NBI-921352-FOS2022 OLE
Research type
Research Study
Full title
Prospective, Long-Term, Interventional, Active Extension Study to Evaluate the Safety and Tolerability of NBI-921352 as Adjunctive Therapy in Subjects with Focal Onset Seizures (FOS)
IRAS ID
1006553
Contact name
Amanda Richter
Contact email
Sponsor organisation
Neurocrine Biosciences, Inc.
Eudract number
2021-004265-12
Research summary
Epilepsy is one of the most common neurological disorders, affecting approximately 65 million people worldwide. It is characterised by abnormal electrical activity in the brain leading to seizures. Focal Onset Seizures (FOS) are the most common subset of seizures, reported in approximately 60% of patients of epilepsy.
The purpose of this research study is to determine the safety and tolerability of NBI-921352 (study drug) in adults with FOS when taken for a longer period of time. The study will also look at: the study drug effect on long term seizure control in adults with FOS when taken for a longer period of time; how much study drug and substances produced when the body breaks down the study drug (metabolites), are present in the blood after taking the study drug; the effects of study drug on the amount of antiseizure medications (ASMs) and their metabolites in the blood; and study drug impact on quality of life.
Patients with FOS will be eligible if they meet all the inclusion criteria as listed in the study Protocol. Approximately 100 participants will participate in this research study, which will include up to 107 weeks of study drug dosing. Participants will enrol after completing 11 weeks of treatment in the parent study (direct enrolment) or if they completed participation in the parent study more than 30 days ago (indirect enrolment). Direct enrolment will mean the study lasts up to 111 weeks; indirect enrolment will mean the study lasts up to 119 weeks.
For participants who enrol directly, the study will consist of 4 periods: a blinded dose conversion period (1 week); an open-label treatment period (104 wk); a taper period (0-2 weeks); and a safety follow-up period (4 weeks). For participants who enrol indirectly, the study will consist of 5 periods: a screening period (up to 8 weeks); an open-label dose titration period (1 week); an open-label treatment period (104 weeks); a taper period (0-2 weeks); and a safety follow-up period (4 weeks).
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
22/EE/0276
Date of REC Opinion
9 Feb 2023
REC opinion
Further Information Favourable Opinion