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    Summary
    EudraCT Number:2015-003749-24
    Sponsor's Protocol Code Number:MGLACC07810
    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:2016-04-20
    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 ConcernedFrance - ANSM
    A.2EudraCT number2015-003749-24
    A.3Full title of the trial
    Effects of MagneB6® (470.0 mg Magnesium Lactate Dihydrate + 5.0 mg Pyridoxine Hydrochloride, Coated Tablet) Supplementation (8 Weeks) on Stress Levels of Chronically Stressed Subjects, with Suboptimal Serum Magnesium Levels- A Randomized, Single-blind Active Comparator, Multicentric Clinical Trial - Comparison with Magnespasmyl® (465.4 mg Magnesium Lactate Dihydrate, Coated Tablet)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of the Effects of MagneB6 (Magnesium + pyridoxine) Versus Magnespasmyl (Magnesium) on Stress Levels in Chronically Stressed Subjects with Suboptimal Serum Magnesium Level (MB6 SUPERIORITY)
    A.3.2Name or abbreviated title of the trial where available
    MB6 SUPERIORITY
    A.4.1Sponsor's protocol code numberMGLACC07810
    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 SponsorSanofi-Aventis Group
    B.1.3.4CountryFrance
    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 supportSanofi-aventis group
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-aventis France
    B.5.2Functional name of contact pointDirection des Opérations Cliniques
    B.5.3 Address:
    B.5.3.1Street Address82 avenue Raspail
    B.5.3.2Town/ cityGentilly
    B.5.3.3Post code94255
    B.5.3.4CountryFrance
    B.5.4Telephone number+330800222555
    B.5.6E-mailPublic-registry-MA-France@sanofi.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 Magné B6 48 mg/5 mg coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-aventis France
    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.3.4Pharmaceutical form 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 INNMagnesium Lactate Dihydrate
    D.3.9.3Other descriptive nameMAGNESIUM LACTATE DIHYDRATE
    D.3.9.4EV Substance CodeSUB23354
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number470
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPYRIDOXINE HYDROCHLORIDE
    D.3.9.1CAS number 58-56-0
    D.3.9.4EV Substance CodeSUB15062MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 Magnespasmyl
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATOIRES ETHYPHARM
    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.3.4Pharmaceutical form 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 INNmagnesium lactate dihydrate
    D.3.9.3Other descriptive nameMAGNESIUM LACTATE DIHYDRATE
    D.3.9.4EV Substance CodeSUB23354
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number465.4
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the superiority of Magne B6 versus Magnespasmyl (magnesium only) supplementation on stress level, evaluated by the stress subscale from the Depression Anxiety Stress Scale (DASS)-42 test, in chronically stressed subjects with suboptimal serum magnesium levels.
    E.2.2Secondary objectives of the trial
    -To compare the effect of Magne B6 versus Magnespasmyl supplementation on depression and anxiety subscales from the DASS-42 test.
    -To compare the effect of Magne B6 versus Magnespasmyl supplementation on cortisol awakening response (CAR) measured over a 2-day period.
    -To compare the effect of Magne B6 versus Magnespasmyl supplementation on magnesium levels in erythrocytes.
    -Adverse events (AEs).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Male and female subjects aged between 18 and 50 years, chronically stressed (screening DASS-42 scale for chronic stress >18).
    -Signed written informed consent.
    -Moderate hypomagnesemic and low serum magnesium level subjects (0.5mmol/L <Mg serum levels <0.85mmol/L).
    -Women must use an effective contraceptive method during the study period.
    -Body mass index (BMI) >18.5 and ≤29.9 kg/m^2.
    -Able to understand the study, including risks and adverse events; collaborating with Investigator and proceeding according with protocol.
    E.4Principal exclusion criteria
    -Any technical/administrative reason (eg, subject homeless) that makes it impossible to randomize the patient in the study.
    -Subject who has previously participated in any clinical trial of Magne B6 or Magnespasmyl.
    -Subject who has taken other investigational drugs or prohibited therapy for this study within 3 months from screening.
    -Conditions/situations such as:
    -Subjects with conditions/concomitant diseases making them non evaluable for the primary endpoint.
    -Requirement for concomitant treatment that could bias primary endpoint.
    -Impossibility to meet specific protocol requirements (eg, for hospitalization).
    -Subject is the Investigator or any Subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
    -Subject not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions or subjects potentially at risk of noncompliance to study procedures.
    -Subjects with severe hypomagnesemia (serum magnesium less than or equal to 0.45 mmol/L).
    -Subjects with moderate and severe kidney failure.
    -Subjects treated with Levodopa.
    -Subjects treated with quinidine.
    -Any known allergies to the test substances, or with fructose intolerance, glucose and galactose malabsorption syndrome or sucrase-isomaltase deficiency due to sucrose content (excipient).
    -Any known addiction to drugs and alcohol.
    -Alcohol intake of at least 3 drinks/day.
    -Type 1 or 2 diabetes mellitus.
    -Active neoplasms.
    -Known hyperthyroidism unless treated and under control.
    -History of hepatic, renal, pulmonary, gastrointestinal, neurologic, hematologic, psychiatric, cardiac, or allergic disease clinically relevant.
    -Laboratory results out of the normal range. In this case, subject can be included if the alterations are considered by the doctor as not relevant.
    -The subject has an excessive tobacco consumption (smokes more than 10 cigarettes/day).
    -Have used regular medication for 2 weeks before the study, except contraceptive oral method for women.
    -Hospitalization up to 8 weeks before the study start.
    -Treatment within 3 months before the study starts with a drug considered toxic.
    -Treatment with proton-pump inhibitors (eg, omeprazole, pantoprazole, esomeprazole, lansoprazole/dexlansoprazole, rabeprazole/dexrabeprazole)
    -Subject which has donate or lost 450 mL or more of blood within 3 months before the study.
    -Maintaining therapy with any drug, except contraceptive oral pills.
    -All contraindications of the Magnespasmyl or waning/precaution of use as displayed in the respective National Product Labeling that was used for defining these exclusion criteria. Any update of contraindications in labeling document (Magnespasmyl) occuring during the course of the study that should be considered systematically as a new exclusion criterion.
    -Pregnant, lactating, or females planning pregnancy in the next year or women with noneffective contraceptive method during the study period.
    -Subject who has withdrawn consent before enrollment/randomization.
    -Despite screening of the subject, enrollment/randomization is stopped at the study level.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline of DASS-42 Stress subscale
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, 8 weeks
    E.5.2Secondary end point(s)
    a)Change from baseline of DASS-42 Stress subscale
    b)Change from baseline of DASS-42 Anxiety subscale
    c)Change from baseline of DASS-42 Depression subscale
    d)Change from baseline in cortisol awakening response (CAR) measured by the mean over a 2 day of total area under curve AUCt (T0, T30, T45) of CAR
    e)Change from baseline in absolute increase of cortisol (AINC) measured by the mean over a 2 day of total area under curve AUCt (T0, T30, T45) of AINC
    f)Change from baseline in increase of cortisol (MINC) measured by the mean over a 2 day of total area under curve AUCt (T0, T30, T45) of MINC
    g)Change from baseline on erythrocytes magnesium level
    E.5.2.1Timepoint(s) of evaluation of this end point
    a) Baseline, 4 weeks
    b), c), d), e), f), g) : Baseline, 4 weeks and 8 weeks

    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 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) 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 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 concerned4
    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 years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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) No
    F.1.2.1Number of subjects for this age range: 264
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 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 state264
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 264
    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
    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 Decision2016-03-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-01
    P. End of Trial
    P.End of Trial StatusCompleted
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