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 140. ドラベ症候群 [臨床試験数:34,薬物数:27(DrugBank:8),標的遺伝子数:42,標的パスウェイ数:53] 

Searched query = "Dorabe syndrome", "Dravet syndrome"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04069689August 29, 201930 September 2019Study of Safety and Pharmacokinetics of Oral Doses of EPX-100 in Healthy Subjects.A Phase I, Placebo-Controlled, Double-Blind, 2-Period Study to Assess Safety and Pharmacokinetics of Escalating Single and Multiple Oral Doses of EPX-100 in Fasting Healthy Subjects and Following a High-Fat MealDravet SyndromeDrug: EPX-100 (Clemizole Hydrochloride);Drug: PlacebosEpygenixRecruiting18 Years50 YearsAll24Phase 1United States
2NCT03936777April 22, 201924 June 2019A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut SyndromeAn Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy for Seizures in Patients With Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut SyndromeDravet Syndrome;Lennox Gastaut Syndrome;Epileptic EncephalopathyDrug: ZX008 (Fenfluramine Hydrochloride)Zogenix, Inc.Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.Recruiting2 YearsN/AAll650Phase 3United States
3NCT03650452August 8, 20184 November 2019A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Patients With Developmental and/or Epileptic EncephalopathiesA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 as an Adjunctive Therapy in Pediatric Patients With Developmental and/or Epileptic EncephalopathiesEpilepsy;Dravet Syndrome;Lennox-Gastaut SyndromeDrug: TAK-935;Drug: PlaceboTakedaOvid Therapeutics Inc.Recruiting2 Years17 YearsAll126Phase 2United States;Australia;Canada;China;Israel;Poland;Portugal;Spain
4NCT03635073July 19, 201822 October 2019A Phase 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study to Assess the Long-Term Safety and Tolerability of TAK-935 (OV935) as Adjunctive Therapy in Patients With Rare EpilepsyA Phase 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study to Assess the Long-Term Safety and Tolerability of TAK-935 (OV935) as Adjunctive Therapy in Patients With Rare EpilepsyEpilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome, Dup15q Syndrome, CDKL5 Deficiency DisorderDrug: TAK-935TakedaOvid Therapeutics Inc.Recruiting2 Years65 YearsAll176Phase 2United States;Australia;China;Israel;Poland;Spain
5NCT03780127April 15, 20182 September 2019ZX008 Expanded Access ProtocolZX008 Expanded Access Protocol - Dravet Syndrome Treatment PlanDravet SyndromeDrug: Fenfluramine HydrochlorideZogenix, Inc.Not recruiting2 YearsN/AAllPhase 1
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT03254680March 201811 June 2018Turmeric as Treatment in EpilepsyTurmeric as Treatment in EpilepsyEpilepsy;Dravet Syndrome;Lennox-Gastaut Syndrome;Tuberous Sclerosis;Focal SeizuresDietary Supplement: TurmericNew York University School of MedicineNot recruiting1 Year70 YearsAll0N/AUnited States
7NCT03467113January 19, 201830 September 2019A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With DS or LGS Currently Taking CBDAn Open-Label Trial to Assess the Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Combination With Cannabidiol, as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome or Lennox-Gastaut SyndromeDravet Syndrome;Lennox Gastaut SyndromeDrug: ZX008 0.2 and 0.8 mg/kg/dayZogenix International Limited, Inc., a subsidiary of Zogenix, Inc.Not recruiting2 Years18 YearsAll25Phase 1/Phase 2United States
8NCT02318563December 30, 201718 January 2018Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Dravet SyndromeA Multicenter, Randomized, Double-blind, Placebo- Controlled, Interventional Study to Assess the Safety and Efficacy of Pharmaceutical Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Subjects With Inadequately Controlled Dravet SyndromeDravet SyndromeDrug: Cannabidiol Oral Solution;Drug: Placebo SolutionINSYS Therapeutics IncNot recruiting1 Year30 YearsAll0Phase 3
9NCT03299842August 23, 201724 June 2019A Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet SyndromeAn Exploratory, Pilot Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome: A Sub-study to the ZX008-1503 Open-Label Extension TrialDravet SyndromeDrug: ZX008 (Fenfluramine Hydrochloride)Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.RecruitingN/AN/AAll20Phase 3United States
