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    Clinical Trial Results:
    An Open-label, Multicenter, Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of UCB0942 When Used as Adjunctive Therapy for Partial-onset Seizures in Adult Subjects With Highly Drug-resistant Focal Epilepsy

    Summary
    EudraCT number
    2015-001268-20
    Trial protocol
    NL   DE   BE   BG   HU   ES   IT  
    Global end of trial date
    24 Nov 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    13 Dec 2021
    First version publication date
    13 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EP0073
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02625090
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB Biopharma SRL
    Sponsor organisation address
    Allée de la Recherche 60, Brussels, Belgium, 1070
    Public contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
    Scientific contact
    Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Dec 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Nov 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Nov 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the long-term safety and tolerability of UCB0942 at individualized doses between 100 milligrams (mg)/day to a maximum of 800 mg/day in participants with highly drug-resistant focal epilepsy
    Protection of trial subjects
    During the conduct of the study all participants were closely monitored, including review of echocardiograms to detect cardiac adverse events.
    Background therapy
    Background therapy as permitted in the protocol.
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    03 Dec 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    Bulgaria: 2
    Country: Number of subjects enrolled
    Germany: 7
    Country: Number of subjects enrolled
    Hungary: 3
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    Spain: 21
    Worldwide total number of subjects
    42
    EEA total number of subjects
    42
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    42
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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

    Pre-assignment
    Screening 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.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    UCB0942
    Arm 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.
    Arm type
    Experimental

    Investigational medicinal product name
    UCB0942
    Investigational medicinal product code
    UCB0942
    Other name
    Padsevonil
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All enrolled participants received UCB0942 film-coated tablets daily administered orally during the study allowed in doses 100 mg (50 mgbid), bid), 200 mg (100mg bid), 400 mg (200 mg bid), 600 mg (300 mg bid), or 800 mg (400 mg bid) for up to approximately 5 years.

    Number of subjects in period 1
    UCB0942
    Started
    42
    Completed
    0
    Not completed
    42
         Protocol Deviation
    2
         Sponsor's Decision
    9
         Participant wants to be pregnant
    2
         Lack of efficacy
    16
         Adverse event, non-fatal
    3
         Negative Benefit/Risk
    1
         Somnolence
    1
         Study terminated by Sponsor
    7
         For the Promoter
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    UCB0942
    Reporting 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.

    Reporting group values
    UCB0942 Total
    Number of subjects
    42 42
    Age Categorical
    Units: participants
        <=18 years
    0 0
        Between 18 and 65 years
    42 42
        >=65 years
    0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    35.4 ± 10.5 -
    Sex: Female, Male
    Units: participants
        Female
    21 21
        Male
    21 21

    End points

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    End points reporting groups
    Reporting group title
    UCB0942
    Reporting 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.

    Subject analysis set title
    UCB0942 (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set 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).

    Subject analysis set title
    UCB0942 (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set 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.

    Primary: 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

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    End point 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 [1]
    End point 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. The Safety Set (SS) consisted of all enrolled study participants who took at least 1 dose of UCB0942 in the EP0073 study.
    End point type
    Primary
    End point timeframe
    From Entry Visit to End of Safety Follow-Up Visit (up to 5 years)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was done, as this is an open label study with only one treatment arm. Thus no statistical comparison is possible.
    End point values
    UCB0942 (SS)
    Number of subjects analysed
    42
    Units: percentage of participants
        number (not applicable)
    90.5
    No statistical analyses for this end point

    Primary: 75% Responder Rate by 3-month interval (Month >3-6) over the Evaluation Period

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    End point title
    75% Responder Rate by 3-month interval (Month >3-6) over the Evaluation Period [2]
    End point description
    A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures (Type IA1, IB, and IC) relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100. 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.
    End point type
    Primary
    End point timeframe
    Over 3-month interval over the Evaluation Period (Month >3-6)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was done, as this is an open label study with only one treatment arm. Thus no statistical comparison is possible.
    End point values
    UCB0942 (FAS)
    Number of subjects analysed
    41
    Units: percentage of participants
        number (not applicable)
    24.4
    No statistical analyses for this end point

    Primary: 75% Responder Rate by 3-month interval (Month 0 to 3) over the Evaluation Period

