Extension Study to Evaluate how safe and tolerable the drug NBI-921352 is when used as Adjunctive Therapy in Subjects With SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE).

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 52

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term safety and tolerability of NBI-921352 when administered for up to 106 weeks.;Secondary Objective: To investigate the effect of NBI-921352 on long-term seizure control.;Primary end point(s): •The subject incidence of serious TEAEs, TEAEs leading to discontinuation of studytreatment, and fatal TEAEs.;Timepoint(s) of evaluation of this end point: Treatment period : Day 1 to Week 106.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Percentage change from baseline in 28-day seizure frequency for countable motorseizures during the Treatment Period of the study at Weeks 5, 30, 54, 78, and 104.<br>;Timepoint(s) of evaluation of this end point: Treatment period

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