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

  
12 trials found
No.TrialIDDate_
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PhaseCountries
1NCT03778424
(ClinicalTrials.gov)
January 9, 201927/11/2018An Extended Access Program (EAP) for Participants Who Have Completed Rufinamide Study E2080-G000-303An Extended Access Program (EAP) for Rufinamide in Pediatric Participants With Inadequately Controlled Lennox-Gastaut SyndromeLennox Gastaut SyndromeDrug: RufinamideEisai Inc.NULLAvailable4 YearsN/AAllPoland
2NCT02175173
(ClinicalTrials.gov)
June 13, 201310/6/2014Post-marketing Surveillance of Long-term Administration of Inovelon Tablets in Patients With Lennox-Gastaut SyndromeLennox-Gastaut SyndromeDrug: RufinamideEisai Co., Ltd.NULLRecruitingN/AN/AAll728Japan
3JPRN-JapicCTI-132169
29/5/201321/06/2013Post-marketing surveillance of long-term administration of Inovelon tablets in patients with Lennox-Gastaut syndromePost-marketing surveillance of long-term administration of Inovelon tablets in patients with Lennox-Gastaut syndrome Lennox-Gastaut syndromeIntervention 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.NULLrecruitingBOTH300NAJapan
4EUCTR2010-023505-36-GR
(EUCTR)
08/08/201208/08/2012A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
75United States;Greece;South Africa;Italy
5EUCTR2010-023505-36-IT
(EUCTR)
29/09/201105/01/2012A 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 SyndromeA 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 UKNULLNot RecruitingFemale: yes
Male: yes
75Greece;Italy
6NCT01405053
(ClinicalTrials.gov)
June 16, 201127/7/2011Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic DrugsA 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 SyndromeLennox-Gastaut SyndromeDrug: Rufinamide;Drug: Any other approved Antiepileptic DrugEisai Inc.NULLCompleted1 Year3 YearsAll37Phase 3United States;Canada;France;Greece;Italy;Poland;South Africa;India
7NCT01151540
(ClinicalTrials.gov)
November 201014/6/2010A Long Term Extension Study of E2080 in Lennox-Gastaut PatientsA Long Term Extension Study of E2080 in Lennox-Gastaut PatientsLennox-Gastaut SyndromeDrug: RufinamideEisai Co., Ltd.NULLCompleted4 Years30 YearsAll54Phase 3Japan
8NCT01146951
(ClinicalTrials.gov)
June 201014/6/2010A 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 PatientsLennox-Gastaut SyndromeDrug: Rufinamide (E2080);Drug: PlaceboEisai LimitedNULLCompleted4 Years30 YearsAll66Phase 3Japan
9EUCTR2016-004952-30-Outside-EU/EEA
(EUCTR)
13/02/2017A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome PatientsA 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.NULLNAFemale: yes
Male: yes
58Phase 3Japan
10EUCTR2010-023505-36-Outside-EU/EEA
(EUCTR)
13/02/2017A 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 LtdNULLNAFemale: yes
Male: yes
75Phase 3United States;Canada
11EUCTR2016-004953-34-Outside-EU/EEA
(EUCTR)
23/02/2017A Long Term Extension Study of E2080 in Patients with Lennox-GastautSyndromeA 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.NULLNAFemale: yes
Male: yes
54Phase 3Japan
12EUCTR2010-023505-36-FR
(EUCTR)
19/05/2011A 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 LtdNULLNAFemale: yes
Male: yes
75Phase 3United States;France;Greece;Italy;India