CLOBAZAM ( DrugBank: Clobazam )


2 diseases
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5
144レノックス・ガストー症候群7

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
1NCT02187809
(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
2NCT02174094
(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
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

144. レノックス・ガストー症候群


臨床試験数 : 111 薬物数 : 72 - (DrugBank : 14) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 61
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2007-004350-82-BG
(EUCTR)
10/11/200813/11/2008Safety and Effectiveness of Open-Label Clobazam in Subjects with Lennox Gastaut Syndrome - Lennox-Gastaut syndrome
MedDRA version: 9.1;Level: LLT;Classification code 10048816;Term: Lennox-Gastaut syndrome
Trade Name: Clobazam
Product Name: Clobazam Tablets
Product Code: Clobazam Tablets 5mg
INN or Proposed INN: CLOBAZAM
Other descriptive name: Clobazam PhEur
Trade Name: Clobazam
Product Name: Clobazam Tablets
Product Code: Clobazam Tablets 10mg
INN or Proposed INN: Clobazam
Other descriptive name: Clobazam PhEur
Trade Name: Clobazam
Product Name: Clobazam Tablets
Product Code: Clobazam Tablets 20mg
INN or Proposed INN: Clobazam
Other descriptive name: Clobazam Pheur
Ovation PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
304Bulgaria;Lithuania
2EUCTR2007-004322-24-BG
(EUCTR)
28/10/200803/11/2008Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Clobazam (0.25, 0.5 and 1.0 mg/kg/day) in Patients with Lennox-Gastaut Syndrome.Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Clobazam (0.25, 0.5 and 1.0 mg/kg/day) in Patients with Lennox-Gastaut Syndrome. Lennox-Gastaut Syndrome
MedDRA version: 9.1;Level: LLT;Classification code 10048816;Term: Lennox-Gastaut syndrome
Trade Name: Clobazam
Product Name: Clobazam Tablets 5mg
INN or Proposed INN: Clobazam
Other descriptive name: Clobazam PhEur
Ovation Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
240Bulgaria;Lithuania
3EUCTR2007-004322-24-LT
(EUCTR)
17/03/200821/01/2008Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Clobazam (0.25, 0.5 and 1.0 mg/kg/day) in Patients with Lennox-Gastaut Syndrome.Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Clobazam (0.25, 0.5 and 1.0 mg/kg/day) in Patients with Lennox-Gastaut Syndrome. Lennox-Gastaut Syndrome
MedDRA version: 9.1;Level: LLT;Classification code 10048816;Term: Lennox-Gastaut syndrome
Trade Name: Clobazam
Product Name: Clobazam Tablets 5mg
INN or Proposed INN: Clobazam
Other descriptive name: Clobazam PhEur
Lundbeck IncNULLNot RecruitingFemale: yes
Male: yes
240Bulgaria;Lithuania
4EUCTR2007-004350-82-LT
(EUCTR)
17/03/200821/01/2008Safety and Effectiveness of Open-Label Clobazam in Subjects with Lennox Gastaut Syndrome - Lennox-Gastaut syndrome
MedDRA version: 9.1;Level: LLT;Classification code 10048816;Term: Lennox-Gastaut syndrome
Trade Name: Clobazam
Product Name: Clobazam Tablets
Product Code: Clobazam Tablets 5mg
INN or Proposed INN: CLOBAZAM
Other descriptive name: Clobazam PhEur
Trade Name: Clobazam
Product Name: Clobazam Tablets
Product Code: Clobazam Tablets 10mg
INN or Proposed INN: Clobazam
Other descriptive name: Clobazam PhEur
Trade Name: Clobazam
Product Name: Clobazam Tablets
Product Code: Clobazam Tablets 20mg
INN or Proposed INN: Clobazam
Other descriptive name: Clobazam Pheur
Lundbeck IncNULLNot RecruitingFemale: yes
Male: yes
304Bulgaria;Lithuania
5NCT00518713
(ClinicalTrials.gov)
August 200720/8/2007Clobazam in Patients With Lennox-Gastaut SyndromeDouble-Blind, Placebo-Controlled, Efficacy and Safety Study of Clobazam in Patients With Lennox-Gastaut SyndromeEpilepsy;Epilepsy, Generalized;SeizuresDrug: Clobazam Low Dose;Drug: Clobazam Medium Dose;Drug: Clobazam High Dose;Drug: PlaceboLundbeck LLCNULLCompleted2 Years60 YearsAll238Phase 3United States;Australia;Belarus;India;Lithuania;Serbia
6NCT01160770
(ClinicalTrials.gov)
December 200518/6/2010Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut SyndromeSafety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut SyndromeLennox-Gastaut SyndromeDrug: ClobazamLundbeck LLCNULLCompleted2 Years60 YearsAll267Phase 3NULL
7NCT00162981
(ClinicalTrials.gov)
October 20059/9/2005Clobazam in Subjects With Lennox-Gastaut SyndromeSafety and Efficacy of Clobazam in Subjects With Lennox-Gastaut SyndromeEpilepsy;Epilepsy, Generalized;SeizuresDrug: Clobazam Low Dose;Drug: Clobazam High DoseLundbeck LLCNULLCompleted2 Years30 YearsAll68Phase 2United States