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    Clinical Trial Results:
    An International Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral Lacosamide (SPM 927) in Patients With Partial Seizures

    Summary
    EudraCT number
    2004-000152-16
    Trial protocol
    LT   HU   CZ   FI   SE   ES   GB  
    Global end of trial date
    05 Aug 2010

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

    Trial information

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    Trial identification
    Sponsor protocol code
    SP0774
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00515619
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB BIOSCIENCES GmbH
    Sponsor organisation address
    Alfred-Nobel-Str. 10, Monheim, Germany, 40789
    Public contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, +49 2173 4815 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
    29 Sep 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Aug 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objectives of this study were: • To obtain information about the safety of Lacosamide (LCM) following long-term exposure • To obtain data on seizure reduction and the maintenance of efficacy by LCM during longterm exposure • To allow subjects who had completed a LCM epilepsy study to receive LCM
    Protection of trial subjects
    Not applicable
    Background therapy
    Concomitant Anti-Epileptic Drug (AED) medications.
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    21 Dec 2004
    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
    Finland: 16
    Country: Number of subjects enrolled
    Spain: 26
    Country: Number of subjects enrolled
    Lithuania: 42
    Country: Number of subjects enrolled
    Russian Federation: 31
    Country: Number of subjects enrolled
    United Kingdom: 20
    Country: Number of subjects enrolled
    France: 10
    Country: Number of subjects enrolled
    Czech Republic: 50
    Country: Number of subjects enrolled
    Hungary: 31
    Country: Number of subjects enrolled
    Poland: 37
    Country: Number of subjects enrolled
    Croatia: 31
    Country: Number of subjects enrolled
    Australia: 31
    Country: Number of subjects enrolled
    Germany: 35
    Country: Number of subjects enrolled
    Sweden: 16
    Worldwide total number of subjects
    376
    EEA total number of subjects
    314
    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)
    5
    Adults (18-64 years)
    368
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was started in December of 2004 with recruitment occurring in Australia, Croatia, Czech Republic, Finland, France, Germany, Hungary, Lithuania, Poland, Russia, Spain, Sweden, and the United Kingdom. The study had last patient last visit in August of 2010.

    Pre-assignment
    Screening details
    Participant Flow refers to the Safety Set, consisting of all subjects who received at least 1 dose of Lacosamide.

    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
    50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
    Arm type
    Experimental

    Investigational medicinal product name
    Lacosamide
    Investigational medicinal product code
    SPM 927
    Other name
    Vimpat
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)

    Number of subjects in period 1
    Lacosamide
    Started
    376
    Completed
    160
    Not completed
    216
         Non-Fatal, Serious AE(s)
    15
         Protocol deviation
    3
         Request from sponsor
    1
         Fatal, Serious AE(s) and Non-Fatal, Serious AE(s)
    1
         Lack of efficacy
    92
         Drug available on license
    1
         Consent withdrawn by subject
    66
         Subject cannot attend visits
    2
         Physician decision
    1
         Subject required surgery
    1
         Pregnancy
    1
         Subject interested in other AED
    1
         Subject moved to another country
    1
         Site discontinuing trials
    2
         Non-Fatal, Non-Serious AE(s)
    16
         Fatal, Serious AE(s)
    2
         Lost to follow-up
    4
         Unsatisfactory compliance
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lacosamide
    Reporting group description
    50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)

    Reporting group values
    Lacosamide Total
    Number of subjects
    376 376
    Age Categorical
    Units: Subjects
        <=18 years
    7 7
        Between 18 and 65 years
    366 366
        >=65 years
    3 3
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    37.8 ± 11.5 -
    Gender Categorical
    Units: Subjects
        Female
    169 169
        Male
    207 207
    Region of Enrollment
    Units: Subjects
        Finland
    16 16
        Spain
    26 26
        Lithuania
    42 42
        Russian Federation
    31 31
        United Kingdom
    20 20
        France
    10 10
        Czech Republic
    50 50
        Hungary
    31 31
        Poland
    37 37
        Croatia
    31 31
        Australia
    31 31
        Germany
    35 35
        Sweden
    16 16

    End points

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    End points reporting groups
    Reporting group title
    Lacosamide
    Reporting group description
    50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)

    Primary: Number of subjects reporting at least 1 treatment-emergent adverse event (TEAE) during the Treatment Period (up to 5.5 years)

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    End point title
    Number of subjects reporting at least 1 treatment-emergent adverse event (TEAE) during the Treatment Period (up to 5.5 years) [1]
    End point description
    Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
    End point type
    Primary
    End point timeframe
    During the Treatment Period (up to 5.5 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 planned for this study. Results were summarized in tables as descriptive statistics only.
    End point values
    Lacosamide
    Number of subjects analysed
    376
    Units: Subjects
        Number of subjects
    311
    No statistical analyses for this end point

    Primary: Number of subjects prematurely discontinuing due to a treatment-emergent adverse event (TEAE) during the Treatment Period (up to 5.5 years)

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    End point title
    Number of subjects prematurely discontinuing due to a treatment-emergent adverse event (TEAE) during the Treatment Period (up to 5.5 years) [2]
    End point description
    Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
    End point type
    Primary
    End point timeframe
    During the Treatment Period (up to 5.5 years)
    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
    376
    Units: Subjects
        Number of subjects
    33
    No statistical analyses for this end point

    Primary: Number of subjects reporting at least 1 serious adverse event (SAE) during the Treatment Period (up to 5.5 years)

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    End point title
    Number of subjects reporting at least 1 serious adverse event (SAE) during the Treatment Period (up to 5.5 years) [3]
    End point description
    A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.
    End point type
    Primary
    End point timeframe
    During the Treatment Period (up to 5.5 years)
    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
    Number of subjects analysed
    376
    Units: Subjects
        Number of subjects
    87
    No statistical analyses for this end point

    Secondary: Median percentage change from Baseline in 28-day seizure frequency during the Treatment Period (up to 5.5 years)

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    End point title
    Median percentage change from Baseline in 28-day seizure frequency during the Treatment Period (up to 5.5 years)
    End point description
    Median percentage change is the median value with respect to the percent change from Baseline across the population of subjects. Percentage change is calculated as 100 times the difference of the seizure frequency for the treatment period and the Baseline seizure frequency divided by the baseline seizure frequency. Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.
    End point type
    Secondary
    End point timeframe
    Baseline, Treatment Period (up to 5.5 years)
    End point values
    Lacosamide
    Number of subjects analysed
    376
    Units: Percentage change
    median (full range (min-max))
        median (full range)
    -49.9 (-100 to 422.8)
    No statistical analyses for this end point

    Secondary: Percentage of at least 50 % Responders during the Treatment Period (up to 5.5 years)

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    End point title
    Percentage of at least 50 % Responders during the Treatment Period (up to 5.5 years)
    End point description
    At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study. This endpoint reflects the percentage of subjects with at least 50% reduction (ie, at least 50% change) in 28-day partial onset seizure frequency
    End point type
    Secondary
    End point timeframe
    Treatment Period (up to 5.5 years)
    End point values
    Lacosamide
    Number of subjects analysed
    376
    Units: Percentage of subjects
    number (not applicable)
        Percentage of subjects
    50
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients.
    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
    50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)

