Status:
COMPLETED
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy
Lead Sponsor:
UCB Biopharma S.P.R.L.
Conditions:
Epilepsy
Eligibility:
All Genders
1-16 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of brivaracetam (BRV) administered intravenously (iv) in subjects \>= 1 month to \< 16 years of age with epi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03405714
Start Date
June 1 2018
End Date
November 4 2020
Last Update
May 11 2022
Active Locations (17)
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1
Ep0065 252
The Bronx, New York, United States, 10467
2
Ep0065 237
Durham, North Carolina, United States, 27710
3
Ep0065 502
Hradec Králové, Czechia
4
Ep0065 240
Prague, Czechia