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An Open-Label, Multicenter, Follow-up Study to Evaluate the Long-Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization

An Open-Label, Multicenter, Follow-up Study to Evaluate the Long-Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080223631
Enrollment
214
Registered
2017-08-21
Start date
2017-08-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy and epilepsy syndrome

Interventions

investigational material(s) Generic name etc : brivaracetam INN of investigational material : brivaracetam Therapeutic category code : 113 Antiepileptics Dosage and Administration for Investigational

Sponsors

UCB Japan Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Subject completed the Treatment Period and Transition Period of EP0083 or is ongoing in N01379 sites in Japan - The following criteria must also be met for directly enrolled subjects in Japan. - Well-characterized focal epilepsy/epileptic syndrome according to the 1989 International League Against Epilepsy (ILAE) classification - Presence of an electroencephalogram (EEG) reading compatible with the clinical diagnosis of focal epilepsy within the last 10 years - Subject has 1 to <8 partial seizures (according to the 1981 ILAE classification) during the 8 weeks prior to BRV administration

Exclusion criteria

Exclusion criteria: - Subject has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core study - Severe medical, neurological or psychiatric disorders, or laboratory values which may have an impact on the safety of the subject - Poor compliance with the visit schedule or medication intake in the previous BRV studies - The following criteria must also be met for directly enrolled subjects in Japan * Subject has a history or presence of status epilepticus during the 30 days preceding the Screening Visit * Subject has a history or presence of known psychogenic nonepileptic seizures

Design outcomes

Primary

MeasureTime frame
safety - Adverse Events during the study—

Secondary

MeasureTime frame
efficacy - Percent reduction in partial seizure frequency per 28 days from Baseline of EP0083 or N01358 to the Evaluation Period - Responder rate in partial seizure frequency per 28 days over the Evaluation Period - Percentage of subjects continuously seizure-free for partial seizure and all seizure types at least 6 months and at least 12 months during the Evaluation Period - Seizure freedom during the Evaluation Period—

Countries

Asia except Japan, Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026