Open-label, Pharmacokinetic, Safety and Efficacy Study of Adjunctive Brivaracetam in Children With Epilepsy.
NCT ID: NCT00422422
Last Updated: 2018-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2011-07-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Brivaracetam
Brivaracetam
Oral solution
Evaluation period (3 weeks up-titration):
For subjects ≥8 years:
* \~0.4 mg/kg bid for Week 1
* \~0.8 mg/kg bid for Week 2
* \~1.6 mg/kg bid for Week 3
For subjects \<8 years:
* \~0.5 mg/kg bid for Week 1
* \~1.0 mg/kg bid for Week 2
* \~2.0 mg/kg bid for Week 3
Down-titration period (up to 2 weeks):
For subjects ≥8 years:
* \~0.8 mg/kg bid for Week 4
* \~0.4 mg/kg bid for Week 5
For subjects \<8 years:
* \~1.0 mg/kg bid for Week 4
* \~0.5 mg/kg bid for Week 5
Interventions
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Brivaracetam
Oral solution
Evaluation period (3 weeks up-titration):
For subjects ≥8 years:
* \~0.4 mg/kg bid for Week 1
* \~0.8 mg/kg bid for Week 2
* \~1.6 mg/kg bid for Week 3
For subjects \<8 years:
* \~0.5 mg/kg bid for Week 1
* \~1.0 mg/kg bid for Week 2
* \~2.0 mg/kg bid for Week 3
Down-titration period (up to 2 weeks):
For subjects ≥8 years:
* \~0.8 mg/kg bid for Week 4
* \~0.4 mg/kg bid for Week 5
For subjects \<8 years:
* \~1.0 mg/kg bid for Week 4
* \~0.5 mg/kg bid for Week 5
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Month
16 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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108
Gulf Breeze, Florida, United States
110
Miami, Florida, United States
103
Wellington, Florida, United States
106
Boston, Massachusetts, United States
101
Saint Paul, Minnesota, United States
113
Chesterfield, Missouri, United States
105
Buffalo, New York, United States
104
Rochester, New York, United States
107
Cincinnati, Ohio, United States
114
Pittsburgh, Pennsylvania, United States
109
Nashville, Tennessee, United States
117
Houston, Texas, United States
202
Brussels, , Belgium
203
Brussels, , Belgium
201
Leuven, , Belgium
502
Hradec Králové, , Czechia
504
Ostrava Porubo, , Czechia
501
Prague, , Czechia
602
Aguascalientes, , Mexico
611
Chihuahua City, , Mexico
609
Ciuliacan, , Mexico
603
Guadalajara, , Mexico
604
Mexico City, , Mexico
610
Monterrey, , Mexico
607
San Luis Potosí City, , Mexico
404
Bialystok, , Poland
403
Gdansk, , Poland
406
Kielce, , Poland
402
Krakow, , Poland
401
Poznan, , Poland
408
Rzeszów, , Poland
407
Szczecin, , Poland
405
Wroclaw, , Poland
309
Barcelona, , Spain
306
Madrid, , Spain
301
Palma de Mallorca, , Spain
304
Santander, , Spain
308
Valencia, , Spain
303
Zaragoza, , Spain
Countries
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Other Identifiers
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2006-006536-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
N01263
Identifier Type: -
Identifier Source: org_study_id
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