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The purpose of the study is to evaluate the long-term safety and tolerability of Brivaracetam (BRV) in focal epilepsy subjects with partial seizures and to evaluate the maintenance of efficacy of BRV over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brivaracetam | Experimental | Subjects randomized to this arm will receive open-label Brivaracetam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brivaracetam | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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. | From Baseline until end of the safety follow up (up to 88.5 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Partial Seizure Frequency (PSF) Per 28 Days From Baseline of EP0083 or N01358 to the Evaluation Period for Rollover Study Participants | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ep0085 905 | Beijing | China | ||||
| Ep0085 901 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40549270 | Derived | Fujimoto A, Qin B, Bourikas D, Dickson N, Moseley B, Sano T, Soma T, Sun W, Watanabe J, Zhou D, Inoue Y. Safety, Tolerability, and Efficacy of Adjunctive Brivaracetam in Japanese and Chinese Patients with Focal-Onset Seizures: Interim Analysis of a Phase 3 Open-Label Extension Trial. Adv Ther. 2025 Sep;42(9):4335-4349. doi: 10.1007/s12325-025-03253-0. Epub 2025 Jun 23. |
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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).
The study started to enroll participants in August 2017 and concluded in December 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 15, 2023 | Jun 9, 2025 |
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| Baseline of EP0083 or N01358 and up to 84 months of Evaluation Period |
| 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 | 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. | Baseline of EP0083 or N01358 and up to 84 months of Evaluation Period |
| Percent Change in Partial Seizure Frequency Per 28 Days From Baseline of Directly Enrolled Study Participants to 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. | Baseline (8 weeks prior to BRV administration), up to 39 months of Evaluation Period |
| 50 % Responder Rate in Partial Seizure Frequency Per 28 Days Over the Evaluation Period for Directly Enrolled Study Participants | 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. | Baseline (8 weeks prior to BRV administration), up to 39 months of Evaluation Period |
| 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 | 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. | During the Evaluation Period (up to 84 months) |
| 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 | 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. | During the Evaluation Period (up to 84 months) |
| Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types During the Evaluation Period for Rollover Study Participants | 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. | During the Evaluation Period (up to 84 months) |
| 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 | 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. | During the Evaluation Period (up to 39 months) |
| 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 | 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. | During the Evaluation Period (up to 39 months) |
| Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types During the Evaluation Period for Directly Enrolled Study Participants | 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. | During the Evaluation Period (up to 39 months) |
| Chengdu |
| China |
| Ep0085 902 | Guangzhou | China |
| Ep0085 909 | Guangzhou | China |
| Ep0085 917 | Guangzhou | China |
| Ep0085 920 | Guangzhou | China |
| Ep0085 924 | Guangzhou | China |
| Ep0085 912 | Hangzhou | China |
| Ep0085 908 | Lanzhou | China |
| Ep0085 921 | Nanchang | China |
| Ep0085 926 | Pingxiang | China |
| Ep0085 910 | Shijiazhuang | China |
| Ep0085 925 | Suzhou | China |
| Ep0085 913 | Wenzhou | China |
| Ep0085 930 | Xinxiang | China |
| Ep0085 916 | Yinchuan | China |
| Ep0085 918 | Zhanjiang | China |
| Ep0085 904 | Zhengzhou | China |
| Ep0085 923 | Zunyi | China |
| Ep0085 148 | Adachi-ku | Japan |
| Ep0085 116 | Asaka | Japan |
| Ep0085 126 | Bunkyō City | Japan |
| Ep0085 127 | Bunkyō City | Japan |
| Ep0085 122 | Hachinohe | Japan |
| Ep0085 111 | Hamamatsu | Japan |
| Ep0085 141 | Higashisonogi-gun Kawatana-cho | Japan |
| Ep0085 110 | Hiroshima | Japan |
| Ep0085 121 | Itami | Japan |
| Ep0085 102 | Kagoshima | Japan |
| Ep0085 142 | Kamakura | Japan |
| Ep0085 140 | Kawasaki | Japan |
| Ep0085 123 | Kodaira | Japan |
| Ep0085 115 | Kokubunji | Japan |
| Ep0085 132 | Kōriyama | Japan |
| Ep0085 112 | Kōshi | Japan |
| Ep0085 128 | Kurume | Japan |
| Ep0085 124 | Kyoto | Japan |
| Ep0085 147 | Kyoto | Japan |
| Ep0085 105 | Nagakute | Japan |
| Ep0085 118 | Nagoya | Japan |
| Ep0085 136 | Nagoya | Japan |
| Ep0085 117 | Nara | Japan |
| Ep0085 129 | Neyagawa | Japan |
| Ep0085 106 | Niigata | Japan |
| Ep0085 850 | Osaka | Japan |
| Ep0085 130 | Ôsaka | Japan |
| Ep0085 131 | Ōtsu | Japan |
| Ep0085 114 | Saitama | Japan |
| Ep0085 101 | Sapporo | Japan |
| Ep0085 103 | Sendai | Japan |
| Ep0085 144 | Shinjuku-ku | Japan |
| Ep0085 104 | Shizuoka | Japan |
| Ep0085 108 | Suita | Japan |
| Ep0085 137 | Suita | Japan |
| Ep0085 138 | Tsukuba | Japan |
| Ep0085 133 | Ushiku | Japan |
| Ep0085 109 | Yamagata | Japan |
| Ep0085 120 | Yokohama | Japan |
| Ep0085 150 | Yokohama | Japan |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Evaluation Period | Participants who entered Visit 1 of EP0085 were considered starting the Evaluation Period. |
|
| Down-Titration Period | Participants who had an Early Discontinuation Visit (EDV) and had at least 1 dose of study drug after the date of EDV were considered to start Down-Titration Period. |
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| Study Drug-Free Period | Participants who had at least one contact after the date of the last dose of BRV were considered to start study Drug-Free period. |
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| COMPLETED |
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| NOT COMPLETED |
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Baseline Characteristics refer to the Safety Set (SS) which consisted of all participants who took at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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. | The Safety Set consisted of all participants who took at least 1 dose of study medication. | Posted | Number | percentage of participants | From Baseline until end of the safety follow up (up to 88.5 months) |
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| Secondary | Percent Change in Partial Seizure Frequency (PSF) Per 28 Days From Baseline of EP0083 or N01358 to the Evaluation Period for Rollover Study Participants | 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. | 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. | Posted | Median | Full Range | percent change | Baseline of EP0083 or N01358 and up to 84 months of Evaluation Period |
