine hydrochloride
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Zogenix International LimitedNULLNot RecruitingFemale: yes
Male: yes
110Phase 3France;United States;Canada;Spain;Netherlands;Germany;United Kingdom
2EUCTR2016-000474-38-GB
(EUCTR)
06/04/201717/01/2017A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults with Dravet Syndrome (Cohort 2)A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults with Dravet Syndrome (Cohort 2) Dravet's syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Fenfluramine hydrochloride
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Product Name: Fenfluramine hydrochloride
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Product Name: Fenfluramine hydrochloride
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Zogenix International LimitedNULLNot Recruiting Female: yes
Male: yes
110 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Spain;Netherlands;Germany;United Kingdom
3EUCTR2016-000474-38-DE
(EUCTR)
31/03/201727/12/2016A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults with Dravet Syndrome (Cohort 2)A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults with Dravet Syndrome (Cohort 2) Dravet's syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Fenfluramine hydrochloride
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Product Name: Fenfluramine hydrochloride
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Product Name: Fenfluramine hydrochloride
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Zogenix International LimitedNULLNot Recruiting Female: yes
Male: yes
110 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Spain;Netherlands;Germany;United Kingdom
4NCT02926898
(ClinicalTrials.gov)
January 27, 201710/8/2016A 2-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children = 2 Years Old and Young Adults With Dravet SyndromeA Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults With Dravet Syndrome (Cohort 2)Dravet SyndromeDrug: ZX008 (Fenfluramine Hydrochloride);Drug: Matching PlaceboZogenix International Limited, Inc., a subsidiary of Zogenix, Inc.NULLCompleted2 Years18 YearsAll87Phase 3United States;Canada;France;Germany;Netherlands;Spain;United Kingdom
5EUCTR2016-000474-38-NL
(EUCTR)
13/09/201630/03/2016A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults with Dravet Syndrome (Cohort 2)A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care (Cohort 1), Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults with Dravet Syndrome (Cohort 2) Dravet's syndrome
MedDRA version: 18.1;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Fenfluramine hydrochloride
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Product Name: Fenfluramine hydrochloride
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Product Name: Fenfluramine hydrochloride
Product Code: ZX008
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
Zogenix International LimitedNULLNot RecruitingFemale: yes
Male: yes
110Phase 3Spain;Germany;Netherlands;United Kingdom
6NCT02239276
(ClinicalTrials.gov)
September 201410/9/2014Expanded Access Use of Stiripentol in Dravet Syndrome or Sodium Channel Mutation Epileptic EncephalopathiesExpanded Access Use of Stiripentol in Participants With Dravet Syndrome or Epileptic Encephalopathies Associated With Sodium Channel MutationsDravet Syndrome;Epileptic Encephalopathies Associated With SCN1A MutationsDrug: StiripentolCook Children's Health Care SystemNULLNo longer available6 Months18 YearsAllUnited States
7NCT01983722
(ClinicalTrials.gov)
October 20137/11/2013Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet SyndromeTreatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet SyndromeDravet SyndromeDrug: StiripentolChildren's Hospital Medical Center, CincinnatiNULLApproved for marketing6 MonthsN/AAllUnited States
8NCT01835314
(ClinicalTrials.gov)
May 201315/4/2013Compassionate Use of Stiripentol in Dravet SyndromeCompassionate Use of Stiripentol in Dravet SyndromeDravet SyndromeDrug: StiripentolUniversity of Colorado, DenverNULLNo longer available1 Year21 YearsAllUnited States
