Clinical trial NCT03405714: A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy
Keywords: Epilepsy
Brivaracetam
Briviact
Open-label
pediatric
intravenous
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2018-01-23
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 epilepsy.


Eligibility 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

Primary outcomes:
measure: Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3
timeFrame: Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 3 (Day 1 of IV PK period)
measure: Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 3
timeFrame: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)
measure: Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 3
timeFrame: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)
measure: Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 4
timeFrame: Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 4 (Day 2 of IV PK period)
measure: Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 4
timeFrame: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)
measure: Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 4
timeFrame: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)
measure: Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5
timeFrame: Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 5 (Day 2 of IV PK period)
measure: Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5
timeFrame: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)
measure: Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5
timeFrame: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)
measure: Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3 by Infusion Duration - 15 Minutes
timeFrame: Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 3 (Day 1 of IV PK period)
measure: Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 3 by Infusion Duration- 15 Minutes
timeFrame: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)
measure: Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 3 by Infusion Duration- 15 Minutes
timeFrame: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)
measure: Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 4 by Infusion Duration- 15 Minutes
timeFrame: Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 4 (Day 2 of IV PK period)
measure: Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 4 by Infusion Duration- 15 Minutes
timeFrame: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)
measure: Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 4 by Infusion Duration- 15 Minutes
timeFrame: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)
measure: Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5 by Infusion Duration- 15 Minutes
timeFrame: Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 5 (Day 2 of IV PK period)
measure: Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5 by Infusion Duration- 15 Minutes
timeFrame: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)
measure: Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5 by Infusion Duration- 15 Minutes
timeFrame: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)
measure: Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3 by Infusion Duration- Bolus
timeFrame: Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 3 (Day 1 of IV PK period)
measure: Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 3 by Infusion Duration- Bolus
timeFrame: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)
measure: Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 3 by Infusion Duration- Bolus
timeFrame: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)
measure: Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 4 by Infusion Duration- Bolus
timeFrame: At <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 4 (Day 2 of IV PK period)
measure: Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 4 by Infusion Duration- Bolus
timeFrame: At 15 minutes post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)
measure: Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 4 by Infusion Duration- Bolus
timeFrame: At 3 hours post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)
measure: Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5 by Infusion Duration- Bolus
timeFrame: Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 5 (Day 2 of IV PK period)
measure: Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5 by Infusion Duration- Bolus
timeFrame: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)
measure: Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5 by Infusion Duration- Bolus
timeFrame: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From Screening until last visit (up to Day 68)
measure: Number of Participant Withdrawals Due to Adverse Events
timeFrame: From Screening until last visit (up to Day 68)
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Ep0065 252
state: New York
city: Durham
country: United States
facility: Ep0065 237
state: North Carolina
city: Hradec Králové
country: Czechia
facility: Ep0065 502
city: Praha 4
country: Czechia
facility: Ep0065 240
city: Berlin
country: Germany
facility: Ep0065 242
city: Bielefeld
country: Germany
facility: Ep0065 254
city: Budapest
country: Hungary
facility: Ep0065 210
city: Budapest
country: Hungary
facility: Ep0065 224
city: Budapest
country: Hungary
facility: Ep0065 247
city: Debrecen
country: Hungary
facility: Ep0065 222
city: Miskolc
country: Hungary
facility: Ep0065 232
city: Milan
country: Italy
facility: Ep0065 264
city: Pavia
country: Italy
facility: Ep0065 238
city: Pavia
country: Italy
facility: Ep0065 239
city: Roma
country: Italy
facility: Ep0065 230
city: Aguas Calientes
country: Mexico
facility: Ep0065 223
city: Sevilla
country: Spain
facility: Ep0065 248
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: Farkas MK, Kang H, Fogarasi A, Bozorg A, James GD, Krauwinkel W, Morita D, Will E, Elshoff JP. Pharmacokinetics, safety, and tolerability of intravenous brivaracetam in pediatric patients with epilepsy: An open-label trial. Epilepsia. 2022 Apr;63(4):855-864. doi: 10.1111/epi.17187. Epub 2022 Feb 23.