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CompletedNCT03405714Updated May 11, 2022Results posted

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

A Phase 2 interventional study of Brivaracetam in Epilepsy, sponsored by UCB Biopharma S.P.R.L.. Completed at 17 sites in 7 countries. Open to participants aged 1 Month to 16 Years. Per ClinicalTrials.gov, last updated 2022-05-11.

Sponsored by UCB Biopharma S.P.R.L. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
1 Month to 16 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Epilepsy

Browse trials for

Keywords

  • Epilepsy
  • Brivaracetam
  • Briviact
  • Open-label
  • pediatric
  • intravenous
03

Who can participate

Ages eligible
1 Month to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Brivaracetam

    Brivaracetam will be administered to various age-based cohorts. Cohort 1: Subjects \>=12 to \<16 years; Cohort 2: Subjects \>=6 to \<12 years; Cohort 3: Subjects \>=2 to \<6 years; Cohort 4: Subjects 1 month to \<2 years. Enrollment will be sequential by descending age beginning with Cohort 1. For each cohort, the first half will receive a 15-minute iv infusion. The Data Monitoring Committee (DMC) will then review safety and, as available, PK data to make the following recommendations: the progression of the current cohort (up to 2-minute iv bolus infusion) and progression to initiate enrollment in the preceding cohort.

    Drug: Brivaracetam

Interventions

  • DrugBrivaracetam

    * Pharmaceutical form: Solution for iv injection * Route of administration: intravenous use * Concentration: 10 mg/ml

    Also known as: Briviact

05

What researchers measure

Primary outcomes

  1. Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3

    Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

    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)

  2. Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 3

    Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

    Time frame: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)

  3. Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 3

    Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

    Time frame: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)

  4. Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 4

    Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

    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)

  5. Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 4

    Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

    Time frame: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)

  6. Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 4

    Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

    Time frame: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)

  7. Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5

    Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

    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)

  8. Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5

    Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

    Time frame: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)

  9. Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5

    Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

    Time frame: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)

  10. Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3 by Infusion Duration - 15 Minutes

    Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

    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)

  11. Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 3 by Infusion Duration- 15 Minutes

    Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

    Time frame: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)

  12. Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 3 by Infusion Duration- 15 Minutes

    Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

    Time frame: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)

  13. Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 4 by Infusion Duration- 15 Minutes

    Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

    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)

  14. Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 4 by Infusion Duration- 15 Minutes

    Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

    Time frame: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)

  15. Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 4 by Infusion Duration- 15 Minutes

    Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

    Time frame: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)

  16. Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5 by Infusion Duration- 15 Minutes

    Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

    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)

  17. Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5 by Infusion Duration- 15 Minutes

    Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

    Time frame: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)

  18. Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5 by Infusion Duration- 15 Minutes

    Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

    Time frame: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)

  19. Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3 by Infusion Duration- Bolus

    Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

    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)

  20. Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 3 by Infusion Duration- Bolus

    Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

    Time frame: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)

  21. Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 3 by Infusion Duration- Bolus

    Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

    Time frame: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)

  22. Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 4 by Infusion Duration- Bolus

    Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

    Time frame: At <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 4 (Day 2 of IV PK period)

  23. Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 4 by Infusion Duration- Bolus

    Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

    Time frame: At 15 minutes post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)

  24. Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 4 by Infusion Duration- Bolus

    Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

    Time frame: At 3 hours post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)

  25. Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5 by Infusion Duration- Bolus

    Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

    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)

  26. Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5 by Infusion Duration- Bolus

    Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

    Time frame: Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)

  27. Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5 by Infusion Duration- Bolus

    Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

    Time frame: Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)

  28. Number of Participants With Adverse Events (AEs)

    An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.

    Time frame: From Screening until last visit (up to Day 68)

  29. Number of Participant Withdrawals Due to Adverse Events

    An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.

    Time frame: From Screening until last visit (up to Day 68)

06

Results

Posted Nov 26, 2021

Participant flow

The study started to enroll participants in June 2018 and concluded in November 2020.

