Phase 2
Completed N=208
A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.
Source: ClinicalTrials.gov NCT00175825 ↗Enrolled (actual)
208
Serious AEs
0.5%
Results posted
Aug 2018
Primary outcomePrimary: Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period — 1.81; 1.61; 1.55; 0.92 Seizures per week — p==0.240
Summary
This trial will evaluate the efficacy and safety of brivaracetam (at doses of 5, 20 and 50 mg/day in twice a day administration) as add-on therapy in subjects with focal epilepsy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period |
1.81; 1.61; 1.55; 0.92 | =0.240 |
| SECONDARY Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period |
-21.7; -29.91; -42.56; -53.04 | — |
| SECONDARY Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period |
2.23; 2.21; 2.50; 1.99; 1.81; 1.61 | — |
| SECONDARY Absolute Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Over the Treatment Period |
-0.37; -0.66; -0.84; -0.92 | — |
| SECONDARY Absolute Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period |
-0.40; -0.66; -0.80; -0.92 | — |
| SECONDARY Percentage Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period |
-24.35; -29.91; -41.57; -53.05 | — |
| SECONDARY Responder Rate in Partial Onset Seizures (Type I) Over the Treatment Period |
16.7; 32.0; 44.2; 55.8 | — |
| SECONDARY Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period |
18.5; 8.0; 9.6; 13.5; 35.2; 38.0 | — |
| SECONDARY Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period |
1.9; 8.0; 7.7; 5.8; 1.9; 0 | — |
| SECONDARY Number of Seizure-free Days Per 4 Weeks |
22.66; 22.86; 22.84; 24.65 | — |
| SECONDARY Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period |
4.0; 4.0; 4.5; 7.0; 17.0; 20.0 | — |
Eligibility Criteria
Inclusion Criteria
- Male/female from 16 to 65 years
- Well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
- History of partial onset seizures
- Subjects having at least 4 partial onset seizures during the 4-week Baseline Period and at least 2 partial onset seizures during the 3 months prior to Visit 1
- Subjects taking 1 or 2 concomitant Antiepileptic drugs (AED(s)) that have been at a stable dose.
Exclusion Criteria
- Seizure type IA non-motor as only seizure type
- Seizures occurring only in clusters
- Status epilepticus during the last 2 years before Visit 1
- History of cerebrovascular accident (CVA)
- Presence of any sign suggesting rapidly progressing brain disorder or brain tumor
Data sourced from ClinicalTrials.gov (NCT00175825). 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.