ong-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

eurocrine Biosciences, Inc.0 个研究点目标入组 24 人开始时间: 2022年2月11日最近更新: 2024年8月5日

适应症

试验速览

暂无简介。

•1. Completed 12 weeks of treatment in Study NBI-827104-CSWS2010.
•2. For subjects who did not participate in Study NBI-827104-CSWS2010, they must have a diagnosis of EECSWS including confirmation by the Diagnosis Confirmation Panel.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 24
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Planned surgical intervention related to structural abnormalities of the brain from screening through the Week 6 Visit.
•2. Used any active investigational drug other than NBI-827104 in the context of a clinical study within 30 days or 5 half-lives (whichever is longer) before Day 1 or plans to use such an investigational drug (other than NBI-827104) during the study.
•3. Have developed any other disorder for which the treatment takes priority over treatment of EECSWS or is likely to interfere with study treatment or impair treatment compliance.
•4. For subjects who did not participate in NBI-827104-CSWS2010, they must meet the above exclusion criteria in addition to the following (4-6): presence of relevant neurological disorders other than EECSWS and its underlying conditions as judged by the investigator. Symptomatic conditions underlying EECSWS (eg, neonatal strokes) have to be stable for at least 1 year prior to screening.
•5. Body weight = 15 kg at Day 1
•6. Clinically relevant findings related to cardiovascular or laboratory parameters at screening as determined by the investigator.

发起方

eurocrine Biosciences, Inc.