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: July 22, 2014
Last verified: July 2014
  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:


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: From Baseline to End of Study (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: From Baseline to End of Study (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 (up to 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 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.

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01364597

  Hide Study Locations
Locations
United States, Florida
108
Gulf Breeze, Florida, United States
103
Wellington, Florida, United States
United States, Massachusetts
106
Boston, Massachusetts, United States
United States, Minnesota
101
St. Paul, Minnesota, United States
United States, Missouri
113
Chesterfield, Missouri, United States
United States, New York
105
Buffalo, New York, United States
104
Rochester, New York, United States
United States, Ohio
107
Cincinnati, Ohio, United States
111
Columbus, Ohio, United States
United States, Pennsylvania
114
Pittsburgh, Pennsylvania, United States
United States, Tennessee
109
Nashville, Tennessee, United States
United States, Texas
117
Houston, Texas, United States
Belgium
203
Brussels, Belgium
202
Brussels, Belgium
201
Leuven, Belgium
Czech Republic
502
Hradec Kralove, Czech Republic
504
Ostrava Prouba, Czech Republic
501
Praha 4, Czech Republic
Mexico
611
Chihuahua, Mexico
609
Ciuliacan, Mexico
603
Guadalajara, Mexico
610
Monterrey, Mexico
Poland
404
Bialystok, Poland
403
Gdansk, Poland
406
Kielce, Poland
402
Krakow, Poland
401
Poznan, Poland
408
Rzeszow, Poland
407
Szczecin, Poland
405
Wroclaw, Poland
Spain
309
Barcelona, Spain
306
Madrid, Spain
310
Madrid, Spain
301
Palma de Mallorca, Spain
308
Valencia, Spain
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: July 22, 2014
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 August 28, 2014