NCT05159908

A Study to Investigate How Effective, Safe and Tolerable the Drug NBI-921352 is When Used With Anti-seizure Medications in Adults With Focal Onset Seizures

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Neurocrine Biosciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety, pharmacokinetics, and efficacy of three different doses of NBI-921352 versus placebo in adults with focal onset seizures

Conditions

• Focal Onset Seizure
• Focal Onset Epilepsy

Interventions

Type	Name	Description
DRUG	NBI-921352	Tablets for oral administration
DRUG	Placebo	Matching placebo tablets for oral administration

Timeline

• Start date: 2021-11-08
• Primary completion: 2023-08-21
• Completion: 2023-08-21
• First posted: 2021-12-16
• Last updated: 2024-09-26

Locations

28 sites across 7 countries: Australia, Belgium, Czechia, France, Hungary, Italy, Spain