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    End point title
    75% Responder Rate by 3-month interval (Month 0 to 3) over the Evaluation Period [3]
    End point description
    A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures (Type IA1, IB, and IC) relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100. 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.
    End point type
    Primary
    End point timeframe
    Over 3-month interval over the Evaluation Period (Month 0-3)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was done, as this is an open label study with only one treatment arm. Thus no statistical comparison is possible.
    End point values
    UCB0942 (FAS)
    Number of subjects analysed
    41
    Units: percentage of participants
        number (not applicable)
    24.4
    No statistical analyses for this end point

    Primary: 75% Responder Rate by 3-month interval (Month >6-9) over the Evaluation Period

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    End point title
    75% Responder Rate by 3-month interval (Month >6-9) over the Evaluation Period [4]
    End point description
    A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures (Type IA1, IB, and IC) relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100. 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.
    End point type
    Primary
    End point timeframe
    Over 3-month interval over the Evaluation Period (Month >6-9)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was done, as this is an open label study with only one treatment arm. Thus no statistical comparison is possible.
    End point values
    UCB0942 (FAS)
    Number of subjects analysed
    34
    Units: percentage of participants
        number (not applicable)
    20.6
    No statistical analyses for this end point

    Primary: 75% Responder Rate by 3-month interval (Month >9-12) over the Evaluation Period

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    End point title
    75% Responder Rate by 3-month interval (Month >9-12) over the Evaluation Period [5]
    End point description
    A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures (Type IA1, IB, and IC) relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100. 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.
    End point type
    Primary
    End point timeframe
    Over 3-month interval over the Evaluation Period (Month >9-12)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was done, as this is an open label study with only one treatment arm. Thus no statistical comparison is possible.
    End point values
    UCB0942 (FAS)
    Number of subjects analysed
    28
    Units: percentage of participants
        number (not applicable)
    28.6
    No statistical analyses for this end point

    Primary: 75% Responder Rate by 3-month interval (Month >12-15) over the Evaluation Period

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    End point title
    75% Responder Rate by 3-month interval (Month >12-15) over the Evaluation Period [6]
    End point description
    A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures (Type IA1, IB, and IC) relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100. 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.
    End point type
    Primary
    End point timeframe
    Over 3-month interval over the Evaluation Period (Month >12-15)
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was done, as this is an open label study with only one treatment arm. Thus no statistical comparison is possible.
    End point values
    UCB0942 (FAS)
    Number of subjects analysed
    26
    Units: percentage of participants
        number (not applicable)
    23.1
    No statistical analyses for this end point

    Primary: 75% Responder Rate by 3-month interval (Month >15-18) over the Evaluation Period

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    End point title
    75% Responder Rate by 3-month interval (Month >15-18) over the Evaluation Period [7]
    End point description
    A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures (Type IA1, IB, and IC) relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100. 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.
    End point type
    Primary
    End point timeframe
    Over 3-month interval over the Evaluation Period (Month >15-18)
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was done, as this is an open label study with only one treatment arm. Thus no statistical comparison is possible.
    End point values
    UCB0942 (FAS)
    Number of subjects analysed
    26
    Units: percentage of participants
        number (not applicable)
    23.1
    No statistical analyses for this end point

    Primary: 75% Responder Rate by 3-month interval (Month >18-21) over the Evaluation Period

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    End point title
    75% Responder Rate by 3-month interval (Month >18-21) over the Evaluation Period [8]
    End point description
    A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures (Type IA1, IB, and IC) relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100. 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.
    End point type
    Primary
    End point timeframe
    Over 3-month interval over the Evaluation Period (Month >18-21)
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was done, as this is an open label study with only one treatment arm. Thus no statistical comparison is possible.
    End point values
    UCB0942 (FAS)
    Number of subjects analysed
    26
    Units: percentage of participants
        number (not applicable)
    26.9
    No statistical analyses for this end point

    Primary: 75% Responder Rate by 3-month interval (Month >21-24) over the Evaluation Period

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    End point title
    75% Responder Rate by 3-month interval (Month >21-24) over the Evaluation Period [9]
    End point description
    A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures (Type IA1, IB, and IC) relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100. 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.
    End point type
    Primary
    End point timeframe
    Over 3-month interval over the Evaluation Period (Month >21-24)
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was done, as this is an open label study with only one treatment arm. Thus no statistical comparison is possible.
    End point values
    UCB0942 (FAS)
    Number of subjects analysed
    22
    Units: percentage of participants
        number (not applicable)
    27.3
    No statistical analyses for this end point

