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Trial record 1 of 1 for:    EP0073
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An Open-label Extension Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02625090
Recruitment Status : Terminated (Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizure)
First Posted : December 9, 2015
Results First Posted : January 31, 2022
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Highly Drug-resistant Focal Epilepsy
Intervention Drug: UCB0942
Enrollment 42
Recruitment Details The study started to enroll study participants in December 2015 and concluded in November 2020.
Pre-assignment Details 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.
Arm/Group Title UCB0942
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 42
Completed 0
Not Completed 42
Reason Not Completed
Participant wants to be pregnant             2
For the Promoter             1
Sponsor's Decision             9
Somnolence             1
Study terminated by Sponsor             7
Negative Benefit/Risk             1
Protocol Deviation             2
Lack of Efficacy             16
Adverse Event             3
Arm/Group Title UCB0942
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 42
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Safety Set (SS) consisted of all enrolled study participants who took at least 1 dose of UCB0942 in the EP0073 study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
<=18 years
0
   0.0%
Between 18 and 65 years
42
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants
35.4  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Female
21
  50.0%
Male
21
  50.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
White
40
  95.2%
Other/mixed
2
   4.8%
1.Primary Outcome
Title 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
Hide Description

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.

Time Frame From Entry Visit to End of Safety Follow-Up Visit (up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all enrolled study participants who took at least 1 dose of UCB0942 in the EP0073 study.
Arm/Group Title UCB0942 (SS)
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 42
Measure Type: Number
Unit of Measure: percentage of participants
90.5
2.Primary Outcome
Title 75% Responder Rate by 3-month Interval (Month 0 to 3) Over the Evaluation Period
Hide Description 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.
Time Frame Over 3-month interval over the Evaluation Period (Month 0-3)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title UCB0942 (FAS)
Hide Arm/Group Description:
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 FAS.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: percentage of participants
24.4
3.Primary Outcome
Title 75% Responder Rate by 3-month Interval (Month >3-6) Over the Evaluation Period
Hide Description 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.
Time Frame Over 3-month interval over the Evaluation Period (Month >3-6)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title UCB0942 (FAS)
Hide Arm/Group Description:
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 FAS.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: percentage of participants
24.4
4.Primary Outcome
Title 75% Responder Rate by 3-month Interval (Month >6-9) Over the Evaluation Period
Hide Description 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.
Time Frame Over 3-month interval over the Evaluation Period (Month >6-9)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title UCB0942 (FAS)
Hide Arm/Group Description:
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 FAS.
Overall Number of Participants Analyzed 34
Measure Type: Number
Unit of Measure: percentage of participants
20.6
5.Primary Outcome
Title 75% Responder Rate by 3-month Interval (Month >9-12) Over the Evaluation Period
Hide Description 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.
Time Frame Over 3-month interval over the Evaluation Period (Month >9-12)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title UCB0942 (FAS)
Hide Arm/Group Description:
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 FAS.
Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: percentage of participants
28.6
6.Primary Outcome
Title 75% Responder Rate by 3-month Interval (Month >12-15) Over the Evaluation Period
Hide Description 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.
Time Frame Over 3-month interval over the Evaluation Period (Month >12-15)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title UCB0942 (FAS)
Hide Arm/Group Description:
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 FAS.
Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: percentage of participants
23.1
7.Primary Outcome
Title 75% Responder Rate by 3-month Interval (Month >15-18) Over the Evaluation Period
Hide Description 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.
Time Frame Over 3-month interval over the Evaluation Period (Month >15-18)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title UCB0942 (FAS)
Hide Arm/Group Description:
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 FAS.
Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: percentage of participants
23.1
8.Primary Outcome
Title 75% Responder Rate by 3-month Interval (Month >18-21) Over the Evaluation Period
Hide Description 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.
Time Frame Over 3-month interval over the Evaluation Period (Month >18-21)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title UCB0942 (FAS)
Hide Arm/Group Description:
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 FAS.
Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: percentage of participants
26.9
9.Primary Outcome
Title 75% Responder Rate by 3-month Interval (Month >21-24) Over the Evaluation Period
Hide Description 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.
Time Frame Over 3-month interval over the Evaluation Period (Month >21-24)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title UCB0942 (FAS)
Hide Arm/Group Description:
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 FAS.
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: percentage of participants
27.3
10.Primary Outcome
Title 75% Responder Rate by 3-month Interval (Month >24-27) Over the Evaluation Period
Hide Description 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.
Time Frame Over 3-month interval over the Evaluation Period (Month >24-27)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title UCB0942 (FAS)
Hide Arm/Group Description:
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 FAS.
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: percentage of participants
26.1
11.Primary Outcome
Title 75% Responder Rate by 3-month Interval (Month >27-30) Over the Evaluation Period
Hide Description 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.
Time Frame Over 3-month interval over the Evaluation Period (Month >27-30)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title UCB0942 (FAS)
Hide Arm/Group Description:
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 FAS.
Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: percentage of participants
33.3
12.Primary Outcome
Title 75% Responder Rate by 3-month Interval (Month >30-33) Over the Evaluation Period
Hide Description 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.
Time Frame Over 3-month interval over the Evaluation Period (Month >30-33)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title UCB0942 (FAS)
Hide Arm/Group Description:
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 FAS.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: percentage of participants
25.0
13.Primary Outcome
Title 75% Responder Rate by 3-month Interval (Month >33-36) Over the Evaluation Period
Hide Description 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.
Time Frame Over 3-month interval over the Evaluation Period (Month >33-36)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title UCB0942 (FAS)
Hide Arm/Group Description:
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 FAS.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: percentage of participants
35.0
14.Primary Outcome
Title 75% Responder Rate by 3-month Interval (Month >36-39) Over the Evaluation Period
Hide Description 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.
Time Frame Over 3-month interval over the Evaluation Period (Month >36-39)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title UCB0942 (FAS)
Hide Arm/Group Description:
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 FAS.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: percentage of participants
27.8
15.Primary Outcome
Title 75% Responder Rate by 3-month Interval (Month >39-42) Over the Evaluation Period
Hide Description 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.
Time Frame Over 3-month interval over the Evaluation Period (Month >39-42)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title UCB0942 (FAS)
Hide Arm/Group Description:
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 FAS.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: percentage of participants
27.8
16.Primary Outcome
Title 75% Responder Rate by 3-month Interval (Month >42-45) Over the Evaluation Period
Hide Description 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.
Time Frame Over 3-month interval over the Evaluation Period (Month >42-45)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title UCB0942 (FAS)
Hide Arm/Group Description:
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 FAS.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: percentage of participants
50.0
17.Primary Outcome
Title 75% Responder Rate by 3-month Interval (Month >45-48) Over the Evaluation Period
Hide Description 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.
Time Frame Over 3-month interval over the Evaluation Period (Month >45-48)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title UCB0942 (FAS)
Hide Arm/Group Description:
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 FAS.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: percentage of participants
40.0
18.Primary Outcome
Title 75% Responder Rate by 3-month Interval (Month >48-51) Over the Evaluation Period
Hide Description 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.
Time Frame Over 3-month interval over the Evaluation Period (Month >48-51)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title UCB0942 (FAS)
Hide Arm/Group Description:
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 FAS.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: percentage of participants
40.0
19.Primary Outcome
Title 75% Responder Rate by 3-month Interval (Month >51-54) Over the Evaluation Period
Hide Description 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.
Time Frame Over 3-month interval over the Evaluation Period (Month >51-54)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title UCB0942 (FAS)
Hide Arm/Group Description:
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 FAS.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: percentage of participants
40.0
20.Primary Outcome
Title 75% Responder Rate by 3-month Interval (Month >54-57) Over the Evaluation Period
Hide Description 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.
