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

    Summary
    EudraCT number
    2014-004398-18
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    28 Oct 2009

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

    Trial information

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    Trial identification
    Sponsor protocol code
    SP0756
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00522275
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    SCHWARZ BIOSCIENCES INC.
    Sponsor organisation address
    8010 Arco Corporate Drive, Raleigh, United States, 27617
    Public contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, 0049 2173 48 15 15, clinicaltrials@ucb.com
    Scientific contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, 0049 2173 48 15 15,
    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
    14 Jan 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Oct 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - To obtain information about the safety of Lacosamide (LCM) during long-term exposure - To obtain data on seizure reduction and the maintenance of efficacy by LCM during long-term exposure - To allow subjects who had completed an LCM epilepsy study to receive LCM
    Protection of trial subjects
    Subject’s informed consent was obtained and documented in accordance with local regulations, ICH-GCP requirements, and to the ethical principles that have their origin in the principles of the Declaration of Helsinki. Prior to obtaining informed consent, information was given in a language and at a level of complexity understandable to the subject in both oral and written form by the investigator or designee. Each subject had the opportunity to discuss the trial and its alternatives with the investigator.
    Background therapy
    N/A
    Evidence for comparator
    N/A
    Actual start date of recruitment
    04 Oct 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
    United States: 308
    Worldwide total number of subjects
    308
    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)
    4
    Adults (18-64 years)
    297
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The SP0756 study began recruitment in October 2004 and concluded in October 2009. Recruitment occurred in the United States.

    Pre-assignment
    Screening details
    N/A

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

    Arms
    Arm title
    Lacosamide
    Arm description
    Up to 800 mg/day lacosamide (flexible dosing)
    Arm type
    Experimental

    Investigational medicinal product name
    Lacosamide
    Investigational medicinal product code
    SPM 927
    Other name
    Vimpat
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Up to 800 mg/day Lacosamide (flexible dosing).

    Number of subjects in period 1
    Lacosamide
    Started
    308
    Completed
    138
    Not completed
    170
         Other: Subject arrested
    1
         Protocol deviation
    1
         Other: Subject ran out of medication
    1
         Lack of efficacy
    80
         Other: Subject had surgery for epilepsy
    2
         Other: Travel to / from site difficulty
    3
         Other: Site / clinic closed
    4
         Other: Sponsor request
    2
         Other: Subject wants to become pregnant
    2
         Non-Fatal, Serious AE
    8
         Subject withdrew consent
    16
         Other: Subject is pregnant
    2
         Other: Subject relocated
    2
         Non-Fatal, Non-Serious AE
    25
         Fatal, Serious AE
    2
         Unsatisfactory compliance
    11
         Lost to follow-up
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lacosamide
    Reporting group description
    Up to 800 mg/day lacosamide (flexible dosing)

    Reporting group values
    Lacosamide Total
    Number of subjects
    308 308
    Age Categorical
    Units: Subjects
        <=18 years
    10 10
        Between 18 and 65 years
    291 291
        >=65 years
    7 7
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    37.7 ± 12.5 -
    Gender categorical
    Units: Subjects
        Female
    146 146
        Male
    162 162
    Region of Enrollment
    Units: Subjects
        Asian
    5 5
        Black
    29 29
        White
    251 251
        Other/ mixed
    23 23

    End points

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    End points reporting groups
    Reporting group title
    Lacosamide
    Reporting group description
    Up to 800 mg/day lacosamide (flexible dosing)

    Primary: Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the treatment period (Maximum 6 years)

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    End point title
    Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the treatment period (Maximum 6 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 (Maximum 6 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: The primary variables for this study were all aimed at evaluating the long term safety of LCM using descriptive data summaries. Analysis of seizure reduction was considered secondary/ exploratory and was descriptive only. No statistical comparisons were planned based on the nature of the study design (no treatment comparator, open label flexible dosing, etc).
    End point values
    Lacosamide
    Number of subjects analysed
    308
    Units: subjects
        number
    288
    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 (maximum 6 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 (maximum 6 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 (Maximum 6 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: The primary variables for this study were all aimed at evaluating the long term safety of LCM using descriptive data summaries. Analysis of seizure reduction was considered secondary/ exploratory and was descriptive only. No statistical comparisons were planned based on the nature of the study design (no treatment comparator, open label flexible dosing, etc).
    End point values
    Lacosamide
    Number of subjects analysed
    308
    Units: subjects
        number
    33
    No statistical analyses for this end point

    Primary: Number of subjects reporting at least 1 Serious Adverse Event (SAE) during the treatment period (maximum 6 years)

