Trial Outcomes & Findings for An Open-label Extension Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy (NCT NCT02625090)

Last Updated: 2022-03-09

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. Percentage of participants experiencing at least one treatment-emergent adverse event (reported by the participant and/or caregiver or observed by the Investigator or inpatient staff) are reported.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

42 participants

Primary outcome timeframe

From Entry Visit to End of Safety Follow-Up Visit (up to 5 years)

Results posted on

2022-03-09

Participant Flow

The study started to enroll study participants in December 2015 and concluded in November 2020.

Participant flow refers to the Safety Set. Participants who experienced substantial benefit from UCB0942 with acceptable tolerability in the EP0069 (NCT02495844) study had opportunity to continue treatment in this study.

Participant milestones

Participant milestones
Measure	UCB0942 All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 milligrams (mg) (50 mg twice daily \[bid\]), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years.
Overall Study STARTED	42
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	42

Reasons for withdrawal

Reasons for withdrawal
Measure	UCB0942 All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 milligrams (mg) (50 mg twice daily \[bid\]), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years.
Overall Study Participant wants to be pregnant	2
Overall Study For the Promoter	1
Overall Study Sponsor's Decision	9
Overall Study Somnolence	1
Overall Study Study terminated by Sponsor	7
Overall Study Negative Benefit/Risk	1
Overall Study Protocol Deviation	2
Overall Study Lack of Efficacy	16
Overall Study Adverse Event	3

Baseline Characteristics

An Open-label Extension Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	UCB0942 n=42 Participants All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg twice daily \[bid\]), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	35.4 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Race/Ethnicity, Customized White	40 Participants n=5 Participants
Race/Ethnicity, Customized Other/mixed	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Entry Visit to End of Safety Follow-Up Visit (up to 5 years)

Population: The Safety Set (SS) consisted of all enrolled study participants who took at least 1 dose of UCB0942 in the EP0073 study.

Outcome measures

Outcome measures
Measure	UCB0942 (SS) n=42 Participants All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) From the Beginning at Entry Visit (EV) of the Evaluation Period to End of Safety Follow-Up Visit During the EP0073 Study	90.5 percentage of participants

PRIMARY outcome

Timeframe: Over 3-month interval over the Evaluation Period (Month 0-3)

Population: The Full Analysis Set (FAS) consisted of all enrolled study participants who took at least 1 dose of UCB0942 and completed at least 1 seizure diary during the Evaluation Period in EP0073. Here, number of participants analyzed included those participants who were evaluable for the assessment.

A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100.

Outcome measures

Outcome measures
Measure	UCB0942 (SS) n=41 Participants All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
75% Responder Rate by 3-month Interval (Month 0 to 3) Over the Evaluation Period	24.4 percentage of participants

PRIMARY outcome

Timeframe: Over 3-month interval over the Evaluation Period (Month >3-6)

Population: The FAS consisted of all enrolled study participants who took at least 1 dose of UCB0942 and completed at least 1 seizure diary during the Evaluation Period in EP0073. Here, number of participants analyzed included those participants who were evaluable for the assessment.

Outcome measures

Outcome measures
Measure	UCB0942 (SS) n=41 Participants All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
75% Responder Rate by 3-month Interval (Month >3-6) Over the Evaluation Period	24.4 percentage of participants

PRIMARY outcome

Timeframe: Over 3-month interval over the Evaluation Period (Month >6-9)

Outcome measures

Outcome measures
Measure	UCB0942 (SS) n=34 Participants All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
75% Responder Rate by 3-month Interval (Month >6-9) Over the Evaluation Period	20.6 percentage of participants

PRIMARY outcome

Timeframe: Over 3-month interval over the Evaluation Period (Month >9-12)

Outcome measures

Outcome measures
Measure	UCB0942 (SS) n=28 Participants All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
75% Responder Rate by 3-month Interval (Month >9-12) Over the Evaluation Period	28.6 percentage of participants

PRIMARY outcome

Timeframe: Over 3-month interval over the Evaluation Period (Month >12-15)

Outcome measures

Outcome measures
Measure	UCB0942 (SS) n=26 Participants All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
75% Responder Rate by 3-month Interval (Month >12-15) Over the Evaluation Period	23.1 percentage of participants

PRIMARY outcome

Timeframe: Over 3-month interval over the Evaluation Period (Month >15-18)

Outcome measures

Outcome measures
Measure	UCB0942 (SS) n=26 Participants All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
75% Responder Rate by 3-month Interval (Month >15-18) Over the Evaluation Period	23.1 percentage of participants

