Safety and Tolerability of Intravenous Brivaracetam (Infusion or Bolus) as Adjunctive Antiepileptic Therapy



Status:Completed
Conditions:Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:16 - 70
Updated:7/13/2018
Start Date:August 2011
End Date:July 2012

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A Multi-center, Open-label, Four-arm, Randomized Trial Evaluating the Safety and Tolerability of Brivaracetam Intravenous Infusion and Bolus, Administered in BID Regimen as an Adjunctive Antiepileptic Treatment in Subjects From 16 to 70 Years Suffering From Epilepsy

This is a multicenter, open-label, 4-arm, randomized, parallel-group study to evaluate safety
and tolerability of Brivaracetam Intravenous (BRV iv) as adjunctive treatment for adults with
epilepsy according to an initiation or a conversion scheme, during repeated dosing (100
mg/administration twice daily for 4.5 days).

Eligible subjects will be randomized in a 1:1:1:1 ratio to the 4 treatment arms

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
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