A study to evaluate the pharmacokinetics, safety, and tolerability of intravenous brivaracetam in subjects >= 1 month to < 16 years of age with epilepsy

Phase 1

• Conditions: ocalization-related, generalized or undetermined whether focal or generalized epileptic syndrome, according to ILAE classification; MedDRA version: 21.0Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-002452-25-IT
• Lead Sponsor: CB Biopharma SR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-11-04
• Study Start: 2021-01-22
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

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
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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the PK, safety, and tolerability of BRV administered intravenously in subjects >= 1 month to < 16 years of age with epilepsy;Secondary Objective: N/A;Primary end point(s): - Incidence of adverse events throughout the study<br>- Number of subject withdrawals due to AEs<br>- Plasma concentration of brivaracetam (BRV);Timepoint(s) of evaluation of this end point: 1+2: From Screening (Day -20 to -1) until last visit (up to day 68)<br>3: Blood samples will be collected <= 1 hour pre-initiation of intravenous<br>(iv) BRV infusion and 15 min<br>and 3 hours post-initiation of iv BRV infusion