EUCTR2021-004393-62-PTActive, not recruitingPhase 1
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 sites52 target enrollmentStarted: March 20, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 52
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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.
Investigators
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