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   38573   clinical trials with a EudraCT protocol, of which   6335   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 Multicenter, Open-label Trial to Assess the Safety and Tolerability of a Single Intravenous Loading Dose of Lacosamide Followed by Oral Lacosamide Maintenance as Adjunctive Therapy in Subjects With Partial-onset Seizures

    Summary
    EudraCT number
    2014-004378-40
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    23 Sep 2009

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

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    SP0925
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00655551
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB BIOSCIENCES Inc.
    Sponsor organisation address
    8010 Arco Corporate Drive, Raleigh, United States, 27517
    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
    18 Nov 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Sep 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study was to evaluate the safety and tolerability of the rapid initiation of adjunctive lacosamide (LCM) via a single intravenous (iv) loading dose (iv LCM 200 mg, 300 mg, or 400 mg) and oral LCM maintenance treatment in adult subjects with partial-onset seizures.
    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
    08 Apr 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 100
    Worldwide total number of subjects
    100
    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)
    99
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    The SP0925 study began recruitment in April 2008. Recruitment took place in the United States. 100 participants entered the study, which concluded in September 2009.

    Pre-assignment
    Screening details
    N/A

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Lacosamide (200 mg)
    Arm description
    Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
    Arm type
    Experimental

    Investigational medicinal product name
    Lacosamide
    Investigational medicinal product code
    SPM 927
    Other name
    Vimpat
    Pharmaceutical forms
    Infusion, Coated tablet
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Single loading intravenous (iv) Lacosamide 200 mg dose administered over a 15 minute infusion duration followed by oral Lacosamide 200 mg/day (100 mg twice daily) for 6.5 days.

    Arm title
    Lacosamide (300 mg)
    Arm description
    Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
    Arm type
    Experimental

    Investigational medicinal product name
    Lacosamide
    Investigational medicinal product code
    SPM 927
    Other name
    Vimpat
    Pharmaceutical forms
    Infusion, Coated tablet
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Single loading intravenous (iv) Lacosamide 200 mg dose administered over a 15 minute infusion duration followed by oral Lacosamide 200 mg/day (100 mg twice daily) for 6.5 days.

    Arm title
    Lacosamide (400 mg)
    Arm description
    Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
    Arm type
    Experimental

    Investigational medicinal product name
    Lacosamide
    Investigational medicinal product code
    SPM 927
    Other name
    Vimpat
    Pharmaceutical forms
    Infusion, Coated tablet
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Single loading intravenous (iv) Lacosamide 200 mg dose administered over a 15 minute infusion duration followed by oral Lacosamide 200 mg/day (100 mg twice daily) for 6.5 days.

    Number of subjects in period 1
    Lacosamide (200 mg) Lacosamide (300 mg) Lacosamide (400 mg)
    Started
    25
    50
    25
    Completed
    25
    47
    21
    Not completed
    0
    3
    4
         Non-Fatal, Non-Serious AE
    -
    3
    4

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Lacosamide (200 mg)
    Reporting group description
    Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily

    Reporting group title
    Lacosamide (300 mg)
    Reporting group description
    Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily

    Reporting group title
    Lacosamide (400 mg)
    Reporting group description
    Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily

    Reporting group values
    Lacosamide (200 mg) Lacosamide (300 mg) Lacosamide (400 mg) Total
    Number of subjects
    25 50 25 100
    Age Categorical
    Units: Subjects
        <=18 years
    0 2 0 2
        Between 18 and 65 years
    25 48 25 98
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    39.1 ± 11.8 38.6 ± 11.5 39.6 ± 12.2 -
    Gender categorical
    Units: Subjects
        Female
    14 26 9 49
        Male
    11 24 16 51

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Lacosamide (200 mg)
    Reporting group description
    Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily

    Reporting group title
    Lacosamide (300 mg)
    Reporting group description
    Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily

    Reporting group title
    Lacosamide (400 mg)
    Reporting group description
    Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily

    Primary: Number of subjects with at least one adverse event during the treatment period (up to 7 days)

    Close Top of page
    End point title
    Number of subjects with at least one adverse event during the treatment period (up to 7 days) [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
    Treatment period (up to 7 days)
    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 objective of this open-label study was to evaluate the safety and tolerability of a single iv loading dose of lacosamide in subjects aged 16 to 60 years. The purpose of the study was to provide a description of the safety profile of a single iv loading dose of lacosamide across several safety variables. Therefore no statistical comparisons were applied in this safety study.
    End point values
    Lacosamide (200 mg) Lacosamide (300 mg) Lacosamide (400 mg)
    Number of subjects analysed
    25
    50
    25
    Units: subjects
        number
    17
    42
    20
    No statistical analyses for this end point

    Primary: Number of subjects who withdrew from the trial due to an adverse event

    Close Top of page
    End point title
    Number of subjects who withdrew from the trial due to an adverse event [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
    Entire trial period (up to 6 weeks), screening through safety follow-up period (2 weeks post last medication)
    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 objective of this open-label study was to evaluate the safety and tolerability of a single iv loading dose of lacosamide in subjects aged 16 to 60 years. The purpose of the study was to provide a description of the safety profile of a single iv loading dose of lacosamide across several safety variables. Therefore no statistical comparisons were applied in this safety study.
    End point values
    Lacosamide (200 mg) Lacosamide (300 mg) Lacosamide (400 mg)
    Number of subjects analysed
    25
    50
    25
    Units: subjects
        number
    0
    3
    4
    No statistical analyses for this end point

    Secondary: Number of subjects with at least one adverse event with an onset within 4 hours of start of infusion

    Close Top of page
    End point title
    Number of subjects with at least one adverse event with an onset within 4 hours of start of infusion
    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
    Secondary
    End point timeframe
    0-4 hours post start of the infusion
    End point values
    Lacosamide (200 mg) Lacosamide (300 mg) Lacosamide (400 mg)
    Number of subjects analysed
    25
    50
    25
    Units: subjects
        number
    5
    24
    16
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    up to 7 days
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    9.1
    Reporting groups
    Reporting group title
    Lacosamide (200 mg)
    Reporting group description
    Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily

    Reporting group title
    Lacosamide (400 mg)
    Reporting group description
    Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily

    Reporting group title
    Lacosamide (300 mg)
    Reporting group description
    Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily

    Serious adverse events
    Lacosamide (200 mg) Lacosamide (400 mg) Lacosamide (300 mg)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    0 / 50 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Lacosamide (200 mg) Lacosamide (400 mg) Lacosamide (300 mg)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 25 (28.00%)
    20 / 25 (80.00%)
    37 / 50 (74.00%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    5 / 25 (20.00%)
    15 / 25 (60.00%)
    23 / 50 (46.00%)
         occurrences all number
    6
    19
    27
    Somnolence
         subjects affected / exposed
    0 / 25 (0.00%)
    9 / 25 (36.00%)
    17 / 50 (34.00%)
         occurrences all number
    0
    9
    18
    Headache
         subjects affected / exposed
    2 / 25 (8.00%)
    4 / 25 (16.00%)
    2 / 50 (4.00%)
         occurrences all number
    2
    4
    2
    Paraesthesia
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 25 (4.00%)
    3 / 50 (6.00%)
         occurrences all number
    2
    4
    3
    Tremor
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    1
    3
    Coordination abnormal
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    0
    3
    Hypoaesthesia
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    1
    2
    Eye disorders
    Diplopia
         subjects affected / exposed
    1 / 25 (4.00%)
    5 / 25 (20.00%)
    3 / 50 (6.00%)
         occurrences all number
    1
    6
    3
    Vision blurred
         subjects affected / exposed
    0 / 25 (0.00%)
    3 / 25 (12.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    3
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 25 (0.00%)
    3 / 25 (12.00%)
    9 / 50 (18.00%)
         occurrences all number
    0
    3
    9
    Gait disturbance
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 25 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    2
    0
    1
    Chest pain
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 25 (8.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    2
    0
    Feeling Drunk
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    0
    2
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 25 (0.00%)
    6 / 25 (24.00%)
    8 / 50 (16.00%)
         occurrences all number
    0
    8
    8
    Dry mouth
         subjects affected / exposed
    0 / 25 (0.00%)
    3 / 25 (12.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    3
    3
    Paraesthesia oral
         subjects affected / exposed
    1 / 25 (4.00%)
    2 / 25 (8.00%)
    2 / 50 (4.00%)
         occurrences all number
    1
    2
    2
    Hypoaesthesia oral
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 25 (8.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    2
    5
    Vomiting
         subjects affected / exposed
    0 / 25 (0.00%)
    3 / 25 (12.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    3
    2
    Diarrhoea
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (0.00%)
    4 / 50 (8.00%)
         occurrences all number
    0
    0
    4
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 25 (8.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    2
    0
    Pruritus
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    1
    3

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Oct 2008
    • Administrative changes including contact and title information for the Associate Clinical Program Director, the Senior Clinical Project Manager, the Clinical Trial Biostatistician, and the Associate Medical Director were incorporated in the protocol • Current information on the Central Laboratory Services, Central Electrocardiogram Services, and Central Bioanalytical Services were included in the protocol • Current information on the members of the DMC was incorporated • Text was added to permit subjects withdrawing from the LCM 300 mg group or the LCM 400 mg group, due to lack of tolerability to enter the open-label extension study at a dose as low as 100 mg/day • The exclusion criteria for heart rate and diastolic blood pressure were revised • The plasma sample collection for LCM determination at the Early Withdrawal Visit was added to Section 6.1 of the protocol and in the Schedule of Study Procedures footnote • Reference to pharmacogenomic analysis was removed from the protocol • A urine drug screen at Visit 1 was not performed. All reference to the urine drug screen was removed from the protocol • Clinical protocol text was modified to provide a realistic timeframe for ECG measurement during the iv LCM infusion which allowed for any possible future alterations by the DMC to the initial protocol-specified infusion duration of 15 minutes • Clinical protocol text was modified to provide a more realistic and acceptable timeframe for PK plasma sample collection for clinical site personnel • A window period of +3 days for Visit 3/Day 8 for all LCM dose groups was added to the protocol and AE reporting was added to the LCM 300 mg group and the LCM 400 mg group under Unscheduled Visit in the Schedule of Study Procedures • Information that the brief physical examination was to be performed after dosing was added to Section 5.4 of the protocol for consistency within the protocol

    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