Open-label, Pharmacokinetic, Safety and Efficacy Study of Adjunctive Brivaracetam in Children With Epilepsy.

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: Brivaracetam

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