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    Clinical Trial Results:
    A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy, Safety/Tolerability, and Pharmacokinetic Profile of UCB0942 in Adults with Highly Drug-Resistant Focal Epilepsy

    Summary
    EudraCT number
    2014-003330-12
    Trial protocol
    DE   BE   NL   HU   ES  
    Global end of trial date
    18 Jul 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    03 Aug 2018
    First version publication date
    03 Aug 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EP0069
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02495844
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB Biopharma SPRL
    Sponsor organisation address
    Allée de la Recherche 60, Brussels, Belgium, B-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
    31 Jul 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jul 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate the efficacy of UCB0942 administered concomitantly with each subject’s current, stable antiepileptic drug (AED) regimen in subjects who had 4 or more focal seizures with or without secondary generalization per week and who failed to achieve seizure control with >= 4 AED regimens of adequate dose and duration.
    Protection of trial subjects
    During the conduct of the study all subjects were closely monitored.
    Background therapy
    Patients remained on their background antiepileptic medications during the entire study.
    Evidence for comparator
    -
    Actual start date of recruitment
    28 Aug 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 8
    Country: Number of subjects enrolled
    Bulgaria: 5
    Country: Number of subjects enrolled
    Germany: 13
    Country: Number of subjects enrolled
    Hungary: 4
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    Spain: 22
    Worldwide total number of subjects
    55
    EEA total number of subjects
    55
    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)
    55
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Enrollment started in August 2015 and concluded in July 2017.

    Pre-assignment
    Screening details
    Participant Flow refers to the Randomized Set.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Carer, Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo/UCB0942
    Arm description
    After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).
    Arm type
    Placebo

    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
    Tablets in 2 strengths: 100 mg and 200 mg. 100 mg and 200 mg tablets have the same size and appearance.

    Arm title
    UCB0942/UCB0942
    Arm description
    Subjects received UCB0942.
    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
    Tablets in 2 strengths: 100 mg and 200 mg. 100 mg and 200 mg tablets have the same size and appearance.

    Number of subjects in period 1
    Placebo/UCB0942 UCB0942/UCB0942
    Started
    27
    28
    Completed
    26
    24
    Not completed
    1
    4
         Hepatitis Positivity
    -
    1
         AE, non-fatal
    -
    1
         Lack of efficacy
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo/UCB0942
    Reporting group description
    After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).

    Reporting group title
    UCB0942/UCB0942
    Reporting group description
    Subjects received UCB0942.

    Reporting group values
    Placebo/UCB0942 UCB0942/UCB0942 Total
    Number of subjects
    27 28 55
    Age categorical
    Units: Subjects
        <=18 years
    0 0 0
        Between 18 and 65 years
    27 28 55
        >=65 years
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    35.2 ± 8.7 36.2 ± 11.4 -
    Gender categorical
    Units: Subjects
        Male
    13 13 26
        Female
    14 15 29
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 0 0
        Asian
    0 0 0
        Native Hawaiian or Other Pacific Islander
    0 0 0
        Black or African American
    0 1 1
        White
    27 25 52
        More than one race
    0 2 2
        Unknown or Not Reported
    0 0 0
    Race/Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    1 3 4
        Not Hispanic or Latino
    26 25 51
    BMI (kg/m^2)
    Units: units on a scale
        arithmetic mean (standard deviation)
    25.66 ± 4.82 27.20 ± 4.32 -

    End points

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    End points reporting groups
    Reporting group title
    Placebo/UCB0942
    Reporting group description
    After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).

    Reporting group title
    UCB0942/UCB0942
    Reporting group description
    Subjects received UCB0942.

    Subject analysis set title
    Placebo/UCB0942 (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).

    Subject analysis set title
    UCB0942/UCB0942 (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects received UCB0942.

    Subject analysis set title
    Placebo/UCB0942 (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).

    Subject analysis set title
    UCB0942/UCB0942 (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received UCB0942.

