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    Summary
    EudraCT Number:2017-003387-12
    Sponsor's Protocol Code Number:DopamineGenetics01
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2017-10-25
    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 ConcernedGermany - BfArM
    A.2EudraCT number2017-003387-12
    A.3Full title of the trial
    Dopamine action on metabolism depending on genetic heterogeneity – a randomized, placebo-controlled double blind study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dopamine action on metabolism depending on genetic heterogeneity – a randomized, placebo-controlled double blind study
    A.3.2Name or abbreviated title of the trial where available
    Dopamine Genetics01
    A.4.1Sponsor's protocol code numberDopamineGenetics01
    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 SponsorUniversity Hospital Tuebingen
    B.1.3.4CountryGermany
    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 supportDZD
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital of Tuebingen
    B.5.2Functional name of contact pointZentrum fuer klinische Studien
    B.5.3 Address:
    B.5.3.1Street AddressFrondsbergstr. 23
    B.5.3.2Town/ cityTuebingen
    B.5.3.3Post code72070
    B.5.3.4CountryGermany
    B.5.4Telephone number004970712985273
    B.5.5Fax number004970712925080
    B.5.6E-mailzks-pm@med.uni-tuebingen.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 namePravidel (Bromocriptin) 1.25 mg
    D.3.4Pharmaceutical form Capsule, hard
    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 INNBROMOCRIPTINE
    D.3.9.1CAS number 25614-03-3
    D.3.9.4EV Substance CodeSUB05918MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.25
    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) Yes
    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 nameActrapid
    D.3.4Pharmaceutical form Nasal spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINSULIN HUMAN
    D.3.9.1CAS number 11061-68-0
    D.3.9.3Other descriptive nameActrapid
    D.3.9.4EV Substance CodeSUB08197MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Yes
    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 Yes
    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 namePravidel (Bromocriptin) 2.5mg
    D.3.4Pharmaceutical form Capsule, hard
    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 INNBROMOCRIPTINE
    D.3.9.1CAS number 25614-03-3
    D.3.9.4EV Substance CodeSUB05918MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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) Yes
    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: 4
    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 namePravidel (Bromocriptin) 3.75mg
    D.3.4Pharmaceutical form Capsule, hard
    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 INNBROMOCRIPTINE
    D.3.9.1CAS number 25614-03-3
    D.3.9.4EV Substance CodeSUB05918MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3,75
    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) Yes
    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: 5
    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 namePravidel (Bromocriptin) 5.0mg
    D.3.4Pharmaceutical form Capsule, hard
    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 INNBROMOCRIPTINE
    D.3.9.1CAS number 25614-03-3
    D.3.9.4EV Substance CodeSUB05918MIG
    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) Yes
    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 placeboCapsule
    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
    Adipositas ist eine weit verbreitete und in ihrer Prävalenz zunehmende Erkrankung, die mit schwerwiegenden Folgeerkrankungen einhergeht. Von häufigen genetischen Polymorphismen haben Varianten im FTO Lokus die höchste Effektgröße auf das Körpergewicht. Preliminäre, bisher unveröffentlichte Ergebnisse Zeigen, dass eine Verstärkung des DA-signalings mit dem DA-agonisten Bromocriptin in Abhängigkeit vom FTO Genotyp entweder eine Gewichtsreduktion induziert oder einen gewichtsneutralen Effekt hat.
    E.1.1.1Medical condition in easily understood language
    Adipositas, FTO Polymorphismus, Bromocriptin
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10051361
    E.1.2Term Adipositas
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10029883
    E.1.2Term Obesity
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10029885
    E.1.2Term Obesity, unspecified
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Das primäre Ziel der Studie ist die Überprüfung der Annahme, dass der FTO Genotyp mit einer 18-wöchigen Therapie mit Bromocriptin im Hinblick auf die Änderung des Körpergewichts interagiert.

    Effektivität und Sicherheit
    E.2.2Secondary objectives of the trial
    Effektivität und Sicherheit
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • BMI ≥ 30kg/m²
    • Alter zwischen 18 Jahre und 70 Jahre
    • Unterschriebene Einwilligungserklärung
    • Frauen im gebärfähigen Alter müssen zustimmen, während der Behandlungsdauer mit dem Prüfpräparat eine zuverlässige Kontrazeptionsmethode verwenden oder von heterosexuellen Kontakt völlig abstinent bleiben.Ein postmenopausaler Zustand ist definiert als
    fehlende Menstruation für 12 Monate ohne andere
    medizinische Ursache.
    • Männer müssen zustimmen, während der Behandlungsdauer mit dem Prüfpräparat bei jedem heterosexuellen Kontakt ein Latex Kondom zu verwenden und für diese Zeit an keiner Samenspende teilzunehmen
    E.4Principal exclusion criteria
    • Überempfindlichkeit gegen einen der verwendeten Stoffe
    • Diabetes mellitus
    • Vorliegen einer Schilddrüsenüberfunktion
    • Schwangerschaft oder Stillzeit
    • Unkontrollierbaren Hypertonie
    • Bekanntes Vorliegen einer Koronaren Herzerkrankung (KHK)
    • Bekanntes Vorliegen einer peripheren arteriellen
    Verschlusskrankheit (pAVK)
    • Bekanntes Vorliegen einer der folgenden
    Lebererkrankung: akute und chronische
    Virushepatitis, Leberzirrhose
    • Bekanntes Vorliegen einer chronischen Niereninsuffizienz mit einer glomerulären Filtrationsrate (GFR) ≤ 60ml/min (Berechnung erfolgt nach der MDRD-Formel)
    • Bekanntes Vorliegen eines Morbus Parkinson
    • Bekanntes aktuelles Vorliegen oder positive Anamnese einer der folgenden psychiatrischen
    Erkrankungen: endogene Depression, Manie,
    Angst- und Panikstörung, Zwangsstörung,
    Schizophrenie, Psychose, Suchterkrankung
    • Bekanntes Vorliegen einer hypophysären Erkrankungen
    • Vortherapie mit Bromocriptin in den letzten 12
    Monaten
    • Bekanntes Vorliegen einer dementiellen Erkrankungen
    • Bekanntes Vorliegen eines Magen- bzw.
    Darmgeschwüres
    • Bekanntes Vorliegen einer malignen Erkrankung in
    den letzten 5 Jahren
    • Bekanntes Vorliegen einer Herzinsuffizienz
    entsprechend NYHA III oder IV
    • Co-Medikation mit Präparaten: Methyldopa Levodopa, Dopamin-Antagonisten, Metoclopramid, Domperidon, Glycerolnitrat, Griseofulvin, Azolantimykotika, Makrolidantibiotika, Octreotid, Orlistat, Tamoxifen, Liraglutid
    • Personen, die nicht entfernbare Metallteile im oder am Körper tragen wie z.B.:
    - Herzschrittmacher
    - künstliche Herzklappen
    - Metallprothesen
    -implantierte magnetische Metallteile (Schrauben, Platten von Operationen)

    - Metallsplitter/Granatsplitter
    - feste Zahnspange (Retainer über mehr als 4 Zähne)
    - Akupunktur-Nadel
    - Insulinpumpe
    - Intraport etc.
    -Tätowierungen > 14 cm, Lidschatten
    • Personen mit eingeschränkter Temperaturempfindung und/oder erhöhter Empfindlichkeit gegenüber Erwärmung des Körpers
    • Zustand nach Schlaganfall
    • Personen mit einer Gehörerkrankung oder einer erhöhte Empfindlichkeit für laute Geräusche
    • Personen mit Platzangst (Klaustrophobie)
    • Teilnahme an anderen interventionellen Prüfungen
    sowie Erhalt einer anderen Prüfmedikation in den
    letzten 30 Tagen
    • Personen, die nicht zustimmen über zufällig entdeckte pathologische Befunde informiert zu werden

    •Aktive Raucher

    Probanden müssen bei der klinischen Untersuchung durch einen Prüfarzt in gutem Allgemeinzustand sein, und es dürfen keine schweren Grunderkrankungen vorliegen. Bei Zweifel an diesen Voraussetzungen werden nach klinischer Untersuchung gegebenenfalls gezielt weitere Laborwerte bestimmt. Sollte bei der
    Untersuchung durch den Prüfarzt eine der oben
    genannten Erkrankungen die Ausschlusskriterium sind
    festgestellt werden, ist eine weitere Teilnahme an der
    klinischen Prüfung nicht möglich.
    E.5 End points
    E.5.1Primary end point(s)
    Das primäre Ziel der Studie ist die Überprüfung der Annahme, dass der FTO Genotyp mit einer 18-wöchigen Therapie mit Bromocriptin im Hinblick auf die Änderung des Körpergewichts interagiert.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline und V9
    E.5.2Secondary end point(s)
    Änderung des Körpergewichtes
    Änderung der Nahrungsaufnahme
    Änderung der zentralnervösen Verarbeitung von Essensreizen
    Änderung der Körperfettverteilung
    Änderung der Insulinsensitivität
    Änderung der glukosestimulierten Insulinsekretion
    Änderung der Glukosetoleranz
    Änderung der zentralnervösen Insulinsensitivität
    Änderung des Ruheenergieumsatzes
    Änderung des Bewegungsverhaltens
    Änderung des Prolaktinspiegels
    E.5.2.1Timepoint(s) of evaluation of this end point
    Änderung des Körpergewichtes: Baseline und V9
    Änderung der Nahrungsaufnahme: Baseline und V9
    Änderung der zentralnervösen Verarbeitung von Essensreizen: Baseline und V9
    Änderung der Körperfettverteilung: Baseline und V9
    Änderung der Insulinsensitivität: Baseline und V9
    Änderung der glukosestimulierten Insulinsekretion: Baseline und V9
    Änderung der Glukosetoleranz : Baseline und V9
    Änderung der zentralnervösen Insulinsensitivität: Baseline und V9
    Änderung des Ruheenergieumsatzes : Baseline und V9
    Änderung des Bewegungsverhaltens : Baseline und V9
    Änderung des Prolaktinspiegels: Basline, V3,V5,V7,V9
    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 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) Yes
    E.7.1.1First administration to humans Yes
    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.8.2.4Number 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
    Die Einnahme der Prüfmedikation wird nach der Dauer von 18 Wochen beendet. Die Studie endet nach 30 Wochen.
    Das Prüfungsende ist definiert als die letzte Visite des letzten Patienten (LPLV).

    Für weitere Informationen s. Kapitel 6.7
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years36
    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) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 45
    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 state145
    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)
    Ein schrittweises Ausschleichen der Therapie ist nicht notwendig und das Absetzen kann unabhängig von der zuletzt verabreichten Dosis erfolgen. Während des 3-monatigen Follow- Ups ist keine medikamentöse Therapie geplant.
    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 Decision2018-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-15
    P. End of Trial
    P.End of Trial StatusRestarted
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