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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00422422
First received: January 10, 2007
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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
Epilepsy
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, Inc.:

Primary Outcome Measures:
  • Plasma concentrations of brivaracetam at first brivaracetam study specified dose level. [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Plasma concentrations of Brivaracetam on second brivaracetam study specified dose level. [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • Plasma concentrations of brivaracetam on third brivaracetam study specified dose level. [ Time Frame: Day 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:

  • ~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

Ages Eligible for Study:   1 Month to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00422422

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

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00422422     History of Changes
Other Study ID Numbers: N01263, 2006-006536-22
Study First Received: January 10, 2007
Last Updated: March 18, 2014
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, Inc.:
Brivaracetam
Epilepsy
Child
Pharmacokinetics
Adolescents

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 22, 2014