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    Clinical Trial Results:
    A Multicenter, Open-label, Follow-up Study to Assess the Long-term Use of Lacosamide (Flexible Dose From 200 to 600 mg/Day) Used as Monotherapy in Subjects Who Completed SP0994 and Received Lacosamide Monotherapy Treatment

    Summary
    EudraCT number
    2015-001549-96
    Trial protocol
    FI   SE   DE   LV   BG   PL   FR  
    Global end of trial date
    06 Jan 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    26 Dec 2020
    First version publication date
    26 Dec 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SP1042
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02582866
    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
    04 Feb 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Jan 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jan 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the long-term safety and tolerability of lacosamide dosed at 200 mg/day to 600 mg/day when used as monotherapy in subjects, with partial-onset seizures or generalized tonic-clonic seizures (without clear focal origin), who completed SP0994
    Protection of trial subjects
    During the conduct of the study all participants were closely monitored.
    Background therapy
    Not Applicable
    Evidence for comparator
    Not Applicable
    Actual start date of recruitment
    18 Jan 2016
    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
    Bulgaria: 4
    Country: Number of subjects enrolled
    Finland: 6
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Germany: 14
    Country: Number of subjects enrolled
    Japan: 6
    Country: Number of subjects enrolled
    Korea, Republic of: 5
    Country: Number of subjects enrolled
    Latvia: 1
    Country: Number of subjects enrolled
    Mexico: 1
    Country: Number of subjects enrolled
    Philippines: 8
    Country: Number of subjects enrolled
    Poland: 4
    Country: Number of subjects enrolled
    Romania: 19
    Country: Number of subjects enrolled
    Russian Federation: 11
    Country: Number of subjects enrolled
    Sweden: 13
    Country: Number of subjects enrolled
    Switzerland: 4
    Country: Number of subjects enrolled
    Ukraine: 7
    Worldwide total number of subjects
    106
    EEA total number of subjects
    64
    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)
    92
    From 65 to 84 years
    13
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    The study started to enroll study participants in January 2016 and concluded in January 2020.

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

    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 (LCM) was administered orally, twice daily from 200 mg/day to 600 mg/day, in 2 divided doses at approximately 12 hour intervals in the morning and in the evening. The investigator may have maintained the subject’s LCM dose, decreased the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increased the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day. Participants stopping LCM should have been tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper was permitted but the duration of tapering should not have exceeded 6 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Lacosamide
    Investigational medicinal product code
    LCM
    Other name
    Vimpat
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Lacosamide (LCM) was administered orally twice daily from 200 mg/day to 600 mg/day (at approximately 12 hour intervals in the morning and in the evening) in 2 divided doses.

    Number of subjects in period 1
    Lacosamide
    Started
    106
    Completed
    84
    Not completed
    22
         Investigator decision
    5
         Participant wants to get pregnant
    1
         Lack of efficacy
    2
         Pregnancy
    2
         Adverse event, serious fatal
    1
         Consent withdrawn by subject
    7
         Withdrawal due to personal reasons
    1
         Sponsor decision
    1
         Lost to follow-up
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lacosamide
    Reporting group description
    Lacosamide (LCM) was administered orally, twice daily from 200 mg/day to 600 mg/day, in 2 divided doses at approximately 12 hour intervals in the morning and in the evening. The investigator may have maintained the subject’s LCM dose, decreased the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increased the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day. Participants stopping LCM should have been tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper was permitted but the duration of tapering should not have exceeded 6 weeks.

    Reporting group values
    Lacosamide Total
    Number of subjects
    106 106
    Age categorical
    Units: Subjects
        <=18 years
    2 2
        Between 18 and 65 years
    90 90
        >=65 years
    14 14
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    43.5 ± 17.1 -
    Gender categorical
    Units: Subjects
        Female
    48 48
        Male
    58 58

    End points

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    End points reporting groups
    Reporting group title
    Lacosamide
    Reporting group description
    Lacosamide (LCM) was administered orally, twice daily from 200 mg/day to 600 mg/day, in 2 divided doses at approximately 12 hour intervals in the morning and in the evening. The investigator may have maintained the subject’s LCM dose, decreased the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increased the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day. Participants stopping LCM should have been tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper was permitted but the duration of tapering should not have exceeded 6 weeks.

