Evaluation of Long-term Safety, and Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects With Epilepsy

This study is currently recruiting participants.
Verified January 2014 by UCB, Inc.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc. ( UCB Pharma SA )
ClinicalTrials.gov Identifier:
NCT01728077
First received: October 26, 2012
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

N01372 study is to evaluate the long-term safety, tolerability, maintenance of efficacy of Brivaracetam (BRV); as well as the effect of BRV on subjects' health-related quality of life and to explore the direct medical resource use for BRV (for subjects entering N01372 from a study where pharmacoeconomic data was collected). BRV will be used at doses up to maximum of 200 mg/day, as adjunctive treatment in subjects aged 16 years or older with Epilepsy.


Condition Intervention Phase
Epilepsy
Drug: Brivaracetam
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older With Epilepsy Phase 3b

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • The incidence of Treatment Emergent Adverse Events (TEAEs) during Evaluation Period [ Time Frame: From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months) ] [ Designated as safety issue: No ]
  • Withdrawal due to an Adverse Event (AE) during the Evaluation Period [ Time Frame: From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months) ] [ Designated as safety issue: No ]
  • Occurrence of a Serious Adverse Event (SAE) during the Evaluation Period [ Time Frame: From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of Partial-Onset Seizure (POS) Type I per 28 days during the Evaluation Period for subjects with focal-onset Epilepsy [ Time Frame: From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months) ] [ Designated as safety issue: No ]
    The POS frequency is standardized to a 28-day duration.

  • Percent of reduction in Partial-Onset-Seizure (POS) Type I frequency per 28 days from Baseline of the previous study to the Evaluation Period for subjects with focal-onset Epilepsy entering N01372 from a study where Baseline seizure data was collected [ Time Frame: From Baseline of the previous study to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 49 months) ] [ Designated as safety issue: No ]
    The POS frequency is standardized to a 28-day duration.

  • 50 % responder rate in Partial-Onset-Seizure (POS) Type I frequency from Baseline of the previous study to the Evaluation Period for subjects with focal-onset Epilepsy entering N01372 from a study where Baseline seizure data was collected [ Time Frame: From Baseline of the previous study to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 49 months) ] [ Designated as safety issue: No ]
    The POS frequency is standardized to a 28-day duration.


Estimated Enrollment: 650
Study Start Date: October 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brivaracetam
At Entry Visit (EV), subjects will start on the individualized Brivaracetam (BRV) dose that they had reached at the completion of the previous study. Dose adjustments of the Investigational Medicinal Product (IMP) are allowed at any time based on the clinical judgment of the investigator. The BRV dose can be increased or decreased in increments of 50 mg/day based on the individual subject's seizure control and/or tolerability; however, the BRV dose should not exceed 200 mg/day during the study and must always be administered as a symmetrical morning and evening dose. Upon completion or early discontinuation from this study, there will be a Down-Titration Period in steps of 50 mg/day on a weekly basis until 20 mg/day for 1 week is reached, followed by a Post-Treatment Period (between 2 and 4 weeks) during which the subject will not receive study drug. No down-Titration Period will be applicable if subjects are continued on BRV after they complete this study.
Drug: Brivaracetam
Flexible dosing, can up and down-titrate as needed.
Other Name: UCB34714

Detailed Description:

Flexible dosing up to 200 mg/day, twice daily (10, 25 and 50 mg oral film-coated tablets). The study will continue until either regulatory approval of BRV has been granted by any Health Authority in an indication of adjunctive treatment of Epilepsy, or until the Sponsor decides to close the study, or until the BRV development is stopped by the Sponsor.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is male or female and 16 years or older. Subjects under 18 years of age may be included only where legally permitted and ethically accepted
  • Subjects having completed the Treatment Period of an applicable previous BRV study, and have access to the present study
  • Subject for whom the investigator believes a reasonable benefit from the long-term administration of BRV may be expected
  • Female subjects without childbearing potential (postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method
  • Subjects must be able to take the oral film-coated tablets of BRV

Exclusion Criteria:

  • Subject has developed hypersensitivity to any components of the Investigational Medicinal Product (IMP) or comparative drugs as stated in the protocol during the course of the prior study
  • Severe medical, neurological, or psychiatric disorders, or laboratory values that may have an impact on the safety of the subject
  • Poor compliance with the visit schedule or medication intake in the previous BRV study
  • Planned participation in any other clinical study of another investigational drug or device during this study
  • Pregnant or lactating woman
  • Any medical condition which, in the investigator's opinion, warrants exclusion
  • Subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either question 4 or question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at the last visit of the previous study or at the Entry Visit of this study if not completed at the last visit of the previous study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01728077

Contacts
Contact: UCB Clinical Trial Call Center +1 877 822 9493

Locations
United States, Arkansas
103 Recruiting
Little Rock, Arkansas, United States
United States, Kentucky
108 Recruiting
Lexington, Kentucky, United States
United States, New York
109 Recruiting
New York, New York, United States
United States, Ohio
106 Recruiting
Akron, Ohio, United States
United States, Texas
110 Recruiting
Dallas, Texas, United States
United States, Utah
102 Recruiting
Salt Lake City, Utah, United States
France
201 Recruiting
Paris, France
Germany
303 Recruiting
Bernau, Germany
300 Recruiting
Kehl-Kork, Germany
Spain
502 Recruiting
Sevilla, Spain
Sponsors and Collaborators
UCB Pharma SA
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc. ( UCB Pharma SA )
ClinicalTrials.gov Identifier: NCT01728077     History of Changes
Other Study ID Numbers: N01372, 2012-000827-42
Study First Received: October 26, 2012
Last Updated: January 3, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
United States: Food and Drug Administration

Keywords provided by UCB, Inc.:
Brivaracetam
Long-term Follow-up
Epilepsy
Partial Onset Seizures
Adjunctive treatment

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

ClinicalTrials.gov processed this record on April 22, 2014