    Primary: 75% Responder Rate by 3-month interval (Month >24-27) over the Evaluation Period

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    End point title
    75% Responder Rate by 3-month interval (Month >24-27) over the Evaluation Period [10]
    End point description
    A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures (Type IA1, IB, and IC) relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100. 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.
    End point type
    Primary
    End point timeframe
    Over 3-month interval over the Evaluation Period (Month >24-27)
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was done, as this is an open label study with only one treatment arm. Thus no statistical comparison is possible.
    End point values
    UCB0942 (FAS)
    Number of subjects analysed
    23
    Units: percentage of participants
        number (not applicable)
    26.1
    No statistical analyses for this end point

    Primary: 75% Responder Rate by 3-month interval (Month >27-30) over the Evaluation Period

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    End point title
    75% Responder Rate by 3-month interval (Month >27-30) over the Evaluation Period [11]
    End point description
    A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures (Type IA1, IB, and IC) relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100. 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.
    End point type
    Primary
    End point timeframe
    Over 3-month interval over the Evaluation Period (Month >27-30)
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was done, as this is an open label study with only one treatment arm. Thus no statistical comparison is possible.
    End point values
    UCB0942 (FAS)
    Number of subjects analysed
    21
    Units: percentage of participants
        number (not applicable)
    33.3
    No statistical analyses for this end point

    Primary: 75% Responder Rate by 3-month interval (Month >30-33) over the Evaluation Period

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    End point title
    75% Responder Rate by 3-month interval (Month >30-33) over the Evaluation Period [12]
    End point description
    A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures (Type IA1, IB, and IC) relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100. 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.
    End point type
    Primary
    End point timeframe
    Over 3-month interval over the Evaluation Period (Month >30-33)
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was done, as this is an open label study with only one treatment arm. Thus no statistical comparison is possible.
    End point values
    UCB0942 (FAS)
    Number of subjects analysed
    20
    Units: percentage of participants
        number (not applicable)
    25.0
    No statistical analyses for this end point

    Primary: 75% Responder Rate by 3-month interval (Month >33-36) over the Evaluation Period

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    End point title
    75% Responder Rate by 3-month interval (Month >33-36) over the Evaluation Period [13]
    End point description
    A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures (Type IA1, IB, and IC) relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100. 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.
    End point type
    Primary
    End point timeframe
    Over 3-month interval over the Evaluation Period (Month >33-36)
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was done, as this is an open label study with only one treatment arm. Thus no statistical comparison is possible.
    End point values
    UCB0942 (FAS)
    Number of subjects analysed
    20
    Units: percentage of participants
        number (not applicable)
    35.0
    No statistical analyses for this end point

    Primary: 75% Responder Rate by 3-month interval (Month >36-39) over the Evaluation Period

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    End point title
    75% Responder Rate by 3-month interval (Month >36-39) over the Evaluation Period [14]
    End point description
    A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures (Type IA1, IB, and IC) relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100. 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.
    End point type
    Primary
    End point timeframe
    Over 3-month interval over the Evaluation Period (Month >36-39)
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was done, as this is an open label study with only one treatment arm. Thus no statistical comparison is possible.
    End point values
    UCB0942 (FAS)
    Number of subjects analysed
    18
    Units: percentage of participants
        number (not applicable)
    27.8
    No statistical analyses for this end point

    Primary: 75% Responder Rate by 3-month interval (Month >42-45) over the Evaluation Period

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    End point title
    75% Responder Rate by 3-month interval (Month >42-45) over the Evaluation Period [15]
    End point description
    A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures (Type IA1, IB, and IC) relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100. 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.
    End point type
    Primary
    End point timeframe
    Over 3-month interval over the Evaluation Period (Month >42-45)
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was done, as this is an open label study with only one treatment arm. Thus no statistical comparison is possible.
    End point values
    UCB0942 (FAS)
    Number of subjects analysed
    14
    Units: percentage of participants
        number (not applicable)
    50.0
    No statistical analyses for this end point

    Primary: 75% Responder Rate by 3-month interval (Month >39-42) over the Evaluation Period

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    End point title
    75% Responder Rate by 3-month interval (Month >39-42) over the Evaluation Period [16]
    End point description
    A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures (Type IA1, IB, and IC) relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100. 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.
    End point type
    Primary
    End point timeframe
    Over 3-month interval over the Evaluation Period (Month >39-42)
    Notes
    [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was done, as this is an open label study with only one treatment arm. Thus no statistical comparison is possible.
    End point values
    UCB0942 (FAS)
    Number of subjects analysed
    18
    Units: percentage of participants
        number (not applicable)
    27.8
    No statistical analyses for this end point

