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    Summary
    EudraCT Number:2013-001834-16
    Sponsor's Protocol Code Number:AD101_01
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-10-14
    Trial 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-001834-16
    A.3Full title of the trial
    EVALUATION OF SEIZURE CONTROL AND QUALITY OF LIFE IN PATIENTS WITH BRAIN TUMOR RELATED EPILEPSY TREATED WITH LACOSAMIDE AS ADD-ON THERAPY: A PROSPECTIVE EXPLORATIVE STUDY
    VALUTAZIONE DEL CONTROLLO DELLE CRISI E DELLA QUALITA’ DI VITA IN PAZIENTI AFFETTI DA EPILESSIA SECONDARIA A NEOPLASIA CEREBRALE IN TRATTAMENTO CON LACOSAMIDE (Vimpat®) IN ADD-ON : STUDIO PROSPETTICO ESPLORATIVO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EVALUATION OF SEIZURE CONTROL AND QUALITY OF LIFE IN PATIENTS WITH BRAIN TUMOR RELATED EPILEPSY TREATED WITH LACOSAMIDE AS ADD-ON THERAPY: A PROSPECTIVE EXPLORATIVE STUDY
    VALUTAZIONE DEL CONTROLLO DELLE CRISI E DELLA QUALITA’ DI VITA IN PAZIENTI AFFETTI DA EPILESSIA SECONDARIA A NEOPLASIA CEREBRALE IN TRATTAMENTO CON LACOSAMIDE (Vimpat®) IN ADD-ON : STUDIO PROSPETTICO ESPLORATIVO
    A.3.2Name or abbreviated title of the trial where available
    LACO_ADD_ON
    A.4.1Sponsor's protocol code numberAD101_01
    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 SponsorISTITUTI FISIOTERAPICI OSPITALIERI
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUCB Pharma
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationISTITUTI FISIOTERAPICI OSPITALIERI
    B.5.2Functional name of contact pointSEGRETERIA COMITATO ETICO
    B.5.3 Address:
    B.5.3.1Street AddressVIA ELIO CHIANESI 53
    B.5.3.2Town/ cityROMA
    B.5.3.3Post code00144
    B.5.3.4CountryItaly
    B.5.6E-mailcomitatoetico@ifo.it
    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 SA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form 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.3.9.4EV Substance CodeSUB25407
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number200 to 400
    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
    PATIENTS WITH BRAIN TUMOR RELATED EPILEPSY
    PAZIENTI CON EPILESSIA SECONDARIA A NEOPLASIA CEREBRALE
    E.1.1.1Medical condition in easily understood language
    PATIENTS WITH BRAIN TUMOR RELATED EPILEPSY
    PAZIENTI CON EPILESSIA SECONDARIA A NEOPLASIA CEREBRALE
    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 LLT
    E.1.2Classification code 10068330
    E.1.2Term Symptomatic epilepsy
    E.1.2System Organ Class 100000004852
    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 effect of LCM treatment on seizure control as add-on in patients with brain tumor-related epilepsy, after 6 months period of treatment.
    Valutare l’effetto del trattamento con lacosamide in add-on sul controllo delle crisi epilettiche correlate a neoplasia cerebrale durante 6 mesi di trattamento
    E.2.2Secondary objectives of the trial
    1. Responder rate ≥50%, 75%, 100%
    2. To monitor the impact on QoL, on mood and on functional status at 3 and 6 months as compared with baseline
    3. To evaluate the possible modifications of blood levels of LCM
    4. To evaluate the occurrence of adverse events during therapy with LCM using Adverse Events Profile (AEP)
    Valutare l’impatto del trattamento con lacosamide in add-on sulla qualità di vita, sull’umore e sul functional status a 3 e a 6 mesi.
    o Valutare le eventuali modificazioni plasmatiche di lacosamide durante il trattamento.
    o Valutare l’incidenza di eventi avversi durante il trattamento con lacosamide
    mediante un test di valutazione degli effetti avversi specifico per pazienti in
    trattamento con AEDs.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients Age ≥18 years ≤75 (both sexes) with primary BT (astrocytoma II and III WHO, oligodendroglioma II and III WHO and multiform glioblastoma), cerebral lymphoma, with previous surgical resection or biopsy.
    Informed consent signature
    Patients in a stable phase of disease (evidenced by unchanged neuroradiological examinations).
    Symptomatic epilepsy characterized by partial seizures with or without secondary generalization; ≥ 2 seizure in the last month, despite treatment with the maximum tolerated stable dose of 1-2 AED.
    Seizure retrospective count at least in the last 28 days.
    Patients could be also in treatment with CT, radiotherapy and corticosteroids started before LCM introduction not generating specific adverse effects.
    Patients treated for the oncological disease following international oncological guidelines
    ): pazienti con neoplasia cerebrale con crisi parziali farmacoresitenti, di età compresa tra i 18 ed i 75 anni, con neoplasia cerebrale primitiva (astrocitoma II e III WHO, oligodendroglioma II e III WHO e glioblastoma multiforme), linfoma cerebrale sottoposti precedentemente a resezione chirurgica o a biopsia. I pazienti potranno essere in trattamento chemioterapico concomitante e/o in terapia corticosteroidea. Tutti i pazienti devono essere in fase di stabilità di malattia come evidenziato dalle neuroimmagini.
    Le crisi parziali con o senza secondaria generalizzazione devono essere farmaco resistenti e in numero di almeno 2 episodi nel mese precedente.
    E.4Principal exclusion criteria
    Patients Age ≤18 years ≥75 (both sexes) with primary BT
    Karnofsky Performace Status <60
    Patients with a previous epilepsy before tumor onset
    Patients with other chronic neurological and psychiatric diseases
    Patients with brain metastases
    Patients child bearing or breastfeeding
    Allergy or intolerance to soya, peanuts, lacosamide, lacosamide tablet eccipients.
    Patients with known preexisting second or third degree AV block.
    Età <18 anni>75
    Karnofsky Performance Status <60
    Pazienti con epilessia non secondaria
    Pazienti affetti da qualunque altra patologia neurologica o psichiatrica
    Pazienti con metastasi cerebrali
    Pazienti in gravidanza o allattamento
    Pazienti intolleranti alla soya, noccioline, lacosamide, o agli eccipienti delle compresse di LCM.
    E.5 End points
    E.5.1Primary end point(s)
    Mean seizure frequency reduction as compared with baseline period available during the 6 months of treatment period after having reached minimal effective dose of 200mg/day.
    Riduzione della frequenza media di crisi al follow-up finale rispetto al tempo 0 (baseline) dopo aver raggiunto la minima dose efficace di lacosamide di 200mg/die.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 MONTHS
    6 MESI
    E.5.2Secondary end point(s)
    Seizure freedom rate at 6 months of treatment period.

    Responder rate using a ≥ 50% and 75% reduction of seizure frequency as compared with baseline. A patient responder is defined as a patient having achieved at least a 50% monthly seizure reduction during the six months of treatment as compared with seizure frequency at baseline. Seizure frequency will be evaluated as mean of the seizure frequency during the 6 months of the treatment period.
    Stability of blood levels of LCM during the follow-up.
    Libertà di crisi a 3 e 6 mesi di trattamento.
    _ Responder Rate del ≥ 50% e del 75% di riduzione della frequenza media di crisi
    rispetto al tempo 0 (baseline). La frequenza delle crisi sarà valutata come media
    della frequenza crisi durante i 6 mesi di follow-up.
    _ Stabilità dei livelli ematologici di LCM durante il follow-up
    _ Effetto di lacosamide sulla qualità di vita valutata utilizzando il QOLIE 31-P (10) e
    l’Eortc QLQ-C30 (11).
    _ Effetto di lacosamide sul tono dell’umore utilizzando la Zung Self Depression Rating
    Scale (12).
    E.5.2.1Timepoint(s) of evaluation of this end point
    3-6 MONTHS
    3-6 MESI
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned2
    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 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
    LVLS
    LVLS
    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 months19
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months19
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    NONE
    NORMALE PRATICA CLINICA
    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 Decision2014-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-27
    P. End of Trial
    P.End of Trial StatusOngoing
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