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 | EUCTR2021-002482-17-GR (EUCTR) | 17/03/2022 | 24/01/2022 | Open-Label Extension Study of Soticlestat in Dravet and Lennox-Gastaut Syndromes | A 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, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 376 | Phase 3 | United States;Serbia;Greece;Spain;Ukraine;Russian Federation;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Latvia;Netherlands;China;Japan | ||
| 2 | EUCTR2021-002481-40-BE (EUCTR) | 20/12/2021 | 12/08/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 234 | Phase 3 | Japan;China;Latvia;Netherlands;Australia;Belgium;Poland;Canada;Hungary;France;Italy;United Kingdom;Russian Federation;Ukraine;Spain;Greece;United States;Serbia | ||
| 3 | EUCTR2021-002481-40-NL (EUCTR) | 04/11/2021 | 09/08/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 234 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Latvia;Netherlands;China;Japan | ||
| 4 | EUCTR2021-002481-40-HU (EUCTR) | 22/10/2021 | 25/10/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 234 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan | ||
| 5 | EUCTR2021-002481-40-PL (EUCTR) | 20/10/2021 | 17/09/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 234 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan | ||
| 6 | EUCTR2021-002481-40-ES (EUCTR) | 05/10/2021 | 30/07/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 234 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan | ||
| 7 | EUCTR2021-002481-40-GR (EUCTR) | 22/09/2021 | 09/08/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 234 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan | ||
| 8 | EUCTR2018-002485-39-PL (EUCTR) | 13/08/2019 | 07/05/2019 | 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) | 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 176 | Phase 2 | Portugal;United States;Canada;Spain;Poland;Australia;Israel;China | ||
| 9 | NCT03650452 (ClinicalTrials.gov) | August 8, 2018 | 27/8/2018 | A 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 Encephalopathies | A 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 Encephalopathies | Epilepsy;Dravet Syndrome;Lennox-Gastaut Syndrome | Drug: TAK-935;Drug: Placebo | Takeda | Ovid Therapeutics Inc. | Completed | 2 Years | 17 Years | All | 141 | Phase 2 | United States;Australia;Canada;China;Israel;Poland;Portugal;Spain |
| 10 | NCT03635073 (ClinicalTrials.gov) | July 19, 2018 | 6/8/2018 | A Study of Soticlestat in Adults and Children With Rare Epilepsies | A 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: Soticlestat | Takeda | NULL | Active, not recruiting | 2 Years | N/A | All | 156 | Phase 2 | United States;Australia;Canada;China;Israel;Poland;Portugal;Spain |
| 11 | EUCTR2021-002481-40-LV (EUCTR) | 02/08/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome | A 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. | NULL | NA | Female: yes Male: yes | 234 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan | |||
| 12 | EUCTR2021-002482-17-BE (EUCTR) | 20/12/2021 | Open-Label Extension Study of Soticlestat in Dravet and Lennox-Gastaut Syndromes | A 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, Inc | NULL | NA | Female: yes Male: yes | 376 | Phase 3 | United States;Serbia;Greece;Spain;Ukraine;Russian Federation;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Latvia;Netherlands;China;Japan | |||
| 13 | EUCTR2021-002481-40-FR (EUCTR) | 29/07/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome | A 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. | NULL | NA | Female: yes Male: yes | 234 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan | |||
| 14 | EUCTR2021-002481-40-Outside-EU/EEA (EUCTR) | 22/07/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome | A 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. | NULL | NA | Female: yes Male: yes | Phase 3 | Australia;Canada;China;Japan;Russian Federation;Serbia;Ukraine;United States;Belgium;France;Greece;Hungary;Italy;Latvia;Netherlands;Poland;Spain;United Kingdom |