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 Pharma
ClinicalTrials.gov Identifier:
NCT01364597
First received: May 31, 2011
Last updated: October 16, 2014
Last verified: October 2014

May 31, 2011
October 16, 2014
July 2011
September 2017   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT01364597 on ClinicalTrials.gov Archive Site
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 ]
Change from previous study baseline in seizure counts over the evaluation period [ Time Frame: From Previous Study Baseline to Approximately 3 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy
Open-label, Single-arm, Multicenter, Long-term Study to Evaluate Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Pediatric Subjects With Epilepsy

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

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.

Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Epilepsy
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).

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.
Intervention: Drug: Brivaracetam (BRV)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
600
September 2017
September 2017   (final data collection date for primary outcome measure)

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
Both
up to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Spain,   Poland,   Czech Republic,   Mexico
 
NCT01364597
N01266, 2011-000374-60
No
UCB Pharma
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP