A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy

UCB Biopharma SRL449 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

449

Conditions

Partial Seizures With or Without Secondary Generalization Epilepsy

Interventions

PlaceboDRUG

* Pharmaceutical form: Film-coated tablets * Route of administration: Oral use

BrivaracetamDRUG

* Pharmaceutical form: Film-coated tablets * Concentration: 25 mg tablets and 50 mg tablets * Route of administration: Oral use

Eligibility

Sex: ALLMin age: 16 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (94)

Outcomes

Primary Outcomes

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. Treatment-Emergent AEs were defined as AEs which had onset on or after the first dose of IMP. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.

Time frame: From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (up to 4 Years 10 Months)

Percentage of Participants With Treatment-Emergent AEs (TEAEs) Leading to Study Withdrawal

Time frame: From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (up to 4 Years 10 Months)

Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)

Serious Adverse event (SAE) was defined as any events which: • results in death, • is life-threatening threatening (note that this did not include a reaction that might have caused death had it occurred in a more severe form.), •results in significant or persistent disability/incapacity, • results in a congenital anomaly/birth defect (including that occurring in a fetus), • results in Important medical event that, based upon appropriate medical judgment, may jeopardize the participant and might require medical or surgical intervention to prevent 1 of the other outcomes listed here, and • results in initial inpatient hospitalization or prolongation of hospitalization. As per planned analysis, safety data for all study periods was combined excluding Open-Label Temporary period.

Time frame: From start of the Treatment Period (Week 0) until Safety Visit (up to Week 18); only for OLTP- From last visit of Transition Period to beginning of MAP (up to 4 Years 10 Months)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Ep0083 905

Beijing, China

Ep0083 906

Beijing, China

Ep0083 907

Changchun, China

Ep0083 901

Chengdu, China

Ep0083 902

Guangzhou, China

Ep0083 909

Guangzhou, China

Ep0083 917

Guangzhou, China

Ep0083 920

Guangzhou, China

Ep0083 922

Guangzhou, China

Ep0083 924

Guangzhou, China

...and 84 more locations

Secondary Outcomes

50% Responder Rate Based on Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period

Responders were those participants with at least 50% reduction from Baseline to the 12-week Treatment Period in partial seizure frequency per 28 days. 50% Responder rate was calculated for treatment period by dividing the number of 50% responders by the number of participants in the analysis set and multiplying the resulting value by 100.

Time frame: From Baseline to 12-week Treatment Period

Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period

Percent change from Baseline to the Treatment Period in partial seizure frequency was calculated by subtracting 28-day adjusted Treatment Period partial seizure frequency from 28-day adjusted Baseline Period partial seizure frequency, and multiplying the resulting quantity by 100 and dividing by the Baseline Period 28-day adjusted partial seizure frequency. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline to the Treatment Period.

Time frame: From Baseline to 12-week Treatment Period

Percentage of Participants With Categorized Percent Change in Partial Seizure Frequency Per 28 Days From Baseline to the 12-week Treatment Period

The percentage of participants within each of the following categories of percent change in partial seizure frequency from Baseline to the Treatment Period were summarized for each treatment group: 100%, 75% to less than 100%, 50% to less than 75%, 25% to less than 50%, -25% to less than 25%, and less than -25%. Percent change from Baseline to the Treatment Period in partial seizure frequency was calculated by subtracting 28-day adjusted Treatment Period partial seizure frequency from 28-day adjusted Baseline Period partial seizure frequency and multiplying the resulting quantity by 100 and dividing by the Baseline Period 28-day adjusted partial seizure frequency.

Time frame: From Baseline to 12-week Treatment Period

All Seizure Frequency (Partial, Generalized, and Unclassified Epileptic Seizures) Per 28 Days During the 12-week Treatment Period

There were three types of epileptic seizures: Partial epileptic seizures (Type I), Generalized epileptic seizures (Type II) and unclassified epileptic seizures (Type III). 28 day adjusted seizure frequency for all seizure types was calculated for treatment period by dividing the number of targeted seizures by the number of days for which the DRC was completed for treatment period and multiplying the resulting value by 28.