    Primary: 75% Responder Rate by 3-month interval (Month >45-48) over the Evaluation Period

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    End point title
    75% Responder Rate by 3-month interval (Month >45-48) over the Evaluation Period [17]
    End point description
    A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures (Type IA1, IB, and IC) relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100. 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.
    End point type
    Primary
    End point timeframe
    Over 3-month interval over the Evaluation Period (Month >45-48)
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was done, as this is an open label study with only one treatment arm. Thus no statistical comparison is possible.
    End point values
    UCB0942 (FAS)
    Number of subjects analysed
    10
    Units: percentage of participants
        number (not applicable)
    40.0
    No statistical analyses for this end point

    Primary: 75% Responder Rate by 3-month interval (Month >51-54) over the Evaluation Period

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    End point title
    75% Responder Rate by 3-month interval (Month >51-54) over the Evaluation Period [18]
    End point description
    A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures (Type IA1, IB, and IC) relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100. 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.
    End point type
    Primary
    End point timeframe
    Over 3-month interval over the Evaluation Period (Month >51-54)
    Notes
    [18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was done, as this is an open label study with only one treatment arm. Thus no statistical comparison is possible.
    End point values
    UCB0942 (FAS)
    Number of subjects analysed
    5
    Units: percentage of participants
        number (not applicable)
    40.0
    No statistical analyses for this end point

    Primary: 75% Responder Rate by 3-month interval (Month >48-51) over the Evaluation Period

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    End point title
    75% Responder Rate by 3-month interval (Month >48-51) over the Evaluation Period [19]
    End point description
    A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures (Type IA1, IB, and IC) relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100. 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.
    End point type
    Primary
    End point timeframe
    Over 3-month interval over the Evaluation Period (Month >48-51)
    Notes
    [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was done, as this is an open label study with only one treatment arm. Thus no statistical comparison is possible.
    End point values
    UCB0942 (FAS)
    Number of subjects analysed
    10
    Units: percentage of participants
        number (not applicable)
    40.0
    No statistical analyses for this end point

    Primary: 75% Responder Rate by 3-month interval (Month >54-57) over the Evaluation Period

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    End point title
    75% Responder Rate by 3-month interval (Month >54-57) over the Evaluation Period [20]
    End point description
    A 75% responder is defined as a participant with a ≥75% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures (Type IA1, IB, and IC) relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. It was calculated using formula: Count of 75% responders during the Period/ number of participants during the Period × 100. 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.
    End point type
    Primary
    End point timeframe
    Over 3-month interval over the Evaluation Period (Month >54-57)
    Notes
    [20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was done, as this is an open label study with only one treatment arm. Thus no statistical comparison is possible.
    End point values
    UCB0942 (FAS)
    Number of subjects analysed
    1
    Units: percentage of participants
        number (not applicable)
    0
    No statistical analyses for this end point

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

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    End point title
    Median partial-onset seizure frequency per 28 days by 3-month intervals over the Evaluation Period of the EP0073 study
    End point description
    Median partial-onset seizure frequency per 28 days by 3-month intervals over the Evaluation Period of the EP0073 study was reported. 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, 'n' signifies participants who were evaluable at specified time points.
    End point type
    Secondary
    End point 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
    End point values
    UCB0942 (FAS)
    Number of subjects analysed
    42
    Units: seizure frequency per 28 days
    median (inter-quartile range (Q1-Q3))
        Month 0-3 (n=42)
    18.98 (10.89 to 48.22)
        Month >3-6 (n=42)
    22.99 (13.07 to 66.18)
        Month >6-9 (n=35)
    23.33 (8.09 to 56.00)
        Month >9-12 (n=29)
    18.67 (6.84 to 37.96)
        Month >12-15 (n=27)
    23.23 (9.02 to 49.47)
        Month >15-18 (n=27)
    19.91 (11.20 to 41.48)
        Month >18-21 (n=27)
    16.80 (8.09 to 42.00)
        Month >21-24 (n=23)
    14.31 (5.91 to 36.09)
        Month >24-27 (n=24)
    14.31 (8.71 to 38.53)
        Month >27-30 (n=22)
    14.16 (5.91 to 38.58)
        Month >30-33 (n=21)
    16.80 (7.78 to 42.62)
        Month >33-36 (n=21)
    19.29 (6.84 to 46.67)
        Month >36-39 (n=19)
    13.69 (7.16 to 45.11)
        Month >39-42 (n=19)
    9.96 (5.91 to 57.24)
        Month >42-45 (n=15)
    13.07 (3.73 to 63.17)
        Month >45-48 (n=11)
    10.58 (2.80 to 59.42)
        Month >48-51 (n=11)
    9.02 (1.56 to 48.16)
        Month >51-54 (n=6)
    7.80 (3.73 to 33.60)
        Month >54-57 (n=1)
    7.84 (7.84 to 7.84)
    No statistical analyses for this end point

    Secondary: Median partial-onset seizure frequency per 28 days by seizure type by 3-month intervals type over the Evaluation Period of the EP0073 study

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    End point title
    Median partial-onset seizure frequency per 28 days by seizure type by 3-month intervals type over the Evaluation Period of the EP0073 study
    End point 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. 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, 'n' signifies participants who were evaluable at specified time points.
    End point type
    Secondary
    End point 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
    End point values
    UCB0942 (FAS)
    Number of subjects analysed
    42
    Units: seizure frequency per 28 days
    median (inter-quartile range (Q1-Q3))
        Type IA1: Month 0-3 (n=42)
    0.00 (0.00 to 2.18)
        Type IA1: Month >3-6 (n=42)
    0.00 (0.00 to 7.47)
        Type IA1: Month >6-9 (n=35)
    0.00 (0.00 to 4.36)
        Type IA1: Month >9-12 (n=29)
    0.00 (0.00 to 0.00)
        Type IA1: Month >12-15 (n=27)
    0.00 (0.00 to 1.24)
        Type IA1: Month >15-18 (n=27)
    0.00 (0.00 to 1.87)
        Type IA1: Month >18-21 (n=27)
    0.00 (0.00 to 4.36)
        Type IA1: Month >21-24 (n=23)
    0.00 (0.00 to 2.80)
        Type IA1: Month >24-27 (n=24)
    0.00 (0.00 to 3.27)
        Type IA1: Month >27-30 (n=22)
    0.00 (0.00 to 0.93)
        Type IA1: Month >30-33 (n=21)
    0.00 (0.00 to 2.49)
        Type IA1: Month >33-36 (n=21)
    0.00 (0.00 to 2.49)
        Type IA1: Month >36-39 (n=19)
    0.00 (0.00 to 3.42)
        Type IA1: Month >39-42 (n=19)
    0.00 (0.00 to 2.80)
        Type IA1: Month >42-45 (n=15)
    0.00 (0.00 to 7.47)
        Type IA1: Month >45-48 (n=11)
    0.00 (0.00 to 4.67)
        Type IA1: Month >48-51 (n=11)
    0.00 (0.00 to 3.73)
        Type IA1: Month >51-54 (n=6)
    0.00 (0.00 to 1.87)
        Type IA1: Month >54-57 (n=1)
    4.48 (4.48 to 4.48)
        Type IB: Month 0-3 (n=42)
    10.73 (4.67 to 35.00)
        Type IB: Month >3-6 (n=42)
    12.67 (1.56 to 28.00)
        Type IB: Month >6-9 (n=35)
    9.33 (0.00 to 34.68)
        Type IB: Month >9-12 (n=29)
    9.64 (1.24 to 26.11)
        Type IB: Month >12-15 (n=27)
    15.56 (0.93 to 34.84)
        Type IB: Month >15-18 (n=27)
    13.38 (2.18 to 37.64)
        Type IB: Month >18-21 (n=27)
    13.07 (0.62 to 33.91)
        Type IB: Month >21-24 (n=23)
    7.78 (0.93 to 25.20)
        Type IB: Month >24-27 (n=24)
    9.80 (2.49 to 27.38)
        Type IB: Month >27-30 (n=22)
    9.49 (1.87 to 33.75)
        Type IB: Month >30-33 (n=21)
    9.64 (3.11 to 32.98)
        Type IB: Month >33-36 (n=21)
    7.47 (2.49 to 25.67)
        Type IB: Month >36-39 (n=19)
    6.53 (3.73 to 35.47)
        Type IB: Month >39-42 (n=19)
    6.84 (0.31 to 24.58)
        Type IB: Month >42-45 (n=15)
    5.29 (2.18 to 20.84)
        Type IB: Month >45-48 (n=11)
    4.36 (1.24 to 26.96)
        Type IB: Month >48-51 (n=11)
    4.67 (0.31 to 43.87)
        Type IB: Month >51-54 (n=6)
    3.29 (1.06 to 33.60)
        Type IB: Month >54-57 (n=1)
    3.36 (3.36 to 3.36)
        Type IC: Month 0-3 (n=42)
    0.00 (0.00 to 0.00)
        Type IC: Month >3-6 (n=42)
    0.00 (0.00 to 0.00)
        Type IC: Month >6-9 (n=35)
    0.00 (0.00 to 0.00)
        Type IC: Month >9-12 (n=29)
    0.00 (0.00 to 0.00)
        Type IC: Month >12-15 (n=27)
    0.00 (0.00 to 0.00)
        Type IC: Month >15-18 (n=27)
    0.00 (0.00 to 0.00)
        Type IC: Month >18-21 (n=27)
    0.00 (0.00 to 0.00)
        Type IC: Month >21-24 (n=23)
    0.00 (0.00 to 0.00)
        Type IC: Month >24-27 (n=24)
    0.00 (0.00 to 0.00)
        Type IC: Month >27-30 (n=22)
    0.00 (0.00 to 0.00)
        Type IC: Month >30-33 (n=21)
    0.00 (0.00 to 0.00)
        Type IC: Month >33-36 (n=21)
    0.00 (0.00 to 0.00)
        Type IC: Month >36-39 (n=19)
    0.00 (0.00 to 0.31)
        Type IC: Month >39-42 (n=19)
    0.00 (0.00 to 0.00)
        Type IC: Month >42-45 (n=15)
    0.00 (0.00 to 0.00)
        Type IC: Month >45-48 (n=11)
    0.00 (0.00 to 0.31)
        Type IC: Month >48-51 (n=11)
    0.00 (0.00 to 0.31)
        Type IC: Month >51-54 (n=6)
    0.00 (0.00 to 1.87)
        Type IC: Month >54-57 (n=1)
    0.00 (0.00 to 0.00)
    No statistical analyses for this end point

