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    Clinical Trial Results:
    A multicenter, double-blind, double-dummy, follow-up study evaluating the long-term safety of lacosamide (200 to 600mg/day) in comparison with carbamazepine (400 to 1200mg/day), used as monotherapy in subjects with partial-onset or generalized tonic-clonic seizures >= 16 years of age coming from the SP0993 study.

    Summary
    EudraCT number
    		 2010-021238-74
    Trial protocol
    		 DE   HU   ES   BE   SE   FI   PT   GB   CZ   SK   PL   IT   LV   LT   GR   BG   Outside EU/EEA  
    Global end of trial date
    03 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Jul 2017
    First version publication date
    13 Jul 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SP0994
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01465997
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UCB BIOSCIENCES GmbH
    Sponsor organisation address
    Alfred-Nobel-Strasse 10, Monheim, Germany, 40789
    Public contact
    Clinical Trial Registries and 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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Apr 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To obtain information about the long-term safety of Lacosamide (LCM) in comparison with Carbamazepine (CBZ-CR) when used as monotherapy in subjects with recently diagnosed partial-onset or generalized tonic-clonic seizures. To allow subjects who completed the monotherapy study SP0993 to continue to receive LCM or CBZ-CR.
    Protection of trial subjects
    During the conduct of the study all subjects were closely monitored.
    Background therapy
    		 Adjunctive chronic treatment with antiepileptic drugs (AEDs) was not allowed. Other background therapy was permitted, as defined in the study protocol.
    Evidence for comparator
    		 In the 2006 and 2013 International League Against Epilepsy (ILAE) treatment guidelines, carbamazepine (CBZ-CR) is considered an efficacious treatment as monotherapy for partial-onset-seizures (POS) and is a first choice for treatment for POS. Carbamazepine (controlled release) is preferred as it minimizes AEs and limits the number of discontinuations. For these reasons, CBZ-CR may be regarded as the best standard comparator.
    Actual start date of recruitment
    16 May 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Slovakia: 19
    Country: Number of subjects enrolled
    Spain: 27
    Country: Number of subjects enrolled
    Sweden: 23
    Country: Number of subjects enrolled
    Switzerland: 5
    Country: Number of subjects enrolled
    Thailand: 10
    Country: Number of subjects enrolled
    Ukraine: 16
    Country: Number of subjects enrolled
    United Kingdom: 5
    Country: Number of subjects enrolled
    United States: 17
    Country: Number of subjects enrolled
    Australia: 19
    Country: Number of subjects enrolled
    Belgium: 12
    Country: Number of subjects enrolled
    Bulgaria: 28
    Country: Number of subjects enrolled
    Canada: 21
    Country: Number of subjects enrolled
    Czech Republic: 15
    Country: Number of subjects enrolled
    Finland: 9
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Germany: 38
    Country: Number of subjects enrolled
    Greece: 8
    Country: Number of subjects enrolled
    Hungary: 32
    Country: Number of subjects enrolled
    Italy: 23
    Country: Number of subjects enrolled
    Japan: 14
    Country: Number of subjects enrolled
    Korea, Republic of: 32
    Country: Number of subjects enrolled
    Latvia: 2
    Country: Number of subjects enrolled
    Lithuania: 15
    Country: Number of subjects enrolled
    Mexico: 4
    Country: Number of subjects enrolled
    Philippines: 16
    Country: Number of subjects enrolled
    Poland: 24
    Country: Number of subjects enrolled
    Portugal: 24
    Country: Number of subjects enrolled
    Romania: 58
    Country: Number of subjects enrolled
    Russian Federation: 28
    Worldwide total number of subjects
    548
    EEA total number of subjects
    366
    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)
    7
    Adults (18-64 years)
    464
    From 65 to 84 years
    77
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Enrollment started in May 2012 and concluded in January 2017 - 551 patients. Due to the political and civil unrest in Luhansk PAREXEL was not able to conduct further site visits to one site in Ukraine and to collect further data for 2 subjects,they were excluded from SP0994, leaving 549 patients in the Enrolled Set out of 551 initially enrolled.

    Pre-assignment
    Screening details
    		 A total of 549 subjects gave informed consent in SP0994 and were included in the Enrolled Set, 548 subjects received at least 1 dose of study medication and were included in the Safety Set (SS). Participant Flow refers to the Safety Population including all enrolled subjects who received at least 1 dose of study medication in the current study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Lacosamide
    Arm description
    		 50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Carbamazepine-Controlled Release-placebo
    Investigational medicinal product code
    CBZ-CR-PBO
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects randomized to LCM treatment received CBZ-CR-PBO capsules to maintain the blinding.

    Investigational medicinal product name
    Lacosamide
    Investigational medicinal product code
    LCM
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    LCM was orally administered twice daily (bid) in 2 equally divided doses of 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years).

    Arm title
    		 Carbamazepine-Controlled Release (CBZ-CR)
    Arm description
    		 200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Lacosamide-placebo
    Investigational medicinal product code
    LCM-PBO
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects randomized to CBZ-CR treatment received LCM-PBO tablets to maintain the blinding.

    Investigational medicinal product name
    Carbamazepine-Controlled Release
    Investigational medicinal product code
    CBZ-CR
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    CBZ-CR was orally administered twice daily (bid) in 2 equally divided doses of 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years).

    Number of subjects in period 1
    		Lacosamide Carbamazepine-Controlled Release (CBZ-CR)
    Started
    279
    269
    Completed
    211
    180
    Not completed
    68
    89
         Adverse event, serious fatal
    -
    1
         investigator's decision
    1
    1
         decision by site staff
    -
    1
         withdrew before follow-up
    -
    13
         Consent withdrawn by subject
    32
    35
         local lab unblinded site
    1
    -
         Adverse event, non-fatal
    12
    22
         subject left participation SP0993
    -
    1
         subject withdrew consent
    1
    -
         Lost to follow-up
    6
    9
         sponsor's decision
    1
    1
         Lack of efficacy
    13
    1
         Protocol deviation
    1
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lacosamide
    Reporting group description
    		 50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.

    Reporting group title
    Carbamazepine-Controlled Release (CBZ-CR)
    Reporting group description
    		 200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.

    Reporting group values
    		 Lacosamide Carbamazepine-Controlled Release (CBZ-CR) Total
    Number of subjects
    		 279 269 548
    Age Categorical
    Units: Subjects
        <=18 years
    		 8 8 16
        Between 18 and 65 years
    		 230 225 455
        >=65 years
    		 41 36 77
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 43.2 ± 17.2 42.7 ± 16.7 -
    Gender Categorical
    Units: Subjects
        Male
    		 154 144 298
        Female
    		 125 125 250

    End points

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    End points reporting groups
    Reporting group title
    Lacosamide
    Reporting group description
    		 50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.

    Reporting group title
    Carbamazepine-Controlled Release (CBZ-CR)
    Reporting group description
    		 200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.

    Subject analysis set title
    Lacosamide (SS)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.

    Subject analysis set title
    Carbamazepine-Controlled Release (CBZ-CR) (SS)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.

    Primary: Number of subjects with at least one treatment-emergent Adverse Event (AE) during the Treatment Phase (Maximum of 3.5 Years)

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    End point title
    		 Number of subjects with at least one treatment-emergent Adverse Event (AE) during the Treatment Phase (Maximum of 3.5 Years) [1]
    End point description
    Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent.
    End point type
    Primary
    End point timeframe
    Up to 3.5 Years (Duration of the Treatment Phase)
    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 end point. Results were summarized as descriptive statistics only.
    End point values
    		 Lacosamide (SS) Carbamazepine-Controlled Release (CBZ-CR) (SS)
    Number of subjects analysed
    279
    269
    Units: Participants
        Number of subjects
    181
    182
    No statistical analyses for this end point

    Primary: Number of subjects who withdrew from the study due to a treatment-emergent Adverse Event (AE) during the Treatment Phase (Maximum 3.5 Years)

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    End point title
    		 Number of subjects who withdrew from the study due to a treatment-emergent Adverse Event (AE) during the Treatment Phase (Maximum 3.5 Years) [2]
    End point description
    Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent.
    End point type
    Primary
    End point timeframe
    Up to 3.5 Years (Duration of the Treatment Phase)
    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 end point. Results were summarized as descriptive statistics only.
    End point values
    		 Lacosamide Carbamazepine-Controlled Release (CBZ-CR)
    Number of subjects analysed
    279
    269
    Units: Patricipants
        Number of subjects
    12
    21
    No statistical analyses for this end point

    Primary: Number of subjects with at least one treatment-emergent Serious Adverse Event (SAE) during the Treatment Phase (Maximum of 3.5 years)

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    End point title
    		 Number of subjects with at least one treatment-emergent Serious Adverse Event (SAE) during the Treatment Phase (Maximum of 3.5 years) [3]
    End point description
    A Serious Adverse Event is any untoward medical occurrence that at any dose results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity is a congenital anomaly/birth defect.
    End point type
    Primary
    End point timeframe
    Up to 3.5 Years (Duration of the Treatment Phase)
    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 end point. Results were summarized as descriptive statistics only.
    End point values
    		 Lacosamide Carbamazepine-Controlled Release (CBZ-CR)
    Number of subjects analysed
    279
    269
    Units: Participants
        Number of subjects
    32
    22
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During the entire study period, up to 5 years
    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
    		 50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.

    Reporting group title
    Carbamazepine-Controlled Release (CBZ-CR) (SS)
    Reporting group description
    		 200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.

    Serious adverse events
    		 Lacosamide (SS) Carbamazepine-Controlled Release (CBZ-CR) (SS)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    32 / 279 (11.47%)
    22 / 269 (8.18%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Breast cancer
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Central nervous system lymphoma
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial adenocarcinoma
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign breast neoplasm
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid neoplasm
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma multiforme
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine cancer
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy on contraceptive
         subjects affected / exposed
    0 / 279 (0.00%)
    2 / 269 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Epididymitis
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary oedema
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    1 / 279 (0.36%)
    2 / 269 (0.74%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adjustment disorder with depressed mood
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal behaviour
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 279 (0.00%)
    2 / 269 (0.74%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    1 / 279 (0.36%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intentional overdose
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periorbital haematoma
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    2 / 279 (0.72%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 279 (0.36%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    2 / 279 (0.72%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervicobrachial syndrome
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cognitive disorder
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Grand mal convulsion
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    White matter lesion
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reversible ischaemic neurological deficit
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Eosinophilia
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vestibular ataxia
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Exophthalmos
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Lumbar hernia
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mallory-Weiss syndrome
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Gallbladder disorder
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bone lesion
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    1 / 279 (0.36%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dupuytren's contracture
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthropathy
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint instability
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    1 / 279 (0.36%)
    0 / 269 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 279 (0.00%)
    3 / 269 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    0 / 279 (0.00%)
    1 / 269 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Lacosamide (SS) Carbamazepine-Controlled Release (CBZ-CR) (SS)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    45 / 279 (16.13%)
    42 / 269 (15.61%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    17 / 279 (6.09%)
    16 / 269 (5.95%)
         occurrences all number
    28
    26
    Dizziness
         subjects affected / exposed
    12 / 279 (4.30%)
    17 / 269 (6.32%)
         occurrences all number
    13
    19
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    20 / 279 (7.17%)
    16 / 269 (5.95%)
         occurrences all number
    40
    22

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Jan 2011
    The primary purpose of this substantial protocol amendment was to revise the withdrawal criteria and follow-up recommendations for abnormal liver function tests (LFTs) based upon newly adopted US FDA Guidance on Drug-Induced Liver Injury (July 2009) and a recommendation from the US FDA to re-insert previously included wording regarding additional withdrawal criteria and follow-up recommendations for abnormal LFTs in LCM protocols. In addition, clarification of study procedures for the sites was included.
    09 Dec 2011
    The primary purposes of this substantial protocol amendment were to revise the exclusion criterion related to a history of suicidality, add a withdrawal criterion related to suicidality, and add a list of anticipated serious adverse events (SAEs). The Columbia-Suicide Severity Rating Scale (C-SSRS; Columbia University Medical Center, 2008) was implemented to evaluate and identify subjects at risk for suicide while participating in a clinical study of a drug with central nervous system activity based upon the US FDA’s recommendation (FDA, Guidance for Industry, 2010). In addition, a withdrawal criterion related to suicidality and a list of anticipated SAEs, in compliance with the recent US FDA guidance on safety reporting requirements for studies conducted under an open Investigational New Drug (effective 28 Mar 2011; FDA, Guidance for Industry and Investigators, 2010) were added. The Sponsor’s name was changed to UCB BIOSCIENCES GmbH and specific sponsor contact information was updated. In addition, details for the SP0994 Open-Label Phase were provided.
    22 Aug 2013
    Based on the date of the amendment, 116 subjects entered the study prior to the date of this amendment. The primary purpose of this substantial protocol amendment was to eliminate the Open-Label Phase of the study, including associated Open-Label Visits. SP0994 was blinded until SP0993 database lock and unblinding. Following the database lock and unblinding of SP0993, SP0994 was unblinded and closed for all subjects. Subjects in SP0994 who were receiving LCM had access to open-label follow-up treatment with LCM according to local laws. Subjects who were receiving CBZ-CR and wished to continue treatment after the close of SP0994 may have received prescribed CBZ (ie, not supplied by UCB BIOSCIENCES). For clarification, the exploratory efficacy variable “retention rate (ie, duration of treatment in the study),” was changed to “time to discontinuation.” Section 7.8 of the protocol (concomitant medications/treatments) was updated to be consistent with the corresponding section of the SP0993 protocol.
    27 Feb 2015
    Based on the date of the amendment, 478 subjects entered the study prior to the date of this amendment. The primary purpose of this substantial protocol amendment was to add additional routine visits to SP0994 in case the study was still ongoing and the subject had passed Visit 14.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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