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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: Anticonvulsants; Brivaracetam

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