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Extension Study to Evaluate the Safety and Tolerability of NBI-921352 When Used With Anti-seizure Medications in Adults With Focal Onset Seizures

NCT05493293 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2024-04-12

No results posted yet for this study

Summary

This Phase 2, prospective, interventional, active extension study was designed to evaluate the long-term safety and tolerability of NBI-921352 as adjunctive therapy in adult participants with focal onset seizures who completed 11 weeks of treatment in randomized, double-blind, placebo-controlled Study NBI-921352-FOS2021. Eligible participants may enroll directly following the completion of the Week 11 study visit of Study NBI-921352-FOS2021 or after a gap following completion of that study.

Conditions

  • Focal Onset Seizure
  • Focal Onset Epilepsy

Interventions

DRUG

NBI-921352

Tablets for oral administration

Sponsors & Collaborators

  • Neurocrine Biosciences

    lead INDUSTRY

Principal Investigators

  • Clinical Development Lead · Neurocrine Biosciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
67 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-09
Primary Completion
2024-03-11
Completion
2024-03-11

Countries

  • Australia
  • Belgium
  • Czechia
  • France
  • Hungary
  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05493293 on ClinicalTrials.gov