Participant flow — Overall Study
MilestoneAge Cohort: >=12 to <16 YearsAge Cohort: >=6 to <12 YearsAge Cohort: >=2 to <6 YearsAge Cohort: >=1 Month to <2 Years
Started12121313
Completed12121313
Not completed0000

Outcome measures

PrimaryPlasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

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)
Reported as:
Geometric mean · nanograms per milliliter (ng/mL)
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3
nanograms per milliliter (ng/mL)Age Cohort: >=12 to <16 Years (PK-PPS)Age Cohort: >=6 to <12 Years (PK-PPS)Age Cohort: >=2 to <6 Years (PK-PPS)Age Cohort : >=1 Month to <2 Years (PK-PPS)
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3149.0 (27.6 to 805.1)NA (NA to NA)NA (NA to NA)310.6 (92.5 to 1042.7)
PrimaryPlasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 3

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Time frame:
Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)
Reported as:
Geometric mean · ng/mL
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 3
ng/mLAge Cohort: >=12 to <16 Years (PK-PPS)Age Cohort: >=6 to <12 Years (PK-PPS)Age Cohort: >=2 to <6 Years (PK-PPS)Age Cohort : >=1 Month to <2 Years (PK-PPS)
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 31844.6 (1110.4 to 3064.3)2058.8 (1726.4 to 2455.2)1774.9 (1087.4 to 2897.1)1566.6 (973.1 to 2522.2)
PrimaryPlasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 3

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Time frame:
Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)
Reported as:
Geometric mean · ng/mL
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 3
ng/mLAge Cohort: >=12 to <16 Years (PK-PPS)Age Cohort: >=6 to <12 Years (PK-PPS)Age Cohort: >=2 to <6 Years (PK-PPS)Age Cohort : >=1 Month to <2 Years (PK-PPS)
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 31260.6 (962.6 to 1650.8)1189.5 (1005.5 to 1407.1)1225.3 (676.8 to 2218.6)1341.7 (657.9 to 2735.9)
PrimaryPlasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 4

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

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)
Reported as:
Geometric mean · ng/mL
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 4
ng/mLAge Cohort: >=12 to <16 Years (PK-PPS)Age Cohort: >=6 to <12 Years (PK-PPS)Age Cohort: >=2 to <6 Years (PK-PPS)Age Cohort : >=1 Month to <2 Years (PK-PPS)
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 4—290.5 (101.2 to 834.0)——
PrimaryPlasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 4

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Time frame:
Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)
Reported as:
Geometric mean · ng/mL
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 4
ng/mLAge Cohort: >=12 to <16 Years (PK-PPS)Age Cohort: >=6 to <12 Years (PK-PPS)Age Cohort: >=2 to <6 Years (PK-PPS)Age Cohort : >=1 Month to <2 Years (PK-PPS)
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 4—2084.3 (681.2 to 6377.0)——
PrimaryPlasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 4

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Time frame:
Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)
Reported as:
Geometric mean · ng/mL
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 4
ng/mLAge Cohort: >=12 to <16 Years (PK-PPS)Age Cohort: >=6 to <12 Years (PK-PPS)Age Cohort: >=2 to <6 Years (PK-PPS)Age Cohort : >=1 Month to <2 Years (PK-PPS)
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 4—1149.8 (613.1 to 2156.4)——
PrimaryPlasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

