Please select the eligibility criteria that correspond to the clinical trial below.
Title: An International, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Study: Evaluation of the Safety and Efficacy of Brivaracetam in Subjects (≥ 16 to 70 Years Old) Suffering From Localization-related or Generalized Epilepsy.
Brief Summary: This study will compare the safety and efficacy of Brivaracetam at flexible dose with Placebo in subjects suffering from Epilepsy.


Options:
A: Inclusion Criteria:

* Subject is male or female, 18 to 70 years of age, inclusive
* Subject has an established diagnosis of epilepsy
* Subject has been admitted to the institution's Epilepsy Monitoring Unit (EMU) for seizure characterization or noninvasive presurgical evaluation or such admission is planned within 21 days of Screening

Exclusion Criteria:

* Subject has previously participated in this study and was treated with study drug. Re-screen is permitted
* Subject has participated in another study of an investigational medicinal product (IMP) or a medical device within the previous 30 days of Epilepsy Monitoring Unit (EMU) admission or is currently participating in another study of an IMP or a medical device
* Subject has taken brivaracetam (BRV) in the 21 days prior to EMU admission
* History or presence of status epilepticus during the 6 months prior to EMU admission
* Subject has a medical or psychiatric condition that in the opinion of the Investigator could jeopardize or would compromise the subject's ability to participate in this study
* Subject has \> 2x upper limit of normal (ULN) of any of the following: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, or \> ULN total bilirubin
* Subject has chronic liver disease
* Subject has hypersensitivity to BRV or any of its excipients
* Subject has a history of alcohol or drug abuse during the 6 months prior to EMU admission
* Subject with a history of psychogenic seizures
* Subject is a pregnant or lactating female
* Subject has a history of a significant Adverse Event (AE) due to a benzodiazepine in the opinion of the Investigator
* Subject has respiratory failure (or is at risk for respiratory failure), untreated sleep apnea, or other severe cardiorespiratory disease with New York Heart Association Class III or IV functional status, or requires supplemental oxygen
* Subject has acute narrow-angle glaucoma or myasthenia gravis
* Subject is receiving benzodiazepine treatment (defined as an average of \>=4 administrations per week) that started less than 28 days prior to EMU admission
* Subject has a known allergic reaction or intolerance to benzodiazepines or benzodiazepine excipients
B: 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
C: Inclusion Criteria:

* Well-characterized focal epilepsy/epileptic syndrome according to the 1989 International League Against Epilepsy (ILAE) classification
* Presence of an EEG reading compatible with the clinical diagnosis of focal epilepsy within the last 5 years
* Presence of a brain MRI/computed tomography (CT) scan performed within the last 2 years
* Subjects having at least 8 Type I seizures \[POS; focal seizures (according to the 1981 ILAE classification)\] during the 8-week Baseline Period with at least 2 Type I seizures during each 4-week interval of the Baseline Period
* Subjects having at least 2 partial onset seizures whether or not secondarily generalized per month during the 3 months preceding V1
* Subjects being uncontrolled while treated by 1 or 2 permitted concomitant AED(s). Vagal Nerve Stimulation (VNS) is allowed and will be counted as a concomitant AED
* Permitted concomitant AED(s) and VNS being stable and at optimal dosage for the subject from at least 1 month (3 months for phenobarbital, phenytoin, and primidone) before V1 and expected to be kept stable during the Baseline and Treatment Period. Benzodiazepine taken more than once a week (for any indication) will be considered as a concomitant AED

Exclusion Criteria:

* Subject previously randomized within this study or any other prior study with BRV as a dosing arm
* Seizure type IA (1981 ILAE classification) nonmotor as only seizure type.
* Subject is currently treated with LEV or has taken LEV within 90 days prior to V1
* Subject has any medical or psychiatric condition, obvious cognitive impairment or mental retardation that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study
* Subjects whose seizures could not be reliably counted on a regular basis due to their fast and repetitive occurrence (clusters or flurries)
* Subject has history or presence of status epilepticus during the year preceding V1 or during Baseline
* Subject has history or presence of known psychogenic nonepileptic seizures
* Subject on felbamate with less than 18 months exposure before V1
* Subject currently on vigabatrin. Subject with history of vigabatrin use but either no visual fields examination report available including standard static (Humphrey or Octopus) or kinetic perimetry (Goldman) or results of these examinations are abnormal
* Subject taking any drug with possible central nervous system (CNS) effects except if stable from at least 1 month before V1 and expected to be kept stable during the Treatment Period
* Subject has history of cerebrovascular accident, including transient ischemic attack, in the last 6 months
* Subject is suffering from severe cardiovascular disease or peripheral vascular disease
* Subject has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months
* Subject has ongoing psychiatric disease other than mild controlled disorder
D: Inclusion Criteria:

* Subject completed the Treatment Period of N01358 or the evaluation period of N01258
* Male/female subject from 16 years or older. Subject under 18 years may only be included where legally permitted and ethically accepted
* Subject for whom the Investigator believes a reasonable benefit from the long term administration of BRV may be expected
* Female subject without childbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible

Exclusion Criteria:

* Subject has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core studies
* Severe medical, neurological, or psychiatric disorders, or laboratory values which may have an impact on the safety of the subject
* Poor compliance with the visit schedule or medication intake in the previous BRV study
* Planned participation in any other clinical study of another investigational drug or device during this study
* Pregnant or lactating woman
* Any medical condition which, in the Investigator's opinion, warrants exclusion
* Subject has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months

Answer: B