PRIMARY outcome

Timeframe: Over 3-month interval over the Evaluation Period (Month >18-21)

Outcome measures

Outcome measures
Measure	UCB0942 (SS) n=26 Participants All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
75% Responder Rate by 3-month Interval (Month >18-21) Over the Evaluation Period	26.9 percentage of participants

PRIMARY outcome

Timeframe: Over 3-month interval over the Evaluation Period (Month >21-24)

Outcome measures

Outcome measures
Measure	UCB0942 (SS) n=22 Participants All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
75% Responder Rate by 3-month Interval (Month >21-24) Over the Evaluation Period	27.3 percentage of participants

PRIMARY outcome

Timeframe: Over 3-month interval over the Evaluation Period (Month >24-27)

Outcome measures

Outcome measures
Measure	UCB0942 (SS) n=23 Participants All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
75% Responder Rate by 3-month Interval (Month >24-27) Over the Evaluation Period	26.1 percentage of participants

PRIMARY outcome

Timeframe: Over 3-month interval over the Evaluation Period (Month >27-30)

Outcome measures

Outcome measures
Measure	UCB0942 (SS) n=21 Participants All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
75% Responder Rate by 3-month Interval (Month >27-30) Over the Evaluation Period	33.3 percentage of participants

PRIMARY outcome

Timeframe: Over 3-month interval over the Evaluation Period (Month >30-33)

Outcome measures

Outcome measures
Measure	UCB0942 (SS) n=20 Participants All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
75% Responder Rate by 3-month Interval (Month >30-33) Over the Evaluation Period	25.0 percentage of participants

PRIMARY outcome

Timeframe: Over 3-month interval over the Evaluation Period (Month >33-36)

Outcome measures

Outcome measures
Measure	UCB0942 (SS) n=20 Participants All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
75% Responder Rate by 3-month Interval (Month >33-36) Over the Evaluation Period	35.0 percentage of participants

PRIMARY outcome

Timeframe: Over 3-month interval over the Evaluation Period (Month >36-39)

Outcome measures

Outcome measures
Measure	UCB0942 (SS) n=18 Participants All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
75% Responder Rate by 3-month Interval (Month >36-39) Over the Evaluation Period	27.8 percentage of participants

PRIMARY outcome

Timeframe: Over 3-month interval over the Evaluation Period (Month >39-42)

Outcome measures

Outcome measures
Measure	UCB0942 (SS) n=18 Participants All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
75% Responder Rate by 3-month Interval (Month >39-42) Over the Evaluation Period	27.8 percentage of participants

PRIMARY outcome

Timeframe: Over 3-month interval over the Evaluation Period (Month >42-45)

Outcome measures

Outcome measures
Measure	UCB0942 (SS) n=14 Participants All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
75% Responder Rate by 3-month Interval (Month >42-45) Over the Evaluation Period	50.0 percentage of participants

PRIMARY outcome

Timeframe: Over 3-month interval over the Evaluation Period (Month >45-48)

Outcome measures

Outcome measures
Measure	UCB0942 (SS) n=10 Participants All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
75% Responder Rate by 3-month Interval (Month >45-48) Over the Evaluation Period	40.0 percentage of participants

PRIMARY outcome

Timeframe: Over 3-month interval over the Evaluation Period (Month >48-51)

Outcome measures

Outcome measures
Measure	UCB0942 (SS) n=10 Participants All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
75% Responder Rate by 3-month Interval (Month >48-51) Over the Evaluation Period	40.0 percentage of participants

PRIMARY outcome

Timeframe: Over 3-month interval over the Evaluation Period (Month >51-54)

Outcome measures

Outcome measures
Measure	UCB0942 (SS) n=5 Participants All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
75% Responder Rate by 3-month Interval (Month >51-54) Over the Evaluation Period	40.0 percentage of participants

PRIMARY outcome

Timeframe: Over 3-month interval over the Evaluation Period (Month >54-57)

Outcome measures

Outcome measures
Measure	UCB0942 (SS) n=1 Participants All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
75% Responder Rate by 3-month Interval (Month >54-57) Over the Evaluation Period	0 percentage of participants

SECONDARY outcome

Timeframe: Over the 3-month interval: Month 0-3, >3-6, >6-9, >9-12, >12-15, >15-18, >18-21, >21-24, >24-27, >27-30, >30-33, >33-36, >36-39, >39-42, >42-45, >45-48, >48-51, >51-54, >54-57 over the Evaluation Period

Population: The FAS consisted of all enrolled study participants who took at least 1 dose of UCB0942 and completed at least 1 seizure diary during the Evaluation Period in EP0073. Here, number analyzed signifies participants who were evaluable at specified time points.

