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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.
Information provided by (Responsible Party):
UCB Pharma Identifier:
First received: May 31, 2011
Last updated: August 31, 2017
Last verified: August 2017
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: Intervention Model: Single Group Assignment
Masking: None (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:

Further study details as provided by UCB Pharma:

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: From Baseline to End of Study (approximately 3 years) ]
  • Number of subjects with at least one treatment-emergent adverse event leading to discontinuation during the evaluation period (up to 3 years) [ Time Frame: From Baseline to End of Study (approximately 3 years) ]

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 (up to 3 years) ]

Estimated Enrollment: 600
Study Start Date: July 2011
Estimated Study Completion Date: October 2021
Estimated Primary Completion Date: October 2021 (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 0.5 mg/kg of brivaracetam twice daily (bid). The maximum allowable brivaracetam dose is 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day for subjects with body weight >40 kg. Subjects <7 years of age will receive oral solution.

Subjects ≥7 years of age will receive tablets and should transition from the oral solution to the equivalent oral tablet dose. The maximum BRV tablet dose allowed in this study will be 200 mg/day (100 mg bid).

Subjects will continue to receive brivaracetam in this study 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 the study, brivaracetam 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.

With Protocol Amendment 4, enrollment for "directly enrolled" subjects was modified from 'up to' an additional 100 subjects to "at least" 100 subjects, keeping the planned total enrollment of approximately 600 subjects to allow flexibility in the number of patients reaching 1 year of exposure.

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.


Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Long Term Follow-up Subjects:

  • 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:

  • 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
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 identifier: NCT01364597

  Hide Study Locations
United States, Florida
Gulf Breeze, Florida, United States
Wellington, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Minnesota
Saint Paul, Minnesota, United States
United States, Missouri
Chesterfield, Missouri, United States
United States, New York
Buffalo, New York, United States
Rochester, New York, United States
United States, Ohio
Cincinnati, Ohio, United States
Columbus, Ohio, United States
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States
United States, Texas
Houston, Texas, United States
Brussels, Belgium
Brussels, Belgium
Leuven, Belgium
Hradec Kralove, Czechia
Ostrava Prouba, Czechia
Chihuahua, Mexico
Ciuliacan, Mexico
Guadalajara, Mexico
Monterrey, Mexico
Bialystok, Poland
Gdansk, Poland
Kielce, Poland
Krakow, Poland
Poznan, Poland
Szczecin, Poland
Wroclaw, Poland
Barcelona, Spain
Madrid, Spain
Palma de Mallorca, Spain
Valencia, Spain
Sponsors and Collaborators
UCB Pharma
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: UCB Pharma Identifier: NCT01364597     History of Changes
Other Study ID Numbers: N01266
2011-000374-60 ( EudraCT Number )
Study First Received: May 31, 2011
Last Updated: August 31, 2017

Keywords provided by UCB Pharma:

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on September 21, 2017