Extension Study to Evaluate NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2, multicenter, open-label extension, interventional study to evaluate the long-term safety, tolerability, and effectiveness of NBI-827104 in pediatric subjects with EECSWS. This study will enroll subjects who completed treatment in the Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group Study NBI-827104-CSWS2010.

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

Details

• Lead Sponsor: Neurocrine Biosciences

Criteria

Key Inclusion Criteria:

1. Completed 12 weeks of treatment in Study NBI-827104-CSWS2010

Key Exclusion Criteria:

1. 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.

2. Body weight <10 kg at randomization Day 1.

3. Clinically relevant findings related to cardiovascular or laboratory parameters at screening as determined by the investigator.

4. 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 screening or plans to use such an investigational drug (other than NBI-827104) during the study.