Median partial-onset seizure frequency per 28 days by 3-month intervals over the Evaluation Period of the EP0073 study was reported.

Outcome measures

Outcome measures
Measure	UCB0942 (SS) n=42 Participants All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
Median Partial-onset Seizure Frequency Per 28 Days by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >51-54	7.80 seizure frequency per 28 days Interval 3.73 to 33.6
Median Partial-onset Seizure Frequency Per 28 Days by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month 0-3	18.98 seizure frequency per 28 days Interval 10.89 to 48.22
Median Partial-onset Seizure Frequency Per 28 Days by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >3-6	22.99 seizure frequency per 28 days Interval 13.07 to 66.18
Median Partial-onset Seizure Frequency Per 28 Days by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >6-9	23.33 seizure frequency per 28 days Interval 8.09 to 56.0
Median Partial-onset Seizure Frequency Per 28 Days by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >9-12	18.67 seizure frequency per 28 days Interval 6.84 to 37.96
Median Partial-onset Seizure Frequency Per 28 Days by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >12-15	23.23 seizure frequency per 28 days Interval 9.02 to 49.47
Median Partial-onset Seizure Frequency Per 28 Days by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >15-18	19.91 seizure frequency per 28 days Interval 11.2 to 41.48
Median Partial-onset Seizure Frequency Per 28 Days by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >18-21	16.80 seizure frequency per 28 days Interval 8.09 to 42.0
Median Partial-onset Seizure Frequency Per 28 Days by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >21-24	14.31 seizure frequency per 28 days Interval 5.91 to 36.09
Median Partial-onset Seizure Frequency Per 28 Days by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >24-27	14.31 seizure frequency per 28 days Interval 8.71 to 38.53
Median Partial-onset Seizure Frequency Per 28 Days by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >27-30	14.16 seizure frequency per 28 days Interval 5.91 to 38.58
Median Partial-onset Seizure Frequency Per 28 Days by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >30-33	16.80 seizure frequency per 28 days Interval 7.78 to 42.62
Median Partial-onset Seizure Frequency Per 28 Days by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >33-36	19.29 seizure frequency per 28 days Interval 6.84 to 46.67
Median Partial-onset Seizure Frequency Per 28 Days by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >36-39	13.69 seizure frequency per 28 days Interval 7.16 to 45.11
Median Partial-onset Seizure Frequency Per 28 Days by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >39-42	9.96 seizure frequency per 28 days Interval 5.91 to 57.24
Median Partial-onset Seizure Frequency Per 28 Days by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >42-45	13.07 seizure frequency per 28 days Interval 3.73 to 63.17
Median Partial-onset Seizure Frequency Per 28 Days by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >45-48	10.58 seizure frequency per 28 days Interval 2.8 to 59.42
Median Partial-onset Seizure Frequency Per 28 Days by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >48-51	9.02 seizure frequency per 28 days Interval 1.56 to 48.16
Median Partial-onset Seizure Frequency Per 28 Days by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >54-57	7.84 seizure frequency per 28 days Interval 7.84 to 7.84

SECONDARY outcome

Population: The FAS consisted of all enrolled study participants who took at least 1 dose of UCB0942 and completed at least 1 seizure diary during the Evaluation Period in EP0073. Here, number analyzed signifies participants who were evaluable at specified time points.

Median partial-onset seizure frequency per 28 days by seizure type (Type IA1, Type IB, Type IC) by 3-month intervals over the Evaluation Period of the EP0073 study was reported. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981.

Outcome measures

Outcome measures
Measure	UCB0942 (SS) n=42 Participants All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IA1: Month 0-3	0.00 seizure frequency per 28 days Interval 0.0 to 2.18
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IA1: Month >3-6	0.00 seizure frequency per 28 days Interval 0.0 to 7.47
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IA1: Month >6-9	0.00 seizure frequency per 28 days Interval 0.0 to 4.36
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IA1: Month >9-12	0.00 seizure frequency per 28 days Interval 0.0 to 0.0
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IA1: Month >12-15	0.00 seizure frequency per 28 days Interval 0.0 to 1.24
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IA1: Month >15-18	0.00 seizure frequency per 28 days Interval 0.0 to 1.87
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IA1: Month >18-21	0.00 seizure frequency per 28 days Interval 0.0 to 4.36
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IA1: Month >21-24	0.00 seizure frequency per 28 days Interval 0.0 to 2.8
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IA1: Month >24-27	0.00 seizure frequency per 28 days Interval 0.0 to 3.27
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IA1: Month >27-30	0.00 seizure frequency per 28 days Interval 0.0 to 0.93
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IA1: Month >30-33	0.00 seizure frequency per 28 days Interval 0.0 to 2.49
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IA1: Month >33-36	0.00 seizure frequency per 28 days Interval 0.0 to 2.49
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IA1: Month >36-39	0.00 seizure frequency per 28 days Interval 0.0 to 3.42
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IA1: Month >39-42	0.00 seizure frequency per 28 days Interval 0.0 to 2.8
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IA1: Month >42-45	0.00 seizure frequency per 28 days Interval 0.0 to 7.47
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IA1: Month >45-48	0.00 seizure frequency per 28 days Interval 0.0 to 4.67
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IA1: Month >48-51	0.00 seizure frequency per 28 days Interval 0.0 to 3.73
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IA1: Month >51-54	0.00 seizure frequency per 28 days Interval 0.0 to 1.87
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IA1: Month >54-57	4.48 seizure frequency per 28 days Interval 4.48 to 4.48
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IB: Month 0-3	10.73 seizure frequency per 28 days Interval 4.67 to 35.0
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IB: Month >3-6	12.67 seizure frequency per 28 days Interval 1.56 to 28.0
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IB: Month >6-9	9.33 seizure frequency per 28 days Interval 0.0 to 34.68
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IB: Month >9-12	9.64 seizure frequency per 28 days Interval 1.24 to 26.11
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IB: Month >12-15	15.56 seizure frequency per 28 days Interval 0.93 to 34.84
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IB: Month >15-18	13.38 seizure frequency per 28 days Interval 2.18 to 37.64
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IB: Month >18-21	13.07 seizure frequency per 28 days Interval 0.62 to 33.91
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IB: Month >21-24	7.78 seizure frequency per 28 days Interval 0.93 to 25.2
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IB: Month >24-27	9.80 seizure frequency per 28 days Interval 2.49 to 27.38
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IB: Month >27-30	9.49 seizure frequency per 28 days Interval 1.87 to 33.75
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IB: Month >30-33	9.64 seizure frequency per 28 days Interval 3.11 to 32.98
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IB: Month >33-36	7.47 seizure frequency per 28 days Interval 2.49 to 25.67
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IB: Month >36-39	6.53 seizure frequency per 28 days Interval 3.73 to 35.47
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IB: Month >39-42	6.84 seizure frequency per 28 days Interval 0.31 to 24.58
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IB: Month >42-45	5.29 seizure frequency per 28 days Interval 2.18 to 20.84
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IB: Month >45-48	4.36 seizure frequency per 28 days Interval 1.24 to 26.96
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IB: Month >48-51	4.67 seizure frequency per 28 days Interval 0.31 to 43.87
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IB: Month >51-54	3.29 seizure frequency per 28 days Interval 1.06 to 33.6
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IB: Month >54-57	3.36 seizure frequency per 28 days Interval 3.36 to 3.36
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IC: Month 0-3	0.00 seizure frequency per 28 days Interval 0.0 to 0.0
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IC: Month >3-6	0.00 seizure frequency per 28 days Interval 0.0 to 0.0
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IC: Month >6-9	0.00 seizure frequency per 28 days Interval 0.0 to 0.0
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IC: Month >9-12	0.00 seizure frequency per 28 days Interval 0.0 to 0.0
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IC: Month >12-15	0.00 seizure frequency per 28 days Interval 0.0 to 0.0
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IC: Month >15-18	0.00 seizure frequency per 28 days Interval 0.0 to 0.0
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IC: Month >18-21	0.00 seizure frequency per 28 days Interval 0.0 to 0.0
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IC: Month >21-24	0.00 seizure frequency per 28 days Interval 0.0 to 0.0
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IC: Month >24-27	0.00 seizure frequency per 28 days Interval 0.0 to 0.0
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IC: Month >27-30	0.00 seizure frequency per 28 days Interval 0.0 to 0.0
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IC: Month >30-33	0.00 seizure frequency per 28 days Interval 0.0 to 0.0
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IC: Month >33-36	0.00 seizure frequency per 28 days Interval 0.0 to 0.0
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IC: Month >36-39	0.00 seizure frequency per 28 days Interval 0.0 to 0.31
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IC: Month >39-42	0.00 seizure frequency per 28 days Interval 0.0 to 0.0
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IC: Month >42-45	0.00 seizure frequency per 28 days Interval 0.0 to 0.0
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IC: Month >45-48	0.00 seizure frequency per 28 days Interval 0.0 to 0.31
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IC: Month >48-51	0.00 seizure frequency per 28 days Interval 0.0 to 0.31
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IC: Month >51-54	0.00 seizure frequency per 28 days Interval 0.0 to 1.87
Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study Type IC: Month >54-57	0.00 seizure frequency per 28 days Interval 0.0 to 0.0

SECONDARY outcome

Percent change from Baseline in seizure frequency for observable focal-onset seizures (Type IA1, IB, and IC) to the corresponding interval was calculated using the following formula: change from Baseline in the 28 day adjusted seizure frequency/28 day adjusted seizure frequency during the EP0069 2- week Prospective Outpatient Baseline Period × 100. The numerator is calculated by subtracting the 28-day adjusted seizure frequency during the Period of interest from the 28-day adjusted seizure frequency during the EP0069 2-week prospective outpatient Baseline Period. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981.

Outcome measures

Outcome measures
Measure	UCB0942 (SS) n=41 Participants All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
Percent Change in Partial-onset Seizure Frequency Relative to the Baseline Period Defined in EP0069 by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month 0-3	50.51 percent change Interval 21.74 to 72.53
Percent Change in Partial-onset Seizure Frequency Relative to the Baseline Period Defined in EP0069 by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >3-6	39.14 percent change Interval 12.5 to 72.78
Percent Change in Partial-onset Seizure Frequency Relative to the Baseline Period Defined in EP0069 by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >6-9	56.98 percent change Interval 31.19 to 72.22
Percent Change in Partial-onset Seizure Frequency Relative to the Baseline Period Defined in EP0069 by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >9-12	62.22 percent change Interval 39.99 to 80.54
Percent Change in Partial-onset Seizure Frequency Relative to the Baseline Period Defined in EP0069 by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >12-15	55.74 percent change Interval 40.95 to 72.78
Percent Change in Partial-onset Seizure Frequency Relative to the Baseline Period Defined in EP0069 by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >15-18	54.04 percent change Interval 35.71 to 72.72
Percent Change in Partial-onset Seizure Frequency Relative to the Baseline Period Defined in EP0069 by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >18-21	57.27 percent change Interval 39.42 to 76.28
Percent Change in Partial-onset Seizure Frequency Relative to the Baseline Period Defined in EP0069 by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >21-24	68.57 percent change Interval 46.67 to 76.67
Percent Change in Partial-onset Seizure Frequency Relative to the Baseline Period Defined in EP0069 by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >24-27	60.15 percent change Interval 40.31 to 77.41
Percent Change in Partial-onset Seizure Frequency Relative to the Baseline Period Defined in EP0069 by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >27-30	59.82 percent change Interval 44.79 to 80.06
Percent Change in Partial-onset Seizure Frequency Relative to the Baseline Period Defined in EP0069 by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >30-33	59.57 percent change Interval 41.94 to 76.17
Percent Change in Partial-onset Seizure Frequency Relative to the Baseline Period Defined in EP0069 by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >33-36	59.73 percent change Interval 35.42 to 78.96
Percent Change in Partial-onset Seizure Frequency Relative to the Baseline Period Defined in EP0069 by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >36-39	64.50 percent change Interval 45.56 to 78.9
Percent Change in Partial-onset Seizure Frequency Relative to the Baseline Period Defined in EP0069 by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >39-42	59.01 percent change Interval 37.78 to 80.06
Percent Change in Partial-onset Seizure Frequency Relative to the Baseline Period Defined in EP0069 by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >42-45	68.79 percent change Interval 38.39 to 80.0
Percent Change in Partial-onset Seizure Frequency Relative to the Baseline Period Defined in EP0069 by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >45-48	68.17 percent change Interval 56.98 to 85.0
Percent Change in Partial-onset Seizure Frequency Relative to the Baseline Period Defined in EP0069 by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >48-51	67.12 percent change Interval 51.67 to 91.67
Percent Change in Partial-onset Seizure Frequency Relative to the Baseline Period Defined in EP0069 by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >51-54	73.08 percent change Interval 61.92 to 80.0
Percent Change in Partial-onset Seizure Frequency Relative to the Baseline Period Defined in EP0069 by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >54-57	73.56 percent change Interval 73.56 to 73.56

SECONDARY outcome

A 50% responder was defined as a participant with a ≥50% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. Observable focal-onset seizures refer to Type IA1 (simple partial seizures with motor signs), IB (complex partial seizures), and IC (partial seizures evolving to secondarily generalized seizures) of the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures, 1981. It was calculated using formula: Count of 50% responders during the period/number of participants during the period × 100.

Outcome measures

Outcome measures
Measure	UCB0942 (SS) n=41 Participants All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
50% Responder Rate by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month 0-3	51.2 percentage of participants
50% Responder Rate by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >3-6	39.0 percentage of participants
50% Responder Rate by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >6-9	58.8 percentage of participants
50% Responder Rate by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >9-12	67.9 percentage of participants
50% Responder Rate by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >12-15	65.4 percentage of participants
50% Responder Rate by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >15-18	53.8 percentage of participants
50% Responder Rate by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >18-21	57.7 percentage of participants
50% Responder Rate by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >21-24	72.7 percentage of participants
50% Responder Rate by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >24-27	69.6 percentage of participants
50% Responder Rate by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >27-30	66.7 percentage of participants
50% Responder Rate by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >30-33	70.0 percentage of participants
50% Responder Rate by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >33-36	65.0 percentage of participants
50% Responder Rate by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >36-39	72.2 percentage of participants
50% Responder Rate by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >39-42	72.2 percentage of participants
50% Responder Rate by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >42-45	64.3 percentage of participants
50% Responder Rate by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >45-48	80.0 percentage of participants
50% Responder Rate by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >48-51	90.0 percentage of participants
50% Responder Rate by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >51-54	80.0 percentage of participants
50% Responder Rate by 3-month Intervals Over the Evaluation Period of the EP0073 Study Month >54-57	100 percentage of participants

SECONDARY outcome

Population: The FAS consisted of all enrolled study participants who took at least 1 dose of UCB0942 and completed at least 1 seizure diary during the Evaluation Period in EP0073. Here, number analyzed signifies participants who were evaluable at specified time points.

The number of seizure-free days is defined as the total number of days within an analysis Period or time interval for which no seizures were reported. The percentage of seizure-free days is to be computed as 100 times the number of seizure-free days divided by the number of days for which daily diary data was available in the specified analysis Period. Days without the corresponding daily diary data (ie, "Not Done" is ticked) are not used in these computations.

Outcome measures

Outcome measures
Measure	UCB0942 (SS) n=42 Participants All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
Percentage of Seizure-free Days by 3-month Intervals Over the Evaluation Period Month 0-3	48.33 percentage of days Interval 24.44 to 76.67
Percentage of Seizure-free Days by 3-month Intervals Over the Evaluation Period Month >3-6	42.81 percentage of days Interval 8.89 to 68.89
Percentage of Seizure-free Days by 3-month Intervals Over the Evaluation Period Month >6-9	54.44 percentage of days Interval 10.0 to 80.0
Percentage of Seizure-free Days by 3-month Intervals Over the Evaluation Period Month >9-12	55.56 percentage of days Interval 25.56 to 78.89
Percentage of Seizure-free Days by 3-month Intervals Over the Evaluation Period Month >12-15	54.44 percentage of days Interval 22.22 to 78.89
Percentage of Seizure-free Days by 3-month Intervals Over the Evaluation Period Month >15-18	51.11 percentage of days Interval 25.56 to 73.33
Percentage of Seizure-free Days by 3-month Intervals Over the Evaluation Period Month >18-21	61.11 percentage of days Interval 26.67 to 80.0
Percentage of Seizure-free Days by 3-month Intervals Over the Evaluation Period Month >21-24	57.78 percentage of days Interval 30.0 to 86.67
Percentage of Seizure-free Days by 3-month Intervals Over the Evaluation Period Month >24-27	60.00 percentage of days Interval 31.11 to 77.22
Percentage of Seizure-free Days by 3-month Intervals Over the Evaluation Period Month >27-30	64.44 percentage of days Interval 22.22 to 85.56
Percentage of Seizure-free Days by 3-month Intervals Over the Evaluation Period Month >30-33	57.78 percentage of days Interval 28.89 to 80.0
Percentage of Seizure-free Days by 3-month Intervals Over the Evaluation Period Month >33-36	60.00 percentage of days Interval 21.11 to 77.78
Percentage of Seizure-free Days by 3-month Intervals Over the Evaluation Period Month >36-39	68.89 percentage of days Interval 24.44 to 77.78
Percentage of Seizure-free Days by 3-month Intervals Over the Evaluation Period Month >39-42	67.78 percentage of days Interval 16.67 to 88.89
Percentage of Seizure-free Days by 3-month Intervals Over the Evaluation Period Month >42-45	67.78 percentage of days Interval 6.67 to 86.67
Percentage of Seizure-free Days by 3-month Intervals Over the Evaluation Period Month >45-48	72.22 percentage of days Interval 11.11 to 91.11
Percentage of Seizure-free Days by 3-month Intervals Over the Evaluation Period Month >48-51	73.33 percentage of days Interval 4.0 to 94.44
Percentage of Seizure-free Days by 3-month Intervals Over the Evaluation Period Month >51-54	80.65 percentage of days Interval 6.06 to 86.67
Percentage of Seizure-free Days by 3-month Intervals Over the Evaluation Period Month >54-57	72.00 percentage of days Interval 72.0 to 72.0

SECONDARY outcome

Timeframe: Over the Evaluation Period (up to 5 years)

Population: The FAS consisted of all enrolled study participants who took at least 1 dose of UCB0942 and completed at least 1 seizure diary during the Evaluation Period in EP0073.

Participants were considered seizure free for a given Period or time interval if the participant, completes the Period or time interval, reports no seizures during the Period, and has no more than 10% of days in the Period for which seizure data is not available (ie, "Not Done" is reported on the Seizure Count CRF). The seizure freedom rate (%) for a specific time Period was calculated using the following formula: Count of seizure free participants during the Period/ Number of participants during the Period × 100.

Outcome measures

Outcome measures
Measure	UCB0942 (SS) n=42 Participants All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
Seizure-free Rate Over the Evaluation Period	0 percentage of participants

SECONDARY outcome

Timeframe: Month 3, 7, 13, 19, 25, 31, 37, 43, 49, early discontinuation visit (EDV) (up to Month 58), Relative to Baseline (of EP0069)

The QOLIE-31-P includes 30 items grouped into 7 multi-item subscales (seizure worry, overall quality of life, emotional well-being, energy/fatigue, cognitive functioning, medication effects, and social function) and a health status item. Individual responses for the 30 subscale items are rescaled to 0 to 100 with higher scores reflecting better functioning. Each subscale score is then calculated by summing rescaled responses for that subscale and dividing by number of items with non-missing response. Responses for health status item are multiple of 10 ranging from 0 to 100 with a higher score corresponding to better health status. The QOLIE-31-P total score was calculated as weighted sum of the subscale scores which ranges from 0 to 100 with higher score reflecting better functioning.

Outcome measures

Outcome measures
Measure	UCB0942 (SS) n=39 Participants All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
Changes in Quality of Life in Epilepsy 31-P (QOLIE-31-P) Total Score From Visit 3 (Week 2) of EP0069 Through the Assessment of the Evaluation Period of EP0073 Month 3	3.1 scores on a scale Standard Deviation 14.2
Changes in Quality of Life in Epilepsy 31-P (QOLIE-31-P) Total Score From Visit 3 (Week 2) of EP0069 Through the Assessment of the Evaluation Period of EP0073 Month 7	3.8 scores on a scale Standard Deviation 17.0
Changes in Quality of Life in Epilepsy 31-P (QOLIE-31-P) Total Score From Visit 3 (Week 2) of EP0069 Through the Assessment of the Evaluation Period of EP0073 Month 13	6.8 scores on a scale Standard Deviation 17.7
Changes in Quality of Life in Epilepsy 31-P (QOLIE-31-P) Total Score From Visit 3 (Week 2) of EP0069 Through the Assessment of the Evaluation Period of EP0073 Month 19	5.7 scores on a scale Standard Deviation 18.0
Changes in Quality of Life in Epilepsy 31-P (QOLIE-31-P) Total Score From Visit 3 (Week 2) of EP0069 Through the Assessment of the Evaluation Period of EP0073 Month 25	4.7 scores on a scale Standard Deviation 24.8
Changes in Quality of Life in Epilepsy 31-P (QOLIE-31-P) Total Score From Visit 3 (Week 2) of EP0069 Through the Assessment of the Evaluation Period of EP0073 Month 31	5.4 scores on a scale Standard Deviation 21.7
Changes in Quality of Life in Epilepsy 31-P (QOLIE-31-P) Total Score From Visit 3 (Week 2) of EP0069 Through the Assessment of the Evaluation Period of EP0073 Month 37	3.4 scores on a scale Standard Deviation 18.8
Changes in Quality of Life in Epilepsy 31-P (QOLIE-31-P) Total Score From Visit 3 (Week 2) of EP0069 Through the Assessment of the Evaluation Period of EP0073 Month 43	1.0 scores on a scale Standard Deviation 19.0
Changes in Quality of Life in Epilepsy 31-P (QOLIE-31-P) Total Score From Visit 3 (Week 2) of EP0069 Through the Assessment of the Evaluation Period of EP0073 Month 49	-4.6 scores on a scale Standard Deviation 22.2
Changes in Quality of Life in Epilepsy 31-P (QOLIE-31-P) Total Score From Visit 3 (Week 2) of EP0069 Through the Assessment of the Evaluation Period of EP0073 EDV (up to Month 58)	2.2 scores on a scale Standard Deviation 19.9

