Clinical trial NCT00422422: Open-label, Pharmacokinetic, Safety and Efficacy Study of Adjunctive Brivaracetam in Children With Epilepsy.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy
Keywords: Brivaracetam
Epilepsy
Child
Pharmacokinetics
Adolescents
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-01-17
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Trough Plasma Concentration at 3rd Level for Age Range ≥1 Month to <2 Years
timeFrame: Day 21
measure: Mean Trough Plasma Concentration at 3rd Level for Age Range ≥2 to <12 Years
timeFrame: Day 21
measure: Mean Trough Plasma Concentration at 3rd Level for Age Range ≥12 to <16 Years
timeFrame: Day 21
measure: Mean Max Plasma Concentration for Age Range ≥1 Month to <2 Years
timeFrame: Day 21
measure: Mean Max Plasma Concentration for Age Range ≥2 to <12 Years
timeFrame: Day 21
measure: Mean Max Plasma Concentration for Age Range ≥12 to <16 Years
timeFrame: Day 21
Secondary outcomes:
measure: Number of Subjects With at Least One Treatment-emergent Adverse Event Reported During the 3-week Evaluation Period
timeFrame: Baseline to end of the 3-week evaluation period
measure: Number of Subjects With a 50 % Reduction in Seizures Based on Seizure Diary Data From Baseline to End of the 3-week Evaluation Period
timeFrame: Baseline to end of the 3-week evaluation period
measure: Percent Compliance With Brivaracetam Oral Solution During the 3-week Evaluation Period
timeFrame: Baseline to the end of the 3-week evaluation period
Other outcomes:
Locations:
city: Gulf Breeze
country: United States
facility: 108
state: Florida
city: Miami
country: United States
facility: 110
state: Florida
city: Wellington
country: United States
facility: 103
state: Florida
city: Boston
country: United States
facility: 106
state: Massachusetts
city: Saint Paul
country: United States
facility: 101
state: Minnesota
city: Chesterfield
country: United States
facility: 113
state: Missouri
city: Buffalo
country: United States
facility: 105
state: New York
city: Rochester
country: United States
facility: 104
state: New York
city: Cincinnati
country: United States
facility: 107
state: Ohio
city: Pittsburgh
country: United States
facility: 114
state: Pennsylvania
city: Nashville
country: United States
facility: 109
state: Tennessee
city: Houston
country: United States
facility: 117
state: Texas
city: Brussels
country: Belgium
facility: 202
city: Brussels
country: Belgium
facility: 203
city: Leuven
country: Belgium
facility: 201
city: Hradec Kralove
country: Czechia
facility: 502
city: Ostrava Porubo
country: Czechia
facility: 504
city: Praha 4
country: Czechia
facility: 501
city: Aguascalientes
country: Mexico
facility: 602
city: Chihuahua
country: Mexico
facility: 611
city: Ciuliacan
country: Mexico
facility: 609
city: Guadalajara
country: Mexico
facility: 603
city: Mexico D.F.
country: Mexico
facility: 604
city: Monterrey
country: Mexico
facility: 610
city: San Luis Potosi
country: Mexico
facility: 607
city: Bialystok
country: Poland
facility: 404
city: Gdansk
country: Poland
facility: 403
city: Kielce
country: Poland
facility: 406
city: Krakow
country: Poland
facility: 402
city: Poznan
country: Poland
facility: 401
city: Rzeszow
country: Poland
facility: 408
city: Szczecin
country: Poland
facility: 407
city: Wroclaw
country: Poland
facility: 405
city: Barcelona
country: Spain
facility: 309
city: Madrid
country: Spain
facility: 306
city: Palma de Mallorca
country: Spain
facility: 301
city: Santander
country: Spain
facility: 304
city: Valencia
country: Spain
facility: 308
city: Zaragoza
country: Spain
facility: 303
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: