Phase 3
N=449
A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy
Partial Seizures With or Without Secondary Generalization · Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT03083665 ↗Enrolled (actual)
449
Serious AEs
1.8%
Results posted
Nov 2023
Primary outcome: Primary: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) — 58.4; 57.0; 60.1; 26.6 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); Brivaracetam (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- UCB Biopharma SRL
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) |
58.4; 57.0; 60.1; 26.6; 19.1; 23.0 | — |
| PRIMARY Percentage of Participants With Treatment-Emergent AEs (TEAEs) Leading to Study Withdrawal |
4.7; 2.6; 3.4; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs) |
0.7; 1.3; 2.7; 4.7; 0; 2.7 | — |
| PRIMARY Partial Seizure Frequency Per 28 Days During the 12-week Treatment Period |
7.17; 5.93; 4.19 | 0.0005 sig |
| SECONDARY 50% Responder Rate Based on Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period |
19.0; 41.1; 49.3 | — |
| SECONDARY Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period |
21.3; 38.9; 46.7 | — |
| SECONDARY Percentage of Participants With Categorized Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period |
0; 5.3; 7.4; 3.4; 14.6; 17.6 | — |
| SECONDARY All Seizure Frequency (Partial, Generalized, and Unclassified Epileptic Seizures) Per 28 Days During the 12-week Treatment Period |
7.17; 5.93; 4.19 | — |
| SECONDARY Percentage of Participants Who Are Seizure Free (Partial, All Epileptic Seizures) During the 12-week Treatment Period |
0; 4.6; 6.8; 0; 4.6; 6.8 | — |
| SECONDARY Time to 1st Partial Seizure During the 12-week Treatment Period |
3; 5; 6 | — |
| SECONDARY Time to 5th Partial Seizure During the 12-week Treatment Period |
17; 28; 32 | — |
| SECONDARY Time to 10th Partial Seizure During the 12-week Treatment Period |
43; 59; 69 | — |
| SECONDARY Brivaracetam Plasma Concentration |
0.68556; 3.4340; 0.66523; 2.0615; 0.18427; 1.2144 | — |
Summary
The purpose of the study is to evaluate the efficacy of brivaracetam (BRV) compared to placebo (PBO) as adjunctive treatment in subjects (>=16 to 80 years of age) with partial seizures with or without secondary generalization despite current treatment with 1 or 2 concomitant antiepileptic drugs (AEDs) and to assess the safety and tolerability of BRV in subjects >= 16 years to 80 years of age.
Eligibility Criteria
Inclusion Criteria
- Subjects (male or female) from 16 to 80 years of age at Visit 1, both inclusive
- Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method
- Subjects having at least 8 partial seizures (according to the 1981 ILAE classification) during the 8-Week Baseline Period with at least 2 partial seizures during each 4-week interval of the Baseline Period
- Subjects having at least 2 partial seizures whether or not secondary generalization per month during the 3 months preceding Visit 1
- Subjects uncontrolled while treated by 1 or 2 permitted concomitant antiepileptic drug [AED](s). Vagal Nerve Stimulation (VNS) is allowed and will be counted as a concomitant AED
Exclusion Criteria
- Subject has history or presence of status epilepticus during the year preceding Visit 1 or during Baseline
- Subject is currently treated with levetiracetam
- Subject has taken levetiracetam within 90 days prior to Visit 1
Data sourced from ClinicalTrials.gov (NCT03083665). 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.