    Subject analysis set title
    Lacosamide (SS)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Lacosamide (LCM) was administered orally, twice daily from 200 mg/day to 600 mg/day, in 2 divided doses at approximately 12 hour intervals in the morning and in the evening. The investigator may have maintained the subject’s LCM dose, decreased the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increased the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day. Participants stopping LCM should have been tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper was permitted but the duration of tapering should not have exceeded 6 weeks. Participants formed the Safety Set (SS).

    Primary: Percentage of participants experiencing any Adverse Events (AEs) reported spontaneously by the subject and/or caregiver or observed by Investigator

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    End point title
    Percentage of participants experiencing any Adverse Events (AEs) reported spontaneously by the subject and/or caregiver or observed by Investigator [1]
    End point description
    An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication. The SS consisted of all study participants in the ES who received at least 1 dose of study medication in SP1042.
    End point type
    Primary
    End point timeframe
    From Visit 1 (Week 0) to Final Visit (up to Week 158)
    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 (SS)
    Number of subjects analysed
    106
    Units: percentage of participants
        number (not applicable)
    59.4
    No statistical analyses for this end point

    Primary: Percentage of participants experiencing any Serious Adverse Events (SAEs) reported spontaneously by the subject and/or caregiver or observed by Investigator

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    End point title
    Percentage of participants experiencing any Serious Adverse Events (SAEs) reported spontaneously by the subject and/or caregiver or observed by Investigator [2]
    End point description
    A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: - Results in death - Is life-threatening - Requires in patient hospitalization or prolongation of existing hospitalization - Is a congenital anomaly or birth defect - Is an infection that requires treatment parenteral antibiotics - Other important medical events which based on medical or scientific judgement may jeopardize the study participants, or may require medical or surgical intervention to prevent any of the above. The SS consisted of all study participants in the ES who received at least 1 dose of study medication in SP1042.
    End point type
    Primary
    End point timeframe
    From Visit 1 (Week 0) to Final Visit (up to Week 158)
    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 (SS)
    Number of subjects analysed
    106
    Units: percentage of participants
        number (not applicable)
    14.2
    No statistical analyses for this end point

    Primary: Percentage of participants that withdrew due to Adverse Events (AEs)

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    End point title
    Percentage of participants that withdrew due to Adverse Events (AEs) [3]
    End point description
    An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication. The SS consisted of all study participants in the ES who received at least 1 dose of study medication in SP1042.
    End point type
    Primary
    End point timeframe
    From Visit 1 (Week 0) to Final Visit (up to Week 158)
    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 planned for this study. Results were summarized in tables as descriptive statistics only.
    End point values
    Lacosamide (SS)
    Number of subjects analysed
    106
    Units: percentage of participants
        number (not applicable)
    0.9
    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 Visit 1 (Week 0) to Final Visit (up to Week 158)
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Lacosamide (SS)
    Reporting group description
    Lacosamide (LCM) was administered orally, twice daily from 200 mg/day to 600 mg/day, in 2 divided doses at approximately 12 hour intervals in the morning and in the evening. The investigator may have maintained the subject’s LCM dose, decreased the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increased the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day. Participants stopping LCM should have been tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper was permitted but the duration of tapering should not have exceeded 6 weeks. Participants formed the Safety Set (SS).

    Serious adverse events
    Lacosamide (SS)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 106 (14.15%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Forearm Fracture
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Post Gastric Surgery Syndrome
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tibia Fracture
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Knee Arthroplasty
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Arteriogram Coronary
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast Cancer
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Cardiac Failure
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrial Flutter
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Myocardial Infarction
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ventricular Tachycardia
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Respiratory Distress Syndrome
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    2 / 106 (1.89%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Ischaemic Stroke
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Peripheral Sensorimotor Neuropathy
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Device Dislocation
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sudden Unexplained Death In Epilepsy
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Umbilical Hernia
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    2 / 106 (1.89%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Lacosamide (SS)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 106 (17.92%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 106 (10.38%)
         occurrences all number
    11
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    8 / 106 (7.55%)
         occurrences all number
    17

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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