Phase 3 N=400 Randomized Quadruple-blind Treatment

Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures

Epilepsy

Bottom Line

View on ClinicalTrials.gov: NCT00464269 ↗

Enrolled (actual)

400

Serious AEs

2.0%

Results posted

Apr 2016

Primary outcome: Primary: Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period — 2.15; 1.80; 1.96; 1.70 seizures per week — p==0.025

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Placebo (Other); Brivaracetam 2.5 mg (Drug); Brivaracetam 10 mg (Drug); Brivaracetam 25 mg (Drug)
Age: Pediatric, Adult, Older Adult · 16+ yrs
Sex: All
Sponsor: UCB Pharma
Primary completion: Dec 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period	2.15; 1.80; 1.96; 1.70	=0.025 sig
SECONDARY Responder Rate for Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period	16; 21; 23; 33; 80; 75	—
SECONDARY All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period	2.15; 1.80; 1.96; 1.77	—
SECONDARY Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week	17.75; 19.95; 22.52; 30.47	—
SECONDARY Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period	14.6; 21.9; 14.1; 9.9; 44.8; 31.3	—
SECONDARY Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period	0; 1.0; 1.0; 4.0; 0; 0	—
SECONDARY Time to First Type I Seizure During the 12-week Treatment Period	3; 4; 5; 4	—
SECONDARY Time to Fifth Type I Seizure During the 12-week Treatment Period	15; 14; 17; 19	—
SECONDARY Time to Tenth Type I Seizure During the 12-week Treatment Period	28; 30; 34; 37	—
SECONDARY Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period	56.3; 50.0; 77.8; 63.6	—
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	3.88; 4.07; 5.19; 2.88	—
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	9.36; 3.34; 3.69; 5.97	—
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	1.97; 7.03; 7.73; 2.06	—
SECONDARY Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score	7.44; 7.32; 6.55; 7.99	—
SECONDARY Change From Baseline to the 12-week Treatment Period in Hospital Depression Score	5.36; 4.97; 4.82; 5.81	—
SECONDARY Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit	15.5; 19.8; 18.8; 26.7; 25.0; 24.7	—
SECONDARY Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit	12.6; 12.2; 17.2; 16.3; 20.0; 18.9	—
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	6.41; 2.24; 3.94; 0.45	—
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	2.14; 1.69; 2.07; 1.97	—
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	2.79; 4.26; 6.36; 3.37	—
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	1.02; -2.61; 0.73; 6.07	—
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	5.49; 3.39; 3.66; 2.33	—
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	8.1; 6.9; 7.3; 5.5	—

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 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 (V1)
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 drug(s) (AEDs). Vagal nerve stimulation (VNS) 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00464269). 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.