154. 徐波睡眠期持続性棘徐波を示すてんかん性脳症 Epilepsy with continuous spikes and waves during slow sleep Clinical trials / Disease details
臨床試験数 : 5 / 薬物数 : 4 - (DrugBank : 3) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 7
| 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 | EUCTR2020-003141-11-ES (EUCTR) | 02/11/2021 | 09/06/2021 | A study to assess the efficacy, safety, tolerability and pharmacokinetics of NBI-827104 in pediatric subjects with Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep | Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects with Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep | Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep (EECSWS) MedDRA version: 20.0;Level: PT;Classification code 10077380;Term: Epileptic encephalopathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: NBI-827104 Product Code: NBI-827104 INN or Proposed INN: n/a | Neurocrine Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | France;United States;Canada;Spain;Denmark;Germany;United Kingdom;Switzerland;Italy | ||
| 2 | EUCTR2020-003141-11-DK (EUCTR) | 03/09/2021 | 14/12/2020 | A study to assess the efficacy, safety, tolerability and pharmacokinetics of NBI-827104 in pediatric subjects with Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep | Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects with Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep - Study to evaluate NBI-827104 versus placebo in pediatric subjects with EECSWS | Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep (EECSWS) MedDRA version: 20.0;Level: PT;Classification code 10077380;Term: Epileptic encephalopathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: NBI-827104 Product Code: NBI-827104 INN or Proposed INN: n/a | Neurocrine Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | France;United States;Canada;Spain;Denmark;Germany;United Kingdom;Switzerland;Italy | ||
| 3 | NCT04625101 (ClinicalTrials.gov) | April 26, 2021 | 6/11/2020 | Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep | Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep | Epileptic Encephalopathy;Continuous Spike and Wave During Sleep | Drug: NBI-827104;Drug: Placebo | Neurocrine Biosciences | NULL | Recruiting | 4 Years | 12 Years | All | 24 | Phase 2 | United States;Denmark;Spain;Switzerland |
| 4 | EUCTR2021-006788-11-DK (EUCTR) | 11/02/2022 | A long-duration study to assess the safety and effectiveness of NBI-827104 in children with Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep. | Long-Term, Open-Label Extension Study to Evaluate the Safety and Tolerability of NBI-827104 in Pediatric Subjects with Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep - NBI-827104-CSWS2025 | Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep (EECSWS) MedDRA version: 20.0;Level: PT;Classification code 10077380;Term: Epileptic encephalopathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: NBI-827104 Product Code: NBI-827104 INN or Proposed INN: n/a Other descriptive name: N-[1-((5-cyanopyridin-2-yl)methyl)-1H-pyrazol-3-yl]-2-[4-(1-(trifluoromethyl)cyclopropyl)phenyl]acetamide | Neurocrine Biosciences, Inc. | NULL | NA | Female: yes Male: yes | 24 | Phase 2 | United States;France;Canada;Spain;Denmark;Germany;United Kingdom;Switzerland | |||
| 5 | EUCTR2020-003141-11-DE (EUCTR) | 01/10/2021 | A study to assess the efficacy, safety, tolerability and pharmacokinetics of NBI-827104 in pediatric subjects with Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep | Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects with Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep - Study to evaluate NBI-827104 versus placebo in pediatric subjects with EECSWS | Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep (EECSWS) MedDRA version: 20.0;Level: PT;Classification code 10077380;Term: Epileptic encephalopathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: NBI-827104 Product Code: NBI-827104 INN or Proposed INN: n/a | Neurocrine Biosciences, Inc. | NULL | NA | Female: yes Male: yes | 24 | Phase 2 | United States;France;Canada;Spain;Denmark;Germany;United Kingdom;Switzerland;Italy |