Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   38462   clinical trials with a EudraCT protocol, of which   6315   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A PROSPECTIVE, MULTINATIONAL, OPEN-LABEL, SINGLE-ARM, EXPLORATIVE STUDY TO EVALUATE THE TOLERABILITY AND EFFICACY OF LACOSAMIDE WHEN ADDED TO LEVETIRACETAM WITH WITHDRAWAL OF THE CONCOMITANT SODIUM CHANNEL BLOCKING ANTIEPILEPTIC DRUG IN SUBJECTS WITH UNCONTROLLED PARTIAL-ONSET SEIZURES

    Summary
    EudraCT number
    2011-002461-37
    Trial protocol
    DE   SE   AT   ES   NL   DK   BG   HU  
    Global end of trial date
    10 Jan 2014

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

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    SP0980
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01484977
    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 217348 1515, clinicaltrials@ucb.com
    Scientific contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, +49 217348 1515, 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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 Mar 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to assess the overall effectiveness of Lacosamide (optimized within the range of 200 mg/day to 600 mg/day) when added to a stable dose of Levetiracetam (in the label range of 1000 mg/day to 3000 mg/day) with withdrawal of the concomitant Sodium Channel Blocking Antiepileptic Drug (SCB-AED) in subjects with partial-onset seizures not adequately controlled on their dual LEV and SCB-AED regimen.
    Protection of trial subjects
    Data privacy measures in place
    Background therapy
    Concomitant AED therapy at baseline with LEV and SCB (CBZ, OXC, PHT, LTG or ESL)
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    01 Dec 2011
    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
    Spain: 12
    Country: Number of subjects enrolled
    Sweden: 3
    Country: Number of subjects enrolled
    Bulgaria: 20
    Country: Number of subjects enrolled
    Denmark: 4
    Country: Number of subjects enrolled
    France: 8
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    United States: 53
    Country: Number of subjects enrolled
    Romania: 12
    Country: Number of subjects enrolled
    Australia: 5
    Worldwide total number of subjects
    120
    EEA total number of subjects
    62
    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)
    0
    Adults (18-64 years)
    115
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    The recruitment for the SP0980 study began in December 2011. It concluded in December 2013. This was a multicenter study with subjects enrolled by 30 sites across North America, 12 in Western Europe, 10 in Eastern Europe, and 2 in Oceania.

    Pre-assignment
    Screening details
    The SP0980 study enrolled 147 patients. Out of the 147 enrolled patients, there were 27 screen failures. This resulted in 120 eligible patients for this study.

    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 will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).
    Arm type
    Experimental

    Investigational medicinal product name
    Lacosamide
    Investigational medicinal product code
    SPM927
    Other name
    VIMPAT®, SPM927, Harkoseride
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Maximum duration of study drug administration is approximately 23 weeks.

    Number of subjects in period 1
    Lacosamide
    Started
    120
    Completed
    93
    Not completed
    27
         Protocol deviation
    6
         Lack of efficacy
    4
         Low White Blood Cell Count
    1
         Lack of Compliance
    1
         Moving Overseas
    1
         Non-Fatal, Non-Serious AE(s)
    8
         Consent withdrawn by subject
    4
         Subject Protocol Non-compliant
    1
         Lost to follow-up
    1

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Lacosamide
    Reporting group description
    Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).

    Reporting group values
    Lacosamide Total
    Number of subjects
    120 120
    Age categorical
    The Baseline characteristics consist of subjects in the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
    Units: Subjects
        <=18
    1 1
        >18-<65
    114 114
        >=65
    5 5
    Age continuous
    The Baseline characteristics consist of subjects in the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
    Units: years
        arithmetic mean (standard deviation)
    39.7 ± 12.6 -
    Gender categorical
    The Baseline characteristics consist of subjects in the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
    Units: Subjects
        Female
    74 74
        Male
    46 46
    Racial Group
    The Baseline characteristics consist of subjects in the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
    Units: Subjects
        American Indian/ Alaskan Native
    1 1
        Asian
    3 3
        Black
    8 8
        Native Hawaiian or other Pacific Islander
    0 0
        White
    96 96
        Other/Mixed
    12 12
    Ethnicity
    The Baseline characteristics consist of subjects in the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
    Units: Subjects
        Hispanic or Latino
    17 17
        Not Hispanic or Latino
    103 103
    Weight
    The Baseline characteristics consist of subjects in the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    76.39 ± 19.98 -
    Height
    The Baseline characteristics consist of subjects in the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
    Units: Centimeters
        arithmetic mean (standard deviation)
    168.02 ± 10.55 -
    BMI
    The Baseline characteristics consist of subjects in the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
    Units: kilogram(s)/square meter
        arithmetic mean (standard deviation)
    27 ± 6.45 -

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Lacosamide
    Reporting group description
    Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).

    Primary: Retention at the end of the 21-week Treatment Period

    Close Top of page
    End point title
    Retention at the end of the 21-week Treatment Period [1]
    End point description
    Retention is a summary measure that integrates both the patient’s and clinician’s assessment of efficacy and tolerability in epilepsy clinical studies to provide a measure of effectiveness.
    End point type
    Primary
    End point timeframe
    Duration of the Treatment Period (21 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: Due to system limitations, a single arm study statistical analysis was not entered. Percentage (retention rate (RR) and its 95 % CI), of subjects remaining in the study through the 21-Week Treatment Period will be calculated. Subjects retained through Week 21 will be counted in the numerator. All subjects in the relevant population will be used as the denominator. n=120 RR (95 % CI): 73.3 (65.42, 81.25).
    End point values
    Lacosamide
    Number of subjects analysed
    120
    Units: Percentage of Participants
        number (not applicable)
    73.3
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent Adverse Events (TEAEs) were recorded during the course of the SP0980 study, which began in December 2011 and concluded in December 2013.
    Adverse event reporting additional description
    TEAE reporting refers to the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.
    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 will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).

    Serious adverse events
    Lacosamide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 120 (6.67%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Leukocytosis
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Migraine
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Anxiety
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mental status changes
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Toothache
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    2 / 120 (1.67%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infection
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vulvovaginitis trichomonal
         subjects affected / exposed
    1 / 120 (0.83%)
         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
    48 / 120 (40.00%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    28 / 120 (23.33%)
         occurrences all number
    40
    Headache
         subjects affected / exposed
    18 / 120 (15.00%)
         occurrences all number
    21
    Convulsion
         subjects affected / exposed
    7 / 120 (5.83%)
         occurrences all number
    8
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    10 / 120 (8.33%)
         occurrences all number
    13
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    7 / 120 (5.83%)
         occurrences all number
    7

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Oct 2010
    Protocol Amendment 1, 18 Oct 2011 The protocol was amended in order to revise the age inclusion criterion, which limited enrollment to the adult population (≥18 years). In addition, a withdrawal criterion was added. The withdrawal criterion clarified that subjects must have been withdrawn from the study if their VNS settings were no longer constant or subject required a change to the VNS Settings.
    07 Jun 2013
    Protocol Amendment 2, 07 Jun 2013 The protocol was amended in order to revise the planned termination of the study. Due to difficulty with enrollment, the initially planned enrollment period was extended approximately 6 months. Despite this extension, it was projected that only approximately 100 total subjects would be enrolled instead of the initially intended subject number of approximately 300. Because of the change in the anticipated number of subjects, the study would not have sufficient power to detect a 50 % reduction in the all-cause discontinuation rate and all analyses would have been exploratory in nature. In addition, administrative changes were made to update study personnel and 24-hour safety contact information. Revisions were also made to reflect UCB BIOSCIENCES department name change from Global Clinical Safety and Pharmacovigilance (GCSP) to Drug Safety, to clarify wording in Exclusion Criterion #11, and to clarify the temperature log recording requirements. Minor typographical revisions were also made.

    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
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA