Neurocrine NBI-921352-FOS2021

• Research type

  Research Study

• Full title

  A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of NBI-921352 as Adjunctive Therapy in Adult Subjects with Focal Onset Seizures (FOS)

• IRAS ID

  1005029

• Contact name

  Amanda Richter

• Contact email

  arichter@neurocrine.com

• Sponsor organisation

  Neurocrine Biosciences, Inc.

• Eudract number

  2021-001433-39

• 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 with epilepsy.

  This research study is being done to learn a suitable dose range of NBI-921352 (study drug) for use in subsequent efficacy and safety studies in adult subjects with FOS taking antiseizure medications. The study will investigate the safety, tolerability, and efficacy of NBI-921352 versus placebo.

  Patients with focal onset seizures will be eligible to participate in this study if they meet all the inclusion criteria and none of the exclusion criteria as listed in the study Protocol. Approximately 100 participants will be included into the study, which will last for approximately 23 weeks for the participants who enrol in the separate, active extension study, and approximately 27 weeks for the participants who do not enrol in the active extension study.

  The study consists of five periods: screening/baseline period (up to 12 weeks); treatment Period (3-week titration period); maintenance period (8-week maintenance period); taper period (2 weeks - for participants who choose not to enter the extension study); and a safety follow-up period (2 weeks - for participants who choose not to enter the extension study).

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  22/EE/0165

• Date of REC Opinion

  12 Sep 2022

• REC opinion

  Further Information Favourable Opinion