    Secondary: 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

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    End point 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
    End point 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. 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 'n' signifies participants who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    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)
    End point values
    UCB0942 (FAS)
    Number of subjects analysed
    41
    Units: percent change
    median (inter-quartile range (Q1-Q3))
        Month 0-3 (n=41)
    50.51 (21.74 to 72.53)
        Month >3-6 (n=41)
    39.14 (12.50 to 72.78)
        Month >6-9 (n=34)
    56.98 (31.19 to 72.22)
        Month >9-12 (n=28)
    62.22 (39.99 to 80.54)
        Month >12-15 (n=26)
    55.74 (40.95 to 72.78)
        Month >15-18 (n=26)
    54.04 (35.71 to 72.72)
        Month >18-21 (n=26)
    57.27 (39.42 to 76.28)
        Month >21-24 (n=22)
    68.57 (46.67 to 76.67)
        Month >24-27 (n=23)
    60.15 (40.31 to 77.41)
        Month >27-30 (n=21)
    59.82 (44.79 to 80.06)
        Month >30-33 (n=20)
    59.57 (41.94 to 76.17)
        Month >33-36 (n=20)
    59.73 (35.42 to 78.96)
        Month >36-39 (n=18)
    64.50 (45.56 to 78.90)
        Month >39-42 (n=18)
    59.01 (37.78 to 80.06)
        Month >42-45 (n=14)
    68.79 (38.39 to 80.00)
        Month >45-48 (n=10)
    68.17 (56.98 to 85.00)
        Month >48-51 (n=10)
    67.12 (51.67 to 91.67)
        Month >51-54 (n=5)
    73.08 (61.92 to 80.00)
        Month >54-57 (n=1)
    73.56 (73.56 to 73.56)
    No statistical analyses for this end point

    Secondary: 50% responder rate by 3-month intervals over the Evaluation Period of the EP0073 study

