Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44364   clinical trials with a EudraCT protocol, of which   7388   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-001288-18
    Sponsor's Protocol Code Number:16-API-01
    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:2018-11-06
    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 number2017-001288-18
    A.3Full title of the trial
    ASIC channels and migraine disorders - Proof of concept study on the efficacy of Amiloride in prophylaxis of Migraine with Aura - APAM study
    Canaux ASIC et maladie migraineuse - Etude de preuve de concept sur l’efficacité de l’Amiloride dans la Prophylaxie de l’Aura Migraineuse – Etude APAM
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ASIC channels and migraine disorders - Proof of concept study on the efficacy of Amiloride in prophylaxis of Migraine with Aura - APAM study
    Canaux ASIC et maladie migraineuse - Etude de preuve de concept sur l’efficacité de l’Amiloride dans la Prophylaxie de l’Aura Migraineuse – Etude APAM
    A.3.2Name or abbreviated title of the trial where available
    APAM
    A.4.1Sponsor's protocol code number16-API-01
    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 SponsorCHU de Nice
    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 organisationCHU de Nice
    B.5.2Functional name of contact pointDr Emilie Piquet
    B.5.3 Address:
    B.5.3.1Street Address4, Avenue Reine Victoria
    B.5.3.2Town/ cityNice
    B.5.3.3Post code06000
    B.5.3.4CountryFrance
    B.5.4Telephone number+33492038474
    B.5.5Fax number+33492038541
    B.5.6E-mailhabault.m@chu-nice.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 cp
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires Gerda
    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.3.11 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
    Migraine with aura
    Migraine avec aura
    E.1.1.1Medical condition in easily understood language
    Migraine with aura
    Migraine avec aura
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10027607
    E.1.2Term Migraine with aura
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the efficacy of amiloride (non-specific ASIC-1 channel blocker) in the prophylaxis of migraine with aura
    Evaluer l’efficacité de l’amiloride (bloqueur non spécifique des canaux ASIC-1) dans la prophylaxie de l’aura migraineuse
    E.2.2Secondary objectives of the trial
    - Evaluate the efficacy of amiloride in the prophylaxis of migraine headache
    - Evaluate the efficacy of amiloride by measuring the functional impact in migraine with aura prophylaxis
    - Evaluate the efficacy of amiloride by measuring the emotional impact in migraine with aura prophylaxis
    - Evaluate the efficacy of amiloride by measuring state of health in migraine with aura prophylaxis
    - Evaluate the safety use of amiloride in migraine with aura prophylaxis
    - Evaluer l’efficacité de l’amiloride dans la prophylaxie de la céphalée migraineuse
    - Evaluer l’efficacité de l’amiloride par la mesure du retentissement fonctionnel dans la prophylaxie de la migraine avec aura
    - Evaluer l’efficacité de l’amiloride par la mesure du retentissement émotionnel dans la prophylaxie de la migraine avec aura
    - Evaluer l’efficacité de l’amiloride par la mesure de l’état de santé dans la prophylaxie de la migraine avec aura
    - Evaluer la sécurité d’emploi de l’amiloride dans la prophylaxie de la migraine avec aura
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subjects aged 18 to 80 years
    - Male or female
    - Diagnosis of migraine with aura code 1.2.1 according to ICHD-3 including codes 1.2.1.1.1 and 1.2.1.2
    - At least 1 crisis with aura per month in the 3 months prior to inclusion
    - No prophylactic migraine background treatment for at least 1 month before inclusion
    - For women of childbearing age, use of a reliable contraceptive method at least 3 months before and 1 month after the study
    - Signing of written informed consent
    - Patient affiliated to social security
    - Sujets âgés de 18 à 80 ans
    - Homme ou femme
    - Diagnostic de migraine avec aura code 1.2.1 selon l’ICHD-3 incluant les codes 1.2.1.1 et 1.2.1.2
    - Au moins 1 crise avec aura par mois dans les 3 mois précédant l’inclusion
    - Absence de traitement de fond prophylactique antimigraineux depuis au moins 1 mois avant l’inclusion
    - Pour les femmes en âge de procréer, utilisation d’une méthode contraceptive fiable au moins 3 mois avant et 1 mois après l’étude
    - Signature du consentement éclairé écrit
    - Patient affilié à la sécurité sociale
    E.4Principal exclusion criteria
    - Existence of contraindications to taking amiloride:
    - Known hypersensitivity to the molecule
    - Hyperkalemia
    - Use of another hyperkalemic diuretic or potassium salts
    - Renal insufficiency (clearance < 60 ml/min)
    - Severe hepatocellular insufficiency
    - Patient, who from the investigator's point of view would not be compliant with the study procedure
    - Pregnant or breastfeeding patient
    - Patient under guardianship, protected by law
    - Existence de contre-indication à la prise d’amiloride :
    - Hypersensibilité connue à la molécule
    - Hyperkaliémie
    - Utilisation d’un autre diurétique hyperkaliémiant ou de sels de potassium
    - Insuffisance rénale (clairance < 60 ml/min)
    - Insuffisance hépato cellulaire sévère
    - Patient, qui d’un point de vue de l’investigateur ne serait pas compliant à la procédure de l’étude
    - Patiente enceinte ou allaitante
    - Patient sous tutelle, sous curatelle, protégé par la loi
    E.5 End points
    E.5.1Primary end point(s)
    Number of aura in the last 4 weeks of each therapeutic period
    Nombre d’aura au cours des 4 dernières semaines de chaque période thérapeutique
    E.5.1.1Timepoint(s) of evaluation of this end point
    8 months
    E.5.2Secondary end point(s)
    - Analysis of the number of days with headache, with or without aura.
    - Impact score on the HIT-6 scale
    - Anxiety and depression score on the HAD scale
    - EQ-5D Scale Score
    - Occurrence or absence of significant or unknown adverse events
    - Analyse du nombre de jours avec céphalée, avec ou sans aura.
    - Score d’impact sur l’échelle HIT-6
    - Score d’anxiété et de dépression sur l’échelle HAD
    - Score de l’échelle EQ-5D
    - Survenue ou absence d’effets indésirables notables ou non connus
    E.5.2.1Timepoint(s) of evaluation of this end point
    8 months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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 Yes
    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 concerned3
    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 years
    E.8.9.1In the Member State concerned months24
    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) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 No
    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 state40
    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 Decision2019-01-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-08
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Oct 31 09:33:11 CET 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA