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.TrialIDDate_
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PhaseCountries
1EUCTR2020-003141-11-ES
(EUCTR)
02/11/202109/06/2021A study to assess the efficacy, safety, tolerability and pharmacokinetics of NBI-827104 in pediatric subjects with Epileptic Encephalopathy with Continuous Spike-and-Wave During SleepPhase 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 2France;United States;Canada;Spain;Denmark;Germany;United Kingdom;Switzerland;Italy
2EUCTR2020-003141-11-DK
(EUCTR)
03/09/202114/12/2020A study to assess the efficacy, safety, tolerability and pharmacokinetics of NBI-827104 in pediatric subjects with Epileptic Encephalopathy with Continuous Spike-and-Wave During SleepPhase 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 2France;United States;Canada;Spain;Denmark;Germany;United Kingdom;Switzerland;Italy
3NCT04625101
(ClinicalTrials.gov)
April 26, 20216/11/2020Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During SleepPhase 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 SleepEpileptic Encephalopathy;Continuous Spike and Wave During SleepDrug: NBI-827104;Drug: PlaceboNeurocrine BiosciencesNULLRecruiting4 Years12 YearsAll24Phase 2United States;Denmark;Spain;Switzerland
4EUCTR2020-003141-11-DE
(EUCTR)
01/10/2021A study to assess the efficacy, safety, tolerability and pharmacokinetics of NBI-827104 in pediatric subjects with Epileptic Encephalopathy with Continuous Spike-and-Wave During SleepPhase 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.NULLNAFemale: yes
Male: yes
24Phase 2United States;France;Canada;Spain;Denmark;Germany;United Kingdom;Switzerland;Italy
5EUCTR2021-006788-11-DK
(EUCTR)
11/02/2022A 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.NULLNAFemale: yes
Male: yes
24Phase 2United States;France;Canada;Spain;Denmark;Germany;United Kingdom;Switzerland