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    End point title
    50% responder rate by 3-month intervals over the Evaluation Period of the EP0073 study
    End point description
    A 50% responder was defined as a participant with a ≥50% reduction in partial-onset seizure (POS) frequency for observable focal-onset seizures (Type IA1, IB, and IC) relative to the 2-week Prospective Outpatient Baseline Period defined in EP0069. It was calculated using formula: Count of 50% responders during the Period/number of participants during the Period × 100. 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 'n' signifies participants who were evaluable at specified time points.
    End point type
    Secondary
    End point 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
    End point values
    UCB0942 (FAS)
    Number of subjects analysed
    41
    Units: percentage of participants
    number (not applicable)
        Month 0-3 (n=41)
    51.2
        Month >3-6 (n=41)
    39.0
        Month >6-9 (n=34)
    58.8
        Month >9-12 (n=28)
    67.9
        Month >12-15 (n=26)
    65.4
        Month >15-18 (n=26)
    53.8
        Month >18-21 (n=26)
    57.7
        Month >21-24 (n=22)
    72.7
        Month >24-27 (n=23)
    69.6
        Month >27-30 (n=21)
    66.7
        Month >30-33 (n=20)
    70.0
        Month >33-36 (n=20)
    65.0
        Month >36-39 (n=18)
    72.2
        Month >39-42 (n=18)
    72.2
        Month >42-45 (n=14)
    64.3
        Month >45-48 (n=10)
    80.0
        Month >48-51 (n=10)
    90.0
        Month >51-54 (n=5)
    80.0
        Month >54-57 (n=1)
    100
    No statistical analyses for this end point

    Secondary: Percentage of seizure-free days by 3-month intervals over the Evaluation Period

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    End point title
    Percentage of seizure-free days by 3-month intervals over the Evaluation Period
    End point 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. 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, 'n' signifies participants who were evaluable at specified time points.
    End point type
    Secondary
    End point 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
    End point values
    UCB0942 (FAS)
    Number of subjects analysed
    42
    Units: percentage of days
    median (inter-quartile range (Q1-Q3))
        Month 0-3 (n=42)
    48.33 (24.44 to 76.67)
        Month >3-6 (n=42)
    42.81 (8.89 to 68.89)
        Month >6-9 (n=35)
    54.44 (10.00 to 80.00)
        Month >9-12 (n=29)
    55.56 (25.56 to 78.89)
        Month >12-15 (n=27)
    54.44 (22.22 to 78.89)
        Month >15-18 (n=27)
    51.11 (25.56 to 73.33)
        Month >18-21 (n=27)
    61.11 (26.67 to 80.00)
        Month >21-24 (n=23)
    57.78 (30.00 to 86.67)
        Month >24-27 (n=24)
    60.00 (31.11 to 77.22)
        Month >27-30 (n=22)
    64.44 (22.22 to 85.56)
        Month >30-33 (n=21)
    57.78 (28.89 to 80.00)
        Month >33-36 (n=21)
    60.00 (21.11 to 77.78)
        Month >36-39 (n=19)
    68.89 (24.44 to 77.78)
        Month >39-42 (n=19)
    67.78 (16.67 to 88.89)
        Month >42-45 (n=15)
    67.78 (6.67 to 86.67)
        Month >45-48 (n=11)
    72.22 (11.11 to 91.11)
        Month >48-51 (n=11)
    73.33 (4.00 to 94.44)
        Month >51-54 (n=6)
    80.65 (6.06 to 86.67)
        Month >54-57 (n=1)
    72.00 (72.00 to 72.00)
    No statistical analyses for this end point

    Secondary: Seizure-free rate over the Evaluation Period

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    End point title
    Seizure-free rate over the Evaluation Period
    End point 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 will be calculated using the following formula: Count of seizure free participants during the Period/ Number of participants during the Period × 100. 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.
    End point type
    Secondary
    End point timeframe
    Over the Evaluation Period (up to 5 years)
    End point values
    UCB0942 (FAS)
    Number of subjects analysed
    42
    Units: percentage of participants
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: 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

