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    Clinical Trial Results:
    An open-label pilot study to assess the safety of oral lacosamide as adjunctive therapy for uncontrolled primary generalized tonic-clonic seizures in subjects with idiopathic generalized epilepsy

    Summary
    EudraCT number
    2014-004379-22
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    30 Aug 2011

    Results information
    Results version number
    v1(current)
    This version publication date
    30 Jun 2016
    First version publication date
    27 Jun 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SP0961
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01118949
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB BIOSCIENCES, INC.
    Sponsor organisation address
    8010 Arco Corporate Drive, Raleigh, United States, 27617
    Public contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, +49 2173 48 15 15, clinicaltrials@ucb.com
    Scientific contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, +49 2173 48 15 15, 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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Nov 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Aug 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to assess the safety of Lacosamide (LCM) in subjects with uncontrolled primary generalized tonic-clonic (PGTC) seizures with idiopathic generalized epilepsy (IGE).
    Protection of trial subjects
    No specific measures in the protocol to minimize pain and distress.
    Background therapy
    Not applicable
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    17 May 2010
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    14 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 49
    Worldwide total number of subjects
    49
    EEA total number of subjects
    0
    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)
    3
    Adults (18-64 years)
    46
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Safety Set (SS) includes all enrolled subjects who took at least 1 dose of Lacosamide (LCM).

    Pre-assignment
    Screening details
    Participant Flow and Baseline Characteristics refer to the Safety Set (SS).

    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
    Lacosamide
    Arm description
    Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
    Arm type
    Experimental

    Investigational medicinal product name
    Lacosamide
    Investigational medicinal product code
    Lacosamide LCM
    Other name
    Vimpat
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.

    Number of subjects in period 1
    Lacosamide
    Started
    49
    Completed
    40
    Not completed
    9
         Non-Fatal, Serious AE(s)
    1
         Non-Fatal, Non-Serious AE(s)
    4
         Consent withdrawn by subject
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lacosamide
    Reporting group description
    Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.

    Reporting group values
    Lacosamide Total
    Number of subjects
    49 49
    Age Categorical
    Units: Subjects
        <=18 years
    4 4
        Between 18 and 65 years
    45 45
        >=65 years
    0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    29.7 ± 10.1 -
    Gender Categorical
    Units: Subjects
        Female
    36 36
        Male
    13 13
    Height
    Units: centimeter (cm)
        arithmetic mean (standard deviation)
    168.08 ± 9.32 -
    Weight
    Units: kilogram (kg)
        arithmetic mean (standard deviation)
    77.9 ± 19.8 -

    End points

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    End points reporting groups
    Reporting group title
    Lacosamide
    Reporting group description
    Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.

    Primary: Change in the number of seizure days with absence seizures from the Baseline Phase to the Maintenance Phase

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    End point title
    Change in the number of seizure days with absence seizures from the Baseline Phase to the Maintenance Phase [1]
    End point description
    During the study subjects kept a diary to record daily seizure activity from Visit 1 until the end of study participation. The following information has been recorded: • Seizure type • Seizure frequency A negative value in change of seizure days with absence seizures shows a decrease in seizure days with absence seizures.
    End point type
    Primary
    End point timeframe
    From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13)
    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 planned for this study. Results were summarized in tables as descriptive statistics only.
    End point values
    Lacosamide
    Number of subjects analysed
    44
    Units: number of seizure days
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -0.37 ± 4.8
    No statistical analyses for this end point

    Primary: Change in the number of seizure days with myoclonic seizures from the Baseline Phase to the Maintenance Phase

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    End point title
    Change in the number of seizure days with myoclonic seizures from the Baseline Phase to the Maintenance Phase [2]
    End point description
    During the study subjects kept a diary to record daily seizure activity from Visit 1 until the end of study participation. The following information has been recorded: • Seizure type • Seizure frequency A negative value in change of seizure days with myoclonic seizures shows a decrease in seizure days with myoclonic seizures.
    End point type
    Primary
    End point timeframe
    From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13)
    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 planned for this study. Results were summarized in tables as descriptive statistics only.
    End point values
    Lacosamide
    Number of subjects analysed
    44
    Units: number of seizure days
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -2.19 ± 5.8
    No statistical analyses for this end point

    Secondary: Changes in count of generalized spike-wave discharges on 24-hour ambulatory electroencephalogram (EEG) from Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase)

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    End point title
    Changes in count of generalized spike-wave discharges on 24-hour ambulatory electroencephalogram (EEG) from Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase)
    End point description
    Subjects were asked to return to the clinic on the morning of the day prior to Visit 2 and Visit 6 to begin 24-hour ambulatory EEG recordings for evaluation of spike-wave discharges. Only subjects with an evaluable EEG measurement with > 19 interpretable hours at Visit 2 and Visit 6 are included in this analysis. The general spike-wave discharges are calculated per interpretable hours.
    End point type
    Secondary
    End point timeframe
    From Visit 2 (Week 4) to Visit 6 (Week 8)
    End point values
    Lacosamide
    Number of subjects analysed
    40
    Units: 1/hour
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -3.47 ± 55.85
    No statistical analyses for this end point

    Secondary: Changes in count of 3 Hertz (Hz) spike-wave discharges (during waking hours) on 24-hour ambulatory Electroencephalogram (EEG) from Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase)

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    End point title
    Changes in count of 3 Hertz (Hz) spike-wave discharges (during waking hours) on 24-hour ambulatory Electroencephalogram (EEG) from Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase)
    End point description
    Subjects were asked to return to the clinic on the morning of the day prior to Visit 2 and Visit 6 to begin 24-hour ambulatory EEG recordings for evaluation of spike-wave discharges. Only subjects with an evaluable EEG measurement with > 19 interpretable hours at Visit 2 and Visit 6 are included in this analysis. The 3 Hertz (Hz) spike-wave discharges are calculated per awake hours.
    End point type
    Secondary
    End point timeframe
    From Visit 2 (Week 4) to Visit 6 (Week 8)
    End point values
    Lacosamide
    Number of subjects analysed
    40
    Units: 1/hour
    arithmetic mean (standard deviation)
        mean (standard deviation)
    0.13 ± 2.17
    No statistical analyses for this end point

    Secondary: Number of subjects with treatment emergent adverse events (TEAEs) during the 10-week Treatment Period

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    End point title
    Number of subjects with treatment emergent adverse events (TEAEs) during the 10-week Treatment Period
    End point description
    An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
    End point type
    Secondary
    End point timeframe
    From Visit 2 (Week 4) to Visit 7 (Week 13)
    End point values
    Lacosamide
    Number of subjects analysed
    49
    Units: participants
        TEAEs
    43
    No statistical analyses for this end point

    Secondary: Number of subjects withdrawn from the study due to Treatment Emergent Adverse Events (TEAEs) during the 10-week Treatment Period

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    End point title
    Number of subjects withdrawn from the study due to Treatment Emergent Adverse Events (TEAEs) during the 10-week Treatment Period
    End point description
    An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
    End point type
    Secondary
    End point timeframe
    From Visit 2 (Week 4) to Visit 7 (Week 13)
    End point values
    Lacosamide
    Number of subjects analysed
    49
    Units: participants
        Subject Withdrawal due to TEAE
    5
    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 up to 16 weeks from Baseline (Week 0 - Week 4) over the 3-weeks Titration Period (Week 4 - Week 7) and the 6-weeks Maintenance Period (Week 7 - Week 13) to the Final Clinic Visit at the end of Week 16.
    Adverse event reporting additional description
    Adverse Events refer to the Safety Set (SS). SS includes all enrolled subjects who received at least one dose of Lacosamide.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    9.1
    Reporting groups
    Reporting group title
    Lacosamide
    Reporting group description
    Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.

    Serious adverse events
    Lacosamide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 49 (2.04%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    Petit mal epilepsy
         subjects affected / exposed
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Lacosamide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 49 (79.59%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    3 / 49 (6.12%)
         occurrences all number
    4
    Respiratory, thoracic and mediastinal disorders
    Dyspnea
         subjects affected / exposed
    4 / 49 (8.16%)
         occurrences all number
    4
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    19 / 49 (38.78%)
         occurrences all number
    27
    Somnolence
         subjects affected / exposed
    8 / 49 (16.33%)
         occurrences all number
    8
    Headache
         subjects affected / exposed
    8 / 49 (16.33%)
         occurrences all number
    8
    Migraine
         subjects affected / exposed
    4 / 49 (8.16%)
         occurrences all number
    4
    Tremor
         subjects affected / exposed
    6 / 49 (12.24%)
         occurrences all number
    8
    Petit mal epilepsy
         subjects affected / exposed
    4 / 49 (8.16%)
         occurrences all number
    4
    Eye disorders
    Diplopia
         subjects affected / exposed
    4 / 49 (8.16%)
         occurrences all number
    4
    General disorders and administration site conditions
    Gait Disturbance
         subjects affected / exposed
    5 / 49 (10.20%)
         occurrences all number
    5
    Fatigue
         subjects affected / exposed
    6 / 49 (12.24%)
         occurrences all number
    6
    Chills
         subjects affected / exposed
    4 / 49 (8.16%)
         occurrences all number
    5
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    6 / 49 (12.24%)
         occurrences all number
    6
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    13 / 49 (26.53%)
         occurrences all number
    15
    Vomiting
         subjects affected / exposed
    7 / 49 (14.29%)
         occurrences all number
    9
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    3 / 49 (6.12%)
         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
    02 Nov 2010
    The original protocol, dated 31 Aug 2009, was amended on 02 Nov 2010; changes are described in the following subsection. Protocol Amendment 1 Changes based on the amendment that affected SP0961 included, but were not limited to: • Administrative changes included changes to the Sponsor Authorization and Study Contact Information for the Clinical Program Director and Clinical Trial Biostatistician • Increased the number of study sites from 10 to 25 • Revised the inclusion criterion for number of PGTC seizures prior to Baseline to increase the duration from 28 days to 12 weeks • Removed the inclusion criterion for number of PGTC seizures during the Baseline Phase • Added an exclusion criterion for known sodium channelopathy, such as Brugada syndrome • Revised withdrawal criteria and follow-up recommendations for abnormal liver function tests (LFTs) • The primary variable of percent change in PGTC seizure frequency per 28 days from Baseline Phase to the Maintenance Phase was removed • Clarified that the secondary variable for count of 3Hz SW discharges on 24-hour ambulatory EEG only applied to waking hours • The term “Holter monitor” was replaced by “recording device” for the 24-hour ambulatory EEG recordings • Urinalysis parameter acetone was changed to ketones • “Procedures for Data Monitoring Committee” was replaced by “DMC Charter” Based on the date of the amendment, 9 subjects were enrolled in the study prior to this amendment

    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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