Phase 3
Completed N=480
Brivaracetam as add-on Treatment in Adolescents and Adults Suffering From Epilepsy
Source: ClinicalTrials.gov NCT00504881 ↗Enrolled (actual)
480
Serious AEs
6.0%
Results posted
Mar 2017
Primary outcomePrimary: Percentage of Subjects With at Least One Adverse Event During the 16-week Treatment Period — 66.1; 66.6 percentage of participants
◆ Published Evidence
Highly cited
161citations · ~13 / year
Adjunctive brivaracetam for uncontrolled focal and generalized epilepsies: results of a phase III, double-blind, randomized, placebo-controlled, flexible-dose trial.
Summary
This study will compare the safety and efficacy of Brivaracetam at flexible dose with Placebo in subjects suffering from Epilepsy.
Linked Publications (4)
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Adjunctive brivaracetam for uncontrolled focal and generalized epilepsies: results of a phase III, double-blind, randomized, placebo-controlled, flexible-dose trial.
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Sensitivity and responsiveness of the EQ-5D-3L in patients with uncontrolled focal seizures: an analysis of Phase III trials of adjunctive brivaracetam.
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Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht-Lundborg disease: An open-label, long-term follow-up trial.
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Brivaracetam add-on therapy for drug-resistant epilepsy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With at Least One Adverse Event During the 16-week Treatment Period |
66.1; 66.6 | — |
| PRIMARY Partial Onset Seizure (Type I) Frequency Per Week Over the 16-week Treatment Period |
1.86; 1.74 | =0.125 |
| SECONDARY Responder Rate for Partial Onset Seizures (Type I) Frequency Per Week Over the 16-week Treatment Period |
16.7; 30.3; 83.3; 69.7 | — |
| SECONDARY Seizure Frequency (All Seizure Types) Per Week Over the 16-week Treatment Period |
1.87; 1.74 | — |
| SECONDARY Percent Change From Baseline to the 16-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week |
-18.93; -26.92 | — |
| SECONDARY Categorized Response From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 16-week Treatment Period |
14.8; 18.3; 44.4; 29.1; 24.1; 22.3 | — |
| SECONDARY Seizure Freedom Rate (All Seizure Types) Over the 16-week Treatment Period |
0; 1.5; 0; 0; 100.0; 98.5 | — |
| SECONDARY Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 16-week Treatment Period |
54.3; 47.9 | — |
| SECONDARY Time to First Type I Seizure During the 16-week Treatment Period |
3; 4 | — |
| SECONDARY Time to Fifth Type I Seizure During the 16-week Treatment Period |
14; 18 | — |
| SECONDARY Time to Tenth Type I Seizure During Treatment Period |
36; 38 | — |
| SECONDARY Change From Baseline to the 16-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score |
3.04; 4.22 | — |
| SECONDARY Change From Baseline to the 16-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score |
4.66; 10.29 | — |
| SECONDARY Change From Baseline to the 16-week Treatment Period in Daily Activities / Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score |
5.61; 2.66 | — |
| SECONDARY Change From Baseline to the 16-week Treatment Period in Hospital Anxiety Score |
-0.57; -0.85 | — |
| SECONDARY Change From Baseline to the 16-week Treatment Period in Hospital Depression Score |
0.30; -0.41 | — |
| SECONDARY Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit |
4.73; 5.07 | — |
| SECONDARY Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit |
4.79; 5.00 | — |
| SECONDARY Change From Baseline to the 16-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score |
2.98; 3.34 | — |
| SECONDARY Change From Baseline to the 16-week Treatment Period in Emotional Well-being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score |
1.97; 2.84 | — |
| SECONDARY Change From Baseline to the 16-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score |
2.28; 5.51 | — |
| SECONDARY Change From Baseline to the 16-week Treatment Period in Overall Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score |
-0.48; 4.08 | — |
| SECONDARY Change From Baseline to the 16-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score |
2.83; -0.24 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects were aged from 16 to 70 years, inclusive. Subjects under 18 years of age were only included where legally permitted and ethically accepted
- Subjects had well-characterized localization-related Epilepsy or generalized Epilepsy according to the International League Against Epilepsy (ILAE) classification
- For subjects suffering from localization-related Epilepsy: subjects had at least 2 Partial-Onset Seizures (POSs) whether or not secondarily generalized per month during the 3 months preceding Visit 1 according to the ILAE classification
- For subjects suffering from localization-related Epilepsy: subjects had at least 4 Partial-Onset Seizures (POSs) whether or not secondarily generalized during the 4-week Baseline Period according to the ILAE classification
- For subjects suffering from generalized Epilepsy: subjects had at least 2 Type II-seizure days per month during the 3 months preceding Visit 1 according to the ILAE classification
- For subjects suffering from generalized Epilepsy: subjects had at least 4 Type II-seizure days during the 4 week Baseline Period according to the ILAE classification
- Subjects were uncontrolled while treated by 1 to 3 permitted concomitant Antiepileptic Drugs (AEDs). Vagal nerve stimulation was allowed and was not counted as a concomitant AED
Exclusion Criteria
- For subjects who suffered from localization-related Epilepsy: history or presence of Seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before Visit 2 or occurring only as Type IA non-motor
- Subjects with a history or presence of Status Epilepticus during the year preceding Visit 1 or during Baseline
Data sourced from ClinicalTrials.gov (NCT00504881) 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.