This trial, evaluating the long-term safety and tolerability of brivaracetam will provide subjects suffering from epilepsy, who may have benefited from brivaracetam as adjunctive treatment, the opportunity to receive open label brivaracetam treatment.
Study access was limited to subjects having completed one of the previous brivaracetam (BRV) studies: N01193 \[NCT00175825\], N01252 \[NCT00490035\], N01253 \[NCT00464269\], N01254 \[NCT00504881\].
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
668
* Active Substance: Brivaracetam * Pharmaceutical Form: Tablet * Concentration: 10 mg and 25 mg * Route of Administration: Oral
Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) During the Study Period
Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Time frame: Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Period
Adverse Events (AE) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Time frame: Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Percentage of Participants With a Serious Adverse Event (SAE) During the Study Period
A Serious Adverse Event (SAE) is any untoward medical incidence that occurs at any dose.
Time frame: Visit 1 through last Evaluation Period, Down-Titration, or Post-Treatment Periods (up to 11 years)
Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period
Baseline is the Baseline from subject's previous study of enrollment period. N01193 \[NCT00175825\], N01252 \[NCT00490035\], N01253 \[NCT00464269\], N01254 \[NCT00504881\]. A 28 day Type 1 seizure frequency is the total number of Type 1 seizures divided by the total number of days evaluated multiplied by 28.
Time frame: From Baseline of the previous study to the Evaluation Period (up to 11 years)
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.
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N01199 1051
Phoenix, Arizona, United States
N01199 1362
Phoenix, Arizona, United States
N01199 1374
Tucson, Arizona, United States
N01199 1050
Little Rock, Arkansas, United States
N01199 1078
Fresno, California, United States
N01199 1392
Newport Beach, California, United States
N01199 1087
San Francisco, California, United States
N01199 1368
San Francisco, California, United States
N01199 1396
Atlanta, Georgia, United States
N01199 1385
Augusta, Georgia, United States
...and 90 more locations
Time frame: From Baseline of the previous study to the Evaluation Period (up to 11 years)
Percentage of Participants With Response for Partial Onset Seizure (POS) (Type I) Frequency Over the Evaluation Period
A responder is defined as a subject with a higher than or equal to (\>=) 50 % change in seizure frequency from Baseline period of the previous study.
Time frame: From Baseline of the previous study to the Evaluation Period (up to 11 years)