Open-label, Pharmacokinetic, Safety and Efficacy Study of Adjunctive Brivaracetam in Children With Epilepsy.
Open-Label, Single-Arm, Multicenter, Pharmacokinetic, Safety, and Efficacy Study of Adjunctive Administration of Brivaracetam in Subjects From ≥1 Month to <16 Years Old With Epilepsy
2 other identifiers
interventional
100
6 countries
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2011
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2007
CompletedFirst Posted
Study publicly available on registry
January 17, 2007
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
January 9, 2017
CompletedJuly 11, 2018
November 1, 2016
1.7 years
January 10, 2007
March 14, 2016
June 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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 Trough Plasma Concentration at 3rd Level for Age Range ≥12 to <16 Years
Day 21
Mean Max Plasma Concentration for Age Range ≥1 Month to <2 Years
Day 21
Mean Max Plasma Concentration for Age Range ≥2 to <12 Years
Day 21
Mean Max Plasma Concentration for Age Range ≥12 to <16 Years
Day 21
Secondary Outcomes (3)
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
Study Arms (1)
Brivaracetam
EXPERIMENTALInterventions
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (39)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- UCB Clinical Trial Call Center
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
January 10, 2007
First Posted
January 17, 2007
Study Start
July 1, 2011
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
July 11, 2018
Results First Posted
January 9, 2017
Record last verified: 2016-11