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Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy (BRITE™)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01339559
First received: April 19, 2011
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
  Purpose

This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and single arm study of brivaracetam (BRV).


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

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Occurrence of at least one Treatment-emergent Adverse Event [ Time Frame: From entry Visit 1 through End of Treatment (approximately 4 years) ] [ Designated as safety issue: No ]
  • Withdrawal due to Treatment-emergent Adverse Event [ Time Frame: From entry Visit 1 through End of Treatment (approximately 4 years) ] [ Designated as safety issue: No ]
  • Occurrence of a Serious Advere Event [ Time Frame: From entry Visit 1 through End of Treatment (up to approximately 4 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Partial onset seizure (type I) frequency per 28 days during the Evaluation Period [ Time Frame: Evaluation Period (approximately 4 years) ] [ Designated as safety issue: No ]
    28 day adjusted seizure frequency will be calculated by dividing the number of partial seizures by the number of days for which the diary was completed, and multiplying the resulting value by 28.

  • Percent reduction in partial onset seizures (type I) frequency per 28 days from Baseline of the previous study to the Evaluation Period [ Time Frame: Baseline from originating study; Evaluation Period (approximately 4 years) ] [ Designated as safety issue: No ]
    Baseline is the baseline from subject's original first study of enrollment N01358 (NCT01261325); N01258 (NCT01405508). Negative changes from Baseline indicate an improvement (ie, a reduction).

  • Responder rate in POS (type I) frequency over the Evaluation Period [ Time Frame: Baseline Period: Baseline is the baseline from subject's original first study of enrollment N01358 (NCT01261325); N01258 (NCT01405508). ] [ Designated as safety issue: No ]
    A responder is defined as a subject with a ≥50 % reduction in seizure frequency from the Baseline Period of the previous study.


Estimated Enrollment: 820
Study Start Date: April 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brivaracetam
Brivaracetam with a maximum of 200 mg/day
 Drug: Brivaracetam

Tablet, Flexible dosing up to 200 mg/day, twice daily.

The study will continue until either regulatory approval of brivaracetam has been granted by any Health Authority in an indication of adjunctive treatment of partial onset seizures or until the Sponsor decides to close the study, or until the investigational product development is stopped by the Sponsor.

Other Name: UCB34714

Detailed Description:

The primary objective is to evaluate the long term safety and tolerability of BRV at individualized doses up to a maximum of 200 mg/day in epilepsy subjects.

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject completed the Treatment Period of N01358 or the evaluation period of N01258
  • Male/female subject from 16 years or older. Subject under 18 years may only be included where legally permitted and ethically accepted
  • Subject for whom the Investigator believes a reasonable benefit from the long term administration of BRV may be expected
  • Female subject without childbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible

Exclusion Criteria:

  • Subject has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core studies
  • 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 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 or has suicidal ideation in the past 6 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01339559

  Show 126 Study Locations
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: NCT01339559     History of Changes
Other Study ID Numbers: N01379, 2010-020345-27
Study First Received: April 19, 2011
Last Updated: April 23, 2013
Health Authority: Austria: Agency for Health and Food Safety
Belgium: Directorate general for the protection of Public health: Medicines
Brazil: National Health Surveillance Agency
Canada: Health Canada
Estonia: The State Agency of Medicine
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Czech Republic: State Institute for Drug Control
Finland: Ministry of Social Affairs and Health
France: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department of Health
Hungary: Ministry of Health, Social and Family Affairs
India: Central Drugs Standard Control Organization
Italy: Ministry of Health
Netherlands: Ministry of Health, Welfare and Sport
Poland: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Ministry of Health and Consumption
Sweden: The National Board of Health and Welfare
Taiwan : Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by UCB, Inc.:
Epilepsy
Brivaracetam
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 May 16, 2013