NCT05301894

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

Long-Term, Open-Label Extension Study to Evaluate the Safety and Tolerability of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Neurocrine Biosciences · Industry
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The primary objective for this study is to evaluate the long-term safety and tolerability of NBI-827104 in pediatric participants with epileptic encephalopathy with continuous spike-and-wave during sleep (EECSWS).

Detailed description

This study will enroll participants who completed treatment in the Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group Study NBI-827104-CSWS2010 (NCT04625101). Participants who did not participate in Study NBI-827104-CSWS2010 may also be eligible for enrollment.

Conditions

• Epileptic Encephalopathy
• Continuous Spike and Wave During Sleep

Interventions

Type	Name	Description
DRUG	NBI-827104	T-type calcium channel blocker.

Timeline

• Start date: 2022-06-07
• Primary completion: 2025-01-27
• Completion: 2025-01-27
• First posted: 2022-03-31
• Last updated: 2026-02-13
• Results posted: 2026-02-13

Locations

12 sites across 5 countries: United States, Denmark, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study