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| Secondary | 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 | 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. | 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. | Posted | Number | percentage of responders | Baseline of EP0083 or N01358 and up to 84 months of Evaluation Period |
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| Secondary | Percent Change in Partial Seizure Frequency Per 28 Days From Baseline of Directly Enrolled Study Participants to 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. | 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. | Posted | Median | Full Range | percent change | Baseline (8 weeks prior to BRV administration), up to 39 months of Evaluation Period |
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| Secondary | 50 % Responder Rate in Partial Seizure Frequency Per 28 Days Over the Evaluation Period for Directly Enrolled Study Participants | 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. | 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. | Posted | Number | percentage of responders | Baseline (8 weeks prior to BRV administration), up to 39 months of Evaluation Period |
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| Secondary | 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 | 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. | 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. | Posted | Number | percentage of participants | During the Evaluation Period (up to 84 months) |
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| Secondary | 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 | 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. | 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. | Posted | Number | percentage of participants | During the Evaluation Period (up to 84 months) |
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| Secondary | Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types During the Evaluation Period for Rollover Study Participants | 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. | 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. | Posted | Number | percentage of participants | During the Evaluation Period (up to 84 months) |
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| Secondary | 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 | 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. | 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. | Posted | Number | percentage of participants | During the Evaluation Period (up to 39 months) |
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| Secondary | 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 | 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. | 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. | Posted | Number | percentage of participants | During the Evaluation Period (up to 39 months) |
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| Secondary | Percentage of Participants Continuously Seizure-free for Partial Seizure and All Seizure Types During the Evaluation Period for Directly Enrolled Study Participants | 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. | 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. | Posted | Number | percentage of participants | During the Evaluation Period (up to 39 months) |
|
From Baseline until end of the safety follow up (up to 88.5 months)
Treatment-emergent AEs (TEAEs) were defined as AEs that had onset on or after the day of first BRV dose in EP0085 study. The Safety Set consisted of all participants who took at least 1 dose of study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 54 | 6 | 54 | 41 | 54 |
| EG001 | 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. | 0 | 112 | 23 | 112 | 87 | 112 |
| EG002 | 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. | 0 | 7 | 5 | 7 | 6 | 7 |
| EG003 | 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. | 0 | 34 | 6 | 34 | 27 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Eyelid ptosis | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Gallbladder polyp | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Corona virus infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Gastroenteritis bacterial | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pericoronitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pilonidal cyst | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Brain contusion | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Foreign body | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Scapula fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Bone cyst | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
| |
| Ovarian clear cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Parkinsonism | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Seizure cluster | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Mental disorder due to a general medical condition | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Self injurious behaviour | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Ovarian cyst ruptured | Reproductive system and breast disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Ovarian haemorrhage | Reproductive system and breast disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Brain operation | Surgical and medical procedures | MedDRA 18.1 | Non-systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cranioplasty | Surgical and medical procedures | MedDRA 18.1 | Non-systematic Assessment |
| |
| Vagal nerve stimulator implantation | Surgical and medical procedures | MedDRA 18.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Corona virus infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | 001 844 599 2273 | UCBCares@ucb.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 3, 2025 | Jun 9, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C482793 | brivaracetam |
Not provided
Not provided
Not provided
| 18 - <65 yrs |
|
| 65 - <85 yrs |
|
| >=85 yrs |
|
| Male |
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| Chinese |
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| Other |
|
| OG001 | 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. |
| OG002 | 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. |
|
|
| OG001 | 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. |
| OG002 | 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. |
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| OG001 | 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. |
| OG002 | 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. |
|
|
| OG001 | 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. |
| OG002 | 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. |
|
|
| OG001 | 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. |
| OG002 | 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. |
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