    Primary: 75 % responder rate during the 2-week Inpatient Period

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    End point title
    75 % responder rate during the 2-week Inpatient Period
    End point description
    The 75% responder rate is defined as the percentage of subjects with a 75 % or greater reduction in focal seizure frequency during the 2-week Inpatient Period compared with the Baseline Period.
    End point type
    Primary
    End point timeframe
    During the 2-week Inpatient Period
    End point values
    Placebo/UCB0942 (FAS) UCB0942/UCB0942 (FAS)
    Number of subjects analysed
    27
    28
    Units: percentage of participants
    number (not applicable)
        75% responder rate
    11.1
    30.8
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Placebo/UCB0942 (FAS) v UCB0942/UCB0942 (FAS)
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0679
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.14
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.9
         upper limit
    19.06

    Secondary: Median percent change in weekly focal seizure frequency during the 2-week Inpatient Period

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    End point title
    Median percent change in weekly focal seizure frequency during the 2-week Inpatient Period
    End point description
    A negative value in median percent change reflects a reduction from Baseline.
    End point type
    Secondary
    End point timeframe
    During the 2-week Inpatient Period
    End point values
    Placebo/UCB0942 (FAS) UCB0942/UCB0942 (FAS)
    Number of subjects analysed
    27
    26
    Units: percentage of change
    median (inter-quartile range (Q1-Q3))
        Median (Inter-Quartile Range)
    -12.5 (-57.14 to 41.11)
    -53.68 (-84.61 to -22.73)
    No statistical analyses for this end point

    Secondary: Median percent change in weekly focal seizure frequency during the Outpatient Maintenance Period

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    End point title
    Median percent change in weekly focal seizure frequency during the Outpatient Maintenance Period
    End point description
    A negative value in median percent change reflects a reduction from Baseline.
    End point type
    Secondary
    End point timeframe
    During the Outpatient Maintenance Period (8 weeks)
    End point values
    Placebo/UCB0942 (FAS) UCB0942/UCB0942 (FAS)
    Number of subjects analysed
    27
    25
    Units: percentage of change
    median (inter-quartile range (Q1-Q3))
        Median (Inter-Quartile Range)
    -57.94 (-76.23 to -29.09)
    -26.32 (-77.38 to -3.07)
    No statistical analyses for this end point

    Secondary: Median percent change in weekly focal seizure frequency during the On-UCB0942 Overall Period

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    End point title
    Median percent change in weekly focal seizure frequency during the On-UCB0942 Overall Period
    End point description
    A negative value in median percent change reflects a reduction from Baseline.
    End point type
    Secondary
    End point timeframe
    During the On-UCB0942 Overall Period (approximately 11 weeks)
    End point values
    Placebo/UCB0942 (FAS) UCB0942/UCB0942 (FAS)
    Number of subjects analysed
    27
    27
    Units: percentage of change
    median (inter-quartile range (Q1-Q3))
        Median (Inter-Quartile Range)
    -53.85 (-78.01 to -34.48)
    -29.87 (-76.39 to -11.36)
    No statistical analyses for this end point

    Secondary: Seizure-free rate (all seizures) during the 2-week Inpatient Period

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    End point title
    Seizure-free rate (all seizures) during the 2-week Inpatient Period
    End point description
    Seizure-free rate is reported as the percentage of seizure-free participants during the 2-week Inpatient Period.
    End point type
    Secondary
    End point timeframe
    During the 2-week Inpatient Period
    End point values
    Placebo/UCB0942 (FAS) UCB0942/UCB0942 (FAS)
    Number of subjects analysed
    27
    27
    Units: percentage of particpants
    number (not applicable)
        percentage of participants
    3.7
    7.4
    No statistical analyses for this end point

    Secondary: Seizure-free rate (all seizures) during the last 4 weeks of the Outpatient Maintenance Period

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    End point title
    Seizure-free rate (all seizures) during the last 4 weeks of the Outpatient Maintenance Period
    End point description
    Seizure-free rate is reported as the percentage of seizure-free participants during the last 4 weeks of the Outpatient Maintenance Period.
    End point type
    Secondary
    End point timeframe
    During the last 4 weeks of the Outpatient Maintenance Period
    End point values
    Placebo/UCB0942 (FAS) UCB0942/UCB0942 (FAS)
    Number of subjects analysed
    27
    25
    Units: percentage of participants
    number (not applicable)
        percentage of participants
    0
    0
    No statistical analyses for this end point

