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    Summary
    EudraCT Number:2017-004606-18
    Sponsor's Protocol Code Number:WASH-OUT
    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:2021-10-01
    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 number2017-004606-18
    A.3Full title of the trial
    Terapia di disassuefazione con metilprednisolone e diazepam ev in pazienti affetti da cefalea cronica con uso eccessivo di sintomatici
    Terapia di disassuefazione con metilprednisolone e diazepam ev in pazienti affetti da cefalea cronica con uso eccessivo di sintomatici
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Terapia di disassuefazione con metilprednisolone e diazepam ev in pazienti affetti da cefalea cronica con uso eccessivo di sintomatici
    Terapia di disassuefazione con metilprednisolone e diazepam ev in pazienti affetti da cefalea cronica con uso eccessivo di sintomatici
    A.3.2Name or abbreviated title of the trial where available
    WASH-OUT
    WASH-OUT
    A.4.1Sponsor's protocol code numberWASH-OUT
    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 SponsorUNIVERSITÀ CAMPUS BIO-MEDICO DI ROMA
    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 supportUNIVERSITA' CAMPUS BIO-MEDICO DI ROMA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNIVERSITA' CAMPUS BIO-MEDICO DI ROMA
    B.5.2Functional name of contact pointSTS
    B.5.3 Address:
    B.5.3.1Street AddressVia Alvaro del Portillo 21
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00128
    B.5.3.4CountryItaly
    B.5.4Telephone number06225419076
    B.5.5Fax number000
    B.5.6E-maili.schiralli@unicampus.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 VALIUM - 10MG/2ML SOLUZIONE INIETTABILE 3 FIALE DA 2ML
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE S.P.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.3.1Product namevalium
    D.3.2Product code 0430315
    D.3.4Pharmaceutical form Solution for injection
    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 INNDIAZEPAM
    D.3.9.2Current sponsor code120915
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER ITALIA S.R.L.
    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.3.1Product nameMETILPREDNISOLONE
    D.3.4Pharmaceutical form Solution for injection
    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 INNMETILPREDNISOLONE EMISUCCINATO SODICO
    D.3.9.1CAS number 83-43-2
    D.3.9.2Current sponsor code120915
    D.3.9.3Other descriptive nameMethylprednisolone
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    Emicrania Cronica e Cefalea da Iperuso di Farmaci
    Emicrania Cronica e Cefalea da Iperuso di Farmaci
    E.1.1.1Medical condition in easily understood language
    Emicrania Cronica e Cefalea da Iperuso di Farmaci
    Emicrania Cronica e Cefalea da Iperuso di Farmaci
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10066636
    E.1.2Term Chronic migraine
    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
    riduzione di prevalenza di cefalea durante il wash-out
    riduzione di prevalenza di cefalea durante il wash-out
    E.2.2Secondary objectives of the trial
    differenze di frequenza di assunzione mensile di farmaci sintomatici,differenze nella percezione dell'intensità del dolore, differenze nel profilo
    differenze di frequenza di assunzione mensile di farmaci sintomatici,differenze nella percezione dell'intensità del dolore, differenze nel profilo psicopatologico, valutazione della percentuale di recidive
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Età compresa tra i 18 ei 70 anni
    - diagnosi di 1.3 emicrania cronica e 8.2 cefalea da iperuso di farmaci (ICHD-3 beta)
    - Rilascio volontario di consenso informato
    - Età compresa tra i 18 ei 70 anni
    - diagnosi di 1.3 emicrania cronica e 8.2 cefalea da iperuso di farmaci (ICHD-3 beta)
    - Rilascio volontario di consenso informato
    E.4Principal exclusion criteria
    ipersensibilità nota a diazepam o metilprednisolone
    - cause note di cefalea secondaria
    - ulcera peptica
    - diabete mellito
    - infezioni fungine sistemiche
    - precedenti infezioni micobatteriche
    - ALT / SGOT o AST / SGPT sopra 1,5 volte il limite superiore del valore normale (ULN)
    - iniezione di OnabotulinumtoxinA nei precedenti 3 mesi
    - gravidanza o allattamento
    - obesità definita come indice di massa corporea (BMI) >32
    - abuso di benzodiazepine al momento dell’arruolamento
    - precedente protocollo di disintossicazione per MOH negli ultimi 12 mesi.
    - ipersensibilità nota a diazepam o metilprednisolone
    - cause note di cefalea secondaria
    - ulcera peptica
    - diabete mellito
    - infezioni fungine sistemiche
    - precedenti infezioni micobatteriche
    - ALT / SGOT o AST / SGPT sopra 1,5 volte il limite superiore del valore normale (ULN)
    - iniezione di OnabotulinumtoxinA nei precedenti 3 mesi
    - gravidanza o allattamento
    - obesità definita come indice di massa corporea (BMI) >32
    - abuso di benzodiazepine al momento dell’arruolamento
    - precedente protocollo di disintossicazione per MOH negli ultimi 12 mesi.
    E.5 End points
    E.5.1Primary end point(s)
    valutare la superiorità di una terapia infusionale endovenosa di soluzione fisiologica NaCl 0,9% con 250 ml con metilprednisolone 250 mg più diazepam 10 mg, rispetto ad una infusione di solo diazepam 10 mg in soluzione fisiologica NaCl 0,9% con 250 ml, in termini di riduzione di prevalenza di cefalea durante il wash-out
    E.5.1.1Timepoint(s) of evaluation of this end point
    5 giorni
    E.5.2Secondary end point(s)
    differenze di frequenza di assunzione mensile di farmaci sintomatici (sintomatici/mese) ad uno, tre e sei mesi (T1, T3 e T6 rispettivamente) dopo il protocollo di disintossicazione tra i due gruppi e differenze di frequenza mensile delle cefalee (giorni con cefalea/mese) ; differenze nella percentuale di responder 50% all’assunzione di farmaci ovvero dei pazienti con una riduzione =50% di assunzione mensile di farmaci sintomatici tra i due gruppi; differenze nei number-needed-to-treat a T1 e T3 per ottenere una riduzione =50% di frequenza mensile delle cefalee e di assunzione mensile di farmaci sintomatici tra i due gruppi; differenze nella percezione dell'intensità del dolore (valutato mediante le seguenti scale: BS-11, PPI, BRS-6 e SF-MPQ), nell'impatto e nella disabilità delle cefalee (misurati da HIT-6 e punteggi MIDAS) ; differenze nel profilo psicopatologico (STAI-Y, DERS, BIS-11, TAS-20 scale) nei sottogruppi stratificati basati sulla base del punteggio Z della scala BDI-II (< o = 1,8) ; valutazione della percentuale di recidive ; valutazione delle differenze nel numero di giorni totale di cefalea durante il wash out (0-5) tra i due gruppi ; differenze dei sintomi da astinenza ed effetti collaterali durante il wash out tra i due gruppi; differenza del numero di rescue medication (paracetamolo e metoclopramide) assunta tra i due gruppi; valutazione dell’effetto sulla tipologia della overused medication
    E.5.2.1Timepoint(s) of evaluation of this end point
    uno, tre e sei mesi; uno, tre e sei mesi ; uno, tre e sei mesi ; uno e tre mesi; uno e tre mesi; 12 mesi; 1-5 giorni; 1-5 giorni; 1-5 giorni; 1-5 giorni
    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 No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned13
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA13
    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 years2
    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 years2
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-10-01. Yes
    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 state284
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 284
    F.4.2.2In the whole clinical trial 284
    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)
    NA
    NA
    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 Decision2018-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-02-07
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