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Clinical Trial 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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05301894
Study type Interventional
Source Neurocrine Biosciences
Contact
Status Enrolling by invitation
Phase Phase 2
Start date June 7, 2022
Completion date February 2025

See also
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Recruiting NCT03934268 - A Cohort Study on the Prognosis of Neonatal KCNQ2 Gene-associated Epileptic Encephalopathy
Completed NCT04625101 - Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep Phase 2
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Active, not recruiting NCT03936777 - A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome Phase 3