    Serious adverse events
    Lacosamide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    87 / 376 (23.14%)
         number of deaths (all causes)
    3
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Ischaemia
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Knee meniscectomy
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Shoulder operation
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hospitalisation
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Therapeutic procedure
         subjects affected / exposed
    1 / 376 (0.27%)
         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)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Breast Cancer
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Brain neoplasm malignant
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Social circumstances
    Breast prosthesis user
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    2 / 376 (0.53%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Chest discomfort
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    2 / 376 (0.53%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Epileptic psychosis
         subjects affected / exposed
    2 / 376 (0.53%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Aggression
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pathological gambling
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Confusional state
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Metrorrhagia
         subjects affected / exposed
    2 / 376 (0.53%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    2 / 376 (0.53%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Uterine polyp
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bartholin's cyst
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    3 / 376 (0.80%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    3 / 376 (0.80%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Brain contusion
         subjects affected / exposed
    3 / 376 (0.80%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    3 / 376 (0.80%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Skin laceration
         subjects affected / exposed
    2 / 376 (0.53%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Fall
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skull fracture
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Jaw fracture
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Wrist fracture
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skeletal injury
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Soft tissue injury
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tooth fracture
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Electrocardiogram QT corrected interval prolonged
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Weight decreased
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigation
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Congenital, familial and genetic disorders
    Exomphalos
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Nasal septum deviation
         subjects affected / exposed
    2 / 376 (0.53%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchial disorder
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    15 / 376 (3.99%)
         occurrences causally related to treatment / all
    8 / 21
         deaths causally related to treatment / all
    0 / 0
    Status epilepticus
         subjects affected / exposed
    5 / 376 (1.33%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Epilepsy
         subjects affected / exposed
    7 / 376 (1.86%)
         occurrences causally related to treatment / all
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    Headache
         subjects affected / exposed
    2 / 376 (0.53%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Grand mal convulsion
         subjects affected / exposed
    3 / 376 (0.80%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    2 / 376 (0.53%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Coordination abnormal
         subjects affected / exposed
    2 / 376 (0.53%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    2 / 376 (0.53%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Monoparesis
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Somnolence
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cerebral haematoma
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Paresis
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sciatica
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Visual field defect
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Encephalitis
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Complex partial seizures
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Aura
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hemiparesis
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intracranial pressure increased
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Simple partial seizures
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Diplopia
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Scotoma
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye haemorrhage
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Anal fistula
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mechanical ileus
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Calculus ureteric
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Hepatomegaly
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fibromyalgia
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Inappropriate antidiuretic hormone secretion
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abscess limb
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intervertebral discitis
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pilonidal cyst
         subjects affected / exposed
    1 / 376 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 376 (0.27%)
         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
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    232 / 376 (61.70%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    20 / 376 (5.32%)
         occurrences all number
    29
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    91 / 376 (24.20%)
         occurrences all number
    157
    Headache
         subjects affected / exposed
    54 / 376 (14.36%)
         occurrences all number
    97
    Somnolence
         subjects affected / exposed
    27 / 376 (7.18%)
         occurrences all number
    34
    Tremor
         subjects affected / exposed
    23 / 376 (6.12%)
         occurrences all number
    31
    Balance disorder
         subjects affected / exposed
    19 / 376 (5.05%)
         occurrences all number
    25
    Convulsion
         subjects affected / exposed
    19 / 376 (5.05%)
         occurrences all number
    23
    Eye disorders
    Diplopia
         subjects affected / exposed
    51 / 376 (13.56%)
         occurrences all number
    63
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    22 / 376 (5.85%)
         occurrences all number
    25
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    31 / 376 (8.24%)
         occurrences all number
    35
    Psychiatric disorders
    Depression
         subjects affected / exposed
    19 / 376 (5.05%)
         occurrences all number
    20
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    25 / 376 (6.65%)
         occurrences all number
    33
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    28 / 376 (7.45%)
         occurrences all number
    38
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    52 / 376 (13.83%)
         occurrences all number
    77

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Apr 2005
    Protocol Amendment 2, dated 05 Apr 2005, provided for the following changes: • Change of the clinical research organization (CRO) for Data Monitoring, Drug Safety Officer, and Pharmacokineticist • Increase in the number of expected subjects and duration of the study • Clarification on the use of narcotic analgesics • Addition of Section 4.8. “Allowance for entering SPM 927 Trial SP757” • Change of Visit 10 to Week 78 (6 weeks later) and revision of telephone contacts to occur at Weeks 72, 76, 82, 86, 90, and 94 • Deletion of Visit 11 at Week 84; Visit 11 was to occur at Week 96 (previously Visit 12), Visit 12 was to occur at Week 120 (previously Visit 13), and Visit 13 was to occur at Week 144 (previously Visit 14) • Addition of visit at Week 168 (new Visit 14) and telephone contacts at Weeks 148, 152, 156, 160, 164, 172, 176, 180, 184, and 188 • Correction to the error in the heading for Section 5.5, which inadvertently omitted reference to the Termination Visit • Removal of PK assessments at Visits 12, 13, and 14, at Unscheduled Visits after Year 2, at Early Termination after Year 2 (unless the subject dropped out due to an adverse Event [AE]), and at the Final Clinic Visit • Addition of information regarding surgery as an AE and definition of life-threatening to the AE section • Provide clarification for recording AEs that increase in intensity • Addition of “worsening” as an AE outcome • Remove drop-outs due to AEs from the list of immediately reportable adverse Events (IRAEs) and specification of 1 exception to this rule • Slight modification to the cardiac conduction abnormality IRAE • Addition of Section 7.1.3.8. “Pregnancy during trial participation” • Addition of kit number to bottle label • Change in the dictionary used for coding of AEs from World Health Organization- Adverse Reaction Terms to Medical Dictionary for Regulatory Activities (MedDRA®) • Minor administrative changes
    19 May 2006
    Protocol Amendment 3, dated 19 May 2006, provided for the following changes: • The physical address for SCHWARZ BIOSCIENCES, GmbH was changed in the address for study personnel • Contact information for the Clinical Program Director was changed • Contact information for the Clinical Trial Statistician was changed • Contact information for the Clinical Program Medical Scientist was changed • The title and contact information for the Drug Safety Officer was changed • Additional specifications concerning withdrawal criteria regarding cardiac function were included • The title and contact information for the Safety Monitor were changed
    17 Mar 2008
    Protocol Amendment 4, dated 17 Mar 2008, provided for the following changes: • Contact information for the Associate Medical Director (Medical Therapeutics) and Associate Medical Director (Drug Safety) were added to Section 7.1.3.5, Re-exposure • Section 7.2, Laboratory measurements. In the urinalysis column in the table, albumin was changed to protein, and acetone was changed to ketones to be consistent with terminology in the clinical database • The information in Section 7.4.2, Sample labeling, was changed from “must” be filled in on all labels to “may” be filled in on all labels • Kit number in Section 8.1, Manufacturing, packaging, and labeling, was changed to Kit number (ie, bottle number) • Reference to the Per-Protocol Set in Section 11, Statistics, was removed • In Section 11.1.2, text was revised to accurately state that 1 of the safety variables was changes in 12-lead ECG instead of changes in vital sign measurements. Vital sign measurements are still listed as a safety variable • The CRF numbers were added as a way to identify data in Section 12.5, Subject privacy • The Schedule of Trial Procedures was updated to reflect the removal of the requirement to perform LCM plasma sampling after Year 2 if a subject discontinued due to an AE • The footnote in the Schedule of Trial Procedures describing the Early Termination Visit was updated • The Schedule of Trial Procedures was updated to include the additional visits associated with the additional year of the study • The individuals in Section 16.1, Declarations and signatures of persons responsible for the study, were updated
    17 Mar 2008
    Protocol Amendment 4, dated 17 Mar 2008, provided for the following changes: • The name of the study management and monitoring CRO and the vendor for central ECG services was updated • The title and contact information for the Clinical Project Manager was changed. In addition, the title of the Clinical Program Medical Scientist changed, and clarification was added to the title of the Associate Medical Director. Updates to job titles within SCHWARZ were made throughout the document. Finally, the email addresses of all SCHWARZ contacts were changed • The name of the vendor providing Central ECG Services was updated • The list of abbreviations was updated to no longer include Per-Protocol Set (PPS) • Throughout the protocol, the maximum duration of a subject’s study participation was changed from 4 years to approximately 5 years, or until LCM is otherwise (eg, commercially) available, whichever is earlier • Section 2, Background information, a reference to the most recent Investigator’s Brochure was added • Language was added to clarify that blood sampling for LCM plasma concentrations only needed to be performed through Year 2. Language stating that plasma sampling was necessary after Year 2, if a subject discontinued due to an AE, was deleted • The description of study medication was clarified to note that the tablets were provided in strengths rather than doses of 50 mg and 100 mg • Language was added to Section 4.6, Concomitant medications/treatments, to clarify that in general, it is no longer necessary to discontinue LCM for subjects undergoing surgery, although, it is still essential that each case be discussed on a case-by-case basis with the SCHWARZ Associate Medical Director • Treatment procedures for the new visits added by extending the duration of the study to 5 years were added to Section 5, Treatment procedures by visit • Clarification was added to the definition of a serious adverse event
    08 Jan 2009
    Protocol Amendment 5 dated 08 Jan 2009, provided for the following changes: • Contact information for the data management CRO was changed • The title and contact information for the Medical Director (Medical Therapeutics) was changed • Additional detail was added regarding bioanalytics, including a new vendor • The vendor and contact information for central ECG services was changed • The duration of the study was modified to include “or until the sponsor closes the trial” as an option for conclusion of the study. In addition, information regarding procedures that will be followed if LCM is not commercially available in a subject’s country at the time the sponsor closes the trial was added • Information was added regarding procedures to follow for subjects completing the study who continue on LCM • Instructions for taper of study medication (if a subject withdraws during the trial) were placed in a new section (Section 4.4.2, Taper of trial medication) • A new section was added (Section 4.4.3, Trial completion) describing the procedures to follow for subjects who choose to continue on LCM and for subjects who choose not to continue on LCM • Section 5.5, Early Termination/Termination Visit was changed to Early Termination Visit and a new section, Section 5.6, Termination Visit, was added. Assessments to be conducted or the Early Termination Visit did not change. Assessments to be conducted at the Termination Visit were added • Contact information for the SCHWARZ Safety Scientist was changed • The classification of protocol deviations was revised to be consistent with ICH E3 • Table 1, Table 2, and Table 3 were updated to reflect the changes to the protocol

    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

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/24275520
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