140. ドラベ症候群 Dorabe syndrome Clinical trials / Disease details
臨床試験数 : 104 / 薬物数 : 61 - (DrugBank : 14) / 標的遺伝子数 : 48 - 標的パスウェイ数 : 63
| 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 | NCT05163314 (ClinicalTrials.gov) | March 6, 2022 | 15/12/2021 | A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome | 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) | Drug: Soticlestat | Takeda | NULL | Not yet recruiting | 2 Years | 36 Years | All | 376 | Phase 3 | United States;Australia;Belgium;Canada;China;France;Greece;Hungary;Italy;Japan;Latvia;Netherlands;Poland;Russian Federation;Serbia;Spain;Ukraine |
| 3 | EUCTR2021-002480-22-BE (EUCTR) | 20/12/2021 | 11/08/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult Subjects With Dravet 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 Young Adult Subjects With Dravet Syndrome (DS) | Dravet Syndrome (DS) MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;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 | 142 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan | ||
| 4 | EUCTR2021-002480-22-HU (EUCTR) | 15/11/2021 | 15/11/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult Subjects With Dravet 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 Young Adult Subjects With Dravet Syndrome (DS) | Dravet Syndrome (DS) MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;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 | 142 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan | ||
| 5 | EUCTR2021-002480-22-NL (EUCTR) | 04/11/2021 | 09/08/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult Subjects With Dravet 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 Young Adult Subjects With Dravet Syndrome (DS) | Dravet Syndrome (DS) MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;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 | 142 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Latvia;Netherlands;China;Japan | ||
| 6 | JPRN-jRCT2051210074 | 28/10/2021 | 04/09/2021 | A Study of Soticlestat as an Add-on Therapy in Children and Young Adults With Dravet 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 Young Adult Subjects With Dravet Syndrome (DS) | Dravet Syndrome | Soticlestat Participants weighing <45 kg: Soticlestat, mini-tablets, at the dose of 40 mg to 200 mg, orally or via gastrostomy tube (G-tube) or percutaneous endoscopic gastrostomy (PEG) tube, twice daily (BID) based on the body weight up to 4 weeks in Titration Period. Participants will continue to receive the dose that they are on at the end of the Titration Period, for 12 weeks in the Maintenance Period. The total duration of the treatment will be up to 16 weeks (Treatment Period). The dose will be tapered down if participants decide to discontinue the treatment. Participants weighing >=45 kg: Soticlestat mini-tablets or tablets with a starting dose of 100 mg BID followed by 200 mg BID and, then 300 mg BID, up to 4 weeks in Titration Period. Participants will continue to receive 300 mg BID for 12 weeks in the Maintenance Period. The total duration of the treatment will be up to 16 weeks (Treatment Period). The dose will be tapered down if participants decide to discontinue the treatment. Placebo Soticlestat placebo-matching mini-tablets or tablets, orally or via G-tube or PEG tube, BID, up to 4 weeks in the Titration Period. Participants will continue to receive the soticlestat placebo-matching mini-tablets or tablets for 12 weeks in the Maintenance Period. The total duration of the treatment will be up to 16 weeks. Soticlestat matching tapering will be done to maintain the blind if participants decide to discontinue the treatment. | Nonomura Hidenori | NULL | Recruiting | >= 2age old | <= 21age old | Both | 142 | Phase 3 | Ukraine;United States;Russia;Serbia;Belgium;France;Greece;Hungary;Italy;Latvia;Poland;Netherlands;United Kingdom;Australia;Canada;China;Spain;Japan |
| 7 | NCT04940624 (ClinicalTrials.gov) | October 28, 2021 | 16/6/2021 | A Study of Soticlestat as an Add-on Therapy in Children and Young Adults With Dravet 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 Young Adult Subjects With Dravet Syndrome (DS) | Dravet Syndrome (DS) | Drug: Soticlestat;Drug: Placebo | Takeda | NULL | Recruiting | 2 Years | 21 Years | All | 142 | Phase 3 | United States;Australia;Belgium;Canada;China;France;Greece;Hungary;Italy;Japan;Latvia;Netherlands;Poland;Russian Federation;Serbia;Spain;Ukraine |
| 8 | EUCTR2021-002480-22-ES (EUCTR) | 15/10/2021 | 30/07/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult Subjects With Dravet 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 Young Adult Subjects With Dravet Syndrome (DS) | Dravet Syndrome (DS) MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;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 | 142 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan | ||
| 9 | EUCTR2021-002480-22-PL (EUCTR) | 13/10/2021 | 15/09/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult Subjects With Dravet 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 Young Adult Subjects With Dravet Syndrome (DS) - Study of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult | Dravet Syndrome (DS) MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;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 | 142 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan | ||
| 10 | EUCTR2021-002480-22-IT (EUCTR) | 12/10/2021 | 27/07/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult Subjects With Dravet 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 Young Adult Subjects With Dravet Syndrome (DS) - Skyline | Dravet Syndrome (DS) MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;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 | 142 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan | ||
| 11 | EUCTR2021-002480-22-GR (EUCTR) | 22/09/2021 | 09/08/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult Subjects With Dravet 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 Young Adult Subjects With Dravet Syndrome (DS) | Dravet Syndrome (DS) MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;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 | 142 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan | ||
| 12 | 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 | ||
| 13 | 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 |
| 14 | EUCTR2021-002480-22-Outside-EU/EEA (EUCTR) | 22/07/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult Subjects With Dravet 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 Young Adult Subjects With Dravet Syndrome (DS) | Dravet Syndrome (DS) MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;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;France;Greece;Hungary;Italy;Latvia;Netherlands;Poland;Spain;United Kingdom | ||||
| 15 | EUCTR2021-002480-22-FR (EUCTR) | 29/07/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult Subjects With Dravet 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 Young Adult Subjects With Dravet Syndrome (DS) | Dravet Syndrome (DS) MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;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 | 142 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan | |||
| 16 | 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 | |||
| 17 | EUCTR2021-002480-22-LV (EUCTR) | 02/08/2021 | Study of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult Subjects With Dravet 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 Young Adult Subjects With Dravet Syndrome (DS) | Dravet Syndrome (DS) MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;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 | 142 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Latvia;China;Japan |