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

Focal Onset Seizure Clinical Trial

Official 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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05493293
• Other study ID #: NBI-921352-FOS2022
• Secondary ID: 2021-004265-12
• Status: Terminated
• Phase: Phase 2
• Start date: November 9, 2022
• Est. completion date: March 11, 2024

Study information

• Verified date: April 2024
• Source: Neurocrine Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 82
• Est. completion date: March 11, 2024
• Est. primary completion date: March 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Focal Onset Epilepsy
• Seizures

Intervention

Drug:
• NBI-921352
Tablets for oral administration

Locations

Country	Name	City	State
Australia	Neurocrine Clinical Site	Fitzroy
Australia	Neurocrine Clinical Site	Heidelberg
Australia	Neurocrine Clinical Site	Melbourne
Belgium	Neurocrine Clinical Site	Bruxelles
Belgium	Neurocrine Clinical Site	Ghent
Belgium	Neurocrine Clinical Site	Leuven
Czechia	Neurocrine Clinical Site	Brno
Czechia	Neurocrine Clinical Site	Ostrava
Czechia	Neurocrine Clinical Site	Prague
Czechia	Neurocrine Clinical Site	Praha 6
Czechia	Neurocrine Clinical Site	Praha 8
Czechia	Neurocrine Clinical Site	Rychnov Nad Knežnou
France	Neurocrine Clinical Site	Bron
France	Neurocrine Clinical Site	Lille
France	Neurocrine Clinical Site	Rennes
France	Neurocrine Clinical Site	Toulouse
Hungary	Neurocrine Clinical Site	Budapest
Hungary	Neurocrine Clinical Site	Budapest
Hungary	Neurocrine Clinical Site	Pecs
Italy	Neurocrine Clinical Site	Bologna
Italy	Neurocrine Clinical Site	Milano
Italy	Neurocrine Clinical Site	Pavia
Spain	Neurocrine Clinical Site	Barcelona
Spain	Neurocrine Clinical Site	Madrid
Spain	Neurocrine Clinical Site	Madrid
Spain	Neurocrine Clinical Site	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Neurocrine Biosciences

Countries where clinical trial is conducted

Australia,  Belgium,  Czechia,  France,  Hungary,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurrence of serious treatment-emergent adverse events (TEAEs)		Through Week 111