144. レノックス・ガストー症候群 Lennox-Gastaut syndrome Clinical trials / Disease details
臨床試験数 : 101 / 薬物数 : 68 - (DrugBank : 12) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 60
| 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 | NCT03778424 (ClinicalTrials.gov) | January 9, 2019 | 27/11/2018 | An Extended Access Program (EAP) for Participants Who Have Completed Rufinamide Study E2080-G000-303 | An Extended Access Program (EAP) for Rufinamide in Pediatric Participants With Inadequately Controlled Lennox-Gastaut Syndrome | Lennox Gastaut Syndrome | Drug: Rufinamide | Eisai Inc. | NULL | Available | 4 Years | N/A | All | Poland | ||
| 2 | NCT02175173 (ClinicalTrials.gov) | June 13, 2013 | 10/6/2014 | Post-marketing Surveillance of Long-term Administration of Inovelon Tablets in Patients With Lennox-Gastaut Syndrome | Lennox-Gastaut Syndrome | Drug: Rufinamide | Eisai Co., Ltd. | NULL | Recruiting | N/A | N/A | All | 728 | Japan | ||
| 3 | JPRN-JapicCTI-132169 | 29/5/2013 | 21/06/2013 | Post-marketing surveillance of long-term administration of Inovelon tablets in patients with Lennox-Gastaut syndrome | Post-marketing surveillance of long-term administration of Inovelon tablets in patients with Lennox-Gastaut syndrome | Lennox-Gastaut syndrome | Intervention name : Inovelon INN of the intervention : Rufinamide Dosage And administration of the intervention : Oral Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Eisai Co., Ltd. | NULL | recruiting | BOTH | 300 | NA | Japan | ||
| 4 | EUCTR2010-023505-36-GR (EUCTR) | 08/08/2012 | 08/08/2012 | A controlled clinical trial to look at the effects of treatment with rufinamide on the body, thought process development and its safety in children aged 1 to 4 years with poorly controlled Lennox Gastaut Syndrome. | A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to less than 4 years of age with Inadequately ControlledLennox-Gastaut Syndrome | Lennox Gastaut Syndrome MedDRA version: 14.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: rufinamide oral suspension Product Code: rufinamide oral suspension INN or Proposed INN: RUFINAMIDE Other descriptive name: Rufinamide oral suspension Trade Name: Investigators choice of approved AEDs INN or Proposed INN: Investigators Choice of Approved AED Other descriptive name: N/A | Eisai Ltd | NULL | Not Recruiting | Female: yes Male: yes | 75 | United States;Greece;South Africa;Italy | |||
| 5 | EUCTR2010-023505-36-IT (EUCTR) | 29/09/2011 | 05/01/2012 | A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to less than 4 years of age with Inadequately Controlled Lennox-Gastaut Syndrome | A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to less than 4 years of age with Inadequately Controlled Lennox-Gastaut Syndrome - E2080-G000-303 | Lennox Gastaut Syndrome MedDRA version: 14.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Inovelon Other descriptive name: Rufinamide oral suspension INN or Proposed INN: lamotrigine Other descriptive name: Lamictal INN or Proposed INN: sodio valproato INN or Proposed INN: topimarato Other descriptive name: topimarate | EISAI LTD UK | NULL | Not Recruiting | Female: yes Male: yes | 75 | Greece;Italy | |||
| 6 | NCT01405053 (ClinicalTrials.gov) | June 16, 2011 | 27/7/2011 | Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs | A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to Less Than 4 Years of Age With Inadequately Controlled Lennox-Gastaut Syndrome | Lennox-Gastaut Syndrome | Drug: Rufinamide;Drug: Any other approved Antiepileptic Drug | Eisai Inc. | NULL | Completed | 1 Year | 3 Years | All | 37 | Phase 3 | United States;Canada;France;Greece;Italy;Poland;South Africa;India |
| 7 | NCT01151540 (ClinicalTrials.gov) | November 2010 | 14/6/2010 | A Long Term Extension Study of E2080 in Lennox-Gastaut Patients | A Long Term Extension Study of E2080 in Lennox-Gastaut Patients | Lennox-Gastaut Syndrome | Drug: Rufinamide | Eisai Co., Ltd. | NULL | Completed | 4 Years | 30 Years | All | 54 | Phase 3 | Japan |
| 8 | NCT01146951 (ClinicalTrials.gov) | June 2010 | 14/6/2010 | A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304) | A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients | Lennox-Gastaut Syndrome | Drug: Rufinamide (E2080);Drug: Placebo | Eisai Limited | NULL | Completed | 4 Years | 30 Years | All | 66 | Phase 3 | Japan |
| 9 | EUCTR2016-004953-34-Outside-EU/EEA (EUCTR) | 23/02/2017 | A Long Term Extension Study of E2080 in Patients with Lennox-GastautSyndrome | A Long Term Extension Study of E2080 in Patients with Lennox-GastautSyndrome | Lennox-Gastaut Syndrome;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Inovelon Product Name: rufinamide Product Code: E2080 INN or Proposed INN: RUFINAMIDE | Eisai Co, Ltd. | NULL | NA | Female: yes Male: yes | 54 | Phase 3 | Japan | |||
| 10 | EUCTR2016-004952-30-Outside-EU/EEA (EUCTR) | 13/02/2017 | A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients | A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients | Lennox-Gastaut Syndrome (LSG);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Inovelon Product Name: rufinamide Product Code: E2080 INN or Proposed INN: RUFINAMIDE | Eisai Co, Ltd. | NULL | NA | Female: yes Male: yes | 58 | Phase 3 | Japan | |||
| 11 | EUCTR2010-023505-36-FR (EUCTR) | 19/05/2011 | A controlled clinical trial to look at the effects of treatment with rufinamide on the body, thought process development and its safety in children aged 1 to 4 years with poorly controlled Lennox Gastaut Syndrome. | A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to less than 4 years of age with Inadequately ControlledLennox-Gastaut Syndrome | Lennox Gastaut Syndrome MedDRA version: 13.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: rufinamide oral suspension Product Code: rufinamide oral suspension INN or Proposed INN: RUFINAMIDE Other descriptive name: Rufinamide oral suspension Trade Name: Investigators choice of approved AEDs INN or Proposed INN: Investigators Choice of Approved AED Other descriptive name: N/A | Eisai Ltd | NULL | NA | Female: yes Male: yes | 75 | Phase 3 | United States;France;Greece;Italy;India | |||
| 12 | EUCTR2010-023505-36-Outside-EU/EEA (EUCTR) | 13/02/2017 | A controlled clinical trial to look at the effects of treatment with rufinamide on the body, thought process development and its safety in children aged 1 to 4 years with poorly controlled Lennox Gastaut Syndrome. | A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to less than 4 years of age with Inadequately ControlledLennox-Gastaut Syndrome | Lennox Gastaut Syndrome MedDRA version: 19.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: rufinamide oral suspension Product Code: rufinamide oral suspension INN or Proposed INN: RUFINAMIDE Other descriptive name: Rufinamide oral suspension Trade Name: Investigators choice of approved AEDs INN or Proposed INN: Investigators Choice of Approved AED Other descriptive name: N/A | Eisai Ltd | NULL | NA | Female: yes Male: yes | 75 | Phase 3 | United States;Canada |