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    Summary
    EudraCT Number:2010-022534-84
    Sponsor's Protocol Code Number:SP0978
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-10-20
    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 ConcernedAustria - BASG
    A.2EudraCT number2010-022534-84
    A.3Full title of the trial
    A multi-center, open-label, single-arm study to evaluate hormone and lipid levels in male subjects with partial onset seizures after a switch of treatment from carbamazepine as adjunctive treatment to levetiracetam to lacosamide as adjunctive treatment to levetiracetam.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multi-center, open-label, single-arm study to evaluate hormone and lipid levels in male subjects with partial onset seizures after a switch of treatment from carbamazepine as adjunctive treatment to levetiracetam to lacosamide as adjunctive treatment to levetiracetam.
    A.4.1Sponsor's protocol code numberSP0978
    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 Pharma SA
    B.1.3.4CountryBelgium
    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 Pharma SA
    B.4.2CountryBelgium
    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.5.3.4CountryGermany
    B.5.4Telephone number+492173481515
    B.5.5Fax number+492173481425
    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 Pharma S.A
    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 Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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 175481-36-4
    D.3.9.2Current sponsor codeSPM927
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 2
    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 Pharma S.A
    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 Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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 175481-36-4
    D.3.9.2Current sponsor codeSPM 927
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 14.1
    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 objective of this study is to evaluate the change in hormonal parameters and lipid parameters in serum after switching from Carbamazepine treatment to Lacosamide treatment as adjunctive therapy to Levetiracetam.
    E.2.2Secondary objectives of the trial
    See section 4.1 of the protocol.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.An Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject or legal representative.
    2.Subject/legal representative is considered reliable and capable of adhering to the protocol, visit schedule or medication intake according to the judgment of the investigator.
    3.Subject is male and between 18 and 45 years of age, inclusive.
    4.Subject has a diagnosis of epilepsy with partial-onset seizures according to the International Classification of Epileptic Seizures (1981) (See Section 15.1).
    5.Subject is only taking LEV in combination with CBZ as adjunctive treatment for epilepsy.
    6.Subject has been treated with CBZ for at least 12 months before study entry.
    7.Subject has been maintained on a stable dose of CBZ and LEV during the 30 days before study entry.
    8.The dose of CBZ at Visit 1 is ≥600mg/day to ≤1200mg/day.
    9.The dose of LEV at Visit 1 is ≥1000mg/day.
    10. Subjects for whom a change from adjunctive treatment of CBZ and LEV to adjunctive
    treatment of LCM and LEV are expected to benefit according to the clinical judgment of
    the investigator. These benefits are related to:
    • Seizure control and/or
    • Tolerability of the treatment and/or
    • Endocrine/metabolic function and/or
    • Drug-drug interactions
    E.4Principal exclusion criteria
    Subjects are not permitted to enroll in the study if any of the following criteria are met:
    1.Subject has previously participated in this study or subject has previously been assigned to treatment in a study of LCM.
    2.Subject has participated in another study of an investigational medicinal product (IMP) or an experimental medical device within the last 30 days or is currently participating in another study of an IMP or a medical device.
    3.Subject has a known hypersensitivity to any components of LCM tablets.
    4.Subject has taken an AED other than CBZ and LEV within the last 30 days, excepting 1 time use of benzodiazepines as rescue medication (less than or equal to 3 doses within 24 hours).
    5. Subject has taken lipid lowering agents within the last 30 days.
    6. Subject has taken any medication known to affect endocrine function within the last 30 days, including exogenous hormones (eg, thyroid hormone, anabolic steroids, androgens, or glucocorticoids).
    7.Subject has taken other enzyme inducers within the last 30 days (eg, St. John’s wort, rifampicin).
    8.Subject is suffering from a known endocrine disorder where the condition or its treatment might influence SHBG levels, reproductive hormones, thyroid hormones, or serum lipid levels.
    9.Subject has a medical condition that could reasonably be expected to interfere with drug absorption, distribution, metabolism, or excretion.
    10.Subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject’s ability to participate in this study.
    11.Deleted and no longer applicable beginning with Protocol Amendment 2 (see protocol amendment details in Section 15.3).
    12.Subject has an acute or sub-acute progressive central nervous system disease.
    13.Subject has a history of chronic alcohol or drug abuse within the last 2 years.
    14.Subject has a known history of severe anaphylactic reaction or serious blood dyscrasias.
    15.Subject has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels ≥2x the upper limit of normal (ULN) or has alkaline phosphatase levels ≥3x ULN at Visit 1.
    16.Subject has impaired renal function (ie, creatinine clearance [CLcr] is lower than 30mL/min) at Baseline. Creatinine clearance will be estimated as follows:
    Adult males: CLcr = (140-age) x weight in kg/(72 x serum creatinine in mg/dL)
    17.Subject has a sick sinus syndrome without a pacemaker, or second or third degree atrioventricular (AV) block.
    18.Subject has a known sodium channelopathy, such as Brugada syndrome.
    19.Subject has experienced a myocardial infarction in the last 3 months.
    20.Subject has New York Heart Association Class III or Class IV heart failure.
    21.Subject with concomitant treatment of felbamate or previous felbamate therapy within the last 6 months prior to study entry.
    22.Subject with previous or concomitant vigabatrin use.
    23.Subject has a lifetime history of suicide attempt (including an active 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)
    Change in serum SHBG concentration from Baseline to the end of the Maintenance Period

    E.5.1.1Timepoint(s) of evaluation of this end point
    End of maintenance period (12 weeks after start of treatment)
    E.5.2Secondary end point(s)
    Change in the sex hormone calculated free androgen index (=100x testosterone/SHBG) levels from Baseline to the end of the Maintenance Period

    Change in the serum thyroid hormone fT4 level from Baseline to the end of the end of the Maintenance Period

    Change in total cholesterol levels from Baseline to the end of the Maintenance Period

    E.5.2.1Timepoint(s) of evaluation of this end point
    End of maintenance period (12 weeks after start 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 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
    evaluate change in hormonal & lipid parameters in serum after switching from CBZ to LCM
    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) No
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    The end of the study is defined as the date of the last visit of the last subject in the study.
    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 months4
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 28
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 28
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 28
    F.4.2.2In the whole clinical trial 28
    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)
    Subjects who choose to continue receiving commercial Lacosamide (LCM) after completion are not required to taper off LCM or return for a Safety Follow-Up Visit (LCM is commercially available in Germany and Spain). Subjects who complete or early terminate the study and choose not to continue receiving commercial LCM should gradually be tapered off LCM and should return for a Safety Follow-Up Visit approximately 2 weeks after the last dose of LCM.
    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 Decision2012-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-12-03
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