adjunctive treatment in subjects (>=16 to 80 years of age) with ​partial seizures with or without secondary generalization

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.

BRIVARACETAM®, tablets for oral administration

Brivaracetam

tablets

25/50

Primary Outcome Measures :
Adverse events (AEs) [ Time Frame: From Screening (Week -8) until Safety Visit (up to Week 18) ]
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.

Partial seizure frequency per 28 days during the 12-week Treatment Period [ Time Frame: From Baseline to 12-weeks Treatement Period ]
Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.

Percent change in partial seizure frequency during the 12-week Treatment Period [ Time Frame: From Baseline to 12-weeks Tratement Period ]
Calculated as (seizure frequency Baseline - seizure frequency Treatment) *100/ (seizure frequency Baseline). The higher the values for percent change in partial seizure (PS) frequency, the higher the improvement from Baseline.


Secondary Outcome Measures :
50% responder rate based on percent change in partial seizure frequency per 28 days from Baseline to the 12-week Treatment Period [ Time Frame: From Baseline to 12-week Treatment Period ]
Responders are those subjects with at least 50% reduction from Baseline to the 12-week Treatment Period in partial seizure frequency per 28 days

Percent change in partial seizure frequency per 28 days from Baseline to the 12-week Treatment Period [ Time Frame: From Baseline to 12-week Treatment Period ]
Calculated as 28-day seizure frequency during the Treatment Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100.

A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline to the Treatment Period.


Categorized percent change in partial seizures frequency per 28 days from Baseline to the 12-week Treatment Period [ Time Frame: From Baseline to 12-week Treatment Period ]
Calculated as 28-day seizure frequency during the Treatment Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100.

All seizure frequency (partial, generalized, and unclassified epileptic seizures) per 28 days during the 12-week Treatment Period [ Time Frame: During the 12-week Treatment Period ]
There are three types of epileptic seizures: Partial epileptic seizures (Type I), Generalized epileptic seizures (Type II) and unclassified epileptic seizures (Type III).

Percentage of subjects who are seizure free (partial, all epileptic seizures) during the 12-week Treatment Period [ Time Frame: During the 12-week Treatment Period ]
A subject was considered seizure free, if no seizure was reported during the 12-week Treatment Period.

Time to nth (n= 1, 5, 10) partial seizure during the 12-week Treatment Period [ Time Frame: During the 12-week Treatment Period ]
Number of days to first, fifth, and tenth seizure after baseline.

Brivaracetam plasma concentration [ Time Frame: Plasma samples will be collected in week 2, 4, 8, 12, 14. ]
Blood samples will be collected at indicated time points to determine the brivaracetam plasma concentration.

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