    Secondary: Seizure-free rate (all seizures) during the On-UCB0942 Overall Period

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    End point title
    Seizure-free rate (all seizures) during the On-UCB0942 Overall Period
    End point description
    Seizure-free rate is reported as the percentage of seizure-free participants during the On-UCB0942 Overall Period.
    End point type
    Secondary
    End point timeframe
    During the On-UCB0942 Overall Period (approximately 11 weeks)
    End point values
    Placebo/UCB0942 (FAS) UCB0942/UCB0942 (FAS)
    Number of subjects analysed
    27
    28
    Units: percentage of participants
    number (not applicable)
        percentage of participants
    0
    0
    No statistical analyses for this end point

    Secondary: 75 % responder rate during the last 4 weeks of the Outpatient Maintenance Period

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    End point title
    75 % responder rate during the last 4 weeks of the Outpatient Maintenance Period
    End point description
    The 75 % responder rate is defined as the percentage of subjects who achieve a 75 % or greater reduction in focal seizure frequency.
    End point type
    Secondary
    End point timeframe
    During the last 4 weeks of the Outpatient Maintenance Period
    End point values
    Placebo/UCB0942 (FAS) UCB0942/UCB0942 (FAS)
    Number of subjects analysed
    27
    24
    Units: percentage of participants
    number (not applicable)
        75% responder rate
    33.3
    29.2
    No statistical analyses for this end point

    Secondary: 75 % responder rate during the On-UCB0942 Overall Period

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    End point title
    75 % responder rate during the On-UCB0942 Overall Period
    End point description
    The 75 % responder rate is defined as the percentage of subjects who achieve a 75 % or greater reduction in focal seizure frequency.
    End point type
    Secondary
    End point timeframe
    During the On-UCB0942 Overall Period (approximately 11 weeks)
    End point values
    Placebo/UCB0942 (FAS) UCB0942/UCB0942 (FAS)
    Number of subjects analysed
    27
    27
    Units: percentage of participants
    number (not applicable)
        75% responder rate
    25.9
    25.9
    No statistical analyses for this end point

    Secondary: Percentage of seizure free days (all seizures) during the 2-week Inpatient Period

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    End point title
    Percentage of seizure free days (all seizures) during the 2-week Inpatient Period
    End point description
    For the active group, the 2-week Inpatient Period refers to the last 2 weeks of the Inpatient Period, while for the Placebo group, it refers to the first 2 weeks of the Inpatient Period.
    End point type
    Secondary
    End point timeframe
    During the 2-week Inpatient Period
    End point values
    Placebo/UCB0942 (FAS) UCB0942/UCB0942 (FAS)
    Number of subjects analysed
    27
    27
    Units: percentage of days
    median (inter-quartile range (Q1-Q3))
        Median (Inter-Quartile Range)
    21.43 (7.14 to 57.14)
    57.14 (28.57 to 78.57)
    No statistical analyses for this end point

    Secondary: Percentage of seizure-free days (all seizures) during the Outpatient Maintenance Period

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    End point title
    Percentage of seizure-free days (all seizures) during the Outpatient Maintenance Period
    End point description
    End point type
    Secondary
    End point timeframe
    During the Outpatient Maintenance Period (8 weeks)
    End point values
    Placebo/UCB0942 (FAS) UCB0942/UCB0942 (FAS)
    Number of subjects analysed
    27
    26
    Units: percentage of days
    median (inter-quartile range (Q1-Q3))
        Median (Inter-Quartile Range)
    51.79 (15.79 to 80.70)
    51.35 (29.82 to 69.64)
    No statistical analyses for this end point

    Secondary: Number of patients reporting at least one Serious Adverse Event (SAE) during the course of the study

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    End point title
    Number of patients reporting at least one Serious Adverse Event (SAE) during the course of the study
    End point description
    Number of subjects experiencing at least one serious adverse event (reported by the subject and/or caregiver or observed by the Investigator or inpatient staff).
    End point type
    Secondary
    End point timeframe
    All study duration (approximately 19 to 20 weeks)
    End point values
    Placebo/UCB0942 (SS) UCB0942/UCB0942 (SS)
    Number of subjects analysed
    27
    28
    Units: Participants
        participants
    0
    2
    No statistical analyses for this end point

    Secondary: Number of subject withdrawals due to Adverse Events (AEs) during the course of the study

