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

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Neurocrine Biosciences

Status and phase

Terminated
Phase 2

Conditions

Focal Onset Epilepsy
Focal Onset Seizure

Treatments

Drug: NBI-921352

Study type

Interventional

Funder types

Industry

Identifiers

NCT05493293
NBI-921352-FOS2022
2021-004265-12 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

82 patients

Sex

All

Ages

18 to 67 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Provided informed consent.
  • Completed 11 weeks of treatment in Study NBI-921352-FOS2021.
  • Stable treatment with at least 1 but not more than 4 antiseizure medicines.

Key Exclusion Criteria:

Have developed any other disorder for which the treatment takes priority over the treatment of focal onset seizure or is likely to interfere with study treatment or impair treatment compliance.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

82 participants in 1 patient group

NBI-921352 Treatment
Experimental group
Description:
Treatment for up to 107 weeks.
Treatment:
Drug: NBI-921352

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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