10NCT02815540February 16, 201711 March 2019The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children With Severe EpilepsyThe Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in ChildrenLennox-Gastaut Syndrome;Dravet SyndromeDrug: Cannabidiol;Procedure: 12-Lead ECGGillette Children's Specialty HealthcareNot recruiting2 Years30 YearsAll2Phase 1/Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT02758626November 201610 December 2018Ataluren for Nonsense Mutation in CDKL5 and Dravet SyndromeA Phase 2 Randomized, Double-Masked Placebo-Controlled Crossover Safety and Tolerability Study of Ataluren for Drug Resistant Epilepsy in Patients With Nonsense Mutation CDKL5 or Dravet SyndromeEpilepsyDrug: ataluren;Drug: PlaceboNew York University School of MedicinePTC TherapeuticsNot recruiting2 Years12 YearsAll16Phase 2United States
12EUCTR2016-000474-38-NL13/09/201620 August 2018A 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
Pharmaceutical Form: Oral solution
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
CAS Number: 404-82-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1.25-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Product Name: Fenfluramine hydrochloride
Product Code: ZX008
Pharmaceutical Form: Oral solution
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
CAS Number: 404-82-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Product Name: Fenfluramine hydrochloride
Product Code: ZX008
Pharmaceutical Form: Oral solution
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
CAS Number: 404-82-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Zogenix International LimitedNot RecruitingFemale: yes
Male: yes
110Phase 3Spain;Germany;Netherlands;United Kingdom
13NCT02926898September 201624 June 2019A Two-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 , 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 SyndromeDravet SyndromeDrug: ZX008 - 0.2 mg/kg/day;Drug: ZX008 - 0.4 mg/kg/day;Drug: ZX008 - 20 mg/day maximum dose;Drug: Matching PlaceboZogenix International Limited, Inc., a subsidiary of Zogenix, Inc.Not recruiting2 Years18 YearsAll105Phase 3United States;Canada;France;Germany;Netherlands;Spain;United Kingdom
14NCT02826863July 15, 201630 September 2019A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) as an Adjunctive Therapy in Children and Young Adults With Dravet SyndromeA Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults With Dravet SyndromeDravet SyndromeDrug: ZX008 - 0.8 mg/kg/day;Drug: ZX008 - 0.2 mg/kg/day;Drug: PlaceboZogenix International Limited, Inc., a subsidiary of Zogenix, Inc.Recruiting2 Years18 YearsAll130Phase 3Australia;Belgium;Denmark;France;Germany;Italy;Japan;Spain;United Kingdom;Norway;Sweden
15NCT02823145June 201630 September 2019An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution in Children and Young Adults With Dravet SyndromeAn Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution as an Adjunctive Therapy in Children and Young Adults With Dravet SyndromeDravet SyndromeDrug: ZX008 (Fenfluramine Hydrochloride)Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.Recruiting2 Years35 YearsAll340Phase 3United States;Australia;Belgium;Canada;Denmark;France;Germany;Italy;Netherlands;Spain;United Kingdom;Norway;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2015-004167-37-GB17/05/201621 July 2016Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet SyndromeA Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet SyndromeDravet's syndrome
MedDRA version: 19.0 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
Pharmaceutical Form: Oral solution
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
CAS Number: 404-82-0
Current Sponsor code: ZX008
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1.25-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Product Name: Fenfluramine hydrochloride
Product Code: ZX008
Pharmaceutical Form: Oral solution
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
CAS Number: 404-82-0
Current Sponsor code: ZX008
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Product Name: Fenfluramine hydrochloride
Product Code: ZX008
Pharmaceutical Form: Oral solution
INN or Proposed INN: FENFLURAMINE HYDROCHLORIDE
CAS Number: 404-82-0
Current Sponsor code: ZX008
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Zogenix International LimitedAuthorisedFemale: yes
Male: yes
260Phase 3France;Belgium;Spain;Denmark;Australia;Norway;Germany;Italy;Switzerland;United Kingdom;Sweden
17NCT02682927January 201630 September 2019A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet SyndromeA Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults With Dravet SyndromeDravet Syndrome;Seizure DisorderDrug: ZX008 (Fenfluramine Hydrochloride);Drug: Matching PlaceboZogenix International Limited, Inc., a subsidiary of Zogenix, Inc.Not recruiting2 Years18 YearsAll130Phase 3United States;Canada
18NCT02224573June 201517 June 2019GWPCARE5 - An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet or Lennox-Gastaut SyndromesAn Open Label Extension Study to Investigate the Safety of Cannabidiol (GWP42003-P; CBD) in Children and Young Adults With Inadequately Controlled Dravet or Lennox-Gastaut Syndromes.Epilepsy;Dravet Syndrome;Lennox-Gastaut SyndromeDrug: GWP42003-PGW Research LtdNot recruiting2 YearsN/AAll681Phase 3
19NCT02091375March 201510 October 2016Antiepileptic Efficacy Study of GWP42003-P in Children and Young Adults With Dravet Syndrome (GWPCARE1)A Double Blind, Placebo Controlled Two-part Study to Investigate the Dose-ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet SyndromeEpilepsy;Dravet SyndromeDrug: GWP42003-P;Drug: Placebo controlGW Research LtdNot recruiting2 Years18 YearsBoth120Phase 3United States
20NCT02174094March 20156 October 2015Clobazam as Adjunctive Therapy in Paediatric Patients Aged =1 to =16 Years With Dravet SyndromeMulti-site, Prospective, Randomised, Double-blind, Placebo-controlled, Parallel-group, Interventional Study to Evaluate the Efficacy, Safety, and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged =1 to =16 Years With Dravet SyndromeDravet SyndromeDrug: Clobazam;Drug: PlaceboH. Lundbeck A/SNot recruiting1 Year16 YearsBoth0Phase 3United States;Mexico
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT02187809March 201516 December 2017Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged =1 to =16 Years With Dravet SyndromeMulti-site, Prospective, Open-label, Long-term, Flexible Dose, Interventional Study to Evaluate the Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged =1 to =16 Years With Dravet SyndromeDravet SyndromeDrug: ClobazamH. Lundbeck A/SNot recruiting1 Year16 YearsAll3Phase 3United States;Mexico
22NCT02224703March 201524 October 2016GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet SyndromeA Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome.Epilepsy;Dravet SyndromeDrug: GWP42003-P;Drug: Placebo ControlGW Research LtdRecruiting2 Years18 YearsBoth150Phase 3United States;Netherlands
23NCT02091206October 201410 October 2016A Dose-ranging Pharmacokinetics and Safety Study of GWP42003-P in Children With Dravet Syndrome (GWPCARE1)A Double Blind, Placebo Controlled Two-part Study to Investigate the Dose-ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet SyndromeEpilepsy;Dravet SyndromeDrug: GWP42003-P;Drug: Placebo controlGW Research LtdNot recruiting4 Years10 YearsBoth34Phase 2United States
24EUCTR2014-000995-24-GB09/09/201410 April 2017A study of the safety, pharmacokinetics and efficacy of cannabidiol (GWP42003-P) in children and young adults with Dravet syndromeA double-blind, placebo-controlled two-part study to investigate the dose-ranging safety and pharmacokinetics, followed by the efficacy and safety of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.Dravet Syndrome
MedDRA version: 18.0 Level: PT Classification code 10073677 Term: Severe myoclonic epilepsy of infancy System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cannabidiol (CBD)
Product Code: GWP42003-P
Pharmaceutical Form: Oral solution
INN or Proposed INN: N/A
CAS Number: 13956-29-1
Current Sponsor code: GWP42003-P
Other descriptive name: CANNABIDIOL
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
Product Name: Cannabidiol (CBD)
Product Code: GWP42003-P
Pharmaceutical Form: Oral solution
INN or Proposed INN: N/A
CAS Number: 13956-29-1
Current Sponsor code: GWP42003-P
Other descriptive name: CANNABIDIOL
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Oral solution
Route of administration of the placebo: Oral use
GW Research LtdNot RecruitingFemale: yes