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    End point title
    Number of subjects reporting at least 1 Serious Adverse Event (SAE) during the treatment period (maximum 6 years) [3]
    End point description
    Serious adverse events are any untoward serious 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 (Maximum 6 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: The primary variables for this study were all aimed at evaluating the long term safety of LCM using descriptive data summaries. Analysis of seizure reduction was considered secondary/ exploratory and was descriptive only. No statistical comparisons were planned based on the nature of the study design (no treatment comparator, open label flexible dosing, etc).
    End point values
    Lacosamide
    Number of subjects analysed
    308
    Units: subjects
        number
    71
    No statistical analyses for this end point

    Secondary: Median percentage change from baseline in 28-day seizure frequency during the treatment period (Maximum 6 years)

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    End point title
    Median percentage change from baseline in 28-day seizure frequency during the treatment period (Maximum 6 years)
    End point description
    Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.
    End point type
    Secondary
    End point timeframe
    Baseline (8-week Baseline Period from the parent study SP0754), Treatment Period (Maximum 6 years)
    End point values
    Lacosamide
    Number of subjects analysed
    307
    Units: percentage change
    median (full range (min-max))
        median (full range)
    -48.5 (-100 to 567.7)
    No statistical analyses for this end point

    Secondary: Percentage of at least 50 % Responders during the treatment period (maximum 6 years)

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    End point title
    Percentage of at least 50 % Responders during the treatment period (maximum 6 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.
    End point type
    Secondary
    End point timeframe
    Treatment Period (Maximum 6 years)
    End point values
    Lacosamide
    Number of subjects analysed
    307
    Units: percentage of subjects
    number (not applicable)
        percentage
    48.2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Maximum of 6 years
    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
    Up to 800 mg/day lacosamide (flexible dosing)

