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

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ClinicalTrials.gov Identifier: NCT00422422
Recruitment Status : Completed
First Posted : January 17, 2007
Results First Posted : January 9, 2017
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Description
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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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Brivaracetam Phase 2

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00422422


Locations
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Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
More Information
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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00422422    
Other Study ID Numbers: N01263
2006-006536-22 ( EudraCT Number )
First Posted: January 17, 2007    Key Record Dates
Results First Posted: January 9, 2017
Last Update Posted: July 11, 2018
Last Verified: November 2016
Keywords provided by UCB Pharma:
Brivaracetam
Epilepsy
Child
Pharmacokinetics
Adolescents
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Brivaracetam
Anticonvulsants