Phase 2
N=100
Open-label, Pharmacokinetic, Safety and Efficacy Study of Adjunctive Brivaracetam in Children With Epilepsy.
Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT00422422 ↗Enrolled (actual)
100
Serious AEs
8.1%
Results posted
Jan 2017
Primary outcome: Primary: Mean Trough Plasma Concentration at 3rd Level for Age Range ≥1 Month to <2 Years — 0.825 ug/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Brivaracetam (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- UCB Pharma
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Trough Plasma Concentration at 3rd Level for Age Range ≥1 Month to <2 Years |
0.825 | — |
| PRIMARY Mean Trough Plasma Concentration at 3rd Level for Age Range ≥2 to <12 Years |
0.967 | — |
| PRIMARY Mean Trough Plasma Concentration at 3rd Level for Age Range ≥12 to <16 Years |
1.117 | — |
| PRIMARY Mean Max Plasma Concentration for Age Range ≥1 Month to <2 Years |
2.071 | — |
| PRIMARY Mean Max Plasma Concentration for Age Range ≥2 to <12 Years |
2.673 | — |
| PRIMARY Mean Max Plasma Concentration for Age Range ≥12 to <16 Years |
2.861 | — |
| SECONDARY Number of Subjects With at Least One Treatment-emergent Adverse Event Reported During the 3-week Evaluation Period |
66 | — |
| SECONDARY Number of Subjects With a 50 % Reduction in Seizures Based on Seizure Diary Data From Baseline to End of the 3-week Evaluation Period |
17 | — |
| SECONDARY Percent Compliance With Brivaracetam Oral Solution During the 3-week Evaluation Period |
5; 90; 2 | — |
Summary
Initial study in children with epilepsy to evaluate the pharmacokinetics, safety, tolerability and preliminary efficacy of adjunctive treatment with brivaracetam, and to develop dosing adaptations for future studies.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of epilepsy
- Subject having at least 1 seizure (any type) during the 3 weeks before first visit
- Stable dosing of 1-3 concomitant antiepileptic drugs
Exclusion Criteria
- Pregnant or nursing females
- Concomitant use of Levetiracetam
- Epilepsy secondary to a Progressive cerebral disease/tumor or other neurodegenerative disease
- History of status epilepticus
- Clinically significant acute or chronic illness, underlying disease or medication condition
- History of suicide attempt
Data sourced from ClinicalTrials.gov (NCT00422422). 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.