Trial Outcomes & Findings for A Study to Test the Safety/ Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization (NCT NCT03250377)

Last Updated: 2025-07-29

Results Overview

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs (TEAEs) were defined as AEs that had onset on or after the day of first BRV dose in EP0085 study.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

207 participants

Primary outcome timeframe

From Baseline until end of the safety follow up (up to 88.5 months)

Results posted on

2025-07-29

Participant Flow

The study started to enroll participants in August 2017 and concluded in December 2024.

The Participant Flow refers to the Safety Set (SS). Study consisted of the Evaluation period (duration for rollover participants - 84 Months and for direct enrollers - 39 Months); Down-titration period (4 weeks); drug-free period (2 weeks).

Participant milestones

Participant milestones
Measure	EP0083 Placebo Participants who received Placebo in study EP0083 (NCT03083665) and completed the Treatment and Transition Period of study EP0083 are rolled over to this study and received brivaracetam (BRV) 50 milligram per day (mg/day) two times (bid) (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	EP0083 BRV All Participants rolled over from study EP0083 received BRV 50 mg/day bid (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	N01379 BRV Participants rolled over from study N01379 (NCT01339559) (core study N01358 \[NCT01261325\]) received BRV 200 mg/day during the evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	Direct Enrollers BRV Participants directly enrolled in this study received BRV 50mg bid (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. Up to 84 Month, however, were evaluated for 39 months only due to late enrollment). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.
Overall Study STARTED	54	112	7	34
Overall Study Evaluation Period	54	112	7	34
Overall Study Down-Titration Period	20	32	5	15
Overall Study Study Drug-Free Period	39	76	5	17
Overall Study COMPLETED	37	74	4	20
Overall Study NOT COMPLETED	17	38	3	14

Reasons for withdrawal

Reasons for withdrawal
Measure	EP0083 Placebo Participants who received Placebo in study EP0083 (NCT03083665) and completed the Treatment and Transition Period of study EP0083 are rolled over to this study and received brivaracetam (BRV) 50 milligram per day (mg/day) two times (bid) (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	EP0083 BRV All Participants rolled over from study EP0083 received BRV 50 mg/day bid (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	N01379 BRV Participants rolled over from study N01379 (NCT01339559) (core study N01358 \[NCT01261325\]) received BRV 200 mg/day during the evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	Direct Enrollers BRV Participants directly enrolled in this study received BRV 50mg bid (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. Up to 84 Month, however, were evaluated for 39 months only due to late enrollment). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.
Overall Study Adverse Event	2	4	0	4
Overall Study Lack of Efficacy	5	14	1	3
Overall Study Protocol Violation	0	2	0	1
Overall Study Lost to Follow-up	0	1	0	0
Overall Study Withdrawal by Subject	7	7	0	4
Overall Study Investigator's Judgment	1	0	0	0
Overall Study She wanted to change other therapeutic medication	1	0	0	0
Overall Study The Subject Go Abroad and Not Return	1	0	0	0
Overall Study Epilepsy Surgery	0	1	2	0
Overall Study Subject moved to kanagawa (faraway from clinic)	0	1	0	0
Overall Study Request From The Sponsor	0	1	0	0
Overall Study Subject did not follow procedure or study drug	0	1	0	0
Overall Study Subject stopped drug; did not wish to continue	0	1	0	0
Overall Study Subjects did not follow procedures or medication	0	1	0	0
Overall Study Pregnancy Event	0	1	0	0
Overall Study PI's opinion:Subject noncompliant with medication	0	1	0	0
Overall Study Subjects felt no effect;want to discontinue study	0	1	0	0
Overall Study Subjects underweight; intolerant to study drugs	0	1	0	0
Overall Study Patient requested to change hospital	0	0	0	1
Overall Study Admission To Geriatric Health Facility	0	0	0	1

Baseline Characteristics

A Study to Test the Safety/ Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EP0083 Placebo n=54 Participants Participants who received Placebo in study EP0083 (NCT03083665) and completed the Treatment and Transition Period of study EP0083 are rolled over to this study and received brivaracetam (BRV) 50 milligram per day (mg/day) two times (bid) (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	EP0083 BRV All n=112 Participants Participants rolled over from study EP0083 received BRV 50 mg/day bid (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	N01379 BRV n=7 Participants Participants rolled over from study N01379 (NCT01339559) (core study N01358 \[NCT01261325\]) received BRV 200 mg/day during the evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	Direct Enrollers BRV n=34 Participants Participants directly enrolled in this study received BRV 50mg bid (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. Up to 84 Month, however, were evaluated for 39 months only due to late enrollment). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	Total n=207 Participants Total of all reporting groups
Age, Continuous	34.5 years STANDARD_DEVIATION 11.6 • n=5 Participants	35.8 years STANDARD_DEVIATION 13.5 • n=7 Participants	40.7 years STANDARD_DEVIATION 10.9 • n=5 Participants	42.2 years STANDARD_DEVIATION 18.6 • n=4 Participants	36.7 years STANDARD_DEVIATION 14.1 • n=21 Participants
Age, Customized 12 - <18 yrs	2 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	7 Participants n=21 Participants
Age, Customized 18 - <65 yrs	52 Participants n=5 Participants	104 Participants n=7 Participants	7 Participants n=5 Participants	29 Participants n=4 Participants	192 Participants n=21 Participants
Age, Customized 65 - <85 yrs	0 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	7 Participants n=21 Participants
Age, Customized >=85 yrs	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	53 Participants n=7 Participants	3 Participants n=5 Participants	19 Participants n=4 Participants	107 Participants n=21 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	59 Participants n=7 Participants	4 Participants n=5 Participants	15 Participants n=4 Participants	100 Participants n=21 Participants
Race/Ethnicity, Customized Asian	54 Participants n=5 Participants	112 Participants n=7 Participants	7 Participants n=5 Participants	34 Participants n=4 Participants	207 Participants n=21 Participants
Race/Ethnicity, Customized Japanese	32 Participants n=5 Participants	58 Participants n=7 Participants	7 Participants n=5 Participants	34 Participants n=4 Participants	131 Participants n=21 Participants
Race/Ethnicity, Customized Chinese	22 Participants n=5 Participants	53 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	75 Participants n=21 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants

PRIMARY outcome

Timeframe: From Baseline until end of the safety follow up (up to 88.5 months)

Population: The Safety Set consisted of all participants who took at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	EP0083 Placebo n=54 Participants Participants who received Placebo in study EP0083 (NCT03083665) and completed the Treatment and Transition Period of study EP0083 are rolled over to this study and received brivaracetam (BRV) 50 milligram per day (mg/day) two times (bid) (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	EP0083 BRV All n=112 Participants Participants rolled over from study EP0083 received BRV 50 mg/day bid (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	N01379 BRV n=7 Participants Participants rolled over from study N01379 (NCT01339559) (core study N01358 \[NCT01261325\]) received BRV 200 mg/day during the evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	Direct Enrollers BRV n=34 Participants Participants directly enrolled in this study received BRV 50mg bid (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. Up to 84 Month, however, were evaluated for 39 months only due to late enrollment). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)	88.9 percentage of participants	95.5 percentage of participants	100 percentage of participants	94.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline of EP0083 or N01358 and up to 84 months of Evaluation Period

Population: The Full Analysis Set (FAS) consisted of all participants who took at least 1 dose of study medication and have at least 1 seizure record on Daily Record Card (DRC) during the Evaluation Period.

The seizure frequency was calculated as number of seizures per 28 days. Percent change of 28 day PSF from Baseline was defined as the percentage reduction of 28 day PSF for a designated post-baseline period in EP0085 compared with the Baseline 28 day PSF in the core study. Change in seizure frequency from Baseline was calculated: percent change = (\[Baseline 28 day PSF - Post Baseline 28 day PSF\]/\[Baseline 28 day PSF\]) × 100. For rollovers, the Baseline period was obtained from the core studies of EP0083 and N01358 directly. A negative value in percent change from Baseline indicates a decrease in PSF from Baseline. Evaluation Period values for seizure frequency were calculated from the seizure diary data collected during the Evaluation Period on/after the first BRV administration.

Outcome measures

Outcome measures
Measure	EP0083 Placebo n=54 Participants Participants who received Placebo in study EP0083 (NCT03083665) and completed the Treatment and Transition Period of study EP0083 are rolled over to this study and received brivaracetam (BRV) 50 milligram per day (mg/day) two times (bid) (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	EP0083 BRV All n=112 Participants Participants rolled over from study EP0083 received BRV 50 mg/day bid (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	N01379 BRV n=7 Participants Participants rolled over from study N01379 (NCT01339559) (core study N01358 \[NCT01261325\]) received BRV 200 mg/day during the evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	Direct Enrollers BRV Participants directly enrolled in this study received BRV 50mg bid (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. Up to 84 Month, however, were evaluated for 39 months only due to late enrollment). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.
Percent Change in Partial Seizure Frequency (PSF) Per 28 Days From Baseline of EP0083 or N01358 to the Evaluation Period for Rollover Study Participants	60.6 percent change Interval -87.0 to 100.0	43.2 percent change Interval -497.0 to 100.0	67.0 percent change Interval -72.0 to 100.0	—

SECONDARY outcome

Timeframe: Baseline of EP0083 or N01358 and up to 84 months of Evaluation Period

Population: The FAS consisted of all participants who took at least 1 dose of study medication and have at least 1 seizure record on DRC during the Evaluation Period.

The seizure frequency was calculated as number of seizures per 28 days. 50% responders were defined as a participant with a \>= 50% reduction in seizure frequency from the baseline period over the post-baseline period. Percentages are based on the number of participants who performed the seizure assessment at each time point. Evaluation Period values for seizure frequency were calculated from the seizure diary data collected during the Evaluation Period on/after the first BRV administration.

Outcome measures

Outcome measures
Measure	EP0083 Placebo n=54 Participants Participants who received Placebo in study EP0083 (NCT03083665) and completed the Treatment and Transition Period of study EP0083 are rolled over to this study and received brivaracetam (BRV) 50 milligram per day (mg/day) two times (bid) (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	EP0083 BRV All n=112 Participants Participants rolled over from study EP0083 received BRV 50 mg/day bid (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	N01379 BRV n=7 Participants Participants rolled over from study N01379 (NCT01339559) (core study N01358 \[NCT01261325\]) received BRV 200 mg/day during the evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	Direct Enrollers BRV Participants directly enrolled in this study received BRV 50mg bid (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. Up to 84 Month, however, were evaluated for 39 months only due to late enrollment). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.
50 Percent (%) Responder Rate in Partial Seizure Frequency Per 28 Days From Baseline of EP0083 or N01358 to the Evaluation Period for Rollover Study Participants	66.7 percentage of responders	47.3 percentage of responders	57.1 percentage of responders	—

SECONDARY outcome

Timeframe: Baseline (8 weeks prior to BRV administration), up to 39 months of Evaluation Period

Population: The FAS consisted of all participants who took at least 1 dose of study medication and have at least 1 seizure record on DRC during the Evaluation Period.

The seizure frequency was calculated as number of seizures per 28 days. For direct enrollers, the Baseline Period was defined as seizure counts collected from 8 weeks prior to the first BRV administration in EP0085. Change in seizure frequency is calculated as the seizure frequency at the evaluation time point minus the seizure frequency at Baseline of directly enrolled participants. A negative value in percent change from Baseline indicates a decrease in PSF from Baseline. Evaluation Period values for seizure frequency were calculated from the seizure diary data collected during the Evaluation Period on/after the first BRV administration.

Outcome measures

Outcome measures
Measure	EP0083 Placebo n=34 Participants Participants who received Placebo in study EP0083 (NCT03083665) and completed the Treatment and Transition Period of study EP0083 are rolled over to this study and received brivaracetam (BRV) 50 milligram per day (mg/day) two times (bid) (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	EP0083 BRV All Participants rolled over from study EP0083 received BRV 50 mg/day bid (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	N01379 BRV Participants rolled over from study N01379 (NCT01339559) (core study N01358 \[NCT01261325\]) received BRV 200 mg/day during the evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	Direct Enrollers BRV Participants directly enrolled in this study received BRV 50mg bid (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. Up to 84 Month, however, were evaluated for 39 months only due to late enrollment). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.
Percent Change in Partial Seizure Frequency Per 28 Days From Baseline of Directly Enrolled Study Participants to the Evaluation Period	-32.6 percent change Interval -3691.0 to 100.0	—	—	—

SECONDARY outcome

Timeframe: Baseline (8 weeks prior to BRV administration), up to 39 months of Evaluation Period

Population: The FAS consisted of all participants who took at least 1 dose of study medication and have at least 1 seizure record on DRC during the Evaluation Period.

The seizure frequency for directly enrolled participants was calculated as number of seizures per 28 days from 8 weeks prior to BRV administration. 50% responders were defined as a participant with a \>= 50% reduction in seizure frequency from the Baseline Period over the post-baseline period. Percentages are based on the number of participants who performed the seizure assessment at each time point. For direct enrollers, the Baseline Period was defined as seizure counts collected from 8 weeks prior to the first BRV administration in EP0085. Evaluation Period values for seizure frequency were calculated from the seizure diary data collected during the Evaluation Period on/after the first BRV administration.

Outcome measures

Outcome measures
Measure	EP0083 Placebo n=34 Participants Participants who received Placebo in study EP0083 (NCT03083665) and completed the Treatment and Transition Period of study EP0083 are rolled over to this study and received brivaracetam (BRV) 50 milligram per day (mg/day) two times (bid) (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	EP0083 BRV All Participants rolled over from study EP0083 received BRV 50 mg/day bid (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	N01379 BRV Participants rolled over from study N01379 (NCT01339559) (core study N01358 \[NCT01261325\]) received BRV 200 mg/day during the evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	Direct Enrollers BRV Participants directly enrolled in this study received BRV 50mg bid (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. Up to 84 Month, however, were evaluated for 39 months only due to late enrollment). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.
50 % Responder Rate in Partial Seizure Frequency Per 28 Days Over the Evaluation Period for Directly Enrolled Study Participants	26.5 percentage of responders	—	—	—

SECONDARY outcome

Timeframe: During the Evaluation Period (up to 84 months)

Population: The FAS consisted of all participants who took at least 1 dose of study medication and have at least 1 seizure record on DRC during the Evaluation Period. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.

A study participant was considered seizure free, if no seizure occurred during 6 consecutive months in the Evaluation Period and if met all of the following criteria: - the participant completed the designated period during the Evaluation Period - the participant has at least 90% non-missing diary days during the period of time - the participant did not report any seizures during the period.

Outcome measures

Outcome measures
Measure	EP0083 Placebo n=52 Participants Participants who received Placebo in study EP0083 (NCT03083665) and completed the Treatment and Transition Period of study EP0083 are rolled over to this study and received brivaracetam (BRV) 50 milligram per day (mg/day) two times (bid) (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	EP0083 BRV All n=101 Participants Participants rolled over from study EP0083 received BRV 50 mg/day bid (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	N01379 BRV n=7 Participants Participants rolled over from study N01379 (NCT01339559) (core study N01358 \[NCT01261325\]) received BRV 200 mg/day during the evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	Direct Enrollers BRV Participants directly enrolled in this study received BRV 50mg bid (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. Up to 84 Month, however, were evaluated for 39 months only due to late enrollment). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.
Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types (Partial, Generalized, and Unclassified Epileptic Seizure) for at Least 6 Months During the Evaluation Period for Rollover Study Participants	15.4 percentage of participants	19.8 percentage of participants	28.6 percentage of participants	—

SECONDARY outcome

Timeframe: During the Evaluation Period (up to 84 months)

A study participant was considered seizure free, if no seizure occurred during 12 consecutive months in the Evaluation Period and if met all of the following criteria: - the participant completed the designated period during the Evaluation Period - the participant has at least 90% non-missing diary days during the period of time - the participant did not report any seizures during the period.

Outcome measures

Outcome measures
Measure	EP0083 Placebo n=48 Participants Participants who received Placebo in study EP0083 (NCT03083665) and completed the Treatment and Transition Period of study EP0083 are rolled over to this study and received brivaracetam (BRV) 50 milligram per day (mg/day) two times (bid) (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	EP0083 BRV All n=93 Participants Participants rolled over from study EP0083 received BRV 50 mg/day bid (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	N01379 BRV n=6 Participants Participants rolled over from study N01379 (NCT01339559) (core study N01358 \[NCT01261325\]) received BRV 200 mg/day during the evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	Direct Enrollers BRV Participants directly enrolled in this study received BRV 50mg bid (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. Up to 84 Month, however, were evaluated for 39 months only due to late enrollment). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.
Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types (Partial, Generalized, and Unclassified Epileptic Seizure) for at Least 12 Months During the Evaluation Period for Rollover Study Participants	8.3 percentage of participants	14.0 percentage of participants	33.3 percentage of participants	—

SECONDARY outcome

Timeframe: During the Evaluation Period (up to 84 months)

Population: The FAS consisted of all participants who took at least 1 dose of study medication and have at least 1 seizure record on DRC during the Evaluation Period.

A study participant was considered seizure free (partial, all epileptic seizure), if no seizure occurred during the Evaluation Period and if met all of the following criteria: - the participant completed the designated period during the Evaluation Period - the participant has at least 90% non-missing diary days during the period of time - the participant did not report any seizures during the period.

Outcome measures

Outcome measures
Measure	EP0083 Placebo n=54 Participants Participants who received Placebo in study EP0083 (NCT03083665) and completed the Treatment and Transition Period of study EP0083 are rolled over to this study and received brivaracetam (BRV) 50 milligram per day (mg/day) two times (bid) (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	EP0083 BRV All n=112 Participants Participants rolled over from study EP0083 received BRV 50 mg/day bid (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	N01379 BRV n=7 Participants Participants rolled over from study N01379 (NCT01339559) (core study N01358 \[NCT01261325\]) received BRV 200 mg/day during the evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	Direct Enrollers BRV Participants directly enrolled in this study received BRV 50mg bid (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. Up to 84 Month, however, were evaluated for 39 months only due to late enrollment). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.
Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types During the Evaluation Period for Rollover Study Participants Participants with partial seizure-freedom	1.9 percentage of participants	7.1 percentage of participants	14.3 percentage of participants	—
Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types During the Evaluation Period for Rollover Study Participants Participants with all-type seizure-freedom	1.9 percentage of participants	7.1 percentage of participants	14.3 percentage of participants	—

