Phase 3
N=399
Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures
Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT00490035 ↗Enrolled (actual)
399
Serious AEs
3.5%
Results posted
Apr 2016
Primary outcome: Primary: Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period — 1.75; 1.34; 1.49; 1.26 Seizure Frequency per Week — p==0.261
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Other); Brivaracetam (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- UCB Pharma SA
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period |
1.75; 1.34; 1.49; 1.26 | =0.261 |
| SECONDARY Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 12-week Treatment Period |
80.0; 72.7; 72.7; 64.0; 20.0; 27.3 | — |
| SECONDARY All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period |
1.75; 1.34; 1.49; 1.26 | — |
| SECONDARY Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week |
-17.03; -30.03; -26.83; -32.45 | — |
| SECONDARY Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period |
19.0; 10.1; 15.2; 10.0; 41.0; 35.4 | — |
| SECONDARY Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period |
0; 2.0; 0; 4.0; 0; 0 | — |
| SECONDARY Time to First Type I Seizure During the 12-week Treatment Period |
4; 6; 6; 4 | — |
| SECONDARY Time to Fifth Type I Seizure During the 12-week Treatment Period |
19; 25; 24; 24 | — |
| SECONDARY Time to Tenth Type I Seizure During the 12-week Treatment Period |
39; 49; 40; 46 | — |
| SECONDARY Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period. |
45.9; 47.2; 62.5; 41.0 | — |
| SECONDARY Change From Baseline to the 12-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score |
2.29; 4.50; 3.09; 1.78 | — |
| SECONDARY Change From Baseline to the 12-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score |
8.25; 6.23; 5.34; 8.04 | — |
| SECONDARY Change From Baseline to the 12-week Treatment Period in Daily Activities/Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score |
-2.09; 3.35; 3.09; 3.50 | — |
| SECONDARY Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score |
-1.54; -0.59; -0.41; 0.08 | — |
| SECONDARY Change From Baseline to the 12-week Treatment Period in Hospital Depression Score |
-0.65; -0.10; 0.26; -0.24 | — |
| SECONDARY Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit |
4.93; 5.17; 5.04; 5.47 | — |
| SECONDARY Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit |
4.78; 4.99; 4.99; 5.34 | — |
| SECONDARY Change From Baseline to the 12-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score |
3.49; 3.53; 1.95; 1.99 | — |
| SECONDARY Change From Baseline to the 12-week Treatment Period in Emotional Well-Being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score |
3.80; 3.75; 3.13; -2.45 | — |
| SECONDARY Change From Baseline to the 12-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score |
1.80; 5.36; 1.02; 0.69 | — |
| SECONDARY Change From Baseline to the 12-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score |
0.92; 3.64; -0.85; 3.00 | — |
| SECONDARY Change From Baseline to the 12-week Treatment Period in Overall Quality of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score |
5.11; 4.52; 4.55; 2.24 | — |
| SECONDARY Change From Baseline to the 12-week Treatment Period in Health Status of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score |
6.6; 6.9; 9.7; 4.9 | — |
Summary
This study will evaluate the efficacy and safety of Brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.
Eligibility Criteria
Inclusion Criteria
- Subjects were from 16 to 70 years, both inclusive. Subjects under 18 years of age were only included where legally permitted and ethically accepted
- Subjects with well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
- Subjects had a history of partial onset seizures (POS) whether or not secondarily generalized (Type I seizures according to the ILAE classification)
- Subjects had at least 2 POS whether or not secondarily generalized per month during the 3 months preceding Visit 1
- Subjects had at least 8 POS whether or not secondarily generalized during the 8-Week Baseline Period
- Subjects were uncontrolled while treated by 1 to 2 permitted concomitant antiepileptic drugs (AEDs). Vagal nerve stimulation was allowed and was not counted as a concomitant AED
Exclusion Criteria
- History or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before Visit 3
- History or presence of status epilepticus during the year preceding Visit 1 or during Baseline
Data sourced from ClinicalTrials.gov (NCT00490035). 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.