Open-label, Pharmacokinetic, Safety and Efficacy Study of Adjunctive Brivaracetam in Children With Epilepsy.
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Epilepsy |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | Any - 16 |
| Updated: | 7/13/2018 |
| Start Date: | July 2011 |
| End Date: | March 2013 |
Open-Label, Single-Arm, Multicenter, Pharmacokinetic, Safety, and Efficacy Study of Adjunctive Administration of Brivaracetam in Subjects From ≥1 Month to <16 Years Old With Epilepsy
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.
tolerability and preliminary efficacy of adjunctive treatment with brivaracetam, and to
develop dosing adaptations for future studies.
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
We found this trial at
13
sites
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