SECONDARY outcome

Timeframe: During the Evaluation Period (up to 39 months)

Outcome measures

Outcome measures
Measure	EP0083 Placebo n=29 Participants Participants who received Placebo in study EP0083 (NCT03083665) and completed the Treatment and Transition Period of study EP0083 are rolled over to this study and received brivaracetam (BRV) 50 milligram per day (mg/day) two times (bid) (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	EP0083 BRV All Participants rolled over from study EP0083 received BRV 50 mg/day bid (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	N01379 BRV Participants rolled over from study N01379 (NCT01339559) (core study N01358 \[NCT01261325\]) received BRV 200 mg/day during the evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	Direct Enrollers BRV Participants directly enrolled in this study received BRV 50mg bid (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. Up to 84 Month, however, were evaluated for 39 months only due to late enrollment). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.
Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types (Partial, Generalized, and Unclassified Epileptic Seizure) for at Least 6 Months During the Evaluation Period for Directly Enrolled Study Participants	24.1 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: During the Evaluation Period (up to 39 months)

Outcome measures

Outcome measures
Measure	EP0083 Placebo n=26 Participants Participants who received Placebo in study EP0083 (NCT03083665) and completed the Treatment and Transition Period of study EP0083 are rolled over to this study and received brivaracetam (BRV) 50 milligram per day (mg/day) two times (bid) (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	EP0083 BRV All Participants rolled over from study EP0083 received BRV 50 mg/day bid (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	N01379 BRV Participants rolled over from study N01379 (NCT01339559) (core study N01358 \[NCT01261325\]) received BRV 200 mg/day during the evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	Direct Enrollers BRV Participants directly enrolled in this study received BRV 50mg bid (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. Up to 84 Month, however, were evaluated for 39 months only due to late enrollment). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.
Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types (Partial, Generalized, and Unclassified Epileptic Seizure) for at Least 12 Months During the Evaluation Period for Directly Enrolled Study Participants	15.4 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: During the Evaluation Period (up to 39 months)

Population: The FAS consisted of all participants who took at least 1 dose of study medication and have at least 1 seizure record on DRC during the Evaluation Period.

Outcome measures

Outcome measures
Measure	EP0083 Placebo n=34 Participants Participants who received Placebo in study EP0083 (NCT03083665) and completed the Treatment and Transition Period of study EP0083 are rolled over to this study and received brivaracetam (BRV) 50 milligram per day (mg/day) two times (bid) (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	EP0083 BRV All Participants rolled over from study EP0083 received BRV 50 mg/day bid (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	N01379 BRV Participants rolled over from study N01379 (NCT01339559) (core study N01358 \[NCT01261325\]) received BRV 200 mg/day during the evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. up to 84 months). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.	Direct Enrollers BRV Participants directly enrolled in this study received BRV 50mg bid (in total 100 mg/day) at Visit 1 (study entry) and were maintained at this dose for at least 2 weeks unless the participant was unable to tolerate treatment during evaluation period (from Visit 1 to end of study visit or early discontinuation visit i.e. Up to 84 Month, however, were evaluated for 39 months only due to late enrollment). Upon completion or early discontinuation from EP0085, there was a Down-Titration Period of 4 weeks to decrease in dose in steps on a weekly basis, up to 25 mg/day, followed by a 2-week Study Drug-Free Period during which the participant did not receive study drug. The BRV dose was adjusted (based on the individual participants' s seizure control and tolerability) between 50 mg/day and 200 mg/day during the study.
Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types During the Evaluation Period for Directly Enrolled Study Participants Participants with partial seizure-freedom	5.9 percentage of participants	—	—	—
Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types During the Evaluation Period for Directly Enrolled Study Participants Participants with all-type seizure-freedom	5.9 percentage of participants	—	—	—

Adverse Events

EP0083 Placebo

Serious events: 6 serious events

Other events: 41 other events

Deaths: 0 deaths

EP0083 BRV All

Serious events: 23 serious events

Other events: 87 other events

Deaths: 0 deaths

N01379 BRV

Serious events: 5 serious events

Other events: 6 other events

Deaths: 0 deaths

Direct Enrollers BRV

Serious events: 6 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

UCB

Cares

Phone: 001 844 599 2273

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60