A MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF INTRAVENOUS BRIVARACETAM IN SUBJECTS =1 MONTH TO <16 YEARS OF AGE WITH EPILEPSY - A study to evaluate the pharmacokinetics, safety, and tolerability of intravenous brivaracetam in su

CB Biopharma SR0 个研究点目标入组 50 人开始时间: 2021年1月22日最近更新: 2021年8月17日

适应症

试验速览

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•- 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
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- 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.

发起方

CB Biopharma SR