    Serious adverse events
    Lacosamide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    71 / 308 (23.05%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Thrombosis
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Vagal nerve stimulator implantation
         subjects affected / exposed
    1 / 308 (0.32%)
         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)
    Testis cancer
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Breast cancer
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 308 (0.32%)
         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
    5 / 308 (1.62%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Asthenia
         subjects affected / exposed
    2 / 308 (0.65%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Mental status changes
         subjects affected / exposed
    3 / 308 (0.97%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    3 / 308 (0.97%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Depression
         subjects affected / exposed
    2 / 308 (0.65%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Aggression
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sleep attacks
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Abnormal behaviour
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Paranoia
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Anxiety
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    2 / 308 (0.65%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Priapism
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    2 / 308 (0.65%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Drug toxicity
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin laceration
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Traumatic haematoma
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Excoriation
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Limb injury
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skull fracture
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Multiple fractures
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Accidental overdose
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Operative haemorrhage
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Burns third degree
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Jaw fracture
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Electrocardiogram QT corrected interval prolonged
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood pressure increased
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    2 / 308 (0.65%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    2 / 308 (0.65%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax
         subjects affected / exposed
    2 / 308 (0.65%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    11 / 308 (3.57%)
         occurrences causally related to treatment / all
    4 / 13
         deaths causally related to treatment / all
    0 / 1
    Status epilepticus
         subjects affected / exposed
    3 / 308 (0.97%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Dizziness
         subjects affected / exposed
    4 / 308 (1.30%)
         occurrences causally related to treatment / all
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    Complex partial seizures
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Coordination abnormal
         subjects affected / exposed
    2 / 308 (0.65%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Headache
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Myoclonus
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Grand mal convulsion
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Diplopia
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    4 / 308 (1.30%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    2 / 308 (0.65%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 308 (0.65%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Dyspepsia
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mesenteric vein thrombosis
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Peptic ulcer
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrooesophagitis
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    2 / 308 (0.65%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Chronic hepatitis
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioneurotic oedema
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    3 / 308 (0.97%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    Anorexia
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    5 / 308 (1.62%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Enterobacter pneumonia
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cystitis
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Meningitis viral
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Wound infection
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Salpingitis
         subjects affected / exposed
    1 / 308 (0.32%)
         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
    265 / 308 (86.04%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    57 / 308 (18.51%)
         occurrences all number
    90
    Fall
         subjects affected / exposed
    47 / 308 (15.26%)
         occurrences all number
    93
    Skin laceration
         subjects affected / exposed
    38 / 308 (12.34%)
         occurrences all number
    69
    Joint sprain
         subjects affected / exposed
    19 / 308 (6.17%)
         occurrences all number
    20
    Excoriation
         subjects affected / exposed
    18 / 308 (5.84%)
         occurrences all number
    38
    Head injury
         subjects affected / exposed
    17 / 308 (5.52%)
         occurrences all number
    21
    Investigations
    Weight increased
         subjects affected / exposed
    17 / 308 (5.52%)
         occurrences all number
    17
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    17 / 308 (5.52%)
         occurrences all number
    17
    Respiratory, thoracic and mediastinal disorders
    Pharyngolaryngeal pain
         subjects affected / exposed
    27 / 308 (8.77%)
         occurrences all number
    29
    Cough
         subjects affected / exposed
    20 / 308 (6.49%)
         occurrences all number
    23
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    154 / 308 (50.00%)
         occurrences all number
    260
    Tremor
         subjects affected / exposed
    41 / 308 (13.31%)
         occurrences all number
    57
    Headache
         subjects affected / exposed
    67 / 308 (21.75%)
         occurrences all number
    91
    Convulsion
         subjects affected / exposed
    44 / 308 (14.29%)
         occurrences all number
    62
    Coordination abnormal
         subjects affected / exposed
    26 / 308 (8.44%)
         occurrences all number
    30
    Balance disorder
         subjects affected / exposed
    41 / 308 (13.31%)
         occurrences all number
    51
    Nystagmus
         subjects affected / exposed
    34 / 308 (11.04%)
         occurrences all number
    37
    Somnolence
         subjects affected / exposed
    25 / 308 (8.12%)
         occurrences all number
    28
    Memory impairment
         subjects affected / exposed
    20 / 308 (6.49%)
         occurrences all number
    21
    Eye disorders
    Diplopia
         subjects affected / exposed
    46 / 308 (14.94%)
         occurrences all number
    72
    Vision blurred
         subjects affected / exposed
    28 / 308 (9.09%)
         occurrences all number
    39
    General disorders and administration site conditions
    Irritability
         subjects affected / exposed
    19 / 308 (6.17%)
         occurrences all number
    21
    Fatigue
         subjects affected / exposed
    36 / 308 (11.69%)
         occurrences all number
    45
    Gait disturbance
         subjects affected / exposed
    18 / 308 (5.84%)
         occurrences all number
    22
    Psychiatric disorders
    Depression
         subjects affected / exposed
    35 / 308 (11.36%)
         occurrences all number
    45
    Insomnia
         subjects affected / exposed
    28 / 308 (9.09%)
         occurrences all number
    38
    Anxiety
         subjects affected / exposed
    17 / 308 (5.52%)
         occurrences all number
    20
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    56 / 308 (18.18%)
         occurrences all number
    78
    Vomiting
         subjects affected / exposed
    47 / 308 (15.26%)
         occurrences all number
    66
    Diarrhoea
         subjects affected / exposed
    25 / 308 (8.12%)
         occurrences all number
    32
    Constipation
         subjects affected / exposed
    22 / 308 (7.14%)
         occurrences all number
    22
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    20 / 308 (6.49%)
         occurrences all number
    21
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    34 / 308 (11.04%)
         occurrences all number
    46
    Arthralgia
         subjects affected / exposed
    18 / 308 (5.84%)
         occurrences all number
    26
    Pain in extremity
         subjects affected / exposed
    16 / 308 (5.19%)
         occurrences all number
    24
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    53 / 308 (17.21%)
         occurrences all number
    83
    Upper respiratory tract infection
         subjects affected / exposed
    40 / 308 (12.99%)
         occurrences all number
    54
    Sinusitis
         subjects affected / exposed
    32 / 308 (10.39%)
         occurrences all number
    46
    Influenza
         subjects affected / exposed
    26 / 308 (8.44%)
         occurrences all number
    28
    Urinary tract infection
         subjects affected / exposed
    25 / 308 (8.12%)
         occurrences all number
    37
    Bronchitis
         subjects affected / exposed
    17 / 308 (5.52%)
         occurrences all number
    23

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Apr 2005
    This amendment provided information regarding an additional study (SP0757) with an iv formulation of LCM in which subjects at selected sites of the SP0756 study were eligible to participate. In addition, the number of subjects allowed to enroll in the prerequisite double-blind study (SP754) was increased, leading to a longer enrollment period for the SP756 study. Therefore, the estimated number of subjects and the duration of this study were increased.
    19 May 2006
    This amendment provided further specifications concerning the withdrawal criteria regarding cardiac function. Administrative changes were also made.
    20 Mar 2008
    This amendment provided information regarding an extension of the study duration by 2 years to ensure that all subjects had access to LCM until it was otherwise (eg, commercially) available.
    12 Jan 2009
    This amendment provided additional detail for the procedures to be followed for subjects who discontinued from the study prematurely and for subjects who completed the study.

    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/22372628
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