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Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01364597
First received: May 31, 2011
Last updated: May 29, 2013
Last verified: May 2013
History of Changes
  Purpose

This study will evaluate the safety and tolerability of brivaracetam in pediatric subjects with epilepsy.


Condition Intervention Phase
Epilepsy
 Drug: Brivaracetam (BRV)
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label, Single-arm, Multicenter, Long-term Study to Evaluate Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Pediatric Subjects With Epilepsy

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Number of subjects with at least one treatment-emergent adverse event reported during the evaluation period (up to 3 years) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Number of subjects with at least one treatment-emergent adverse event leading to discontinuation during the evaluation period (up to 3 years) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction from Baseline to the end of the Evaluation Period for the number of seizure days [ Time Frame: Baseline to Last Yearly Evaluation Visit or Early Discontinuation Visit (Approximately 3 years) ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: July 2011
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brivaracetam
Subjects entering this study from the previous study must be able to tolerate at least 0.4 mg/kg of brivaracetam twice daily (bid) if ≥8 years of age or at least 0.5 mg/kg bid if <8 years of age.
 Drug: Brivaracetam (BRV)

Subjects must be able to tolerate at least .4mg/kg of BRV twice daily if ≥8 years of age or at least .5mg/kg bid if <8 years of age. The maximum BRV dose for subjects ≥8 years of age is 3.2mg/kg/day and 4.0mg/kg/day for subjects <8 years of age.

Younger subjects (<7 years of age) will be administered BRV oral solution. Subjects above 50kg will be dosed as adults, up to a maximum total daily dose not exceeding 200mg/day, and should transition from the oral solution to the equivalent oral tablet dose. The maximum BRV tablet dose allowed in this study will be 200mg/day (100 mg bid), which is the maximum allowed dose for those subjects dosed as adults.

Subjects will receive BRV for at least 3 years, or until approval for BRV has been obtained for pediatric subjects in their age range, or until the investigational product development is stopped by the Sponsor.

For subjects who prematurely discontinue, BRV will be down titrated over a maximum of 4 weeks (Down-Titration Period).

Detailed Description:

This is a Phase 3, open-label, single-arm, multicenter, long-term study to evaluate the safety and efficacy of brivaracetam (BRV) in children with epilepsy. This study was initially designed for pediatric subjects who had completed a previous BRV study. With Protocol Amendment 3, enrollment was expanded to include up to additional 100 subjects as "directly enrolled subjects" ≥4 years to <17 years of age with partial-onset seizures (POS)who had not previously enrolled in a pediatric BRV study. The primary objective is to evaluate the long-term safety and tolerability of BRV. The secondary objective is to assess the efficacy of BRV during long-term exposure.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participation in a previous brivaracetam pediatric epilepsy study with expected reasonable benefit from long-term administration of brivaracetam
  • Signed informed consent form (ICF) and assent form
  • Directly enrolled subjects: Signed ICF and assent form
  • Clinical diagnosis of POS
  • Minimum of 1 concomitant antiepileptic drug (AED) at stable dose and no additions/deletions for at least 7 days prior to the Screening visit
  • ≥4 years to <17 years
  • Women of childbearing potential, and sexually active only if:
  • Adequate Contraceptive method
  • Negative pregnancy test

Exclusion Criteria:

  • Pregnant or nursing female
  • Severe medical, neurological, or psychiatric disorders or laboratory values, which may have an impact on the safety of the subject
  • Poor compliance with the visit schedule or medication intake in the previous study, if applicable
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01364597

  Show 35 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: NCT01364597     History of Changes
Other Study ID Numbers: N01266, 2011-000374-60
Study First Received: May 31, 2011
Last Updated: May 29, 2013
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
Infant
Adolescents

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

ClinicalTrials.gov processed this record on June 17, 2013