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    Summary
    EudraCT Number:2021-003600-41
    Sponsor's Protocol Code Number:APHP200042
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-09-21
    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 ConcernedFrance - ANSM
    A.2EudraCT number2021-003600-41
    A.3Full title of the trial
    AMIloride for the treatment of Nephrogenic Diabetes insipidus for patients with bipolar disorder treated with lithium: a randomized controlled trial
    AMIloride pour le traitement du diabète insipide néphrogénique chez les patients atteints de trouble bipolaire traités au lithium: essai contrôlé randomisé
    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
    AMIND
    AMIND
    A.4.1Sponsor's protocol code numberAPHP200042
    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 – Hôpitaux 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 supportMinistère de la Santé, PHRC national, 2019
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAPHP
    B.5.2Functional name of contact pointSEYMOUR-INAMO
    B.5.3 Address:
    B.5.3.1Street Address1 Avenue Claude VELLEFAUX
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number+3301 44 84 17 42
    B.5.5Fax number+3301 44 84 17 01
    B.5.6E-mailkarine.seymour@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 MODAMIDE 5 mg
    D.2.1.1.2Name of the Marketing Authorisation holderGERDA
    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 nameAMILORIDE
    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 INNAMILORIDE
    D.3.9.1CAS number 2609-46-3
    D.3.9.4EV Substance CodeSUB05433MIG
    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 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 MODAMIDE 5 mg
    D.2.1.1.2Name of the Marketing Authorisation holderGERDA
    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 nameAMILORIDE
    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 INNAMILORIDE
    D.3.9.1CAS number 2609-46-3
    D.3.9.4EV Substance CodeSUB05433MIG
    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.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
    NA
    Patients traités par lithium et présentant un diabète insipide néphrogénique après 2 mois de traitement
    E.1.1.1Medical condition in easily understood language
    NA
    Diabète insipide néphrogénique
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    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
    NA
    Démontrer l'efficacité de l'amiloride pour réduire le défaut de concentration urinaire chez des patients traités par lithium et présentant un diabète insipide néphrogénique après 2 mois de traitement
    E.2.2Secondary objectives of the trial
    NA
    Démontrer l'efficacité de l'amiloride pour :
    1. Réduire le défaut de concentration urinaire
    2. Réduire la nycturie
    3. Réduire la sensation de soif
    4. Réduire la polyurie
    5. Améliorer la qualité de vie
    6. Réduire le déclin du débit de filtration glomérulaire (DFG) après un an de traitement.

    Evaluer l'effet de l'amiloride dans les cas suivants :
    7. La stabilité de l'humeur
    8. La stabilité des concentrations plasmatiques de lithium
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    NA
    • Adultes (âge ≥ 18 ans)
    • Patient atteint de trouble bipolaire
    • Patient traité par lithium depuis au moins 5 ans
    • Patient présentant un défaut de concentration urinaire défini par une osmolalité urinaire maximale < 600 mOsm/kg
    • Femme en âge de procréer acceptant d’utiliser une méthode contraceptive efficace pendant 12 mois
    E.4Principal exclusion criteria
    NA
    • Insuffisance rénale définie par un DFG < 30 ml/min/1,73m² estimé par l'équation CKD-EPI
    • Hyperkaliémie > 5 mmol/l
    • Hypersensibilité ou allergie connue à l'amiloride
    • Hypersensibilité au lactose
    • Insuffisance surrénale connue
    • Utilisation concomitante d'un autre traitement épargneur de potassium (par exemple spironolactone, inhibiteurs de l'enzyme de conversion de l'angiotensine (IECA), antagonistes des récepteurs de l'angiotensine II (ARA-II)
    • Infection aiguë en cours (moins de 3 jours avant l'inclusion)
    • Insuffisance cardiaque sévère (NYHA > II)
    • Phase aiguë d'un trouble de l'humeur
    • Utilisation antérieure d'amiloride (utilisation à long terme ≥ 6 mois ou/et utilisation dans les 6 mois précédant la randomisation)
    • Femme enceinte ou allaitante
    • Participation à une autre étude clinique impliquant un médicament expérimental ou patient se trouvant dans la période d'exclusion à la fin d'une étude précédente.
    • Refus du patient de participer
    • Non-affiliation à un régime de sécurité sociale ou à la CMU
    • Patient bénéficiant de l’AME
    • Sujet privé de liberté ou sous mesure de protection légale
    E.5 End points
    E.5.1Primary end point(s)
    NA
    Le pourcentage de changement de l'osmolalité urinaire à jeun avant et après 2 mois de traitement
    E.5.1.1Timepoint(s) of evaluation of this end point
    NA
    après 2 mois de traitement
    E.5.2Secondary end point(s)
    NA
    1. Le pourcentage de changement de l’osmolalité urinaire entre baseline (avant le traitement) et à 6 et 12 mois.
    2. Nombre moyen de mictions nocturnes déclaré par le patient avant le traitement et à 2, 6 et 12 mois.
    3. Score des échelles d'intensité de la soif et de détresse avant le traitement et à 2, 6 et 12 mois.
    4. Présence d'une polyurie (définie comme un débit urinaire quotidien > 3 L/jour) après 2, 6 et 12 mois de traitement.
    5. Score de l'échelle de qualité de vie (SF36) avant le traitement et à 2, 6 et 12 mois.
    6. eDFG (estimé par l'équation CKD-EPI basée sur la mesure de la créatinine sérique standardisée) avant le traitement et à 2, 6 et 12 mois.
    7.a Scores de l'échelle d'humeur (YMRS et MADRS), score de l'échelle d'anxiété (GAD7) et score du sommeil de Pittsburgh (PSQI) avant le traitement et à 2, 6 et 12 mois.
    7.b Nombre total d'admissions à l'hôpital pour rechute maniaque ou dépressive pendant les 12 mois de traitement.
    8. Différence des niveaux résiduels de lithium plasmatique avant et après la période de traitement de 2 mois.
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    baseline (avant le traitement) et à 6 et 12 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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 Yes
    E.8.2.3Other No
    E.8.2.3.1Comparator description
    Placebo Amiloride
    E.8.2.4Number of treatment arms in the trial1
    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 concerned6
    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 years3
    E.8.9.1In the Member State concerned months0
    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: 9
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    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 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 state10
    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
    Non
    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 Decision2022-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-09
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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