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

Completed · Phase 2

Conditions studied: Epilepsy

In brief

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 epilepsy.

Key facts

Study ID

NCT03405714

Run by

UCB Biopharma S.P.R.L.

People needed

50

Starts

2018-06-01

Expected to finish

2020-11-04

Last updated by the study team

2022-05-11

Who can join

Age: 0 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ep0065 252 — The Bronx, New York, United States
• Ep0065 237 — Durham, North Carolina, United States
• Ep0065 502 — Hradec Králové, Czechia
• Ep0065 240 — Prague, Czechia
• Ep0065 242 — Berlin, Germany
• Ep0065 254 — Bielefeld, Germany
• Ep0065 210 — Budapest, Hungary
• Ep0065 224 — Budapest, Hungary
• Ep0065 247 — Budapest, Hungary
• Ep0065 222 — Debrecen, Hungary
• Ep0065 232 — Miskolc, Hungary
• Ep0065 264 — Milan, Italy
• Ep0065 238 — Pavia, Italy
• Ep0065 239 — Pavia, Italy
• Ep0065 230 — Roma, Italy
• Ep0065 223 — Aguas Calientes, Mexico
• Ep0065 248 — Seville, Spain

Full record on ClinicalTrials.gov

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