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 : 111 薬物数 : 72 - (DrugBank : 14) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 61

  
18 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2021-002482-17-ES
(EUCTR)
04/04/202220/12/2021Open-Label Extension Study of Soticlestat in Dravet and Lennox-Gastaut SyndromesA Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term Safety and Tolerability of Soticlestat as Adjunctive Therapy in Subjects With Dravet Syndrome or Lennox-Gastaut Syndrome (ENDYMION 2). Dravet Syndrome (DS)Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850
MedDRA version: 20.1;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: soticlestat
Product Code: TAK-935
INN or Proposed INN: SOTICLESTAT
Product Name: soticlestat
Product Code: TAK-935
INN or Proposed INN: SOTICLESTAT
Takeda Development Center Americas, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
376Phase 3United States;Serbia;Greece;Spain;Ukraine;Russian Federation;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Latvia;Netherlands;China;Japan
2EUCTR2021-002482-17-GR
(EUCTR)
17/03/202224/01/2022Open-Label Extension Study of Soticlestat in Dravet and Lennox-Gastaut SyndromesA Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term Safety and Tolerability of Soticlestat as Adjunctive Therapy in Subjects With Dravet Syndrome or Lennox-Gastaut Syndrome (ENDYMION 2). Dravet Syndrome (DS)Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850
MedDRA version: 20.1;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: soticlestat
Product Code: TAK-935
INN or Proposed INN: SOTICLESTAT
Product Name: soticlestat
Product Code: TAK-935
INN or Proposed INN: SOTICLESTAT
Takeda Development Center Americas, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
376Phase 3Serbia;United States;Greece;Spain;Ukraine;Russian Federation;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Latvia;Netherlands;China;Japan
3EUCTR2021-002482-17-NL
(EUCTR)
17/03/202227/12/2021Open-Label Extension Study of Soticlestat in Dravet and Lennox-Gastaut SyndromesA Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term Safety and Tolerability of Soticlestat as Adjunctive Therapy in Subjects With Dravet Syndrome or Lennox-Gastaut Syndrome (ENDYMION 2). Dravet Syndrome (DS)Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850
MedDRA version: 20.1;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: soticlestat
Product Code: TAK-935
INN or Proposed INN: SOTICLESTAT
Product Name: soticlestat
Product Code: TAK-935
INN or Proposed INN: SOTICLESTAT
Takeda Development Center Americas, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
376Phase 3United States;Serbia;Greece;Spain;Ukraine;Russian Federation;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Netherlands;Latvia;China;Japan
4EUCTR2021-002482-17-LV
(EUCTR)
07/01/202210/02/2022Open-Label Extension Study of Soticlestat in Dravet and Lennox-Gastaut SyndromesA Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term Safety and Tolerability of Soticlestat as Adjunctive Therapy in Subjects With Dravet Syndrome or Lennox-Gastaut Syndrome (ENDYMION 2). Dravet Syndrome (DS)Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850
MedDRA version: 20.1;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: soticlestat
Product Code: TAK-935
INN or Proposed INN: SOTICLESTAT
Product Name: soticlestat
Product Code: TAK-935
INN or Proposed INN: SOTICLESTAT
Takeda Development Center Americas, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
376Phase 3United States;Serbia;Greece;Spain;Ukraine;Russian Federation;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Latvia;Netherlands;China;Japan
5EUCTR2021-002481-40-BE
(EUCTR)
20/12/202112/08/2021Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut SyndromeA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.1;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: soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Product Name: Soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Takeda Development Center Americas, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
234Phase 3Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan
6EUCTR2021-002481-40-NL
(EUCTR)
04/11/202109/08/2021Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut SyndromeA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.1;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: soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Product Name: Soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Takeda Development Center Americas, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
234Phase 3Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Latvia;Netherlands;China;Japan
7EUCTR2021-002481-40-HU
(EUCTR)
22/10/202125/10/2021Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut SyndromeA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.1;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: soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Product Name: Soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Takeda Development Center Americas, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
234Phase 3Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan
8EUCTR2021-002481-40-PL
(EUCTR)
20/10/202117/09/2021Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut SyndromeA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.1;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: soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Product Name: Soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Takeda Development Center Americas, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
234Phase 3Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan
9EUCTR2021-002481-40-LV
(EUCTR)
08/10/202102/08/2021Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut SyndromeA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.1;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: soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Product Name: Soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Takeda Development Center Americas, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
234Phase 3Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan
10EUCTR2021-002481-40-ES
(EUCTR)