Time Frame Over 3-month interval over the Evaluation Period (Month >54-57)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title UCB0942 (FAS)
Hide Arm/Group Description:
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 FAS.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: percentage of participants
0
21.Secondary Outcome
Title Median Partial-onset Seizure Frequency Per 28 Days by 3-month Intervals Over the Evaluation Period of the EP0073 Study
Hide Description Median partial-onset seizure frequency per 28 days by 3-month intervals over the Evaluation Period of the EP0073 study was reported.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title UCB0942 (FAS)
Hide Arm/Group Description:
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 FAS.
Overall Number of Participants Analyzed 42
Median (Inter-Quartile Range)
Unit of Measure: seizure frequency per 28 days
Month 0-3 Number Analyzed 42 participants
18.98
(10.89 to 48.22)
Month >3-6 Number Analyzed 42 participants
22.99
(13.07 to 66.18)
Month >6-9 Number Analyzed 35 participants
23.33
(8.09 to 56.00)
Month >9-12 Number Analyzed 29 participants
18.67
(6.84 to 37.96)
Month >12-15 Number Analyzed 27 participants
23.23
(9.02 to 49.47)
Month >15-18 Number Analyzed 27 participants
19.91
(11.20 to 41.48)
Month >18-21 Number Analyzed 27 participants
16.80
(8.09 to 42.00)
Month >21-24 Number Analyzed 23 participants
14.31
(5.91 to 36.09)
Month >24-27 Number Analyzed 24 participants
14.31
(8.71 to 38.53)
Month >27-30 Number Analyzed 22 participants
14.16
(5.91 to 38.58)
Month >30-33 Number Analyzed 21 participants
16.80
(7.78 to 42.62)
Month >33-36 Number Analyzed 21 participants
19.29
(6.84 to 46.67)
Month >36-39 Number Analyzed 19 participants
13.69
(7.16 to 45.11)
Month >39-42 Number Analyzed 19 participants
9.96
(5.91 to 57.24)
Month >42-45 Number Analyzed 15 participants
13.07
(3.73 to 63.17)
Month >45-48 Number Analyzed 11 participants
10.58
(2.80 to 59.42)
Month >48-51 Number Analyzed 11 participants
9.02
(1.56 to 48.16)
Month >51-54 Number Analyzed 6 participants
7.80
(3.73 to 33.60)
Month >54-57 Number Analyzed 1 participants
7.84
(7.84 to 7.84)
22.Secondary Outcome
Title Median Partial-onset Seizure Frequency Per 28 Days by Seizure Type by 3-month Intervals Over the Evaluation Period of the EP0073 Study
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title UCB0942 (FAS)
Hide Arm/Group Description:
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 FAS.
