N/A
Completed N=544
Study to Look at How Effective Briviact is as add-on Treatment for Patients With Epilepsy With Partial Onset Seizures
Epilepsy With POS With or Without Secondary Generalization
Source: ClinicalTrials.gov NCT02687711 ↗
Enrolled (actual)
544
Serious AEs
14.7%
Results posted
Aug 2021
Primary outcomePrimary: Percentage of Participants Remaining in the Study and on BRV Treatment at Month 12 — 57.7 percentage of participants
Summary
Study is the first study after commercialization of brivaracetam. It is designed to collect real world information on the effectiveness of brivaracetam in patients with Partial Onset Seizure epislepsy who are treated in standard clinical practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Remaining in the Study and on BRV Treatment at Month 12 |
57.7 | — |
| SECONDARY Percentage of Participants Remaining in the Study and on BRV Treatment at Month 3 |
82.4 | — |
| SECONDARY Percentage of Participants Remaining in the Study and on BRV Treatment at Month 6 |
70.6 | — |
| SECONDARY Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 3 |
4.54 | — |
| SECONDARY Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 6 |
3.29 | — |
| SECONDARY Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 12 |
3.75 | — |
| SECONDARY Absolute Change in Partial-onset Seizure (POS) Frequency From Baseline to End of Observation Period |
1.69 | — |
| SECONDARY Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 3 |
-5.39 | — |
| SECONDARY Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 6 |
-10.64 | — |
| SECONDARY Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to Month 12 |
7.05 | — |
| SECONDARY Percent Change in Partial-onset Seizure (POS) Frequency From Baseline to End of Observation Period |
-9.54 | — |
| SECONDARY Number of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 3 |
170 | — |
| SECONDARY Percent of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 3 |
47.0 | — |
| SECONDARY Number of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 6 |
146 | — |
| SECONDARY Percent of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 6 |
47.4 | — |
| SECONDARY Number of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 12 |
139 | — |
| SECONDARY Percent of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at Month 12 |
60.4 | — |
| SECONDARY Number of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at End of Observation Period |
175 | — |
| SECONDARY Percent of Responders Based on Percent Reduction (>=50%) in Partial-onset Seizure (POS) Frequency at End of Observation Period |
51.6 | — |
| SECONDARY Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 3 |
81 | — |
| SECONDARY Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 3 |
16.3 | — |
| SECONDARY Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 3 |
81 | — |
| SECONDARY Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 3 |
17.8 | — |
| SECONDARY Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 6 |
54 | — |
| SECONDARY Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 6 |
10.6 | — |
| SECONDARY Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 6 |
54 | — |
| SECONDARY Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 6 |
11.8 | — |
| SECONDARY Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 12 |
37 | — |
| SECONDARY Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=no) at Month 12 |
13.8 | — |
| SECONDARY Number of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 12 |
37 | — |
| SECONDARY Percent of Seizure Free Participants (When Discontinuations Were Counted as Seizure Freedom=Missing) at Month 12 |
13.8 | — |
| SECONDARY Time to First Seizure After First Dose of Brivaracetam |
15 | — |
| SECONDARY Number of Seizure Free Participants at End of Observation Period |
NA | — |
| SECONDARY Percent of Seizure Free Participants at End of Observation Period |
NA | — |
Eligibility Criteria
Inclusion Criteria
- Patient has never been treated with brivaracetam (BRV) prior to enrollment in this Non-Interventional Study (NIS)
- The decision by the treating physician to prescribe BRV is made independently of the participation in the NIS
- Patient is a male or female ≥16 years of age
- Patient has a clinical diagnosis of epilepsy with partial-onset seizures POS with or without secondary generalization
- Patient uses an epilepsy/seizure diary.
Exclusion Criteria
No specific exclusion criteria
Data sourced from ClinicalTrials.gov (NCT02687711). 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.