Status:
COMPLETED
Open-label, Pharmacokinetic, Safety and Efficacy Study of Adjunctive Brivaracetam in Children With Epilepsy.
Lead Sponsor:
UCB Pharma
Conditions:
Epilepsy
Eligibility:
All Genders
1-16 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00422422
Start Date
July 1 2011
End Date
March 1 2013
Last Update
July 11 2018
Active Locations (39)
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1
108
Gulf Breeze, Florida, United States
2
110
Miami, Florida, United States
3
103
Wellington, Florida, United States
4
106
Boston, Massachusetts, United States