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    Summary
    EudraCT Number:2015-004827-30
    Sponsor's Protocol Code Number:RASLOW
    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:2021-09-30
    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 number2015-004827-30
    A.3Full title of the trial
    RAPID VERSUS SLOW WITHDRAWAL OF ANTIEPILEPTIC MONOTHERAPY IN TWO-YEAR SEIZURE-FREE ADULTS PATIENTS WITH EPILEPSY (RASLOW) STUDY: A PRAGMATIC MULTICENTRE, PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY.
    RAPID VERSUS SLOW WITHDRAWAL OF ANTIEPILEPTIC MONOTHERAPY IN TWO-YEAR SEIZURE-FREE ADULTS PATIENTS WITH EPILEPSY (RASLOW) STUDY: A PRAGMATIC MULTICENTRE, PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Rapid versus slow withdrawal of antiepileptci monotherapy in two-year seizure free patients.
    Sospensione rapida contro sospensione lenta della monoterapia con un farmaco antiepilettico in pazienti senza crisi da almeno due anni
    A.3.2Name or abbreviated title of the trial where available
    RASLOW
    RASLOW
    A.4.1Sponsor's protocol code numberRASLOW
    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 SponsorAZIENDA OSPEDALIERA "BIANCHI-MELACRINO-MORELLI"
    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 supportMinistero della Salute
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportREGIONE CALABRIA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS ISTITUTO DI RICERCHE FARMACOLOGICHE "MARIO NEGRI" DI MILANO
    B.5.2Functional name of contact pointLABORATORIO MALATTIE NEUROLOGICHE
    B.5.3 Address:
    B.5.3.1Street AddressVIA LA MASA 19
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20068
    B.5.3.4CountryItaly
    B.5.4Telephone number0239014604
    B.5.5Fax number0239001916
    B.5.6E-mailraslow@marionegri.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 KEPPRA - 1000MG-COMPRESSA RIVESTITA CON FILM-USO ORALE BLISTER DIVISIBILE (ALLUMINIO/PVC)-100X1 (DOSE UNITARIA)
    D.2.1.1.2Name of the Marketing Authorisation holderUCB PHARMA S.A.
    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.3.9.2Current sponsor codenon applicabile
    D.3.9.3Other descriptive nameAntiepileptic drugs
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0 to 9999
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Epilessia
    E.1.1.1Medical condition in easily understood language
    Epilepsy
    Epilessia
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10015046
    E.1.2Term Epilepsy, unspecified
    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
    The main objective of the present study will be to establish whether a slow or a rapid withdrawal schedule of antiepileptic monotherapy influence relapse rate in adult patients with epilepsy, who have been seizure-free for at least two years.
    Scopo primario dello studio è quello di stabilire se la sospensione lenta e la sospensione rapida della monoterapia con farmaci antiepilettici influenzano il tasso di ricaduta in pazienti adulti con diagnosi di epilessia liberi da crisi da almeno due anni.
    E.2.2Secondary objectives of the trial
    Secondary objectives will be to establish the compliance rates with these two schedules and the differences in terms of severity of relapses, based on occurrence of status epilepticus, seizure-related injuries and death.
    Gli obiettivi secondari sono quelli di valutare le differenze tra i due gruppi (sospensione lenta contro sospensione rapida) in termini di compliance con il programma di sospensione, di eventi di stato di male epilettico durante e dopo la sospensione, e di mortalità durante il periodo di studio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Age at inclusion 18+ years;
    2) Diagnosis of epilepsy (according to ILAE 1989 criteria);
    3) Age at epilepsy onset of 16 years or older;
    4) Seizure freedom for at least 2 years;
    5) Current treatment with one of the AEDs available for monotherapy available in Italy (carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, topiramate, valproic acid, zonisamide);
    6) Ability to understand and comply with the study requirements and to give written informed consent;
    7) Current drug is the active principle contributing to the achievement of seizure remission regardless of the indication and the tolerability profile;
    8) Absence of any contraindication and special warning for the current antiepileptic drug.
    1) Età superiore a 18 anni;
    2) Diagnosi di epilessia (secondo i criteri ILAE 1989 [15]);
    3) Età all’esordio dell’epilessia =16 anni;
    4) Assenza di crisi da almeno due anni;
    5) Attualmente in trattamento con uno dei farmaci antiepilettici disponibili per il trattamento entiepilettico in monoterapia in Italia (carbamazepina, lamotrigina, levetiracetam, oxcarbazepina, fenobarbital, fenitoina, topiramato, acido valproico, zonisamide);
    6) Capacità di comprendere e di rispettare tutte le procedure dello studio e di fornire un consenso informato;
    7) Il principio attivo attualmente assunto è quello che ha permesso di raggiungere lo stato di remissione indipendentemente dalla sua indicazione e dal profilo di tollerabilità;
    8) Assenza di ogni controindicazione e avvertenza speciale per l’antiepilettico in uso.
    E.4Principal exclusion criteria
    1) Inability to understand the aims or modalities of the study;
    2) Current pregnancy or plans to become pregnant during withdrawal period (e.g. who are not post menopausal, surgically sterile, or using inadequate birth control);
    3) History of seizure relapse after discontinuation of treatment;
    4) History of psychogenic non-epileptic seizures (PNES);
    5) History of status epilepticus;
    6) Poor compliance with previous treatments;
    7) Experimental treatments in previous 3 months;
    8) Men unable to practice contraception for the duration of the treatment.
    1) Incapacità a capire gli scopi o le modalità dello studio;
    2) Gravidanza in atto o pianificazione di gravidanza durante il periodo di sospensione della terapia (ad esempio, donne che non sono in post menopausa, chirurgicamente sterili o che utilizzano un metodo contraccettivo inadeguato);
    3) Storia di recidiva di crisi dopo la sospensione del trattamento;
    4) Storia di crisi psicogeniche non epilettiche (PNES);
    5) Storia di stato epilettico;
    6) Scarsa compliance con i precedenti trattamenti;
    7) Uso di farmaci sperimentali nei 3 mesi precedenti;
    8) Uomini che non vogliono utilizzare un metodo contraccettivo durante il trattamento.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the time to recurrence of an epileptic seizure.
    L’endpoint primario è il tempo alla ricorrenza delle crisi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Anytime during the study
    Qualsiasi momento durante lo studio
    E.5.2Secondary end point(s)
    Secondary endpoints are the compliance with the assigned withdrawal schedule and the severity of relapses, in terms of seizure-related injuries (contusions, wounds, fractures, strain/sprain, head injury, burns, whiplash), status epilepticus (SE) during or after withdrawal period, and mortality.
    Gli endpoint secondari sono la compliance con il trattamento assegnato e la severità delle ricadute, in termini di danni correlati alle crisi (contusioni, ferite, fratture, stiramenti/distorsioni, danni cerebrali, bruciature/ustioni, colpo di frusta), stato di male epilettico durante o dopo il periodo di sospensione e la mortalità.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Anytime during the study
    In ogni momento durante lo studio
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    1) Sospensione rapida: riduzione del 20% della dose iniziale ogni 15 giorni fino alla sospensione co
    1) Rapid withdrawal: reduction by 20% of initial dosage every 15 days until complete discontinuation
    E.8.2.4Number of treatment arms in the trial2
    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 concerned37
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA37
    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 Information not present in EudraCT
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    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 months0
    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 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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state350
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 350
    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)
    Patients will take the best pharmacological treatment for clinical practice chosen by the neurologist.
    Il paziente assumerà la terapia farmacologica che il neurologo riterrà più opportuna per la sua condizione 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 Decision2016-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-21
    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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