Adverse Events

UCB0942 (SS)

Serious events: 12 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	UCB0942 (SS) n=42 participants at risk All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
Infections and infestations Cellulitis	4.8% 2/42 • Number of events 2 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Infections and infestations Urinary tract infection	2.4% 1/42 • Number of events 1 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Injury, poisoning and procedural complications Animal bite	2.4% 1/42 • Number of events 1 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Injury, poisoning and procedural complications Face injury	2.4% 1/42 • Number of events 1 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Injury, poisoning and procedural complications Fall	2.4% 1/42 • Number of events 1 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Injury, poisoning and procedural complications Head injury	2.4% 1/42 • Number of events 1 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Injury, poisoning and procedural complications Lip injury	2.4% 1/42 • Number of events 1 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Injury, poisoning and procedural complications Lower limb fracture	2.4% 1/42 • Number of events 1 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Injury, poisoning and procedural complications Procedural nausea	2.4% 1/42 • Number of events 1 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Injury, poisoning and procedural complications Subdural haematoma	2.4% 1/42 • Number of events 2 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Nervous system disorders Seizure	7.1% 3/42 • Number of events 3 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Nervous system disorders Status epilepticus	4.8% 2/42 • Number of events 3 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Nervous system disorders Dementia Alzheimer's type	2.4% 1/42 • Number of events 1 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Nervous system disorders Generalised tonic-clonic seizure	2.4% 1/42 • Number of events 1 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Nervous system disorders Memory impairment	2.4% 1/42 • Number of events 1 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Nervous system disorders Seizure cluster	2.4% 1/42 • Number of events 1 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Surgical and medical procedures Myomectomy	2.4% 1/42 • Number of events 1 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Surgical and medical procedures Therapy change	2.4% 1/42 • Number of events 1 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Injury, poisoning and procedural complications Hand fracture	2.4% 1/42 • Number of events 1 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.

Other adverse events

Other adverse events
Measure	UCB0942 (SS) n=42 participants at risk All enrolled participants continued the same UCB0942 dose which they were receiving during last visit of study EP0069 and the dose could be further increased or decreased in participants to optimize the drug tolerability and seizure control for each participant. Daily UCB0942 film-coated tablets were administered orally in doses of 100 mg (50 mg bid), 200 mg (100 mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years. Participants formed the Safety Set (SS).
Gastrointestinal disorders Vomiting	7.1% 3/42 • Number of events 3 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
General disorders Fatigue	21.4% 9/42 • Number of events 13 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Infections and infestations Nasopharyngitis	14.3% 6/42 • Number of events 9 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Infections and infestations Gastroenteritis	9.5% 4/42 • Number of events 4 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Infections and infestations Respiratory tract infection	7.1% 3/42 • Number of events 3 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Infections and infestations Urinary tract infection	7.1% 3/42 • Number of events 3 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Injury, poisoning and procedural complications Skin laceration	9.5% 4/42 • Number of events 4 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Investigations Weight increased	14.3% 6/42 • Number of events 6 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Nervous system disorders Somnolence	26.2% 11/42 • Number of events 16 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Nervous system disorders Dizziness	16.7% 7/42 • Number of events 8 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Nervous system disorders Headache	14.3% 6/42 • Number of events 6 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Nervous system disorders Memory impairment	9.5% 4/42 • Number of events 4 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Psychiatric disorders Depressed mood	7.1% 3/42 • Number of events 5 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Psychiatric disorders Depression	7.1% 3/42 • Number of events 3 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Psychiatric disorders Insomnia	7.1% 3/42 • Number of events 3 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.
Psychiatric disorders Irritability	7.1% 3/42 • Number of events 5 • From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years) Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that started on or after the first dose of UCB0942 in EP0073 or AEs whose intensity worsened on or after the date of first dose of UCB0942 in EP0073.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER