NBI-827104-CSWS2025
Research type
Research Study
Full title
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
IRAS ID
1005724
Contact name
Amanda Richter
Contact email
Sponsor organisation
Neurocrine Biosciences, Inc.
Eudract number
2021-006788-11
Clinicaltrials.gov Identifier
Research summary
Epilepsy with Continuous Spike-and-Wave During Sleep (EECSWS) is a very rare form of epilepsy, which is a condition that affects brain activity, causing seizures or periods of unusual behavior, sensations, and sometimes loss of awareness. EECSWS begins in childhood and can seriously affect neurodevelopment, resulting in long-term impairment of cognitive function.
This type of epilepsy affects children between 2 and 12 years old (average 4 to 5 years of age) and accounts for 0.2% to 0.5% of childhood epilepsy. Epileptic seizures, neurocognitive regressive/stagnation, and electrical status epilepticus during slow sleep (ESES) are the main manifestations of EECSWS. Increased brain activity during sleep may interfere with normal recuperation functions of sleep, thereby adversely affecting learning abilities, language, memory, and other cognitive domains. Although spontaneous improvement of ESES during puberty is observed with EECSWS, neurocognitive deficits can remain. There are no approved treatments for pediatric patients with EECSWS. This study is an extension to a previous study and its main purpose is to evaluate long-term safety and tolerability (up to approximately 2 years) of the study drug, NBI-827104, in children with EECSWS that participated in the previous study. All study participants including those who received placebo will receive the study drug as adjunctive therapy to their current medications.REC name
London - Central Research Ethics Committee
REC reference
22/LO/0518
Date of REC Opinion
1 Sep 2022
REC opinion
Further Information Favourable Opinion