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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 December 2021
• Main ID: NCT03405714
• Date of registration: 12/01/2018
• Prospective Registration: Yes
• Primary sponsor: UCB Biopharma S.P.R.L.
• Public title: A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy
• Scientific title: A Multicenter, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month < 16 Years of Age With Epilepsy
• Date of first enrolment: June 1, 2018
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03405714
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Czechia, Germany, Hungary, Italy, Mexico, Spain, United States

Contacts

• Name: UCB Cares
• Affiliation: 001 844 599 2273 (UCB)

Key inclusion & exclusion criteria

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



Age minimum: 1 Month
Age maximum: 16 Years
Gender: All

Health Condition(s) or Problem(s) studied

Epilepsy

Intervention(s)

Drug: Brivaracetam

Primary Outcome(s)

Number of Participants With Adverse Events (AEs) [Time Frame: From Screening until last visit (up to Day 68)]

Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 4 [Time Frame: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)]

Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5 by Infusion Duration- Bolus [Time Frame: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)]

Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5 by Infusion Duration- 15 Minutes [Time Frame: Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 5 (Day 2 of IV PK period)]

Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 3 [Time Frame: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)]

Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 4 by Infusion Duration- 15 Minutes [Time Frame: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)]

Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5 by Infusion Duration- 15 Minutes [Time Frame: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)]

Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3 by Infusion Duration- Bolus [Time Frame: Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 3 (Day 1 of IV PK period)]

Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 3 by Infusion Duration- 15 Minutes [Time Frame: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)]

Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5 [Time Frame: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)]

Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 4 by Infusion Duration- 15 Minutes [Time Frame: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)]

Number of Participant Withdrawals Due to Adverse Events [Time Frame: From Screening until last visit (up to Day 68)]

Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 3 by Infusion Duration- 15 Minutes [Time Frame: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)]

Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 3 by Infusion Duration- Bolus [Time Frame: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)]

Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5 [Time Frame: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)]

Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 3 [Time Frame: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)]

Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3 [Time Frame: Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 3 (Day 1 of IV PK period)]

Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 4 [Time Frame: Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 4 (Day 2 of IV PK period)]

Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3 by Infusion Duration - 15 Minutes [Time Frame: Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 3 (Day 1 of IV PK period)]

Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 4 by Infusion Duration- Bolus [Time Frame: At 3 hours post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)]

Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 4 by Infusion Duration- Bolus [Time Frame: At <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 4 (Day 2 of IV PK period)]

Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5 [Time Frame: Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 5 (Day 2 of IV PK period)]

Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 3 by Infusion Duration- Bolus [Time Frame: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)]

Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5 by Infusion Duration- 15 Minutes [Time Frame: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)]

Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5 by Infusion Duration- Bolus [Time Frame: Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 5 (Day 2 of IV PK period)]

Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 4 [Time Frame: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)]

Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 4 by Infusion Duration- Bolus [Time Frame: At 15 minutes post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)]

Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5 by Infusion Duration- Bolus [Time Frame: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)]

Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 4 by Infusion Duration- 15 Minutes [Time Frame: Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 4 (Day 2 of IV PK period)]

Secondary ID(s)

2016-002452-25

EP0065

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/11/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03405714