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)
Reported as:
Geometric mean · ng/mL
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5
ng/mLAge Cohort: >=12 to <16 Years (PK-PPS)Age Cohort: >=6 to <12 Years (PK-PPS)Age Cohort: >=2 to <6 Years (PK-PPS)Age Cohort : >=1 Month to <2 Years (PK-PPS)
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5—466.0 (NA to NA)204.5 (0.1 to 383063.7)482.9 (4.8 to 48506.1)
PrimaryPlasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Time frame:
Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)
Reported as:
Geometric mean · ng/mL
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5
ng/mLAge Cohort: >=12 to <16 Years (PK-PPS)Age Cohort: >=6 to <12 Years (PK-PPS)Age Cohort: >=2 to <6 Years (PK-PPS)Age Cohort : >=1 Month to <2 Years (PK-PPS)
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5—2890.0 (NA to NA)1948.8 (690.8 to 5497.7)2072.4 (743.2 to 5778.8)
PrimaryPlasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Time frame:
Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)
Reported as:
Geometric mean · ng/mL
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5
ng/mLAge Cohort: >=12 to <16 Years (PK-PPS)Age Cohort: >=6 to <12 Years (PK-PPS)Age Cohort: >=2 to <6 Years (PK-PPS)Age Cohort : >=1 Month to <2 Years (PK-PPS)
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5—1820 (NA to NA)1203.5 (147.1 to 9847.1)727.4 (144.9 to 3652.9)
PrimaryPlasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3 by Infusion Duration - 15 Minutes

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

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)
Reported as:
Geometric mean · ng/mL
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3 by Infusion Duration - 15 Minutes
ng/mL15-minute Infusion (PK-PPS)
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3 by Infusion Duration - 15 MinutesNA (NA to NA)
PrimaryPlasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 3 by Infusion Duration- 15 Minutes

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Time frame:
Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)
Reported as:
Geometric mean · ng/mL
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 3 by Infusion Duration- 15 Minutes
ng/mL15-minute Infusion (PK-PPS)
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 3 by Infusion Duration- 15 Minutes1903.0 (1474.9 to 2455.4)
PrimaryPlasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 3 by Infusion Duration- 15 Minutes

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Time frame:
Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)
Reported as:
Geometric mean · ng/mL
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 3 by Infusion Duration- 15 Minutes
ng/mL15-minute Infusion (PK-PPS)
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 3 by Infusion Duration- 15 Minutes1130.3 (882.1 to 1448.3)
PrimaryPlasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 4 by Infusion Duration- 15 Minutes

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

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)
Reported as:
Geometric mean · ng/mL
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 4 by Infusion Duration- 15 Minutes
ng/mL15-minute Infusion (PK-PPS)
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 4 by Infusion Duration- 15 Minutes290.5 (101.2 to 834.0)
PrimaryPlasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 4 by Infusion Duration- 15 Minutes

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Time frame:
Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)
Reported as:
Geometric mean · ng/mL
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 4 by Infusion Duration- 15 Minutes
ng/mL15-minute Infusion (PK-PPS)
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 4 by Infusion Duration- 15 Minutes2084.3 (681.2 to 6377.0)
PrimaryPlasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 4 by Infusion Duration- 15 Minutes

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Time frame:
Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)
Reported as:
Geometric mean · ng/mL
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 4 by Infusion Duration- 15 Minutes
ng/mL15-minute Infusion (PK-PPS)
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 4 by Infusion Duration- 15 Minutes1149.8 (613.1 to 2156.4)
PrimaryPlasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5 by Infusion Duration- 15 Minutes

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

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)
Reported as:
Geometric mean · ng/mL
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5 by Infusion Duration- 15 Minutes
ng/mL15-minute Infusion (PK-PPS)
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5 by Infusion Duration- 15 Minutes776.0 (51.9 to 11611.3)
PrimaryPlasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5 by Infusion Duration- 15 Minutes

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Time frame:
Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)
Reported as:
Geometric mean · ng/mL
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5 by Infusion Duration- 15 Minutes
ng/mL15-minute Infusion (PK-PPS)
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5 by Infusion Duration- 15 Minutes2697.8 (1911.1 to 3808.3)
PrimaryPlasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5 by Infusion Duration- 15 Minutes

