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    Clinical Trial Results:
    An open-label extension study to assess the safety and seizure frequency associated with long-term oral lacosamide for uncontrolled primary generalized tonic-clonic seizures in subjects with idiopathic generalized epilepsy

    Summary
    EudraCT number
    2014-004375-23
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    25 Oct 2012

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

    Trial information

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    Trial identification
    Sponsor protocol code
    SP0962
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01118962
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB BIOSCIENCES, Inc
    Sponsor organisation address
    8010 Arco Corporate Drive, Raleigh, United States, 27617
    Public contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, +49 2173 48 15 15, clinicaltrials@ucb.com
    Scientific contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, +49 2173 48 15 15, clinicaltrials@ucb.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Dec 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Oct 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objectives of this study were: - To obtain data on the safety and seizure frequency associated with long-term oral Lacosamide (LCM) for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects with idiopathic generalized epilepsy (IGE) - To allow subjects who completed SP0961 to continue to receive LCM
    Protection of trial subjects
    There were no specific protocol measures in place to protect subjects.
    Background therapy
    Not applicable
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    18 Aug 2010
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    14 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 39
    Worldwide total number of subjects
    39
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    3
    Adults (18-64 years)
    36
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This study began enrollment in August 2010. The study completed in October 2012. The participant flow consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).

    Pre-assignment
    Screening details
    The participant flow refers to the Safety Set, which consists of all subjects that were dosed at least once with Lacosamide (LCM).

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

    Arms
    Arm title
    Lacosamide
    Arm description
    Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses.
    Arm type
    Experimental

    Investigational medicinal product name
    Lacosamide
    Investigational medicinal product code
    Lacosamide LCM
    Other name
    Vimpat
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses.

    Number of subjects in period 1
    Lacosamide
    Started
    39
    Completed
    29
    Not completed
    10
         Protocol deviation
             1
         Non-Fatal, Serious AE
             1
         Lack of efficacy
             1
         Pregnancy
             1
         Non-Fatal, Non-Serious AE
             1
         Non-compliance with Medicinal Product
             1
         Consent withdrawn by subject
             4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lacosamide
    Reporting group description
    Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses.

    Reporting group values
    Lacosamide Total
    Number of subjects
    39 39
    Age Categorical
    Units: Subjects
        <=18 years
    3 3
        Between 18 and 65 years
    36 36
        >=65 years
    0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    30.3 ± 10.7 -
    Gender Categorical
    Units: Subjects
        Female
    28 28
        Male
    11 11
    Region of Enrollment
    Units: Subjects
        United States
    39 39
    Weight
    Units: Kilograms
        arithmetic mean (standard deviation)
    77.66 ± 17.58 -
    Height
    Units: Centimeters
        arithmetic mean (standard deviation)
    167.88 ± 8.25 -

    End points

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    End points reporting groups
    Reporting group title
    Lacosamide
    Reporting group description
    Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses.

    Primary: Number of participants with Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (approximately 61 weeks)

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    End point title
    Number of participants with Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (approximately 61 weeks) [1]
    End point description
    End point type
    Primary
    End point timeframe
    From Visit 1 to the end of study (Approximately 61 weeks)
    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
    39
    Units: participants
        TEAEs
    37
    No statistical analyses for this end point

    Primary: Number of participants withdrawn from the study due to Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (approximately 61 weeks)

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    End point title
    Number of participants withdrawn from the study due to Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (approximately 61 weeks) [2]
    End point description
    End point type
    Primary
    End point timeframe
    From Visit 1 to the end of study (Approximately 61 weeks)
    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
    39
    Units: participants
        Participant withdrawn from study due to TEAE
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    9.1
    Reporting groups
    Reporting group title
    Lacosamide
    Reporting group description
    Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses.

    Serious adverse events
    Lacosamide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 39 (7.69%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    CONVULSION
         subjects affected / exposed
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    MIGRAINE
         subjects affected / exposed
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    ABNORMAL BEHAVIOUR
         subjects affected / exposed
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    PNEUMONIA
         subjects affected / exposed
    1 / 39 (2.56%)
         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
    35 / 39 (89.74%)
    Immune system disorders
    SEASONAL ALLERGY
         subjects affected / exposed
    3 / 39 (7.69%)
         occurrences all number
    3
    General disorders and administration site conditions
    GAIT DISTURBANCE
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    2
    FATIGUE
         subjects affected / exposed
    3 / 39 (7.69%)
         occurrences all number
    4
    Psychiatric disorders
    ANXIETY
         subjects affected / exposed
    4 / 39 (10.26%)
         occurrences all number
    5
    CONFUSIONAL STATE
         subjects affected / exposed
    4 / 39 (10.26%)
         occurrences all number
    4
    DEPRESSION
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    2
    Injury, poisoning and procedural complications
    FALL
         subjects affected / exposed
    4 / 39 (10.26%)
         occurrences all number
    4
    CONTUSION
         subjects affected / exposed
    3 / 39 (7.69%)
         occurrences all number
    3
    JOINT SPRAIN
         subjects affected / exposed
    4 / 39 (10.26%)
         occurrences all number
    5
    EXCORIATION
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    2
    MUSCLE STRAIN
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    2
    SKIN LACERATION
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    2
    Investigations
    WEIGHT INCREASED
         subjects affected / exposed
    4 / 39 (10.26%)
         occurrences all number
    4
    ARTERIAL BRUIT
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    2
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    2
    ASPARTATE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    2
    GAMMA-GLUTAMYLTRANSFERASE INCREASED
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    2
    Cardiac disorders
    PALPITATIONS
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    RESPIRATORY DISORDER
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    2
    DYSPNOEA
         subjects affected / exposed
    4 / 39 (10.26%)
         occurrences all number
    4
    Nervous system disorders
    DIZZINESS
         subjects affected / exposed
    10 / 39 (25.64%)
         occurrences all number
    12
    TREMOR
         subjects affected / exposed
    6 / 39 (15.38%)
         occurrences all number
    6
    HEADACHE
         subjects affected / exposed
    7 / 39 (17.95%)
         occurrences all number
    12
    POSTICTAL STATE
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    9
    Eye disorders
    DIPLOPIA
         subjects affected / exposed
    3 / 39 (7.69%)
         occurrences all number
    4
    Gastrointestinal disorders
    DIARRHOEA
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    2
    NAUSEA
         subjects affected / exposed
    5 / 39 (12.82%)
         occurrences all number
    5
    Skin and subcutaneous tissue disorders
    ALOPECIA
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    MUSCULOSKELETAL PAIN
         subjects affected / exposed
    3 / 39 (7.69%)
         occurrences all number
    3
    ARTHRALGIA
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    4
    Metabolism and nutrition disorders
    INCREASED APPETITE
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    2
    Infections and infestations
    GASTROENTERITIS VIRAL
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    3
    SINUSITIS
         subjects affected / exposed
    3 / 39 (7.69%)
         occurrences all number
    3
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    10 / 39 (25.64%)
         occurrences all number
    13
    INFLUENZA
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    2
    TOOTH ABSCESS
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Nov 2010
    Protocol Amendment 1, dated 02 Nov 2010, provided for the following changes: - To remove the variable of percent change in PGTC seizure frequency per 28 days from Baseline - To revise withdrawal criteria and follow-up recommendations for abnormal liver function tests (LFTs) - To increase the number of study sites from 10 to 25 - To remove the 150mg and 200mg LCM doses of study medication - Minor administrative changes Based on the date of the amendment, 1 subject was enrolled in the study prior to this amendment (Table 1.3.1).
    24 Aug 2011
    Protocol Amendment 2, dated 24 Aug 2011, provided for the following changes: - To add the Columbia-Suicide Severity Rating Scale (C-SSRS) and accompanying necessary revisions - To add the list of anticipated serious adverse events (SAEs) - To change the Sponsor’s name to UCB BIOSCIENCES Inc - Minor administrative changes Based on the date of the amendment, an additional 37 subjects were enrolled in the study prior to this amendment (Table 1.3.1).

    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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