August 17, 2018

Clinical Trail: A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy

The BELLE study is investigating whether Brivaracetam (Briviact®) given intravenously (into the vein) is safe for children and what it does in the body. This study enrolls children who are between 1 month and 16 years of age who have epilepsy and are currently treated with at least one anti-epileptic medicine. All children will receive Brivaracetam in the study, which can take between 3 and 68 days, depending on the child’s condition. The study is running in a total of eight countries, including the US.

Eligibility Criteria:

Ages Eligible for Study: 1 Month to 16 years (child)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Inclusion Criteria:

  • Male or female from >= 1 month to < 16 years of age. For subjects who are < 1 year from birth and who were preterm infants, the corrected gestational age should be used for this entry requirement
  • Weight >= 3 kg (6.6 lbs)
  • Diagnosis of epilepsy
  • Acceptable candidate for venipuncture and intravenous (iv) infusion
  • Treatment with >=1 anti epileptic drug (AED; including BRV) without a change of dose regimen for at least 7 days prior to Screening
  • No treatment with vagus nerve stimulation (VNS), OR the subject is being treated with VNS and the settings have been constant for >=7 days prior to Screening
  • For female subjects: not of childbearing potential, OR of childbearing potential and not sexually active/negative pregnancy test, OR of childbearing potential and sexually active/negative pregnancy test/uses medically acceptable contraceptive methods

Exclusion Criteria:

  • Subject has previously received iv Brivaracetam (BRV) in this study
  • Subject is being treated with BRV at a dose >5mg/kg/day (rounded) or >200mg/day for subjects with body weights >40kg
  • Subject requires or is likely to require a change in concomitant antiepileptic drug(s) (AED[s]), dose of concomitant AED(s), or formulation of AED(s) during the 7 days prior to the intravenous (iv) pharmacokinetic (PK) Period
  • Subject is likely, in the opinion of the Investigator, to require rescue medication during the Initiating Oral BRV (IOB) Treatment or iv PK Periods
  • Subject has experienced generalized convulsive status epilepticus in the 28 days prior to Screening or during the Screening Period

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