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Time frame:
Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)
Reported as:
Geometric mean · ng/mL
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5 by Infusion Duration- 15 Minutes
ng/mL15-minute Infusion (PK-PPS)
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5 by Infusion Duration- 15 Minutes1030.0 (376.1 to 2820.9)
PrimaryPlasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3 by Infusion Duration- Bolus

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

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)
Reported as:
Geometric mean · ng/mL
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3 by Infusion Duration- Bolus
ng/mLBolus (PK-PPS)
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3 by Infusion Duration- Bolus120.5 (44.7 to 325.2)
PrimaryPlasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 3 by Infusion Duration- Bolus

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Time frame:
Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)
Reported as:
Geometric mean · ng/mL
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 3 by Infusion Duration- Bolus
ng/mLBolus (PK-PPS)
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 3 by Infusion Duration- Bolus1704.8 (1237.5 to 2348.4)
PrimaryPlasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 3 by Infusion Duration- Bolus

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Time frame:
Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period)
Reported as:
Geometric mean · ng/mL
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 3 by Infusion Duration- Bolus
ng/mLBolus (PK-PPS)
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 3 by Infusion Duration- Bolus1383.9 (989.3 to 1935.8)
PrimaryPlasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 4 by Infusion Duration- Bolus

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Time frame:
At <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 4 (Day 2 of IV PK period)

No measurements were reported for this outcome.

PrimaryPlasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 4 by Infusion Duration- Bolus

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Time frame:
At 15 minutes post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)

No measurements were reported for this outcome.

PrimaryPlasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 4 by Infusion Duration- Bolus

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Time frame:
At 3 hours post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period)

No measurements were reported for this outcome.

PrimaryPlasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5 by Infusion Duration- Bolus

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

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)
Reported as:
Geometric mean · ng/mL
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5 by Infusion Duration- Bolus
ng/mLBolus (PK-PPS)
Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5 by Infusion Duration- Bolus167.5 (9.6 to 2932.2)
PrimaryPlasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5 by Infusion Duration- Bolus

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Time frame:
Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)
Reported as:
Geometric mean · ng/mL
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5 by Infusion Duration- Bolus
ng/mLBolus (PK-PPS)
Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5 by Infusion Duration- Bolus1531.8 (837.3 to 2802.2)
PrimaryPlasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5 by Infusion Duration- Bolus

Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration.

Time frame:
Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period)
Reported as:
Geometric mean · ng/mL
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5 by Infusion Duration- Bolus
ng/mLBolus (PK-PPS)
Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5 by Infusion Duration- Bolus949.5 (2.8 to 316987.2)
PrimaryNumber of Participants With Adverse Events (AEs)

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.

Time frame:
From Screening until last visit (up to Day 68)
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events (AEs)
ParticipantsAge Cohort: >=12 to <16 Years (SS-iv)Age Cohort: >=6 to <12 Years (SS-iv)Age Cohort: >=2 to <6 Years (SS-iv)Age Cohort: >=1 Month to <2 Years (SS-iv)
Number of Participants With Adverse Events (AEs)3472
PrimaryNumber of Participant Withdrawals Due to Adverse Events

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.

Time frame:
From Screening until last visit (up to Day 68)
Reported as:
Count of participants · Participants
Number of Participant Withdrawals Due to Adverse Events
ParticipantsAge Cohort: >=12 to <16 Years (SS-iv)Age Cohort: >=6 to <12 Years (SS-iv)Age Cohort: >=2 to <6 Years (SS-iv)Age Cohort: >=1 Month to <2 Years (SS-iv)
Number of Participant Withdrawals Due to Adverse Events0000

