Open-label, Pharmacokinetic, Safety and Efficacy Study of Adjunctive Brivaracetam in Children With Epilepsy.
- Registration Number
- NCT00422422
- Lead Sponsor
- UCB Pharma
- 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 future studies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Brivaracetam Brivaracetam -
- Primary Outcome Measures
Name Time Method Mean Trough Plasma Concentration at 3rd Level for Age Range ≥1 Month to <2 Years Day 21 Mean Trough Plasma Concentration at 3rd Level for Age Range ≥2 to <12 Years Day 21 Mean Max Plasma Concentration for Age Range ≥12 to <16 Years Day 21 Mean Max Plasma Concentration for Age Range ≥1 Month to <2 Years Day 21 Mean Trough Plasma Concentration at 3rd Level for Age Range ≥12 to <16 Years Day 21 Mean Max Plasma Concentration for Age Range ≥2 to <12 Years Day 21
- Secondary Outcome Measures
Name Time Method Number of Subjects With at Least One Treatment-emergent Adverse Event Reported During the 3-week Evaluation Period Baseline to end of the 3-week evaluation period Number of Subjects With a 50 % Reduction in Seizures Based on Seizure Diary Data From Baseline to End of the 3-week Evaluation Period Baseline to end of the 3-week evaluation period Percent Compliance With Brivaracetam Oral Solution During the 3-week Evaluation Period Baseline to the end of the 3-week evaluation period
Trial Locations
- Locations (39)
113
🇺🇸Chesterfield, Missouri, United States
611
🇲🇽Chihuahua, Mexico
203
🇧🇪Brussels, Belgium
303
🇪🇸Zaragoza, Spain
201
🇧🇪Leuven, Belgium
406
🇵🇱Kielce, Poland
304
🇪🇸Santander, Spain
407
🇵🇱Szczecin, Poland
602
🇲🇽Aguascalientes, Mexico
402
🇵🇱Krakow, Poland
408
🇵🇱Rzeszow, Poland
609
🇲🇽Ciuliacan, Mexico
403
🇵🇱Gdansk, Poland
404
🇵🇱Bialystok, Poland
401
🇵🇱Poznan, Poland
603
🇲🇽Guadalajara, Mexico
108
🇺🇸Gulf Breeze, Florida, United States
110
🇺🇸Miami, Florida, United States
103
🇺🇸Wellington, Florida, United States
106
🇺🇸Boston, Massachusetts, United States
105
🇺🇸Buffalo, New York, United States
107
🇺🇸Cincinnati, Ohio, United States
202
🇧🇪Brussels, Belgium
104
🇺🇸Rochester, New York, United States
114
🇺🇸Pittsburgh, Pennsylvania, United States
117
🇺🇸Houston, Texas, United States
109
🇺🇸Nashville, Tennessee, United States
502
🇨🇿Hradec Kralove, Czechia
504
🇨🇿Ostrava Porubo, Czechia
501
🇨🇿Praha 4, Czechia
604
🇲🇽Mexico D.F., Mexico
607
🇲🇽San Luis Potosi, Mexico
405
🇵🇱Wroclaw, Poland
301
🇪🇸Palma de Mallorca, Spain
306
🇪🇸Madrid, Spain
309
🇪🇸Barcelona, Spain
308
🇪🇸Valencia, Spain
101
🇺🇸Saint Paul, Minnesota, United States
610
🇲🇽Monterrey, Mexico