Extension Study to Evaluate How Safe and Tolerable NBI-921352 is as an Adjunctive Therapy for Subjects With SCN8A-DEE.

• Status: Not yet recruiting
• Trial end date: 2026-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neurocrine Biosciences

Criteria

Key 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.

4. Have an adequate rescue medication regimen per the investigator's judgment in place for the duration of the study.

Key Exclusion Criteria

1. Have developed any other disorder for which the treatment takes priority over treatment of SCN8A-DEE or is likely to interfere with study treatment or impair treatment compliance.