Open-label, Pharmacokinetic, Safety and Efficacy Study of Adjunctive Brivaracetam in Children With Epilepsy.

This study has been completed.
Information provided by (Responsible Party):
UCB Pharma Identifier:
First received: January 10, 2007
Last updated: July 14, 2015
Last verified: July 2015

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.

Condition Intervention Phase
Drug: Brivaracetam
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Mean Trough Plasma Concentration at 3rd Level for age range ≥1 month to <2 years [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
  • Mean Trough Plasma Concentration at 3rd Level for age range ≥2 to <12 years [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
  • Mean Trough Plasma Concentration at 3rd Level for age range ≥12 to <16 years [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
  • Mean Max Plasma Concentration for age range ≥1 month to <2 years [ Time Frame: Day 7 - 21 ] [ Designated as safety issue: No ]
  • Mean Max Plasma Concentration for age range ≥2 to <12 years [ Time Frame: Day 7 - 21 ] [ Designated as safety issue: No ]
  • Mean Max Plasma Concentration for age range ≥12 to <16 years [ Time Frame: Day 7 - 21 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of subjects with at least one treatment-emergent adverse event reported during the 3-week evaluation period. [ Time Frame: Baseline to end of the 3-week evaluation period ] [ Designated as safety issue: No ]
  • Number of subjects with a 50 % reduction in seizures based on seizure diary data from baseline to end of the 3-week evaluation period [ Time Frame: Baseline to end of the 3-week evaluation period ] [ Designated as safety issue: No ]
  • Percent compliance with brivaracetam oral solution during the 3-week evaluation period [ Time Frame: Baseline to the end of the 3-week evaluation period ] [ Designated as safety issue: No ]

Enrollment: 101
Study Start Date: July 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brivaracetam Drug: Brivaracetam

Oral solution

Evaluation period (3 weeks up-titration):

For subjects ≥8 years:



Ages Eligible for Study:   1 Month to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00422422

  Show 39 Study Locations
Sponsors and Collaborators
UCB Pharma
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB Pharma Identifier: NCT00422422     History of Changes
Other Study ID Numbers: N01263, 2006-006536-22
Study First Received: January 10, 2007
Last Updated: July 14, 2015
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Mexico: Federal Commission for Sanitary Risks Protection
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Turkey: Ministry of Health

Keywords provided by UCB Pharma:

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on September 03, 2015