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    End point 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
    End point 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 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. FAS population was used. Here, number of participants analyzed included those participants who were evaluable for the assessment and ‘n’ signifies participants who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Month 3, 7, 13, 19, 25, 31, 37, 43, 49, early discontinuation visit (EDV) (up to Month 58), Relative to Baseline (of EP0069)
    End point values
    UCB0942 (FAS)
    Number of subjects analysed
    39
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Month 3 (n=39)
    3.1 ± 14.2
        Month 7 (n=31)
    3.8 ± 17.0
        Month 13 (n=25)
    6.8 ± 17.7
        Month 19 (n=24)
    5.7 ± 18.0
        Month 25 (n=22)
    4.7 ± 24.8
        Month 31 (n=20)
    5.4 ± 21.7
        Month 37 (n=18)
    3.4 ± 18.8
        Month 43 (n=13)
    1.0 ± 19.0
        Month 49 (n=4)
    -4.6 ± 22.2
        EDV (up to Month 58) (n=38)
    2.2 ± 19.9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Entry Visit to End of Safety Follow-Up Visit (up to approximately 5 years)
    Adverse event reporting additional 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.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    UCB0942 (SS)
    Reporting 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. Increases or decreases to the dose of UCB0942 was made in steps not exceeding 200 mg/day per week however, 800 mg/day to 500 mg/day change was allowed. 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).

    Serious adverse events
    UCB0942 (SS)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 42 (28.57%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Face injury
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Animal bite
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fall
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lip injury
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Procedural nausea
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hand fracture
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Myomectomy
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Therapy change
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Dementia Alzheimer's type
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Seizure
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Status epilepticus
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Memory impairment
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Seizure cluster
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cellulitis
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    UCB0942 (SS)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 42 (76.19%)
    Injury, poisoning and procedural complications
    Skin laceration
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences all number
    4
    Investigations
    Weight increased
         subjects affected / exposed
    6 / 42 (14.29%)
         occurrences all number
    6
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    11 / 42 (26.19%)
         occurrences all number
    16
    Dizziness
         subjects affected / exposed
    7 / 42 (16.67%)
         occurrences all number
    8
    Headache
         subjects affected / exposed
    6 / 42 (14.29%)
         occurrences all number
    6
    Memory impairment
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences all number
    4
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    9 / 42 (21.43%)
         occurrences all number
    13
    Psychiatric disorders
    Depressed mood
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    5
    Depression
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Insomnia
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Irritability
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    5
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences all number
    4
    Nasopharyngitis
         subjects affected / exposed
    6 / 42 (14.29%)
         occurrences all number
    9
    Urinary tract infection
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Respiratory tract infection
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Dec 2015
    The following major changes were introduced in Protocol Amendment 1: • A PSL 25mg tablet, which was previously unavailable, was introduced and a PSL maintenance dose of 100mg (50mg bid) was permitted to allow investigators to explore the range of doses from 100mg to 800mg per day using bid dosing. • Pharmacokinetic (PK) blood samples for the measurement of plasma concentration of PSL and metabolites were added at several visits. These samples were taken to monitor study participant compliance. Exploratory population PK analysis were performed together with evaluation of longer-term (up to 1 year) exposure-response relationships. • No tapering from the EP0069 dose before the first dose was administered in EP0073 was specified. • If the study participant had active suicidal ideation with a specific plan as indicated by a positive response (“Yes”) to Question 5 of the “Since Last Visit” version of the Columbia-Suicide Severity Rating Scale (C-SSRS), the study participant was required to be referred immediately to a Mental Healthcare Professional and must have been withdrawn from the study.
    14 Nov 2016
    The following changes were introduced in Protocol Amendment 2: • The protocol information pertaining to potential drug-induced liver injury (PDILI) (exclusion criteria, withdrawal criteria, AEs of special interest, and assessment of safety) was updated based on new standard language, which was applied across all protocols at UCB. Note that these additions did not reflect a change in the known safety of the compound. • The estimate of the approximate number of study participants from EP0069 who would be included in EP0073 was increased to approximately 40. • Additional contraceptive requirements for the partners of male study participants were removed (based on nonclinical data).
    09 Nov 2017
    The primary purpose of this substantial amendment was to change the frequency for the ECG assessments after Year 2. Of note, no study participants had reached this milestone at the time of this protocol amendment, and therefore no impact on the safety analysis was expected. In addition, following the annual revision of the investigator’s Brochure 2017 for PSL, the following prohibited concomitant medications were added in this protocol: strong CYP2C19 inhibitors, strong CYP2C19 inducers, and CYP2C19 sensitive substrates. As the recruitment for EP0073 had completed, study participants who were already taking these medications prior to Amendment 3, may have continued to do so, but under close monitoring. The other major changes in this amendment were as follows: • A study participant with a benefit-risk ratio of 0 to 4 (on a scale from 0 to 10) was required to be withdrawn from the study. • AEs of special interest were required to be immediately reported. • The Pharmacokinetic Per-Protocol Set (PK-PPS) that was used for the PK analysis was defined.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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