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    Clinical Trial Results:
    A Multicenter, Open-label Extension Trial to Assess the Long-term Safety and Tolerability of Lacosamide as Adjunctive Therapy in Subjects With Partial-onset Seizures

    Summary
    EudraCT number
    2014-004384-21
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    15 Jun 2010

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

    Trial information

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    Trial identification
    Sponsor protocol code
    SP0926
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00655486
    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, 0049 2173 48 15 15, clinicaltrials@ucb.com
    Scientific contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, 0049 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
    10 Aug 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jun 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objectives of this study were to: • Allow subjects who completed the SP925 study or terminated from the study (Cohorts 2, 3, and 4 only) due to an intolerable adverse event(s) (AE[s]) to continue Lacosamide (LCM) • Obtain additional long-term safety information for LCM
    Protection of trial subjects
    Subject’s informed consent was obtained and documented in accordance with local regulations, ICH-GCP requirements, and 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
    22 Apr 2008
    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: 97
    Worldwide total number of subjects
    97
    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)
    1
    Adults (18-64 years)
    96
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study started in April 2008 with enrollment occuring in the United States only. The study completed June 2010

    Pre-assignment
    Screening details
    N/A

    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 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
    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
    Subjects' dose of Lacosamide may be increased or decreased as needed to maintain a subject's effective and tolerable dose during the study. Tablets are 50 mg or 100 mg each; Dose is 100 mg/day up to 800 mg/day administered twice daily throughout the study (up to 2 years).

    Number of subjects in period 1
    Lacosamide
    Started
    97
    Completed
    69
    Not completed
    28
         Non-Fatal, Serious AE
    1
         Protocol deviation
    1
         Lack of efficacy
    8
         Non-Fatal, Non-Serious AE
    9
         Other: Pregnancy
    1
         Other: Abnormal electrocardiogram (ECG)
    1
         Consent withdrawn by subject
    4
         Other: Could not tolerate BID dosing
    1
         Unsatisfactory compliance
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lacosamide
    Reporting group description
    Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)

    Reporting group values
    Lacosamide Total
    Number of subjects
    97 97
    Age Categorical
    Units: Subjects
        <=18 years
    2 2
        Between 18 and 65 years
    95 95
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    38.8 ± 11.7 -
    Gender categorical
    Units: Subjects
        Female
    47 47
        Male
    50 50

    End points

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    End points reporting groups
    Reporting group title
    Lacosamide
    Reporting group description
    Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)

    Primary: Number of subjects with at least one adverse event during this open-label extension study (maximum study duration 2 years)

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    End point title
    Number of subjects with at least one adverse event during this open-label extension study (maximum study duration 2 years) [1]
    End point description
    An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
    End point type
    Primary
    End point timeframe
    2 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. 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
    97
    Units: subjects
        number
    93
    No statistical analyses for this end point

    Primary: Number of subjects who withdrew from the study due to an adverse event (maximum study duration 2 years)

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    End point title
    Number of subjects who withdrew from the study due to an adverse event (maximum study duration 2 years) [2]
    End point description
    An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
    End point type
    Primary
    End point timeframe
    2 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. 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
    97
    Units: subjects
        number
    10
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    2 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
    Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)

    Serious adverse events
    Lacosamide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 97 (10.31%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Post procedural bile leak
         subjects affected / exposed
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Arrhythmia supraventricular
         subjects affected / exposed
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    2 / 97 (2.06%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Lethargy
         subjects affected / exposed
    1 / 97 (1.03%)
         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
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Drug interaction
         subjects affected / exposed
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Hallucination
         subjects affected / exposed
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Homicidal ideation
         subjects affected / exposed
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Paranoia
         subjects affected / exposed
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Depression suicidal
         subjects affected / exposed
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Giardiasis
         subjects affected / exposed
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 97 (1.03%)
         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
    88 / 97 (90.72%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    5 / 97 (5.15%)
         occurrences all number
    5
    Investigations
    Weight increased
         subjects affected / exposed
    6 / 97 (6.19%)
         occurrences all number
    6
    Nervous system disorders
    Coordination abnormal
         subjects affected / exposed
    11 / 97 (11.34%)
         occurrences all number
    13
    Dizziness
         subjects affected / exposed
    43 / 97 (44.33%)
         occurrences all number
    50
    Somnolence
         subjects affected / exposed
    12 / 97 (12.37%)
         occurrences all number
    13
    Headache
         subjects affected / exposed
    11 / 97 (11.34%)
         occurrences all number
    11
    Balance disorder
         subjects affected / exposed
    11 / 97 (11.34%)
         occurrences all number
    13
    Hypoaesthesia
         subjects affected / exposed
    5 / 97 (5.15%)
         occurrences all number
    7
    Tremor
         subjects affected / exposed
    8 / 97 (8.25%)
         occurrences all number
    10
    Memory impairment
         subjects affected / exposed
    5 / 97 (5.15%)
         occurrences all number
    5
    Eye disorders
    Diplopia
         subjects affected / exposed
    17 / 97 (17.53%)
         occurrences all number
    18
    Vision blurred
         subjects affected / exposed
    10 / 97 (10.31%)
         occurrences all number
    10
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    8 / 97 (8.25%)
         occurrences all number
    9
    Fatigue
         subjects affected / exposed
    12 / 97 (12.37%)
         occurrences all number
    12
    Irritability
         subjects affected / exposed
    5 / 97 (5.15%)
         occurrences all number
    6
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    5 / 97 (5.15%)
         occurrences all number
    5
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    8 / 97 (8.25%)
         occurrences all number
    8
    Insomnia
         subjects affected / exposed
    9 / 97 (9.28%)
         occurrences all number
    9
    Depression
         subjects affected / exposed
    7 / 97 (7.22%)
         occurrences all number
    7
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    16 / 97 (16.49%)
         occurrences all number
    18
    Nausea
         subjects affected / exposed
    13 / 97 (13.40%)
         occurrences all number
    14
    Diarrhoea
         subjects affected / exposed
    12 / 97 (12.37%)
         occurrences all number
    13
    Constipation
         subjects affected / exposed
    5 / 97 (5.15%)
         occurrences all number
    6
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    5 / 97 (5.15%)
         occurrences all number
    5
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    14 / 97 (14.43%)
         occurrences all number
    17
    Sinusitis
         subjects affected / exposed
    8 / 97 (8.25%)
         occurrences all number
    11
    Urinary tract infection
         subjects affected / exposed
    7 / 97 (7.22%)
         occurrences all number
    8
    Nasopharyngitis
         subjects affected / exposed
    6 / 97 (6.19%)
         occurrences all number
    7

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Oct 2008
    SP0926 protocol amendment 1 included the following key changes: • Administrative changes including contact and title information for the Associate Clinical Program Director, the Sr. Clinical Project Manager, the Clinical Trial Biostatistician, and the Associate Medical Director (Medical Therapeutics) were incorporated in the protocol • Current information on the Central Laboratory Services and Central Electrocardiogram Services were included in the protocol • Information in the protocol text was corrected to state that in SP925, subjects in Cohort 2 received Lacosamide (LCM) 300 mg/day (not 200 mg/day) and subjects in Cohort 3 received LCM 400mg/day (not 300 mg/day) • For consistency with the Phase 3 LCM epilepsy adjunctive therapy program, text was added to permit subjects who withdrew from Cohort 2 or 3 in SP0925 due to lack of tolerability to begin SP0926 at a dose as low as LCM 100mg/day increasing the dose no faster than 100 mg/day per week up to a maximum dose of LCM 800 mg/day, based on tolerability • To clarify that IVRS was to be contacted during Unscheduled Visits irrespective of drug dispensation, the wording ‘if applicable’ was removed from Section 5.1.6. • To allow consistency in the observations of the neurological exam between this oral LCM epilepsy study and the oral LCM epilepsy Phase 2/3 program, conduct of the neurological examination was modified to be performed by clinicians with documented training in neurological exams • For clarification, ‘8 weeks’ was added to the Frequency of Visits under ‘Term’ in the Schedule of Procedures (Section 15.1) • For consistency with the LCM epilepsy adjunctive therapy program, as well as appropriate safety oversight, additional phone calls were included where there was a significant time period between visits/frequency of visits had decreased • Information on the window periods was added to the individual visits in Section 5.1 for clarity
    06 Oct 2009
    SP926 protocol amendment 2 included the following key changes: • Detail was added to the protocol to allow subjects who, in consultation with the investigator, chose to initiate treatment with commercially available Lacosamide (LCM) at the end of the study, to do so without taper. In addition, details were added for subjects who chose not to initiate treatment with commercial LCM at the end of the study • The liver function test (LFT) withdrawal criteria were revised to reflect the Sponsor’s current understanding of the safety profile of LCM based on a comprehensive review of the data from clinical studies • The Adverse Events (AE)s of special interest were revised to reflect the Sponsor’s current understanding of the potential risks of LCM based on a comprehensive review of the data from clinical studies and commitments to regulatory agencies • Lacosamide was classified as a controlled substance in the US; thus, it was necessary to add this information to the protocol • The remainder of the changes in this amendment were administrative

    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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