This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and single arm study of brivaracetam (BRV).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
767
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.
Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
Treatment-emergent Adverse Events (TEAEs) were defined as those events which started on or after the date of first dose of investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of study medication. The event does not necessarily have a causal relationship with that treatment or usage.
Time frame: From Entry Visit (Month 0) until the Last Visit (up to 84 months)
Percentage of Participants Who Withdrew Due to Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.
Time frame: From Entry Visit (Month 0) until the Last Visit (up to 84 months)
Percentage of Participants With at Least One Serious Adverse Event (SAE)
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is as infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.
Time frame: From Entry Visit (Month 0) until the Last Visit (up to 84 months)
Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period
The 28 day adjusted seizure frequency was 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.
Time frame: From Baseline of the previous study until the Last Visit (up to 84 months)
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001
Phoenix, Arizona, United States
013
Phoenix, Arizona, United States
006
Tucson, Arizona, United States
775
Little Rock, Arkansas, United States
025
San Francisco, California, United States
060
Aurora, Colorado, United States
071
Miami, Florida, United States
027
Orlando, Florida, United States
064
Port Charlotte, Florida, United States
023
Atlanta, Georgia, United States
...and 174 more locations
Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period
The percent change from the previous study baselines, in Partial Onset Seizure (POS) (Type I) frequency per 28 days is defined as: (the value at the previous study baselines) minus (the value at each time-points during the evaluation period) divided by the value at the previous study baselines. Note: Since N01258 was a safety study, participants were not required to meet seizure frequency requirements during the Baseline Period, and the Baseline Period was short (ie, 7 days). Therefore, participants from N01258 were excluded from efficacy summaries in the variable of percent change in POS frequency.
Time frame: From Baseline of the previous study until the Last Visit (up to 84 months)
Responder Rate in POS (Type I) Frequency Over the Evaluation Period
A responder is defined as a subject with a ≥ 50% reduction in seizure frequency from the Baseline Period of the previous study. Note: Since N01258 was a safety study, participants were not required to meet seizure frequency requirements during the Baseline Period, and the Baseline Period was short (ie, 7 days). Therefore, participants from N01258 were excluded from efficacy summaries in the variable of responder rates in POS frequency.
Time frame: From Baseline of the previous study until the Last Visit (up to 84 months)