Clinical trial NCT01405508 (phase 3, status: completed)
Conditions: epilepsy
ICD codes: G40.803, G40.804, G40.911, G40.919, G40.B11, G40.B19, G40.801
Drugs: brivaracetam tablets, brivaracetam bolus, brivaracetam infusion
SMILES: CCC[C@H]1CN([C@@H](CC)C(N)=O)C(=O)C1, CCC[C@H]1CN([C@@H](CC)C(N)=O)C(=O)C1, CCC[C@H]1CN([C@@H](CC)C(N)=O)C(=O)C1
Eligibility criteria:

        Inclusion Criteria:

          -  An Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved written
             Informed Consent form signed and dated by the subject or by parent(s) or legal
             representative

          -  Subjects from 16 to 70 years

          -  Subjects with a body weight of >/= 40 kg

          -  Female subjects without childbearing potential or female subjects with childbearing
             potential if they use a medically accepted contraceptive method

          -  Subject/legal representative considered as reliable and capable of adhering to the
             protocol

          -  Subjects with well-characterized focal or generalized epilepsy or epileptic syndrome

          -  Subjects with a history of partial-onset seizures whether or not secondarily
             generalized or primary generalized seizures

          -  Subjects being uncontrolled while treated with 1 to 2 permitted concomitant
             antiepileptic drugs (AEDs)

          -  Permitted concomitant antiepileptic drugs (AEDs) and vagus nerve stimulation (VNS)
             being stable and at optimal dosage for the subject from at least 1 month before Visit
             1 and expected to be kept stable during the Run-In and Evaluation Periods

        Exclusion Criteria:

          -  Mentally impaired subjects unable to understand the study purpose

          -  History or presence of status epilepticus during 1 year preceding Visit 1 or Baseline

          -  Subjects on felbamate with less than 18 months continuous exposure before Visit 1

          -  Subjects currently on vigabatrin

          -  Subject taking any drug with possible relevant central nervous system effects except
             is stable from at least 1 month before Visit 1 and expected to be kept stable during
             the trial

          -  Subjects taking any drug that may significantly influence the metabolism of
             Brivaracetam (BRV) except if the dose has been kept stable at least 1 month before
             Visit 1, and is expected to be kept stable during the trial

          -  History of cerebrovascular accident in the last 6 months

          -  Subjects suffering from severe cardiovascular disease or peripheral vascular disease

          -  Presence of any sign suggesting rapidly progressing brain disorder or brain tumor

          -  Any clinical conditions which impair reliable participation in the study or
             necessitate the use of medication not allowed by protocol

          -  Presence of a terminal illness

          -  Presence of a serious infection

          -  Subjects with a history of sever adverse hematologic reaction to any drug

          -  Subjects suffering from severe disturbance of hemostasis

          -  Impaired hepatic function: alanine aminotransferase (ALT), aspartate aminotransferase
             (AST), gamma-glutamyltransferase (GGT) values of more than 3 times the upper limit of
             the reference range

          -  Subjects having clinically significant deviations from reference range values for
             laboratory parameters: creatinine clearance calculated < 50 ml / min, platelets <
             100,000 / µL, or neutrophil cells < 1,800 / µL

          -  Clinically significant electrocardiogram (ECG) abnormalities according to the
             Investigator

          -  History of suicide attempt

          -  In the Investigator's medical judgment, any current suicidal ideation or other serious
             psychiatric disorders requiring of having required hospitalization or medication

          -  Known allergic reaction or intolerance to pyrrolidone derivatives and / or
             investigational product excipients

          -  Known multiple drug allergies or severe drug allergy

          -  Pregnant or lactating women

          -  Known alcohol or drug addiction or abuse within the last 2 years

          -  Subject institutionalized under judicial decision

          -  Problems of venous accessibility

          -  Subject taking part in another clinical / pharmacological study in the month preceding
             enrollment (Visit 1)

          -  Investigators, coinvestigators, their spouses or children, or any study collaborators

          -  Subjects previously treated with Brivaracetam (BRV)

          -  Subject previously screened within this study