Phase 3
Completed N=207
A Study to Test the Safety/ Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization
Partial Seizures With or Without Secondary Generalization · Epilepsy
Source: ClinicalTrials.gov NCT03250377 ↗
Enrolled (actual)
207
Serious AEs
19.3%
Results posted
Jul 2025
Primary outcomePrimary: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) — 88.9; 95.5; 100; 94.1 percentage of participants
◆ Published Evidence
Emerging
1citation · ~1 / year
Safety, Tolerability, and Efficacy of Adjunctive Brivaracetam in Japanese and Chinese Patients with Focal-Onset Seizures: Interim Analysis of a Phase 3 Open-Label Extension Trial.
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.
Linked Publications
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Safety, Tolerability, and Efficacy of Adjunctive Brivaracetam in Japanese and Chinese Patients with Focal-Onset Seizures: Interim Analysis of a Phase 3 Open-Label Extension Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) |
88.9; 95.5; 100; 94.1 | — |
| SECONDARY Percent Change in Partial Seizure Frequency (PSF) Per 28 Days From Baseline of EP0083 or N01358 to the Evaluation Period for Rollover Study Participants |
60.6; 43.2; 67.0 | — |
| SECONDARY 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 |
66.7; 47.3; 57.1 | — |
| SECONDARY Percent Change in Partial Seizure Frequency Per 28 Days From Baseline of Directly Enrolled Study Participants to the Evaluation Period |
-32.6 | — |
| SECONDARY 50 % Responder Rate in Partial Seizure Frequency Per 28 Days Over the Evaluation Period for Directly Enrolled Study Participants |
26.5 | — |
| SECONDARY 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 |
15.4; 19.8; 28.6 | — |
| SECONDARY 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 |
8.3; 14.0; 33.3 | — |
| SECONDARY Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types During the Evaluation Period for Rollover Study Participants |
1.9; 7.1; 14.3; 1.9; 7.1; 14.3 | — |
| SECONDARY 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 |
24.1 | — |
| SECONDARY 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 |
15.4 | — |
| SECONDARY Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types During the Evaluation Period for Directly Enrolled Study Participants |
5.9; 5.9 | — |
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 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)
Data sourced from ClinicalTrials.gov (NCT03250377) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.