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    EudraCT Number:2014-003294-42
    Sponsor's Protocol Code Number:EP0060
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-03-24
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-003294-42
    A.3Full title of the trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to investigate safety and tolerability of intravenous lacosamide as replacement of oral lacosamide in children.
    A.4.1Sponsor's protocol code numberEP0060
    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 pointClin Trial 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.5.4Telephone number+49 2176 481515
    B.5.5Fax number+49 2173 481572
    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. name Vimpat
    D. of the Marketing Authorisation holderUCB Pharma SA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLACOSAMIDE
    D.3.9.1CAS number 175481-36-4
    D.3.9.2Current sponsor codeLCM. SPM 927
    D.3.9.4EV Substance CodeSUB25407
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    E.1.1.1Medical condition in easily understood language
    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 18.1
    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
    To evaluate the safety and tolerability of intravenous (iv) lacosamide (LCM) infusion(s) in subjects ≥4 to <17 years of age with epilepsy, after temporarily switching from the equivalent stable oral LCM dose.
    E.2.2Secondary objectives of the trial
    To evaluate the pharmacokinetics (PK) of intravenous (iv) lacosamide (LCM)
    replacement in pediatric subjects with epilepsy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is male or female from ≥4 to <17 years of age.
    2. Subject is participating in a long-term, open-label study with lacosamide (LCM) or is currently prescribed
    oral VIMPAT and needs to undergo a procedure, is admitted to an epilepsy monitoring unit (EMU) or health care facility, or other situations where intravenous (iv) administration of LCM is clinically appropriate.
    3. Subject is an acceptable candidate for venipuncture and iv infusion.
    Subjects who are participating in a long-term, open-label study with LCM must fulfill the
    following additional inclusion criteria:
    4. Subject is currently enrolled in a long-term, open-label study, receiving oral LCM for the
    treatment of epilepsy.
    5. Subject has been on a stable bid dosage regimen of oral LCM for the last 3 days in their
    long-term, open-label study.
    Subjects who are currently prescribed oral VIMPAT and enroll directly into EP0060 must fulfill
    the following additional inclusion criteria:
    6. Subject has been prescribed oral VIMPAT at a dose of 2mg/kg/day to 12mg/kg/day (for
    subjects <50kg) or 100mg/day to 600mg/day (for subjects ≥50kg).
    7. Subject has been prescribed oral VIMPAT for the treatment of epilepsy for at least 1 month
    prior to Screening and has not been prescribed or maintained on VIMPAT for the purposes of
    participating in EP0060. Prescribed oral VIMPAT dose must be stable for at least 7 days, and
    intake of the prescribed total daily dose confirmed for at least 3 days prior to first infusion.
    E.4Principal exclusion criteria
    1. Subject has previously received intravenous (iv) lacosamide (LCM) in this study.
    2. Subject has any medical, neurological, or psychiatric condition that, in the opinion of the
    investigator, could jeopardize the subject’s health or compromise the subject’s ability to
    participate in EP0060.
    3. Subject has clinically significant hypotension or bradycardia.
    4. Subject ≥6 years of age 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 positive responses (“Yes”) to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening.
    5. Subject does not have a diagnosis of epilepsy.
    6. Subject is taking monoamine oxidase inhibitors (MAOIs).
    Subjects who are participating in a long-term, open-label study with LCM are not permitted to
    enroll in EP0060 if any of the following additional criteria are met:
    7. Subject has any ongoing Adverse Event (AE) in their long-term, open-label study that, in the opinion of the investigator, could jeopardize or would compromise the subject’s ability to participate
    Subjects who are currently prescribed oral VIMPAT are not permitted to directly enroll in
    EP0060 if any of the following additional criteria are met:
    8. Subject has a medical condition that could reasonably be expected to interfere with drug
    distribution, metabolism, or excretion.
    9. Subject has a known hypersensitivity to any component of the investigational medicinal
    product (IMP).
    10. Subject is a female of childbearing potential and does not practice an acceptable method of
    contraception for the duration of participation in EP0060.
    11. 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 30mL/min.
    12. Subject has a clinically relevant electrocardiogram (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).
    13. Subject has hemodynamically significant heart disease (eg, heart failure).
    14. Subject has an arrhythmic heart condition requiring medical therapy.
    15. Subject has a known history of severe anaphylactic reaction or serious blood dyscrasias.
    16. Subject has only nonepileptic events, including psychogenic seizures, which could be
    confused with seizures. If both epileptic and nonepileptic events are present, epileptic events
    must be distinguished from nonepileptic phenomena.
    17. Subject has been treated with felbamate for at least 12 months prior to entering EP0060 and
    has experienced any toxicity issues with this treatment. Note: Any subject who is currently treated with felbamate, and has received felbamate for a period of less than 12 months, is
    excluded from EP0060.
    18. Subject has an acute or subacutely progressive central nervous system disease. Subject has
    epilepsy secondary to a progressing cerebral disease or any other progressive or
    neurodegenerative disease (malignant brain tumor or Rasmussen syndrome).
    19. Subject has a known cardiac sodium channelopathy, such as Brugada syndrome.
    E.5 End points
    E.5.1Primary end point(s)
    1) Number of subjects that withdraw due to treatment emergent adverse events during the study
    2)Number of subjects experiencing at least one treatment emergent adverse event during the study
    3) Number of subjects experiencing at least 1 injection-related treatment emergent adverse event during the study

    E.5.1.1Timepoint(s) of evaluation of this end point
    1) During the treatment period (up to 5 days)
    2) During the treatment period (up to 9 days)
    3) During the treatment period (up to 5 days)
    E.5.2Secondary end point(s)
    Not Applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable
    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 No
    E.6.6Pharmacokinetic No
    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
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    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.8.2.4Number of treatment arms in the trial1
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years9
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days15
    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: 75
    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) No
    F.1.1.5Children (2-11years) Yes
    F. of subjects for this age range: 50
    F.1.1.6Adolescents (12-17 years) Yes
    F. of subjects for this age range: 25
    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 Yes
    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. of subjects incapable of giving consent
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 39
    F.4.2.2In the whole clinical trial 75
    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)
    After completion of or discontinuation from EP0060, only subjects who enrolled into EP0060 from a long-term, open-label study will resume their participation in that study and resume oral LCM treatment accordingly. Subjects who were prescribed Vimpat® should continue antiepileptic drug treatment at the discretion of the treating physician.
    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 Decision2016-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-28
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