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

UCB Biopharma SRL59 sites in 2 countries207 target enrollmentAugust 5, 2017

ConditionsPartial Seizures With or Without Secondary Generalization Epilepsy

InterventionsBrivaracetam

DrugsBrivaracetam

Overview

Phase: Phase 3
Intervention: Brivaracetam
Conditions: Partial Seizures With or Without Secondary Generalization
Sponsor: UCB Biopharma SRL
Enrollment: 207
Locations: 59
Primary Endpoint: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Status: Completed
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to evaluate the long-term safety and tolerability of Brivaracetam (BRV) in focal epilepsy subjects with partial seizures and to evaluate the maintenance of efficacy of BRV over time.

Registry

clinicaltrials.gov

Start Date

August 5, 2017

End Date

December 24, 2024

Last Updated

9 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

UCB Biopharma SRL

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male/female study participant from 16 years of age or older. Study participant who are not legal adults may only be included where legally permitted and ethically accepted
•Study participant completed the Treatment Period and Transition Period of EP0083 or is ongoing in N01379 sites in Japan
•Female study participants with childbearing potential are eligible if they use a medically accepted contraceptive method
•Inclusion Criteria for directly enrollers only: Study participant has 1 to \<8 partial seizures (according to the 1981 International League Against Epilepsy (ILAE) classification) during the 8 weeks prior to brivaracetam (BRV) administration

Exclusion Criteria

•Study participant 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 study participant
•Poor compliance with the visit schedule or medication intake in the previous BRV studies
•Planned participation in any other clinical study of another investigational drug or device during this study
•Pregnant or lactating woman
•Any medical condition which, in the Investigator's opinion, warrants exclusion
•Study participant has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months
•Study participant has \>2 x upper limit of normal (ULN) of any of the following at the Entry Visit (EV): alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or \>ULN total bilirubin (≥1.5x ULN total bilirubin if known Gilbert's syndrome)

Arms & Interventions

Brivaracetam

Subjects randomized to this arm will receive open-label Brivaracetam

Intervention: Brivaracetam

Outcomes

Primary Outcomes

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

Time Frame: From Baseline until end of the safety follow up (up to 88.5 months)

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs (TEAEs) were defined as AEs that had onset on or after the day of first BRV dose in EP0085 study.

Secondary Outcomes

Percent Change in Partial Seizure Frequency (PSF) Per 28 Days From Baseline of EP0083 or N01358 to the Evaluation Period for Rollover Study Participants(Baseline of EP0083 or N01358 and up to 84 months of Evaluation Period)
50 Percent (%) Responder Rate in Partial Seizure Frequency Per 28 Days From Baseline of EP0083 or N01358 to the Evaluation Period for Rollover Study Participants(Baseline of EP0083 or N01358 and up to 84 months of Evaluation Period)
Percent Change in Partial Seizure Frequency Per 28 Days From Baseline of Directly Enrolled Study Participants to the Evaluation Period(Baseline (8 weeks prior to BRV administration), up to 39 months of Evaluation Period)
50 % Responder Rate in Partial Seizure Frequency Per 28 Days Over the Evaluation Period for Directly Enrolled Study Participants(Baseline (8 weeks prior to BRV administration), up to 39 months of Evaluation Period)
Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types (Partial, Generalized, and Unclassified Epileptic Seizure) for at Least 6 Months During the Evaluation Period for Rollover Study Participants(During the Evaluation Period (up to 84 months))
Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types (Partial, Generalized, and Unclassified Epileptic Seizure) for at Least 12 Months During the Evaluation Period for Rollover Study Participants(During the Evaluation Period (up to 84 months))
Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types During the Evaluation Period for Rollover Study Participants(During the Evaluation Period (up to 84 months))
Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types (Partial, Generalized, and Unclassified Epileptic Seizure) for at Least 6 Months During the Evaluation Period for Directly Enrolled Study Participants(During the Evaluation Period (up to 39 months))
Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types (Partial, Generalized, and Unclassified Epileptic Seizure) for at Least 12 Months During the Evaluation Period for Directly Enrolled Study Participants(During the Evaluation Period (up to 39 months))
Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types During the Evaluation Period for Directly Enrolled Study Participants(During the Evaluation Period (up to 39 months))