Overall Number of Participants Analyzed 42
Median (Inter-Quartile Range)
Unit of Measure: seizure frequency per 28 days
Type IA1: Month 0-3 Number Analyzed 42 participants
0.00
(0.00 to 2.18)
Type IA1: Month >3-6 Number Analyzed 42 participants
0.00
(0.00 to 7.47)
Type IA1: Month >6-9 Number Analyzed 35 participants
0.00
(0.00 to 4.36)
Type IA1: Month >9-12 Number Analyzed 29 participants
0.00
(0.00 to 0.00)
Type IA1: Month >12-15 Number Analyzed 27 participants
0.00
(0.00 to 1.24)
Type IA1: Month >15-18 Number Analyzed 27 participants
0.00
(0.00 to 1.87)
Type IA1: Month >18-21 Number Analyzed 27 participants
0.00
(0.00 to 4.36)
Type IA1: Month >21-24 Number Analyzed 23 participants
0.00
(0.00 to 2.80)
Type IA1: Month >24-27 Number Analyzed 24 participants
0.00
(0.00 to 3.27)
Type IA1: Month >27-30 Number Analyzed 22 participants
0.00
(0.00 to 0.93)
Type IA1: Month >30-33 Number Analyzed 21 participants
0.00
(0.00 to 2.49)
Type IA1: Month >33-36 Number Analyzed 21 participants
0.00
(0.00 to 2.49)
Type IA1: Month >36-39 Number Analyzed 19 participants
0.00
(0.00 to 3.42)
Type IA1: Month >39-42 Number Analyzed 19 participants
0.00
(0.00 to 2.80)
Type IA1: Month >42-45 Number Analyzed 15 participants
0.00
(0.00 to 7.47)
Type IA1: Month >45-48 Number Analyzed 11 participants
0.00
(0.00 to 4.67)
Type IA1: Month >48-51 Number Analyzed 11 participants
0.00
(0.00 to 3.73)
Type IA1: Month >51-54 Number Analyzed 6 participants
0.00
(0.00 to 1.87)
Type IA1: Month >54-57 Number Analyzed 1 participants
4.48
(4.48 to 4.48)
Type IB: Month 0-3 Number Analyzed 42 participants
10.73
(4.67 to 35.00)
Type IB: Month >3-6 Number Analyzed 42 participants
12.67
(1.56 to 28.00)
Type IB: Month >6-9 Number Analyzed 35 participants
9.33
(0.00 to 34.68)
Type IB: Month >9-12 Number Analyzed 29 participants
9.64
(1.24 to 26.11)
Type IB: Month >12-15 Number Analyzed 27 participants
15.56
(0.93 to 34.84)
Type IB: Month >15-18 Number Analyzed 27 participants
13.38
(2.18 to 37.64)
Type IB: Month >18-21 Number Analyzed 27 participants
13.07
(0.62 to 33.91)
Type IB: Month >21-24 Number Analyzed 23 participants
7.78
(0.93 to 25.20)
Type IB: Month >24-27 Number Analyzed 24 participants
9.80
(2.49 to 27.38)
Type IB: Month >27-30 Number Analyzed 22 participants
9.49
(1.87 to 33.75)
Type IB: Month >30-33 Number Analyzed 21 participants
9.64
(3.11 to 32.98)
Type IB: Month >33-36 Number Analyzed 21 participants
7.47
(2.49 to 25.67)
Type IB: Month >36-39 Number Analyzed 19 participants
6.53
(3.73 to 35.47)
Type IB: Month >39-42 Number Analyzed 19 participants
6.84
(0.31 to 24.58)
Type IB: Month >42-45 Number Analyzed 15 participants
5.29
(2.18 to 20.84)
Type IB: Month >45-48 Number Analyzed 11 participants
4.36
(1.24 to 26.96)
Type IB: Month >48-51 Number Analyzed 11 participants
4.67
(0.31 to 43.87)
Type IB: Month >51-54 Number Analyzed 6 participants
3.29
(1.06 to 33.60)
Type IB: Month >54-57 Number Analyzed 1 participants
3.36
(3.36 to 3.36)
Type IC: Month 0-3 Number Analyzed 42 participants
0.00
(0.00 to 0.00)
Type IC: Month >3-6 Number Analyzed 42 participants
0.00
(0.00 to 0.00)
Type IC: Month >6-9 Number Analyzed 35 participants
0.00
(0.00 to 0.00)
Type IC: Month >9-12 Number Analyzed 29 participants
0.00
(0.00 to 0.00)
Type IC: Month >12-15 Number Analyzed 27 participants
0.00
(0.00 to 0.00)
Type IC: Month >15-18 Number Analyzed 27 participants
0.00
(0.00 to 0.00)
Type IC: Month >18-21 Number Analyzed 27 participants
0.00
(0.00 to 0.00)
Type IC: Month >21-24 Number Analyzed 23 participants
0.00
(0.00 to 0.00)
Type IC: Month >24-27 Number Analyzed 24 participants
0.00
(0.00 to 0.00)
Type IC: Month >27-30 Number Analyzed 22 participants
0.00
(0.00 to 0.00)
Type IC: Month >30-33 Number Analyzed 21 participants
0.00
(0.00 to 0.00)
Type IC: Month >33-36 Number Analyzed 21 participants
0.00
(0.00 to 0.00)
Type IC: Month >36-39 Number Analyzed 19 participants
0.00
(0.00 to 0.31)
Type IC: Month >39-42 Number Analyzed 19 participants
0.00
(0.00 to 0.00)
Type IC: Month >42-45 Number Analyzed 15 participants
0.00
(0.00 to 0.00)
Type IC: Month >45-48 Number Analyzed 11 participants
0.00
(0.00 to 0.31)
Type IC: Month >48-51 Number Analyzed 11 participants
0.00
(0.00 to 0.31)
Type IC: Month >51-54 Number Analyzed 6 participants
0.00
(0.00 to 1.87)
Type IC: Month >54-57 Number Analyzed 1 participants
0.00
(0.00 to 0.00)
23.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 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, Relative to Baseline (of EP0069)
Hide Outcome Measure Data
Hide Analysis Population Description
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 and number analyzed signifies participants who were evaluable at specified time points.
Arm/Group Title UCB0942 (FAS)
Hide Arm/Group Description:
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 FAS.
Overall Number of Participants Analyzed 41
Median (Inter-Quartile Range)
Unit of Measure: percent change
Month 0-3 Number Analyzed 41 participants
50.51
(21.74 to 72.53)
Month >3-6 Number Analyzed 41 participants
39.14
(12.50 to 72.78)
Month >6-9 Number Analyzed 34 participants
56.98
(31.19 to 72.22)
Month >9-12 Number Analyzed 28 participants
62.22
(39.99 to 80.54)
Month >12-15 Number Analyzed 26 participants
55.74
(40.95 to 72.78)
Month >15-18 Number Analyzed 26 participants
54.04
(35.71 to 72.72)
Month >18-21 Number Analyzed 26 participants
57.27
(39.42 to 76.28)
Month >21-24 Number Analyzed 22 participants
68.57
(46.67 to 76.67)
Month >24-27 Number Analyzed 23 participants
60.15
(40.31 to 77.41)
Month >27-30 Number Analyzed 21 participants
59.82
(44.79 to 80.06)
Month >30-33 Number Analyzed 20 participants
59.57
(41.94 to 76.17)
Month >33-36 Number Analyzed 20 participants
59.73
(35.42 to 78.96)
Month >36-39 Number Analyzed 18 participants
64.50
(45.56 to 78.90)
Month >39-42 Number Analyzed 18 participants
59.01
(37.78 to 80.06)
Month >42-45 Number Analyzed 14 participants
68.79
(38.39 to 80.00)
Month >45-48 Number Analyzed 10 participants
68.17
(56.98 to 85.00)
Month >48-51 Number Analyzed 10 participants
67.12
(51.67 to 91.67)
Month >51-54 Number Analyzed 5 participants
73.08
(61.92 to 80.00)
Month >54-57 Number Analyzed 1 participants
73.56
(73.56 to 73.56)
24.Secondary Outcome
Title 50% Responder Rate by 3-month Intervals Over the Evaluation Period of the EP0073 Study
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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 and number analyzed signifies participants who were evaluable at specified time points.
