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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   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).

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    Summary
    EudraCT Number:2021-002254-86
    Sponsor's Protocol Code Number:NAT-19/GPX
    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:2022-06-01
    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 ConcernedFrance - ANSM
    A.2EudraCT number2021-002254-86
    A.3Full title of the trial
    Double-blind, randomised, placebo-controlled, dose-finding phase IIb trial to evaluate the efficacy, safety, and tolerability of a 12-week-treatment with Naronapride in adult participants with at least moderate idiopathic or diabetic gastroparesis
    Essai de phase IIb en double aveugle, randomisé, contrôlé par placebo, avec recherche de dose, visant à évaluer l'efficacité, la sécurité et la tolérance d'un traitement de 12 semaines par Naronapride chez des participants adultes souffrant au minimum d’une forme modérée de gastroparésie idiopathique ou diabétique
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to show if Naronapride tablets are safe and efficient for treatment of delayed stomach emptying and to find the optimal dose
    Étude clinique visant à montrer si les comprimés de Naronapride sont sûrs et efficaces pour le traitement du retard de vidange de l'estomac et à déterminer la dose optimale.
    A.3.2Name or abbreviated title of the trial where available
    MOVE-IT
    A.4.1Sponsor's protocol code numberNAT-19/GPX
    A.5.4Other Identifiers
    Name:Acronym by sponsorNumber:MOVE-IT
    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 SponsorDr. Falk Pharma GmbH
    B.1.3.4CountryGermany
    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 supportDr. Falk Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr. Falk Pharma GmbH
    B.5.2Functional name of contact pointDept. of Clinical R&D
    B.5.3 Address:
    B.5.3.1Street AddressLeinenweberstr. 5
    B.5.3.2Town/ cityFreiburg
    B.5.3.3Post code79108
    B.5.3.4CountryGermany
    B.5.4Telephone number+4976115140
    B.5.6E-mailzentrale@drfalkpharma.de
    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 No
    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 nameNaronapride 10 mg film-coated tablets
    D.3.4Pharmaceutical form Film-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 INNNaronapride
    D.3.9.2Current sponsor codeATI-7505
    D.3.9.4EV Substance CodeSUB129585
    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 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 No
    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 nameNaronapride 20 mg film-coated tablets
    D.3.4Pharmaceutical form Film-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 INNNaronapride
    D.3.9.2Current sponsor codeATI-7505
    D.3.9.4EV Substance CodeSUB129585
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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: 3
    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 No
    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 nameNaronapride 40 mg film-coated tablets
    D.3.4Pharmaceutical form Film-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 INNNaronapride
    D.3.9.2Current sponsor codeATI-7505
    D.3.9.4EV Substance CodeSUB129585
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 placeboFilm-coated tablet
    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
    idiopathic or diabetic gastroparesis
    gastroparésie idiopathique ou diabétique
    E.1.1.1Medical condition in easily understood language
    stomach cannot empty food in the normal way
    l'estomac ne peut pas vider les aliments de façon normale
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10051153
    E.1.2Term Diabetic gastroparesis
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10021227
    E.1.2Term Idiopathic gastroparesis
    E.1.2System Organ Class 10017947 - Gastrointestinal 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 evaluate the efficacy of a 12-week treatment with naronapride compared to placebo on disease signs and symptoms in participants with at least moderate idiopathic or diabetic gastroparesis.
    Évaluer l’efficacité d’un traitement de 12 semaines par naronapride par rapport à un traitement par placebo des signes et des symptômes chez des participants présentant au moins une gastroparésie idiopathique ou diabétique d’intensité modérée.
    E.2.2Secondary objectives of the trial
    To determine the optimal dose-level of naronapride after completion of a 12-week treatment in participants with at least moderate idiopathic or diabetic gastroparesis,
    To evaluate safety and tolerability of naronapride compared to placebo in participants with at least moderate idiopathic or diabetic gastroparesis
    Déterminer la dose optimale de naronapride à la fin d’un traitement de 12 semaines chez des participants présentant au moins une gastroparésie idiopathique ou diabétique d’intensité modérée.
    Évaluer l’innocuité et tolérance du naronapride par rapport à un traitement par placebo chez des participants présentant au moins une gastroparésie idiopathique ou diabétique d’intensité modérée.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Men and women between ≥18 and ≤75 years of age
    -History of idiopathic or diabetic gastroparesis cardinal symptoms for ≥3 months
    -Evidence of delayed gastric emptying
    -Average weekly total symptom score of ≥2.0
    - Body Mass Index ≥16 and <35 kg/m2
    - Exclusion of any mechanical and/or anatomical obstructions, stenosis, structural diseases, or gastric ulcers by upper gastrointestinal endoscopy/an imaging technique
    - Hommes et femmes âgés de ≥18 à ≤75 ans.
    -Histoire de symptômes cardinaux de gastroparésie idiopathique ou diabétique depuis ≥3 mois.
    -Démonstration d'un retard de vidange gastrique.
    -Score total hebdomadaire moyen des symptômes de ≥2,0.
    - Indice de masse corporelle ≥16 et <35 kg/m2
    - Exclusion de toute obstruction mécanique et/ou anatomique, sténose, maladie structurelle ou ulcère gastrique par endoscopie gastro-intestinale supérieure/technique d'imagerie.
    E.4Principal exclusion criteria
    -Participants without access to an internet-capable terminal and/or without an own e-mail address
    -History of major gastrointestinal surgery
    -Intrapyloric botulinum toxin injection within 12 months
    -Gastric stimulator implant
    -Known secondary causes of gastroparesis
    -Presence of inflammatory bowel disease, eosinophilic oesophagitis, or reflux oesophagitis, acute gastritis
    -Les participants n'ayant pas accès à un terminal compatible avec l'Internet et/ou ne disposant pas d'une adresse électronique personnelle.
    antécédents de chirurgie gastro-intestinale majeure
    -Injection intrapylorique de toxine botulique dans les 12 mois.
    -Implantation d'un stimulateur gastrique
    -Causes secondaires connues de la gastroparésie
    -Présence d'une maladie inflammatoire de l'intestin, d'une oesophagite éosinophile ou d'une oesophagite par reflux, d'une gastrite aiguë.
    E.5 End points
    E.5.1Primary end point(s)
    Change of the average weekly total symptom score from BSL (visit 2) to EOT/WD (visit 6)
    Changement du score total hebdomadaire moyen des symptômes entre le BSL (visite 2) et l'EOT/WD (visite 6)
    E.5.1.1Timepoint(s) of evaluation of this end point
    visit 6 (Day 85)
    Visit 6 (Jour 85)
    E.5.2Secondary end point(s)
    -Change of the modified average weekly total symptom score from BSL (visit 2) to EOT/WD (visit 6)
    -Change of the average weekly symptom score for nausea/early satiety/postprandial fullness/upper abdominal pain/number of vomiting episodes/bloating from BSL to EOT/WD
    -Changement du score total hebdomadaire moyen modifié des symptômes entre le BSL (visite 2) et l'EOT/WD (visite 6).
    -Changement du score hebdomadaire moyen de symptômes pour les nausées, la satiété précoce, la plénitude postprandiale, les douleurs abdominales hautes, le nombre d'épisodes de vomissement et les ballonnements, entre la date de début du traitement et la date de fin du traitement.
    E.5.2.1Timepoint(s) of evaluation of this end point
    visit 6 (Day 85)
    Visit 6 (Jour 85)
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 trial4
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    France
    Poland
    Netherlands
    Switzerland
    Germany
    Belgium
    United Kingdom
    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
    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
    E.8.9.2In all countries concerned by the trial months24
    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: 256
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 64
    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 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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 225
    F.4.2.2In the whole clinical trial 320
    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 Decision2022-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-22
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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