Phase 2
Completed N=50
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy
Source: ClinicalTrials.gov NCT03405714 ↗Enrolled (actual)
50
Serious AEs
2.0%
Results posted
Nov 2021
Primary outcomePrimary: Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3 — 149.0; NA; NA; 310.6 nanograms per milliliter (ng/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3 |
149.0; NA; NA; 310.6 | — |
| PRIMARY Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 3 |
1844.6; 2058.8; 1774.9; 1566.6 | — |
| PRIMARY Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 3 |
1260.6; 1189.5; 1225.3; 1341.7 | — |
| PRIMARY Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 4 |
290.5 | — |
| PRIMARY Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 4 |
2084.3 | — |
| PRIMARY Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 4 |
1149.8 | — |
| PRIMARY Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5 |
466.0; 204.5; 482.9 | — |
| PRIMARY Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5 |
2890.0; 1948.8; 2072.4 | — |
| PRIMARY Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5 |
1820; 1203.5; 727.4 | — |
| PRIMARY Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3 by Infusion Duration - 15 Minutes |
NA | — |
| PRIMARY Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 3 by Infusion Duration- 15 Minutes |
1903.0 | — |
| PRIMARY Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 3 by Infusion Duration- 15 Minutes |
1130.3 | — |
| PRIMARY Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 4 by Infusion Duration- 15 Minutes |
290.5 | — |
| PRIMARY Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 4 by Infusion Duration- 15 Minutes |
2084.3 | — |
| PRIMARY Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 4 by Infusion Duration- 15 Minutes |
1149.8 | — |
| PRIMARY Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5 by Infusion Duration- 15 Minutes |
776.0 | — |
| PRIMARY Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5 by Infusion Duration- 15 Minutes |
2697.8 | — |
| PRIMARY Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5 by Infusion Duration- 15 Minutes |
1030.0 | — |
| PRIMARY Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3 by Infusion Duration- Bolus |
120.5 | — |
| PRIMARY Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 3 by Infusion Duration- Bolus |
1704.8 | — |
| PRIMARY Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 3 by Infusion Duration- Bolus |
1383.9 | — |
| PRIMARY Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 4 by Infusion Duration- Bolus |
— | — |
| PRIMARY Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 4 by Infusion Duration- Bolus |
— | — |
| PRIMARY Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 4 by Infusion Duration- Bolus |
— | — |
| PRIMARY Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5 by Infusion Duration- Bolus |
167.5 | — |
| PRIMARY Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5 by Infusion Duration- Bolus |
1531.8 | — |
| PRIMARY Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5 by Infusion Duration- Bolus |
949.5 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) |
3; 4; 7; 2 | — |
| PRIMARY Number of Participant Withdrawals Due to Adverse Events |
0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female from >= 1 month to = 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
Data sourced from ClinicalTrials.gov (NCT03405714). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.