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

UCB

Status and phase: Completed; Phase 2

Conditions: Epilepsy

Treatments: Drug: Brivaracetam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00422422

2006-006536-22 (EudraCT Number)

N01263

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 1 month to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Brivaracetam

Experimental group

Treatment:

Drug: Brivaracetam