Male: yes
125Phase 2;Phase 3France;United States;Poland;United Kingdom
25NCT01983722February 201422 July 2019Treatment 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, CincinnatiNot recruiting6 MonthsN/AAllPhase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT01835314July 8, 201314 October 2019Compassionate Use of Stiripentol in Dravet SyndromeCompassionate Use of Stiripentol in Dravet SyndromeDravet SyndromeDrug: StiripentolUniversity of Colorado, DenverNot recruiting1 Year21 YearsAllPhase 2United States
27NCT01607073April 20127 April 2015Verapamil as Therapy for Children and Young Adults With Dravet SyndromeVerapamil as Adjunctive Seizure Therapy for Children and Young Adults With Dravet SyndromeDravet SyndromeDrug: VerapamilBeverly S. Wical, M.D.Dartmouth-Hitchcock Medical Center;Mayo Clinic;Ann & Robert H Lurie Children's Hospital of ChicagoNot recruiting2 Years25 YearsBoth2Phase 2United States
28NCT01533506February 201219 February 2015Stiripentol in Dravet SyndromeCompassionate Use of Stiripentol in Intractable Epilepsy Due to Dravet SyndromeDravet SyndromeDrug: stiripentolMayo ClinicNot recruiting11 YearsN/AFemalePhase 4United States
29NCT02239276March 201111 February 2019Expanded 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: StiripentolM. Scott PerryNot recruiting6 Months18 YearsAllPhase 2United States
30JPRN-JapicCTI-10111601/4/201023 April 2019Open Phase III Study of ME2080 in Patients with Dravet SyndromeOpen Phase III Study of ME2080 in Patients with Dravet SyndromeDravet 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.)130BOTH25Phase 3
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31JPRN-JMA-IIA0001401/10/20072 April 2019Use of the antiepileptic drug stiripentol for the treatment of severe myoclonic epilepsy in infancy (SMEI)Clinical evaluation of stiripentol in Dravet syndromeDravet 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 Inoue National Epilepsy Center, Shizuoka Institute of Epilepsy and Neurological DisordersShunya Ikeda Department of Pharmaceutical Sciences, International University of Health and Welfare Yoko Ohtsuka Okayama University, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Hirokazu Oguni Department of Pediatrics, Tokyo Women's Medical University Yukitoshi Takahashi National Epilepsy Center, Shizuoka Institute of Epilepsy and Neurological Disorders Jun Tohyama National Hospital Organization Nishi-Niigata Chuo National Hospital Hiroshi Baba National Hospital Organization Nagasaki Medical Center Katsuyuki Fukushima National Hospital Organization Yakumo HospitalNot Recruiting>=1 YEARSBOTH10NOT APPLICABLEJapan
32EUCTR2007-001784-30-FR19/07/200719 March 2012Population 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
Pharmaceutical Form: Capsule, hard
Trade Name: DIACOMIT
Product Name: DIACOMIT
Pharmaceutical Form: Powder for oral suspension
BIOCODEXAuthorisedFemale: yes
Male: yes
France
33EUCTR2007-002198-30-IT03/07/200717 February 2014A 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 STUDYDravet 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
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Other antiepileptics
Concentration unit: mg milligram(s)
Concentration number: 250-
Trade Name: TOPAMAX
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Topiramate
Concentration unit: mg milligram(s)
Concentration number: 25-
Trade Name: FRISIUM*30CPS 10MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Clobazam
Concentration unit: mg milligram(s)
Concentration number: 10-
Inserm-ISP Pole Recherches cliniques et thérapeutiquesNot RecruitingFemale: yes
Male: yes
90Italy
34EUCTR2007-003702-95-IT03/07/200717 February 2014A 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 - NDDravet Syndrome
Level: PT Classification code 10054859
Trade Name: stiripentolo
Pharmaceutical Form: Capsule, hard
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Trade Name: TOPAMAX
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Topiramate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Trade Name: FRISIUM*30CPS 10MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Clobazam
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
ISTITUTO C. MONDINOAuthorisedFemale: yes
Male: yes
90Italy

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