Arm/Group Title UCB0942 (FAS)
Hide Arm/Group Description:
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 FAS.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: percentage of participants
Month 0-3 Number Analyzed 41 participants
51.2
Month >3-6 Number Analyzed 41 participants
39.0
Month >6-9 Number Analyzed 34 participants
58.8
Month >9-12 Number Analyzed 28 participants
67.9
Month >12-15 Number Analyzed 26 participants
65.4
Month >15-18 Number Analyzed 26 participants
53.8
Month >18-21 Number Analyzed 26 participants
57.7
Month >21-24 Number Analyzed 22 participants
72.7
Month >24-27 Number Analyzed 23 participants
69.6
Month >27-30 Number Analyzed 21 participants
66.7
Month >30-33 Number Analyzed 20 participants
70.0
Month >33-36 Number Analyzed 20 participants
65.0
Month >36-39 Number Analyzed 18 participants
72.2
Month >39-42 Number Analyzed 18 participants
72.2
Month >42-45 Number Analyzed 14 participants
64.3
Month >45-48 Number Analyzed 10 participants
80.0
Month >48-51 Number Analyzed 10 participants
90.0
Month >51-54 Number Analyzed 5 participants
80.0
Month >54-57 Number Analyzed 1 participants
100
25.Secondary Outcome
Title Percentage of Seizure-free Days by 3-month Intervals Over the Evaluation Period
Hide Description 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.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title UCB0942 (FAS)
Hide Arm/Group Description:
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 FAS.
Overall Number of Participants Analyzed 42
Median (Inter-Quartile Range)
Unit of Measure: percentage of days
Month 0-3 Number Analyzed 42 participants
48.33
(24.44 to 76.67)
Month >3-6 Number Analyzed 42 participants
42.81
(8.89 to 68.89)
Month >6-9 Number Analyzed 35 participants
54.44
(10.00 to 80.00)
Month >9-12 Number Analyzed 29 participants
55.56
(25.56 to 78.89)
Month >12-15 Number Analyzed 27 participants
54.44
(22.22 to 78.89)
Month >15-18 Number Analyzed 27 participants
51.11
(25.56 to 73.33)
Month >18-21 Number Analyzed 27 participants
61.11
(26.67 to 80.00)
Month >21-24 Number Analyzed 23 participants
57.78
(30.00 to 86.67)
Month >24-27 Number Analyzed 24 participants
60.00
(31.11 to 77.22)
Month >27-30 Number Analyzed 22 participants
64.44
(22.22 to 85.56)
Month >30-33 Number Analyzed 21 participants
57.78
(28.89 to 80.00)
Month >33-36 Number Analyzed 21 participants
60.00
(21.11 to 77.78)
Month >36-39 Number Analyzed 19 participants
68.89
(24.44 to 77.78)
Month >39-42 Number Analyzed 19 participants
67.78
(16.67 to 88.89)
Month >42-45 Number Analyzed 15 participants
67.78
(6.67 to 86.67)
Month >45-48 Number Analyzed 11 participants
72.22
(11.11 to 91.11)
Month >48-51 Number Analyzed 11 participants
73.33
(4.00 to 94.44)
Month >51-54 Number Analyzed 6 participants
80.65
(6.06 to 86.67)
Month >54-57 Number Analyzed 1 participants
72.00
(72.00 to 72.00)
26.Secondary Outcome
Title Seizure-free Rate Over the Evaluation Period
Hide Description 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.
Time Frame Over the Evaluation Period (up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title UCB0942 (FAS)
Hide Arm/Group Description:
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 FAS.
Overall Number of Participants Analyzed 42
Measure Type: Number
Unit of Measure: percentage of participants
0
27.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Month 3, 7, 13, 19, 25, 31, 37, 43, 49, early discontinuation visit (EDV) (up to Month 58), Relative to Baseline (of EP0069)
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Hide Analysis Population Description
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 and number analyzed signifies participants who were evaluable at specified time points.
Arm/Group Title UCB0942 (FAS)
Hide Arm/Group Description:
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 FAS.
Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Month 3 Number Analyzed 39 participants
3.1  (14.2)
Month 7 Number Analyzed 31 participants
3.8  (17.0)
Month 13 Number Analyzed 25 participants
6.8  (17.7)
Month 19 Number Analyzed 24 participants
5.7  (18.0)
Month 25 Number Analyzed 22 participants
4.7  (24.8)
Month 31 Number Analyzed 20 participants
5.4  (21.7)
Month 37 Number Analyzed 18 participants
3.4  (18.8)
Month 43 Number Analyzed 13 participants
1.0  (19.0)
Month 49 Number Analyzed 4 participants
-4.6  (22.2)
EDV (up to Month 58) Number Analyzed 38 participants
2.2  (19.9)
Time Frame From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years)
Adverse Event Reporting Description 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.
 
Arm/Group Title UCB0942 (SS)
Hide Arm/Group Description 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).
All-Cause Mortality
UCB0942 (SS)
Affected / at Risk (%)
Total   0/42 (0.00%)    
Hide Serious Adverse Events
UCB0942 (SS)
Affected / at Risk (%) # Events
Total   12/42 (28.57%)    
Infections and infestations   
Cellulitis * 1  2/42 (4.76%)  2
Urinary tract infection * 1  1/42 (2.38%)  1
Injury, poisoning and procedural complications   
Animal bite * 1  1/42 (2.38%)  1
Face injury * 1  1/42 (2.38%)  1
Fall * 1  1/42 (2.38%)  1
Head injury * 1  1/42 (2.38%)  1
Lip injury * 1  1/42 (2.38%)  1
Lower limb fracture * 1  1/42 (2.38%)  1
Procedural nausea * 1  1/42 (2.38%)  1
Subdural haematoma * 1  1/42 (2.38%)  2
Hand fracture * 1  1/42 (2.38%)  1
Nervous system disorders   
Seizure * 1  3/42 (7.14%)  3
Status epilepticus * 1  2/42 (4.76%)  3
Dementia Alzheimer's type * 1  1/42 (2.38%)  1
Generalised tonic-clonic seizure * 1  1/42 (2.38%)  1
Memory impairment * 1  1/42 (2.38%)  1
Seizure cluster * 1  1/42 (2.38%)  1
Surgical and medical procedures   
Myomectomy * 1  1/42 (2.38%)  1
Therapy change * 1  1/42 (2.38%)  1
1
Term from vocabulary, MedDRA v22.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
UCB0942 (SS)
Affected / at Risk (%) # Events
Total   32/42 (76.19%)    
Gastrointestinal disorders   
Vomiting * 1  3/42 (7.14%)  3
General disorders   
Fatigue * 1  9/42 (21.43%)  13
Infections and infestations   
Nasopharyngitis * 1  6/42 (14.29%)  9
Gastroenteritis * 1  4/42 (9.52%)  4
Respiratory tract infection * 1  3/42 (7.14%)  3
Urinary tract infection * 1  3/42 (7.14%)  3
Injury, poisoning and procedural complications   
Skin laceration * 1  4/42 (9.52%)  4
Investigations   
Weight increased * 1  6/42 (14.29%)  6
Nervous system disorders   
Somnolence * 1  11/42 (26.19%)  16
Dizziness * 1  7/42 (16.67%)  8
Headache * 1  6/42 (14.29%)  6
Memory impairment * 1  4/42 (9.52%)  4
Psychiatric disorders   
Depressed mood * 1  3/42 (7.14%)  5
Depression * 1  3/42 (7.14%)  3
Insomnia * 1  3/42 (7.14%)  3
Irritability * 1  3/42 (7.14%)  5
1
Term from vocabulary, MedDRA v22.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: UCB
Organization: Cares
Phone: 001-844-599-2273
EMail: UCBCares@ucb.com
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Responsible Party: UCB Pharma ( UCB Biopharma SRL )
ClinicalTrials.gov Identifier: NCT02625090    
Other Study ID Numbers: EP0073
2015-001268-20 ( EudraCT Number )
First Submitted: December 4, 2015
First Posted: December 9, 2015
Results First Submitted: November 23, 2021
Results First Posted: January 31, 2022
Last Update Posted: March 9, 2022