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

Completed · Phase 3 · Has a placebo group

Conditions studied: Epilepsy

In brief

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).

Key facts

Study ID

NCT01405508

Run by

UCB Pharma

People needed

105

Starts

2011-08-01

Expected to finish

2012-07-01

Last updated by the study team

2018-07-11

Who can join

Age: 16 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 001 — Phoenix, Arizona, United States
• 775 — Little Rock, Arkansas, United States
• 780 — Lexington, Kentucky, United States
• 008 — Bethesda, Maryland, United States
• 778 — Columbus, Ohio, United States
• 776 — Nashville, Tennessee, United States
• 777 — Dallas, Texas, United States
• 036 — Charlottesville, Virginia, United States
• 917 — Brno, Czechia
• 915 — Hradec Králové, Czechia
• 916 — Kroměříž, Czechia
• 913 — Ostrava Poruba, Czechia
• 332 — Bielefeld, Germany
• 903 — Bonn, Germany
• 795 — Katowice, Poland
• 479 — Poznan, Poland
• 794 — Warsaw, Poland

Full record on ClinicalTrials.gov

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