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

  
5 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02174094
(ClinicalTrials.gov)
March 20152/6/2014Clobazam 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/SNULLWithdrawn1 Year16 YearsBoth0Phase 3United States;Mexico
2NCT02187809
(ClinicalTrials.gov)
March 20159/7/2014Safety 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/SNULLTerminated1 Year16 YearsAll3Phase 3United States;Mexico
3EUCTR2007-001784-30-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
4EUCTR2007-003702-95-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
5EUCTR2007-002198-30-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