9JPRN-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
10NCT01533506
(ClinicalTrials.gov)
February 20129/2/2012Stiripentol in Dravet SyndromeCompassionate Use of Stiripentol in Intractable Epilepsy Due to Dravet SyndromeDravet SyndromeDrug: stiripentolMayo ClinicNULLNo longer available11 YearsN/AFemalePhase 4United States
11JPRN-JapicCTI-101116
01/4/201028/04/2010Open Phase III Study of ME2080 in Patients with Dravet SyndromeOpen Phase III Study of ME2080 in Patients with Dravet Syndrome Dravet SyndromeIntervention name : ME2080 (stiripentol)
Dosage And administration of the intervention : 50mg/kg/day administered twice or 3 times a day (maximum 2500mg/day)
Meiji Seika Pharma Co., Ltd. (formerly MEIJI SEIKA KAISHA Co., LTD.)NULL130BOTH25Phase 3NULL
12JPRN-JMA-IIA00014
01/10/200706/11/2007Use of the antiepileptic drug stiripentol for the treatment of severe myoclonic epilepsy in infancy (SMEI)Clinical evaluation of stiripentol in Dravet syndrome Dravet syndrome (severe myoclonic epilepsy in infancy: SMEI)Intervention type:DRUG. Intervention1:Stiripentol, Dose form:FINE GRANULES, Route of administration:ORAL, intended dose regimen:Stiripentol will be started at 50 mg/kg (or 1000 mg for patients weighing 20 kg or more) and will be titrated up to 100 mg/kg (maximum of 4.0 g)..Yushi InoueNational Epilepsy Center, Shizuoka Institute of Epilepsy and Neurological DisordersShunya IkedaDepartment of Pharmaceutical Sciences, International University of Health and WelfareYoko OhtsukaOkayama University, Graduate School of Medicine, Dentistry and Pharmaceutical SciencesHirokazu OguniDepartment of Pediatrics, Tokyo Women's Medical UniversityYukitoshi TakahashiNational Epilepsy Center, Shizuoka Institute of Epilepsy and Neurological DisordersJun TohyamaNational Hospital Organization Nishi-Niigata Chuo National HospitalHiroshi BabaNational Hospital Organization Nagasaki Medical CenterKatsuyuki FukushimaNational Hospital Organization Yakumo HospitalCompleted>=1 YEARSBOTH10NOT APPLICABLEJapan
13EUCTR2007-001784-30-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
14EUCTR2007-003702-95-IT
(EUCTR)
03/07/200707/09/2007A MULTICENTRE RANDOMIZED CONTROLLED TRIAL COMPARING TOPIRAMATE, STIRIPENTOL AND CLOBAZAM AS ADJUNCTIVE THERAPY TO VALPROATE AND CLOBAZAM IN PAEDIATRIC PATIENTS WITH DRAVET'S SYNDROME (SMEI) NOT ADEQUATELY CONTROLLED WITH CLOBAZAM AND VALPROATE, AND AUXILIARY PHARMACOGENETIC STUDY - NDA MULTICENTRE RANDOMIZED CONTROLLED TRIAL COMPARING TOPIRAMATE, STIRIPENTOL AND CLOBAZAM AS ADJUNCTIVE THERAPY TO VALPROATE AND CLOBAZAM IN PAEDIATRIC PATIENTS WITH DRAVET'S SYNDROME (SMEI) NOT ADEQUATELY CONTROLLED WITH CLOBAZAM AND VALPROATE, AND AUXILIARY PHARMACOGENETIC STUDY - ND Dravet Syndrome
Level: PTClassification code 10054859
Trade Name: stiripentolo
Trade Name: TOPAMAX
INN or Proposed INN: Topiramate
Trade Name: FRISIUM*30CPS 10MG
INN or Proposed INN: Clobazam
ISTITUTO C. MONDINONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Italy
15EUCTR2007-002198-30-IT
(EUCTR)
03/07/200717/01/2012A MULTICENTRE RANDOMIZED CONTROLLED TRIAL COMPARING TOPIRAMATE, STIRIPENTOL AND CLOBAZAM AT THE MAXIMAL TOLERATED DOSAGE, AS ADJUNCTIVE THERAPY TO VALPROATE AND CLOBAZAM IN PAEDIATRIC PATIENTS WITH DRAVET`S SYNDROME (SMEI), AND AUXILIARY PHARMACOGENETIC STUDYA MULTICENTRE RANDOMIZED CONTROLLED TRIAL COMPARING TOPIRAMATE, STIRIPENTOL AND CLOBAZAM AT THE MAXIMAL TOLERATED DOSAGE, AS ADJUNCTIVE THERAPY TO VALPROATE AND CLOBAZAM IN PAEDIATRIC PATIENTS WITH DRAVET`S SYNDROME (SMEI), AND AUXILIARY PHARMACOGENETIC STUDY Dravet Syndrome
MedDRA version: 14.1;Level: PT;Classification code 10054859;Term: Myoclonic epilepsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: stiripentolo
INN or Proposed INN: Other antiepileptics
Trade Name: TOPAMAX
INN or Proposed INN: Topiramate
Trade Name: FRISIUM*30CPS 10MG
INN or Proposed INN: Clobazam
Inserm-ISP Pole Recherches cliniques et thérapeutiquesNULLNot RecruitingFemale: yes
Male: yes
90Italy