140. Dorabe syndrome Clinical trials / Disease details
Clinical trials : 116 / Drugs : 65 - (DrugBank : 17) / Drug target genes : 50 - Drug target pathways : 64
Showing 1 to 10 of 22 diseases
| 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-ES (EUCTR) | 04/04/2022 | 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). A Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term ... | 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] Dravet Syndrome (DS)Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.0;Level: LLT;Classification cod ... | Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: SOTICLESTAT Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: SOTICLESTAT Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: SOTICLESTAT Product Name: soticles ... | 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 United States;Serbia;Greece;Spain;Ukraine;Russian Federation;Italy;France;Hungary;Canada;Belgium;Pol ... | ||
| 2 | EUCTR2021-002482-17-NL (EUCTR) | 17/03/2022 | 27/12/2021 | 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). A Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term ... | 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] Dravet Syndrome (DS)Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.0;Level: LLT;Classification cod ... | Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: SOTICLESTAT Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: SOTICLESTAT Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: SOTICLESTAT Product Name: soticles ... | 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;Netherlands;Latvia;China;Japan United States;Serbia;Greece;Spain;Ukraine;Russian Federation;Italy;France;Hungary;Canada;Belgium;Pol ... | ||
| 3 | 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). A Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term ... | 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] Dravet Syndrome (DS)Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.0;Level: LLT;Classification cod ... | Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: SOTICLESTAT Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: SOTICLESTAT Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: SOTICLESTAT Product Name: soticles ... | Takeda Development Center Americas, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 376 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Russian Federation;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Latvia;Netherlands;China;Japan Serbia;United States;Greece;Spain;Ukraine;Russian Federation;Italy;France;Hungary;Canada;Poland;Belg ... | ||
| 4 | JPRN-jRCT2051210182 | 04/03/2022 | 02/03/2022 | A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome A Study of Soticlestatas an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gas ... | 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) - ENDYMION 2 A Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term ... | Dravet Syndrome (DS), Lennox Gastaut Syndrome (LGS) | Participants with DS and LGS will receive: Participants weighing <45 kg: Soticlestat, mini-tablets, titrated from lower dose level (60mg to 140mg) to higher dose (100mg to 200mg) twice daily (BID), based on body weight, orally/via gastrostomy tube (G-tube) or percutaneous endoscopic gastrostomy (PEG) tube, up to 2 weeks in Titration Period. Will continue to receive dose that they are on at the end of Titration Period, for approximately 4 years in Maintenance Period. Dose will be tapered down to lower dose (not less than the lowest dose level based on weight) every 3 days until study drug is discontinued (up to 1 week) in Taper Period. Participants weighing >= 45kg or adults: Soticlestat mini-tablets or tablets with starting dose of 200 mg BID followed by 300 mg BID, up to 2 weeks in Titration Period. Will continue to receive 300 mg BID for approximately 4 years in Maintenance Period. Dose will be tapered down up to 100 mg every 3 days until study drug is discontinued (up to 1 week) in Taper Period. Participants with DS and LGS will receive: Participants weighing <45 kg: Soticlestat, mini-tablets, ... | Nonomura Hidenori | NULL | Recruiting | >= 2age old | <= 36age old | Both | 376 | Phase 3 | Australia;Belgium;Canada;China;Spain;France;United Kingdom;Greece;Hungary;Italy;Latvia;Netherlands;Poland;Serbia;Russia;Ukraine;USA;Japan Australia;Belgium;Canada;China;Spain;France;United Kingdom;Greece;Hungary;Italy;Latvia;Netherlands;P ... |
| 5 | NCT05163314 (ClinicalTrials.gov) | March 4, 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 Study of Soticlestatas an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gas ... | 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) A Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term ... | Dravet Syndrome (DS);Lennox Gastaut Syndrome (LGS) | Drug: Soticlestat | Takeda | NULL | Recruiting | 2 Years | 56 Years | All | 376 | Phase 3 | United States;Australia;Belgium;Brazil;Canada;China;France;Germany;Greece;Hungary;Italy;Japan;Latvia;Mexico;Netherlands;Poland;Russian Federation;Serbia;Spain;Ukraine United States;Australia;Belgium;Brazil;Canada;China;France;Germany;Greece;Hungary;Italy;Japan;Latvia ... |
| 6 | EUCTR2021-002482-17-LV (EUCTR) | 07/01/2022 | 10/02/2022 | 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). A Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term ... | 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] Dravet Syndrome (DS)Lennox-Gastaut Syndrome (LGS) MedDRA version: 20.0;Level: LLT;Classification cod ... | Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: SOTICLESTAT Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: SOTICLESTAT Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: SOTICLESTAT Product Name: soticles ... | 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 United States;Serbia;Greece;Spain;Ukraine;Russian Federation;Italy;France;Hungary;Canada;Belgium;Pol ... | ||
| 7 | 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 Study of Soticlestatas 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) A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Ef ... | 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] Dravet Syndrome (DS) MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndr ... | Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: soticlestat Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: soticlestat Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: soticlestat Product Name: soticles ... | 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 Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Can ... | ||
| 8 | 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 Study of Soticlestatas 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) A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Ef ... | 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] Dravet Syndrome (DS) MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndr ... | Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: soticlestat Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: soticlestat Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: soticlestat Product Name: soticles ... | 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 Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Can ... | ||
| 9 | 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 Study of Soticlestatas 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) A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Ef ... | 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] Dravet Syndrome (DS) MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndr ... | Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: soticlestat Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: soticlestat Product Name: soticlestat Product Code: TAK-935 INN or Proposed INN: soticlestat Product Name: soticles ... | 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 Serbia;United States;Greece;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Can ... | ||
| 10 | 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) A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Ef ... | 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 low-profile gastric tube (MIC-KEY button) or jejunostomy tube (J-tube), twice daily (BID) based on the body weight up to 4 weeks in Titration Period. Participants will continue to receive dose that they are on at the end of Titration Period, for 12 weeks in 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 >=45kg: Soticlestat mini-tablets or tablets with a starting dose of 100mg BID followed by 200 mg BID and, then 300mg BID, up to 4 weeks in Titration Period. Participants will continue to receive 300mg 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 MIC-KEY button or J-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. Soticlestat Participants weighing <45 kg: Soticlestat, mini-tablets, at the dose of 40 mg to 200 mg, ... | 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;Brazil;Japan Ukraine;United States;Russia;Serbia;Belgium;France;Greece;Hungary;Italy;Latvia;Poland;Netherlands;Un ... |