Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy (BRITE™)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: April 19, 2011
Last updated: October 28, 2015
Last verified: October 2015
This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and single arm study of brivaracetam (BRV).
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||November 2016 (Final data collection date for primary outcome measure)
Brivaracetam with a maximum of 200 mg/day
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
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.
|Ages Eligible for Study:
||16 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01339559
||UCB Clinical Trial Call Center
||+1 877 822 9493 (UCB)
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 19, 2011
||October 28, 2015
||Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicines and Health Products, FAMHP
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 Pharma:
Partial Onset Seizures
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 27, 2015
Central Nervous System Diseases
Nervous System Diseases