Adverse events

Collected over From Screening until last visit (up to Day 68). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Age Cohort: >=12 to <16 Years (SS-iv)0/12 (0%)0/12 (0%)3/12 (25%)
Age Cohort: >=6 to <12 Years (SS-iv)0/12 (0%)0/12 (0%)4/12 (33.3%)
Age Cohort: >=2 to <6 Years (SS-iv)0/13 (0%)0/13 (0%)7/13 (53.8%)
Age Cohort: >=1 Month to <2 Years (SS-iv)0/13 (0%)1/13 (7.7%)2/13 (15.4%)
Most frequent serious events
Most frequent serious events
EventAge Cohort: >=12 to <16 Years (SS-iv)Age Cohort: >=6 to <12 Years (SS-iv)Age Cohort: >=2 to <6 Years (SS-iv)Age Cohort: >=1 Month to <2 Years (SS-iv)
CoughRespiratory, thoracic and mediastinal disorders0/120/120/131/13
Most frequent other events
Showing 10 of 15
Most frequent other events
EventAge Cohort: >=12 to <16 Years (SS-iv)Age Cohort: >=6 to <12 Years (SS-iv)Age Cohort: >=2 to <6 Years (SS-iv)Age Cohort: >=1 Month to <2 Years (SS-iv)
DizzinessNervous system disorders2/120/120/130/13
PyrexiaGeneral disorders0/120/122/130/13
Ear infectionInfections and infestations0/120/122/130/13
SomnolenceNervous system disorders0/120/122/131/13
VomitingGastrointestinal disorders0/121/120/130/13
FatigueGeneral disorders0/121/121/130/13
PharyngitisInfections and infestations1/120/120/130/13
InsomniaPsychiatric disorders0/121/120/130/13
PruritusSkin and subcutaneous tissue disorders0/121/120/130/13
RashSkin and subcutaneous tissue disorders0/121/121/130/13

Baseline characteristics

Baseline Characteristics refer to SS-iv, which included study participants who received at least 1 dose of iv BRV.

Age, Categorical
Age, Categorical(Participants)Age Cohort: >=12 to <16 YearsAge Cohort: >=6 to <12 YearsAge Cohort: >=2 to <6 YearsAge Cohort: >=1 Month to <2 YearsTotal Title
<=18 years1212131350
Between 18 and 65 years00000
>=65 years00000
Age, Continuous
Age, Continuous(years)Age Cohort: >=12 to <16 YearsAge Cohort: >=6 to <12 YearsAge Cohort: >=2 to <6 YearsAge Cohort: >=1 Month to <2 YearsTotal Title
Mean13.08 ± 1.168.33 ± 1.613.85 ± 0.990.95 ± 0.596.39 ± 4.76
Sex: Female, Male
Sex: Female, Male(Participants)Age Cohort: >=12 to <16 YearsAge Cohort: >=6 to <12 YearsAge Cohort: >=2 to <6 YearsAge Cohort: >=1 Month to <2 YearsTotal Title
Female685524
Male648826
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Age Cohort: >=12 to <16 YearsAge Cohort: >=6 to <12 YearsAge Cohort: >=2 to <6 YearsAge Cohort: >=1 Month to <2 YearsTotal Title
American Indian/Alaskan Native00022
Black10001
White1112131147
07

Study locations

17 sites
  • Ep0065 252
    Bronx, New York 10467, United States
  • Ep0065 237
    Durham, North Carolina 27710, United States
  • Ep0065 502
    Hradec Králové, Czechia
  • Ep0065 240
    Praha 4, 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
    Sevilla, Spain
08

References and documents

Publications

  • 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. PubMed 35196395 ↗

Study documents

  • Study protocol · Jun 19, 2019
  • Statistical analysis plan · Sep 25, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03405714
Lead sponsor
UCB Biopharma S.P.R.L.
Responsible party
Sponsor
First posted
Jan 23, 2018
Start date
Jun 1, 2018
Primary completion
Nov 4, 2020
Completion
Nov 4, 2020
Results posted
Nov 26, 2021
Last update
May 11, 2022

Study contacts

UCB Cares
study director · 001 844 599 2273 (UCB)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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