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

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ClinicalTrials.gov Identifier: NCT01364597
Recruitment Status : Enrolling by invitation
First Posted : June 2, 2011
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )

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

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Brivaracetam (BRV) Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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 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.

With protocol amendment 5, entry criteria for subjects coming for other pediatric core studies in development were included. Additional clarity was provided for subjects enrolled in N01266 that temporary roll over to one of those studies and resume participation in N01266.

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
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
Actual Study Start Date : August 2011
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: Brivaracetam Drug: Brivaracetam (BRV)
The max BRV dose will be 5.0 mg/kg/day,not to exceed a dose of 200 mg/day for subjects with body weight >40kg. Subjects may receive oral solution or oral tablets. The LTFU subjects will start dosing in N01266 on the individualized BRV dose they were receiving at the completion of the core study. Subjects must be able to tolerate the min BRV dose specified in the core study to be eligible for entry into the Evaluation Period of N01266. Dose can be adjusted as considered necessary by the Investigator and required by the subject's medical condition. All subjects who prematurely discontinue the study should complete an EDV and have their BRV dose down titrated by a maximum of half the dose every week for a maximum of 4 weeks until a dose of 1 mg/kg/day (50 mg/day for subjects with body weights >50kg) is reached.




Primary Outcome Measures :
  1. Number of subjects with at least one treatment-emergent adverse event reported during the evaluation period [ Time Frame: From Baseline to End of Study (up to 6 years) ]
  2. Number of subjects with at least one treatment-emergent adverse event leading to discontinuation during the evaluation period [ Time Frame: From Baseline to End of Study (up to 6 years) ]

Secondary Outcome Measures :
  1. 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 6 years) ]


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:

All Subjects:

  • Informed Consent form (ICF) is signed and dated by the parent(s) or legal representative(s)
  • Subject/legal representative is considered reliable and capable of adhering to the protocol
  • For female subjects:
  • subject is not of childbearing potential

OR if women of childbearing potential, and sexually active only if:

  • Adequate Contraceptive method
  • Negative pregnancy test

Long Term Follow-up Subjects:

- Male or female subjects having participated in a core study with a confirmed diagnosis of epilepsy and for whom a reasonable benefit from long-term administration of BRV is expected

Directly Enrolled Subjects:

  • >=4 years to <17 years
  • Clinical diagnosis of partial-onset seizures (POS)
  • Minimum of 1 concomitant antiepileptic drug (AED) at stable dose at least 7 days before Screening Visit (ScrV)

Exclusion Criteria:

All Subjects:

  • Pregnant or nursing female
  • Severe medical, neurological, or psychiatric disorders or laboratory values, which may have an impact on the safety of the subject
  • Subject has any medical condition, which in the Investigator's opinion, warrants exclusion
  • Subject has >1.5x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >1.0xULN total bilirubin (>=1.5xULN total bilirubin if known Gilbert's syndrome)
  • Subject has chronic liver disease

Long Term Follow-up Subjects:

  • Hypersensitivity to Brivaracetam (BRV) or excipients or comparative drugs as stated in this protocol during the course of the core study
  • Poor compliance with the visit schedule or medication intake in the core study
  • Subject >=6 years of age has a lifetime history of suicide attempt

Directly Enrolled Subjects:

  • Previously received BRV
  • Concomitant use of Levetiracetam (LEV) at the ScrV
  • Subject has epilepsy secondary to a progressive cerebral disease or tumor, or any other progressively neurodegenerative disease
  • History of primary generalized epilepsy
  • Subject has a history of status epilepticus in the month immediately prior to the ScrV or during the Up-Titration Period
  • Subject has a history or presence of pseudoseizures
  • Subject is suffering only from febrile seizures
  • Subject is on felbamate with less than 18 months continuous exposure
  • Subjects treated with vigabatrin who have visual field defects
  • Allergy to pyrrolidone derivatives or investigational product excipients or a history of multiple drug allergies
  • Any clinically significant acute or chronic illness as determined during the physical examination or from other information available to the Investigator
  • Underlying disease or is receiving a treatment that may interfere with the absorption, distribution, metabolism, and elimination of the study drug
  • Any medical condition that might interfere with his/her study participation
  • Terminal illness
  • Any clinically significant deviations from reference range values for laboratory parameters as determined by the Investigator
  • Clinically relevant ECG abnormality
  • Major surgery within 6 months prior to the ScrV
  • Subject received any investigational drug or device within the 30 days prior to the ScrV
  • Lifetime history of suicide attempt

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 62 Study Locations
Sponsors and Collaborators
UCB Pharma SA
Investigators
Study Director: UCB Cares +1 877 822 9493 (UCB)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: UCB Pharma SA
ClinicalTrials.gov Identifier: NCT01364597     History of Changes
Other Study ID Numbers: N01266
2011-000374-60 ( EudraCT Number )
First Posted: June 2, 2011    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

Keywords provided by UCB Pharma ( UCB Pharma SA ):
Brivaracetam
Epilepsy
Child
Infant
Adolescents
Partial onset seizures

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