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    Summary
    EudraCT Number:2011-001558-27
    Sponsor's Protocol Code Number:SP847
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-04
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2011-001558-27
    A.3Full title of the trial
    A MULTICENTER, OPEN-LABEL STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF LACOSAMIDE (LCM) ORAL SOLUTION (SYRUP) AS ADJUNCTIVE THERAPY IN CHILDREN WITH PARTIAL ONSET SEIZURES
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to evaluate the saftey, tolerability, the absorption and distribution in the body of Lacosamide syrup as adjunctive therapy in children with patial onset seizures.
    A.4.1Sponsor's protocol code numberSP847
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00938431
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUCB BIOSCIENCES, Inc
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUCB BIOSCIENCES, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClinTrial Reg & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    B.5.3.4CountryGermany
    B.5.4Telephone number49217348 1515
    B.5.5Fax number49217348 1572
    B.5.6E-mailclinicaltrials@ucb.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Vimpat
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLacosamide
    D.3.4Pharmaceutical form Syrup
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLacosamide
    D.3.9.1CAS number N03AX18
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Epilepsy, partial onset seizures
    E.1.1.1Medical condition in easily understood language
    Epilepsy
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10015037
    E.1.2Term Epilepsy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of this study are:
    •To evaluate the safety, tolerability, and PK of Lacosamide when added to 1 to 3 concomitant AEDs in children aged 1 month to 17 years with a diagnosis of uncontrolled partial-onset seizures
    •To obtain preliminary efficacy data on seizure frequency
    E.2.2Secondary objectives of the trial
    See response E.2.1
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. A signed informed consent has been obtained from the parent/legal guardian and assent has been obtained from the subject (when possible or as required according to local Institutional Review Boards/Independent Ethics Committees).
    2. Subject and caregiver (which may be a parent, a legal guardian, or other caregiver) are willing and able to comply with all study requirements including maintaining a daily seizure diary.
    3. Subject is male or female between 1 month (ie, 4 weeks after full term [37 weeks gestational age]) and 17 years of age inclusive. For preterm infants <1 year old, the corrected gestational age should be used when determining eligibility. The generally accepted definition of corrected gestational age, which is calculated by subtracting the number of weeks born before 37 weeks of gestation from the chronological age, will be used for this study.
    4. Subject’s BMI is within the 5th to 95th percentile for his/her age group (subjects ≥2 years of age only; see Section 16.2), and subject must be a minimum of 5kg (11.0 pounds) in body weight.
    5. Subject has a diagnosis of epilepsy with partial-onset seizures.
    a. The results of at least 1 prior electroencephalogram (EEG) AND 1 prior magnetic resonance imaging/computerized tomography scan should be consistent with the above diagnosis.
    6. Subject has been observed to have uncontrolled partial-onset seizures after an adequate course of treatment (in the opinion of the investigator) with at least 2 AEDs (concurrently or sequentially).
    7. Subject has been observed to have at least 2 countable seizures in the 4 week period prior to Screening.
    a. In the case of simple partial seizures, only those with motor signs will be counted towards meeting the inclusion criteria (only partial seizures with a recognizable and countable manifestation).
    8. Subject is on a stable dosage regimen of 1 to 3 AEDs, which should remain stable throughout the course of the study. The daily dosage regimen of concomitant AED therapy must be kept constant for a period of at least 1 week prior to Screening. Vagal nerve stimulation is not counted as medical therapy; however, VNS settings must be kept constant for a period of at least 1 week prior to Screening and during the study.
    9.Subject is an acceptable candidate for venipuncture.
    E.4Principal exclusion criteria
    Subjects are not permitted to enroll in the study if any of the following criteria are met:
    1.Subject is currently participating or has participated within the last 2 months in any study of
    an investigational drug or experimental device
    2.Subject has ever received LCM
    3.Subject has any medical or psychiatric condition that could jeopardize the subject’s health,
    compromise the subject’s ability to participate in this study, and/or confound the planned
    assessments of the study. Subject has any medical condition that would affect renal or
    hepatic clearance of LCM
    4.Subject with seizures that are uncountable due to clustering (ie, an episode lasting less than
    30 minutes in which several seizures occur with such frequency that the initiation and
    completion of each individual seizure cannot be distinguished) during the 8-week period
    prior to study entry for subjects ≥1 year of corrected age or the 4-week period prior to study
    entry for subjects <1 year of corrected age)
    5.Subject has a known hypersensitivity to any component of the investigational medicinal
    product
    6.Subject is a female of childbearing potential or the subject achieves menarche during the
    study and does not practice an acceptable method of contraception for the duration of the
    study
    Medically acceptable contraceptive method includes oral or depot contraceptive
    treatment with at least 30μg ethinylestradiol per intake (or 50μg if associated with
    carbamazepine [or other strong enzyme inducers, eg, phenobarbital, primidone,
    oxcarbazepine]) which must be used in conjunction with a barrier method. Sexual
    abstinence is also an acceptable method of contraception.
    The subject must understand the consequences and potential risks of inadequately
    protected sexual activity, be educated about and understand the proper use of
    contraceptive methods, and undertake to inform the investigator of any potential change
    in status. Females of childbearing potential must have a negative pregnancy test at the
    Screening Visit (Visit 1)
    7.Deleted and no longer applicable beginning with Protocol Amendment 4 (see protocol
    amendment details in Section 26, Section 27, and Section 28)
    8.Subject has had or has a febrile illness within 2 weeks of dosing
    9.Subject is on a ketogenic or other specialized diet. If the subject was on a specialized diet in
    the past, they must be off the diet for at least 2 months prior to the Screening Visit
    10.Subject has an alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total
    bilirubin level greater than or equal to 2 times the upper limit of normal (ULN), or creatinine
    clearance less than 50mL/min
    11.Subject has a clinically relevant ECG abnormality, in the opinion of the principal investigator
    (ie, second or third degree heart block at rest or a QT prolongation greater than 450ms)
    12.Subject has hemodynamically significant heart disease (eg, heart failure)
    13.Subject has an arrhythmic heart condition requiring medical therapy
    14.Subject has a known history of severe anaphylactic reaction or serious blood dyscrasias.
    15.Subject has nonepileptic events, including psychogenic seizures, that could be confused with
    seizures. If both epileptic and nonepileptic events are present, epileptic events must be
    distinguished from nonepileptic phenomena
    16.Subject has a history of primary generalized epilepsy. Subject <2 years of age has EEG
    findings or a clinical history of primary generalized epilepsy
    17.Subject ≥2 years of age has a history of status epilepticus within the 6-month period prior to
    Screening. Subject <2 years of age who has a history of status epilepticus requiring
    hospitalization during the 1-month period prior to Screening
    18.Subject is receiving concomitant treatment with felbamate or has received previous
    felbamate therapy within the last 6 months prior to Screening
    19.Subject has taken or is currently taking vigabatrin
    20.Subject has a progressive neurological disorder (this does not ordinarily exclude
    Lennox-Gastaut, Tuberous Sclerosis, or West Syndrome)
    21.Deleted and no longer applicable beginning with Protocol Amendment 5 (see protocol
    amendment details in Section 29, Section 30, and Section 31)
    22.Subject is taking monoamine oxidase (MAO) inhibitors or narcotic analgesics
    23.Subject has epilepsy secondary to a progressing cerebral disease or any other progressively
    neurodegenerative disease, such as Rasmussen syndrome
    24.Subject <2 years of age has a treatable seizure etiology (eg, febrile seizures). The occurrence
    of febrile seizures per se is not exclusionary
    25.Subject has a known sodium channelopathy, such as Brugada syndrome
    26.Subject has a lifetime history of suicide attempt (including an actual attempt, interrupted
    attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a
    positive response (“Yes”) to either Question 4 or Question 5 of the Columbia-Suicide
    Severity Rating Scale (C-SSRS) at Screening
    E.5 End points
    E.5.1Primary end point(s)
    Number of subjects that report at least one treatment-emergent adverse event
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 13
    E.5.2Secondary end point(s)
    •Mean LCM plasma concentration

    •Mean SPM 12809 plasma concentration
    •Change in seizure frequency
    •Change in Caregiver Global Impression of Change score
    •Change in Caregiver Global Impression of Change


    E.5.2.1Timepoint(s) of evaluation of this end point
    Mean LCM plasma concentration
    -Pre-dose (-1 to 0 hours)
    -18-42 minutes post-dose
    -48-72 minutes post-dose
    -90 to 150 minutes post-dose
    -210 to 270 minutes post-dose
    -6 to 9 hours post-dose
    -11 to 12 hours post-dose
    •Mean SPM 12809 plasma concentration
    -18-42 minutes post-dose
    -48-72 minutes post-dose
    -90 to 150 minutes post-dose
    -210 to 270 minutes post-dose
    -6 to 9 hours post-dose
    -11 to 12 hours post-dose
    Change in seizure frequency
    - Baseline to End of Treatment
    Change in Caregiver Global Impression of Change score
    - Baseline to End of Treatment
    Change in Caregiver Global Impression of Change
    - Baseline to End of Treatment
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Mexico
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 42
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 12
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 23
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 8
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 5
    F.4.2.2In the whole clinical trial 42
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    See protocol section 5.5.1 early termination visit and section 5.5.2 End of study visit.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-07
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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