A Prospective, Long-Term, Interventional, Active Extension Study to Evaluate the Safety and Tolerability of NBI-921352 as Adjunctive Therapy in Subjects with SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE)

eurocrine Biosciences, Inc.0 个研究点目标入组 52 人开始时间: 2022年1月17日最近更新: 2023年12月19日

试验速览

暂无简介。

•1. Written or oral pediatric assent from the subject and written informed consent from the subject’s parent(s) or legal guardian(s) for subjects<18 years of age and for subjects =18 years of age.
•2. Completed 16 weeks of treatment in Study NBI-921352-DEE2012.
•3. Continue to use a nocturnal alerting system or practice consistent with
•standards of care for the duration of the study. Acceptable nocturnal
•alerting systems or practices
•4. Have an adequate rescue medication regimen per the investigator's judgment in place for the duration of the study.
•5. Female subjects of childbearing potential must agree to use
•contraception consistently from Day 1 until the final study visit or 30
•days after the last dose of study treatment, whichever is longer.
•6. A male subject of childbearing potential is defined as a subject who has reached spermarche and has not been vasectomized for at least 3 months prior to Day 1. Male subjects must agree to use contraception consistently from Day 1 until 30 days after the last dose of study treatment
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 23
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 7
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Females who are pregnant or currently breastfeeding.
•2.Have developed any other disorder for which the treatment takes priority over treatment ofSCN8A-DEE or is likely to interfere with study treatment or impair treatment compliance.
•3.The subject or subject’s parent/caregiver is, in the investigator’s opinion, unlikely to comply with the protocol, including the requirement to travel to the study sites for study visits, or is unsuitable for any reason.
•4.Have received any other investigational drug within 30 days or 5 half-lives (if known),whichever is longer, of Day -1 or plan to use an investigational drug (other than the study treatment) during the study.

发起方

eurocrine Biosciences, Inc.