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 |
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | NCT02187809 (ClinicalTrials.gov) | March 2015 | 9/7/2014 | Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged =1 to =16 Years With Dravet Syndrome | Multi-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 Syndrome | Dravet Syndrome | Drug: Clobazam | H. Lundbeck A/S | NULL | Terminated | 1 Year | 16 Years | All | 3 | Phase 3 | United States;Mexico |
2 | NCT02174094 (ClinicalTrials.gov) | March 2015 | 2/6/2014 | Clobazam as Adjunctive Therapy in Paediatric Patients Aged =1 to =16 Years With Dravet Syndrome | Multi-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Aged =1 to =16 Years With Dravet Syndrome | Dravet Syndrome | Drug: Clobazam;Drug: Placebo | H. Lundbeck A/S | NULL | Withdrawn | 1 Year | 16 Years | Both | 0 | Phase 3 | United States;Mexico |
3 | EUCTR2007-001784-30-FR (EUCTR) | 19/07/2007 | 01/06/2007 | Population 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. | Antiepileptic | Trade Name: DIACOMIT Product Name: DIACOMIT Trade Name: DIACOMIT Product Name: DIACOMIT | BIOCODEX | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
4 | EUCTR2007-002198-30-IT (EUCTR) | 03/07/2007 | 17/01/2012 | A 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 | A 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 thérapeutiques | NULL | Not Recruiting | Female: yes Male: yes | 90 | Italy | |||
5 | EUCTR2007-003702-95-IT (EUCTR) | 03/07/2007 | 07/09/2007 | A 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 | A 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. MONDINO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Italy |
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | EUCTR2007-004350-82-BG (EUCTR) | 10/11/2008 | 13/11/2008 | Safety 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 Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 304 | Bulgaria;Lithuania | ||||
2 | EUCTR2007-004322-24-BG (EUCTR) | 28/10/2008 | 03/11/2008 | 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. | 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. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Bulgaria;Lithuania | |||
3 | EUCTR2007-004350-82-LT (EUCTR) | 17/03/2008 | 21/01/2008 | Safety 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 Inc | NULL | Not Recruiting | Female: yes Male: yes | 304 | Bulgaria;Lithuania | ||||
4 | EUCTR2007-004322-24-LT (EUCTR) | 17/03/2008 | 21/01/2008 | 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. | 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 Inc | NULL | Not Recruiting | Female: yes Male: yes | 240 | Bulgaria;Lithuania | |||
5 | NCT00518713 (ClinicalTrials.gov) | August 2007 | 20/8/2007 | Clobazam in Patients With Lennox-Gastaut Syndrome | Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Clobazam in Patients With Lennox-Gastaut Syndrome | Epilepsy;Epilepsy, Generalized;Seizures | Drug: Clobazam Low Dose;Drug: Clobazam Medium Dose;Drug: Clobazam High Dose;Drug: Placebo | Lundbeck LLC | NULL | Completed | 2 Years | 60 Years | All | 238 | Phase 3 | United States;Australia;Belarus;India;Lithuania;Serbia |
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
6 | NCT01160770 (ClinicalTrials.gov) | December 2005 | 18/6/2010 | Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome | Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome | Lennox-Gastaut Syndrome | Drug: Clobazam | Lundbeck LLC | NULL | Completed | 2 Years | 60 Years | All | 267 | Phase 3 | NULL |
7 | NCT00162981 (ClinicalTrials.gov) | October 2005 | 9/9/2005 | Clobazam in Subjects With Lennox-Gastaut Syndrome | Safety and Efficacy of Clobazam in Subjects With Lennox-Gastaut Syndrome | Epilepsy;Epilepsy, Generalized;Seizures | Drug: Clobazam Low Dose;Drug: Clobazam High Dose | Lundbeck LLC | NULL | Completed | 2 Years | 30 Years | All | 68 | Phase 2 | United States |