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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 Pharma
ClinicalTrials.gov Identifier:
NCT00422422
First received: January 10, 2007
Last updated: November 8, 2016
Last verified: November 2016
  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: 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 ]
  • Mean Trough Plasma Concentration at 3rd Level for Age Range ≥2 to <12 Years [ Time Frame: Day 21 ]
  • Mean Trough Plasma Concentration at 3rd Level for Age Range ≥12 to <16 Years [ Time Frame: Day 21 ]
  • Mean Max Plasma Concentration for Age Range ≥1 Month to <2 Years [ Time Frame: Day 21 ]
  • Mean Max Plasma Concentration for Age Range ≥2 to <12 Years [ Time Frame: Day 21 ]
  • Mean Max Plasma Concentration for Age Range ≥12 to <16 Years [ Time Frame: Day 21 ]

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 ]
  • 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 ]
  • Percent Compliance With Brivaracetam Oral Solution During the 3-week Evaluation Period [ Time Frame: Baseline to the end of the 3-week evaluation period ]

Enrollment: 100
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   (Child)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier: NCT00422422

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

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00422422     History of Changes
Other Study ID Numbers: N01263  2006-006536-22 
Study First Received: January 10, 2007
Results First Received: March 14, 2016
Last Updated: November 8, 2016

Keywords provided by UCB Pharma:
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 February 24, 2017