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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:
ClinicalTrials.gov Identifier:
NCT01364597
First Posted: June 2, 2011
Last Update Posted: November 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
UCB Pharma
  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: 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
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
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): NCT01364597


  Show 37 Study Locations
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Cares +1 844 599 2273(UCB)
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01364597     History of Changes
Other Study ID Numbers: N01266
2011-000374-60 ( EudraCT Number )
First Submitted: May 31, 2011
First Posted: June 2, 2011
Last Update Posted: November 27, 2017
Last Verified: November 2017

Keywords provided by UCB Pharma:
Brivaracetam
Epilepsy
Child
Infant
Adolescents

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