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OpenTrials
Completed

NCT Number: NCT00422422

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

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

1 month–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

202, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brivaracetam

Drug

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

Primary outcomes

  1. Mean Trough Plasma Concentration at 3rd Level for Age Range ≥1 Month to <2 Years

    Time frame: Day 21

  2. Mean Trough Plasma Concentration at 3rd Level for Age Range ≥2 to <12 Years

    Time frame: Day 21

  3. Mean Trough Plasma Concentration at 3rd Level for Age Range ≥12 to <16 Years

    Time frame: Day 21

  4. Mean Max Plasma Concentration for Age Range ≥1 Month to <2 Years

    Time frame: Day 21

  5. Mean Max Plasma Concentration for Age Range ≥2 to <12 Years

    Time frame: Day 21

  6. Mean Max Plasma Concentration for Age Range ≥12 to <16 Years

    Time frame: Day 21

Secondary outcomes

  1. 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

  2. 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

  3. Percent Compliance With Brivaracetam Oral Solution During the 3-week Evaluation Period

    Time frame: Baseline to the end of the 3-week evaluation period

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 17, 2007
Registry last updated
Jul 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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