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    End point title
    Number of subject withdrawals due to Adverse Events (AEs) during the course of the study
    End point description
    Number of subjects who withdrew from the study due adverse event (reported by the subject and/or caregiver or observed by the Investigator or inpatient staff).
    End point type
    Secondary
    End point timeframe
    All study duration (approximately 19 to 20 weeks)
    End point values
    Placebo/UCB0942 (SS) UCB0942/UCB0942 (SS)
    Number of subjects analysed
    27
    28
    Units: Participants
        participants
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events were collected from Baseline until Safety Follow Up Visit (up to Week 28).
    Adverse event reporting additional description
    Baseline Characteristics refer to the Safety Set consisting of all subjects in the Randomized Set who received at least 1 dose of Investigational Medicinal Product (IMP). 2 subjects reported multiple Serious Adverse Events (SAEs).
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    UCB0942/UCB0942
    Reporting group description
    Subjects received UCB0942.

    Reporting group title
    Placebo/UCB0942
    Reporting group description
    After 2-week in the Inpatient Period, Placebo subjects received the experimental medicine (UCB0942).

    Serious adverse events
    UCB0942/UCB0942 Placebo/UCB0942
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 27 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    Judgement impaired
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Dysphoria
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    UCB0942/UCB0942 Placebo/UCB0942
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 28 (96.43%)
    26 / 27 (96.30%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 27 (3.70%)
         occurrences all number
    3
    1
    Investigations
    Weight increased
         subjects affected / exposed
    1 / 28 (3.57%)
    3 / 27 (11.11%)
         occurrences all number
    1
    3
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    17 / 28 (60.71%)
    12 / 27 (44.44%)
         occurrences all number
    24
    16
    Headache
         subjects affected / exposed
    10 / 28 (35.71%)
    6 / 27 (22.22%)
         occurrences all number
    13
    9
    Dizziness
         subjects affected / exposed
    14 / 28 (50.00%)
    12 / 27 (44.44%)
         occurrences all number
    19
    51
    Tremor
         subjects affected / exposed
    2 / 28 (7.14%)
    3 / 27 (11.11%)
         occurrences all number
    2
    3
    Disturbance in attention
         subjects affected / exposed
    3 / 28 (10.71%)
    1 / 27 (3.70%)
         occurrences all number
    3
    2
    Dysarthria
         subjects affected / exposed
    3 / 28 (10.71%)
    2 / 27 (7.41%)
         occurrences all number
    5
    2
    Memory impairment
         subjects affected / exposed
    3 / 28 (10.71%)
    1 / 27 (3.70%)
         occurrences all number
    6
    2
    Nystagmus
         subjects affected / exposed
    1 / 28 (3.57%)
    3 / 27 (11.11%)
         occurrences all number
    1
    3
    Amnesia
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 27 (3.70%)
         occurrences all number
    2
    1
    Paraesthesia
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 27 (3.70%)
         occurrences all number
    2
    2
    Simple partial seizures
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 27 (3.70%)
         occurrences all number
    5
    1
    Seizure
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 27 (0.00%)
         occurrences all number
    3
    0
    Ataxia
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    3
    0
    Restless legs syndrome
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    2
    0
    Eye disorders
    Diplopia
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 27 (3.70%)
         occurrences all number
    2
    1
    Vision blurred
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 27 (3.70%)
         occurrences all number
    5
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 28 (14.29%)
    9 / 27 (33.33%)
         occurrences all number
    23
    14
    Gait disturbance
         subjects affected / exposed
    3 / 28 (10.71%)
    2 / 27 (7.41%)
         occurrences all number
    17
    2
    Pyrexia
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    2
    Asthenia
         subjects affected / exposed
    2 / 28 (7.14%)
    2 / 27 (7.41%)
         occurrences all number
    2
    2
    Gastrointestinal disorders
    Dry mouth
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 27 (3.70%)
         occurrences all number
    2
    1
    Constipation
         subjects affected / exposed
    3 / 28 (10.71%)
    1 / 27 (3.70%)
         occurrences all number
    3
    2
    Abdominal pain upper
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    4
    Nausea
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    2
    0
    Dyspepsia
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    4
    Diarrhoea
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    3
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    5 / 28 (17.86%)
    4 / 27 (14.81%)
         occurrences all number
    5
    5
    Insomnia
         subjects affected / exposed
    4 / 28 (14.29%)
    0 / 27 (0.00%)
         occurrences all number
    5
    0
    Depressed mood
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 27 (3.70%)
         occurrences all number
    2
    1
    Disorientation
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    3
    0
    Nervousness
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 27 (7.41%)
         occurrences all number
    1
    3
    Mood swings
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    2
    0
    Parasomnia
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    3
    0
    Aggression
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 27 (7.41%)
         occurrences all number
    0
    2
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 27 (0.00%)
         occurrences all number
    4
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 27 (7.41%)
         occurrences all number
    2
    2
    Muscosloskeletal pain
         subjects affected / exposed
    0 / 28 (0.00%)
    3 / 27 (11.11%)
         occurrences all number
    0
    5
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 28 (7.14%)
    3 / 27 (11.11%)
         occurrences all number
    2
    3
    Hyponatraemia
         subjects affected / exposed
    2 / 28 (7.14%)
    2 / 27 (7.41%)
         occurrences all number
    2
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 27 (0.00%)
         occurrences all number
    2
    0