05/10/202130/07/2021Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut SyndromeA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.1;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: soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Product Name: Soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Takeda Development Center Americas, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
234Phase 3Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan
11EUCTR2021-002481-40-GR
(EUCTR)
22/09/202109/08/2021Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut SyndromeA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.1;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: soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Product Name: Soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Takeda Development Center Americas, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
234Phase 3Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan
12EUCTR2018-002485-39-PL
(EUCTR)
13/08/201907/05/2019A PHASE 2, PROSPECTIVE, INTERVENTIONAL, OPEN-LABEL, MULTI-SITE, EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND TOLERABILITY OF TAK-935 (OV935) AS ADJUNCTIVE THERAPY IN PATIENTS WITH DEVELOPMENTAL EPILEPTIC ENCEPHALOPATHIES INCLUDING DRAVET SYNDROME, LENNOX GASTAUT SYNDROME, CDKL5 DEFICIENCY DISORDER, AND CHROMOSOME 15 DUPLICATION SYNDROME (ENDYMION)A PHASE 2, PROSPECTIVE, INTERVENTIONAL, OPEN-LABEL, MULTI-SITE, EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND TOLERABILITY OF TAK-935 (OV935) AS ADJUNCTIVE THERAPY IN PATIENTS WITH DEVELOPMENTAL EPILEPTIC ENCEPHALOPATHIES INCLUDING DRAVET SYNDROME, LENNOX GASTAUT SYNDROME, CDKL5 DEFICIENCY DISORDER, AND CHROMOSOME 15 DUPLICATION SYNDROME (ENDYMION) developmental and epileptic encephalopathies;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: Soticlestat
Product Code: TAK-935
INN or Proposed INN: Soticlestat
Product Name: Soticlestat
Product Code: TAK-935
INN or Proposed INN: Soticlestat
Ovid Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
176Phase 2Portugal;United States;Canada;Spain;Poland;Australia;Israel;China
13NCT03650452
(ClinicalTrials.gov)
August 8, 201827/8/2018A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic EncephalopathiesA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Patients With Developmental and/or Epileptic EncephalopathiesEpilepsy;Dravet Syndrome;Lennox-Gastaut SyndromeDrug: TAK-935;Drug: PlaceboTakedaOvid Therapeutics Inc.Completed2 Years17 YearsAll141Phase 2United States;Australia;Canada;China;Israel;Poland;Portugal;Spain
14NCT03635073
(ClinicalTrials.gov)
July 19, 20186/8/2018A Study of Soticlestat in Adults and Children With Rare EpilepsiesA Phase 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study to Assess the Long-Term Safety and Tolerability of Soticlestat (TAK-935) as Adjunctive Therapy in Subjects With Developmental Epileptic Encephalopathies Including Dravet Syndrome, Lennox Gastaut Syndrome, CDKL5 Deficiency Disorder, and Chromosome 15 Duplication Syndrome (ENDYMION 1)Epilepsy;Dravet Syndrome (DS);Lennox-Gastaut Syndrome (LGS)Drug: SoticlestatTakedaNULLActive, not recruiting2 YearsN/AAll156Phase 2United States;Australia;Canada;China;Israel;Poland;Portugal;Spain
15EUCTR2022-001315-44-Outside-EU/EEA
(EUCTR)
24/05/2022A Multicenter, Open-label, Pilot Study of Soticlestat (TAK-935/OV935) in Participants With 15Q Duplication Syndrome (Dup 15q) or Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder (ARCADE STUDY)A Multicenter, Open-label, Pilot Study of TAK-935 (OV935) in Patients With 15Q Duplication Syndrome or CDKL5 DeficiencyDisorder (ARCADE Study) - ARCADE Study Epileptic Encephalopathies: Dravet Syndrome, Lennox Gastaut Syndrome, CDKL5 Deficiency Disorder, and Chromosome 15 Duplication Syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.1;Level: PT;Classification code 10048816;Term: Lennox-Gastaut syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 22.1;Classification code 10083005;Term: CDKL5 deficiency disorder;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 23.0;Classification code 10083952;Term: Dup15q syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Soticlestat
Product Code: TAK-935
INN or Proposed INN: Soticlestat
Product Name: Soticlestat
Product Code: TAK-935
INN or Proposed INN: Soticlestat
Takeda Development Center America, Inc.NULLNAFemale: yes
Male: yes
Phase 2United States
16EUCTR2021-002482-17-BE
(EUCTR)
20/12/2021Open-Label Extension Study of Soticlestat in Dravet and Lennox-Gastaut SyndromesA Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term Safety and Tolerability of Soticlestat as Adjunctive Therapy in Subjects With Dravet Syndrome or Lennox-Gastaut Syndrome (ENDYMION 2). Dravet Syndrome (DS)Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850
MedDRA version: 20.1;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: soticlestat
Product Code: TAK-935
INN or Proposed INN: SOTICLESTAT
Product Name: soticlestat
Product Code: TAK-935
INN or Proposed INN: SOTICLESTAT
Takeda Development Center Americas, IncNULLNAFemale: yes
Male: yes
376Phase 3Serbia;United States;Greece;Spain;Ukraine;Russian Federation;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Latvia;Netherlands;China;Japan
17EUCTR2021-002481-40-Outside-EU/EEA
(EUCTR)
22/07/2021Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut SyndromeA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.1;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: soticlestat
Product Code: TAK-935
INN or Proposed INN: SOTICLESTAT
Product Name: soticlestat
Product Code: TAK-935
INN or Proposed INN: SOTICLESTAT
Takeda Development Center Americas, Inc.NULLNAFemale: yes
Male: yes
Phase 3Australia;Canada;China;Japan;United States;Latvia;Russian Federation;Serbia;Ukraine
18EUCTR2021-002481-40-FR
(EUCTR)
29/07/2021Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut SyndromeA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS) Lennox-Gastaut Syndrome (LGS)
MedDRA version: 20.1;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: soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Product Name: Soticlestat
Product Code: TAK-935
INN or Proposed INN: soticlestat
Takeda Development Center Americas, Inc.NULLNAFemale: yes
Male: yes
234Phase 3Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan