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    Summary
    EudraCT Number:2016-002072-26
    Sponsor's Protocol Code Number:P150939
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-28
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-002072-26
    A.3Full title of the trial
    Multicenter randomized placebo controlled trial assessing the efficacy of oral adjuvant magnesium supplementation in the treatment of alcohol withdrawal syndrome.
    Essai randomisé contrôlé contre placebo évaluant l'efficacité de la supplémentation orale adjuvante par magnésium dans le traitement du syndrome de sevrage en alcool.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NA
    NA
    A.3.2Name or abbreviated title of the trial where available
    MAGMA
    A.4.1Sponsor's protocol code numberP150939
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.1.3.4CountryFrance
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCD Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailsylvie.prieur@aphp.fr
    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 MAGNESPASMYL 47, 4 mg
    D.2.1.1.2Name of the Marketing Authorisation holderETHYPHARM
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameMAGNESPASMYL 47, 4 mg
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLactate de magnésium dihydraté
    D.3.9.3Other descriptive nameLactate de magnésium dihydraté
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number47,4
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients experiencing an alcohol withdrawal syndrome.
    NA
    E.1.1.1Medical condition in easily understood language
    NA
    NA
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behaviours [F01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10053164
    E.1.2Term Alcohol withdrawal syndrome
    E.1.2System Organ Class 10037175 - Psychiatric 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 examine the efficacy of oral magnesium supplementation as an adjuvant therapy for decreasing intensity of AWS among inpatients requiring pharmacological treatment of their AWS.
    NA
    E.2.2Secondary objectives of the trial
    1 To examine whether oral magnesium supplementation as an adjuvant drug therapy for AWS:
    a Reduces benzodiazepine consumption;
    b Reduces the length of the withdrawal syndrome;
    c Reduces incidence of seizure and delirium tremens during withdrawal syndrome;
    d Reduces intensity of withdrawal symptoms in patients with severe physical comorbidities;
    e Reduces intensity of withdrawal symptoms in elderly patients (i.e. from 60 to 75 years);
    f Decreases the risk of leaving the hospital before the end of care;
    g Helps patients to enroll in a weaning process;
    h Increases patient satisfaction;
    i Is associated with changes in plasmatic magnesium concentration;
    j Induces adverse effects;
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    Patients eligible for inclusion in this study have to fulfill all the following criteria:
    - Adult inpatients, men and women (i.e. age>18 years and <75 years) ;
    - Current AWS according to DSM-5 criteria;
    - Score at the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar) >8;
    - Written informed consent to participate in the study.
    - Affiliation to the French Social Security Health Care plan
    NA
    E.4Principal exclusion criteria
    Non-inclusion criteria
    - Age less than 18 or greater than 75;
    - Hemodynamic failure;
    - Arythmia;
    - Lack of fulfilling AWS criteria according to DSM-5;
    - Score at the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar) <=8;
    - Other current substance use disorder regarding DSM-5 criteria, including benzodiazepine substance use disorder and except for tobacco. In addition to benzodiazepine substance use disorder, following criteria of inappropriate use of benzodiazepine and related-benzodiazepine hypnotics are also considered as non-inclusion criteria: - over-the-counter consumption; - consumption outside the indications of marketing authorization; - excessive dosage or duration regarding guidelines. Licit or illicit substance consumption that is not fulfilling substance use disorder DSM-5 criteria is not considered as a non-inclusion criterion (e.g. cannabis consumption without sufficient criteria to diagnose substance use disorder regarding DSM-5 criteria);
    - Pregnancy or breast-feeding;
    - Unable to take oral medications;
    - Creatinine clearance <30mL/min according to the Cockcroft-Gault Equation;
    - Cognitive disorders that impair the informed consent, including dementia (except for acute withdrawal delirium);
    - Psychiatric disorder requiring hospitalization or specific cares in emergency (e.g. suicidal crisis, acute psychotic episode);
    - Magnesium supplementation (regardless the type of delivery) within 3 months prior to inclusion;
    - Actual quinidine intake;
    - No written informed consent to participate in the study.
    NA
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    The primary endpoint is the between-group absolute difference of the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar) score change from baseline, 3 days after randomization.
    Secondary endpoints:
    a Total benzodiazepine consumption compared between experimental and control groups throughout the duration of the study (i.e. 15 days);
    b Time required to obtain a total score of 0 at the CIWA-Ar compared between experimental and control groups;
    c Rate of patients experiencing seizures and delirium tremens during the study compared between intervention and control groups;
    d Stratify results of the Primary endpoint following score at the Charlson Comorbidity Index;
    e Stratify results of the Primary endpoint by age;
    f Number of participants who left the hospital against medical advice during the study compared between experimental and control groups;
    g Number of participants who made an appointment in an addiction unit during the study (i.e. before the last follow-up point, 15 days after baseline), compared between experimental and control groups after stratification following AUD duration and number of previous addiction healthcare;
    h Patient Satisfaction Questionnaire-18 (PSQ-18) scores at the last follow-up point (i.e. days after baseline) compared between experimental and control groups;
    i Total plasmatic magnesium concentration changes between baseline, 3 days after baseline, and 7 days after baseline;
    j Rate of all adverse events occurred during the study incidence compared between experimental and control groups;
    NA
    E.5.1.1Timepoint(s) of evaluation of this end point
    NA
    25 mois
    E.5.2Secondary end point(s)
    a Total benzodiazepine consumption compared between experimental and control groups throughout the duration of the study (i.e. 15 days);
    b Time required to obtain a total score of 0 at the CIWA-Ar compared between experimental and control groups;
    c Rate of patients experiencing seizures and delirium tremens during the study compared between intervention and control groups;
    d Stratify results of the Primary endpoint following score at the Charlson Comorbidity Index;
    e Stratify results of the Primary endpoint by age;
    f Number of participants who left the hospital against medical advice during the study compared between experimental and control groups;
    g Number of participants who made an appointment in an addiction unit during the study (i.e. before the last follow-up point, 15 days after baseline), compared between experimental and control groups after stratification following AUD duration and number of previous addiction healthcare;
    h Patient Satisfaction Questionnaire-18 (PSQ-18) scores at the last follow-up point (i.e. days after baseline) compared between experimental and control groups;
    i Total plasmatic magnesium concentration changes between baseline, 3 days after baseline, and 7 days after baseline;
    j Rate of all adverse events occurred during the study incidence compared between experimental and control groups;
    NA
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    25 mois
    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.6.13.1Other scope of the trial description
    Patients experiencing an alcohol withdrawal syndrome.
    Patients souffrant de syndrome de sevrage alcoolique.
    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 No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned9
    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
    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 months1
    E.8.9.1In the Member State concerned 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: 400
    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 Yes
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    NA
    Patient pouvant être dans la situation de l'arrivée du SAMU en réanimation et ne pouvant ni être informé, ni consentir.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state450
    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 Decision2016-08-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-10-25
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