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):
UCB Pharma ( UCB BIOSCIENCES, Inc. )
First received: April 19, 2011
Last updated: March 9, 2017
Last verified: March 2017
This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and single arm study of brivaracetam (BRV).
||Intervention Model: Single Group Assignment
Masking: No masking
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) ]
- Withdrawal due to Treatment-emergent Adverse Event [ Time Frame: From entry Visit 1 through End of Treatment (approximately 4 years) ]
- Occurrence of a Serious Advere Event [ Time Frame: From entry Visit 1 through End of Treatment (up to approximately 4 years) ]
Secondary Outcome Measures:
- Partial onset seizure (type I) frequency per 28 days during the Evaluation Period [ Time Frame: Evaluation Period (approximately 4 years) ]
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) ]
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). ]
A responder is defined as a subject with a ≥50 % reduction in seizure frequency from the Baseline Period of the previous study.
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2017 (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 and older (Child, Adult, Senior)
|Sexes 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 BIOSCIENCES, Inc.
||+1 877 822 9493 (UCB)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Klein P, Schiemann J, Sperling MR, Whitesides J, Liang W, Stalvey T, Brandt C, Kwan P. A randomized, double-blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of adjunctive brivaracetam in adult patients with uncontrolled partial-onset seizures. Epilepsia. 2015 Dec;56(12):1890-8. doi: 10.1111/epi.13212.
||UCB BIOSCIENCES, Inc.
History of Changes
|Other Study ID Numbers:
2010-020345-27 ( EudraCT Number )
|Study First Received:
||April 19, 2011
||March 9, 2017
Keywords provided by UCB Pharma:
Partial Onset Seizures
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 24, 2017
Central Nervous System Diseases
Nervous System Diseases