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Sep 2015
    Protocol Amendment 1 (dated 16-Sep-2015) was implemented after the date of first patient first visit (FPFV on 28-Aug-2015). Two subjects were randomized at the time of the amendment. The rationale for this amendment was to add an echocardiogram during dosing in response to a request from the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte). This echocardiogram was added at Day OP22. In addition, the following changes were made: - It was clarified that either urine or serum pregnancy tests could be used for all visits. - It was pointed out that the decision to continue in the OLE study (EP0073) occurred at Day OP43. - Clarification on the procedure for dose reduction in cases of poor tolerability of UCB0942 400 mg bid (ie, reduction to UCB0942 200 mg bid and in some cases to UCB0942 100 mg bid). - The withdrawal criteria for elevated transaminases were reworded as the previous description was not clear.
    19 Nov 2015
    Protocol Amendment 2 (dated 19-Nov-2015) was implemented after 22 subjects were randomized. The rationale for this amendment was to make the video monitoring language in the protocol more flexible so that sites/Investigators could perform this according to their usual practice. This new language also allowed video- electroencephalogram (EEG) monitoring as some sites did not perform video-only monitoring. A second change was the wording of the drug misuse exclusion criterion. As is customary in most UCB protocols, exclusion for drug misuse is only applicable if the Investigator deems that study participation is either a risk to the subject or that the drug misuse could confound the outcomes measured in the study. The wording of this exclusion criterion was changed to match that of other UCB studies.
    13 May 2016
    Protocol Amendment 3 (dated-13 May-2016) was implemented after 35 subjects were randomized. The rationale for this amendment was to add and describe an optional interim analysis for purposes of planning and designing of future studies. Other reasons for the amendment included the following: - To add an exploratory objective, variable and associated assessment (Diary Addendum). Note that this was already part of the study, but not clearly described in the protocol. - To clarify procedures for dosing when there was intolerance to IMP during the Inpatient Period. - To allow and specify flexibility in dosing during the Outpatient Maintenance Period. - To further specify which subjects required an echocardiogram at 6 months after the last dose of UCB0942. - To expand the range of body mass index (BMI) allowed for inclusion in the study. - To revise procedures for assessment of suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS) (specifically, the C-SSRS withdrawal criterion) in line with revision to UCB SOP, which became effective on 01-Apr-2016. - To update the protocol information pertaining to potential drug-induced liver injury (PDILI) (exclusion criteria, withdrawal criteria, adverse events (AEs) of special interest, and assessments) based on new standard language which was being applied across all protocols at UCB. Note that these additions do not reflect a change in the known safety of the compound.
    10 Oct 2016
    Protocol Amendment 4 (dated 10-Oct-2016) was implemented after all subjects were randomized. The rationale for this amendment was to describe a tiered approach to database lock and unblinding. Other changes included: - Correction of an inconsistency between the Summary section and the Study Design section pertaining to allowable dose changes - Clarification of the reporting period for AEs - Specification that the Baseline version of the Seizure Severity Questionnaire (SSQ) was to be used in all instances where it was administered - Correction of the number of questions in the SSQ from 11 to 10 - Correction of several cross references - Other minor administrative changes

    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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