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    Summary
    EudraCT Number:2015-001456-29
    Sponsor's Protocol Code Number:Mino-TRD(OptiMD)
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-08
    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 ConcernedGermany - BfArM
    A.2EudraCT number2015-001456-29
    A.3Full title of the trial
    A Double-blind, Placebo-controlled, Randomized, Multicenter Proof-of-principle Trial of Adjunctive Minocycline for Patients With Treatment Resistant Unipolar Major Depressive Disorder (MDD)
    Eine doppelt-verblindete, placebo-kontrollierte, randomisierte, mulitzentrische Studie zur Überprüfung der Wirksamkeit einer Minocyclinaugmentation bei Patienten mit therapierefraktärer unipolarer depressiver Erkrankung
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Double-blind, Placebo-controlled, Randomized, Multicenter Proof-of-principle Trial of Adjunctive Minocycline for Patients With Treatment Resistant Unipolar Major Depressive Disorder (MDD)
    Eine doppelt-verblindete, placebo-kontrollierte, randomisierte, mulitzentrische Studie zur Überprüfung der Wirksamkeit einer Minocyclinaugmentation bei Patienten mit therapierefraktärer unipolarer depressiver Erkrankung
    A.3.2Name or abbreviated title of the trial where available
    Mino-TRD
    Mino-TRD
    A.4.1Sponsor's protocol code numberMino-TRD(OptiMD)
    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 SponsorCharité - Universitätsmedizin Berlin
    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 supportBundeministerium für Bildung und Forschung (BMBF)
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut Klinik für Psychiatrie und Psychotherapie
    B.5.2Functional name of contact pointCharité - Campus Benjamin Franklin
    B.5.3 Address:
    B.5.3.1Street AddressHindenburgdamm 30
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code12203
    B.5.3.4CountryGermany
    B.5.4Telephone number+4930450 517522
    B.5.5Fax number+4930450 517930
    B.5.6E-mailisabella.heuser@charite.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 Yes
    D.2.1.1.1Trade name Udima
    D.2.1.1.2Name of the Marketing Authorisation holderDermapharm AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameMinocycline
    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 INNMinocycline Hydrochloride dihydrate
    D.3.9.1CAS number 10118-90-8
    D.3.9.2Current sponsor codeMinocycline Hydrochloride
    D.3.9.3Other descriptive nametetracycline antibiotic
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number50
    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 placeboCapsule, hard
    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
    Minocycline, a broad-spectrum and central nervous system entering tetracycline, reduces within an additional therapy the symptomatology of depressive patients.
    Minocyclin, ein pleiotropes, ZNS-gängiges Tetrazyklin, reduziert im Rahmen einer Begleittherapie die Symptomatik von depressiven Patienten. Ursächlich hierfür ist u.a. eine anti-inflammatorische sowie neuroprotektive Wirkung.
    E.1.1.1Medical condition in easily understood language
    Minocycline, a broad-spectrum and central nervous system entering tetracycline, reduces within an additional therapy the symptomatology of depressive patients.
    Minocyclin, ein Tetrazyklin, reduziert im Rahmen einer Begleittherapie die Symptomatik von depressiven Patienten durch u.a. seine anti-inflammatorische sowie neuroprotektive Wirkung.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    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
    Change in the MADRS value from starting point (week 1) to last visit (week 7), with weekly visits
    Time point of determination of primary target parameters (objective): week 1-6, 7, 6 week after and 6 months after last visit
    Änderung im MADRS-Wert vom Startzeitpunkt (Woche 1) ausgehend bis zur Woche 7, wöchentliche Untersuchung.
    Zeitpunkt der Bestimmung des primären Zielparameters: Woche 1-6, 7, 6 Wochen und 6 Monate nach Studienende
    E.2.2Secondary objectives of the trial
    • Remission; remission is define as reduction of MADRS value is smaller than 9
    • Response to therapy (response is define as reduction of MADRS value more than 50 % in comparison to week 1)
    • Evaluation of CGI-S, BDI, HAMD-17 and SCL-90R,
    TMT-A and B (determination time point CGI-S, BDI, HAMD-17: at the time of screening, during the conduct of the clinical trial in week 1 to 6 and last visit (week 7) as well as in 1FU and 2 FU ((6 Months after end of trial) (not BDI-S); TMT A and B, SCL 90R: at screening, during the study conduct in week 4 (only SCL 90R) and last visit (week 7) as well as in 1 FU (6 week after end of trial)
    • Measurement of the expression levels in peripheral blood mononuclear cell (PBMC) (week 1 and 7) and serum concentration of different Cytokine, cell-type specifically marker, neurotrophic as well as inflammatory processes and cell metabolism determination-factors in week 1, 4 (not PBMCs) and week 7
    • Remission; Remission ist definiert als Reduktion des MADRS-Wertes auf kleiner 9
    • Ansprechen auf die Therapie (Ansprechen ist definiert als Reduktion des MADRS um mehr als 50% im Vergleich zu Woche 1)
    • Erhebung von CGI-S, BDI, HAMD-17 und SCL-90R,
    TMT A und B (Bestimmungszeitpunkte CGI-S, BDI, HAMD-17: je zum Zeitpunkt des Screenings, während der Studie in je Woche 1-6 und zum Studienende (Woche 7) sowie je 6 Wochen und 6 Monate nach Studienende (nicht BDI-S); TMT A und B, SCL 90R: je zum Zeitpunkt des Screenings, während der Studie in Woche 4 (nur SCL-90R) und zum Studienende (Woche 7) sowie in der 1. Nachuntersuchung (6 Wochen nach Studienende)
    • Messung der Expressionslevel in peripheren mononukleären Blutzellen (PBMCs) und der Serumkonzentration diverser Zytokine, zelltypspezifischer Marker, neurotropher sowie an inflammatorischen Prozessen und am Zellmetabolismus beteiligter Faktoren, Bestimmungszeitpunkt je Woche 1, 4 (nicht PBMCs) und Woche 7 (nach Studienende)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subject information sheets and written informed consent
    • Age 18-75
    • BMI 18- inclusive 40
    • negative pregnancy test
    • safe contraxeptive method (peral index <1)
    • Fulfilment of the criteria for a major depressive disorder according to DSM 5
    • Hamilton Rating Scale for Depression (HAMD-17)-score of at least 16
    • Clinical Global Impression Scale (CGI-S) of at least 4
    • Pharmacotherapy with an market approved antidepressiva in appropriate dose according to SmPC for at least 6 weeks from screening without sufficient response to drug according to MGH ATRQ criteria. A simultaneous treatment with further antidepressiva or for treatment in the indication antidepression used IMP Quetiapin or Aripiprazol in any dosage is possible (f.e. for sleep induction), but must administered for at least 6 weeks before screening, thereof 2 weeks in constant dosage
    • durchgeführte Patientenaufklärung und schriftliche Einwilligung
    • Alter 18 - 75 Jahre
    • BMI: 18 - inklusive 40
    • negativer Schwangerschaftstest
    • ausreichende Kontrazeption (pearl index < 1)
    • Erfüllen der Kriterien einer Episode einer Major Depression nach DSM 5
    • Hamilton Depression Rating Scale (HAMD-17)-Wert von mind. 16
    • Clinical Global Impression Scale (CGI-S)-Wert von mind. 4
    • Pharmakotherapie mit einem für die Depressionsbehandlung zugelassenen Antidepressivum in einer ausreichenden Dosierung gemäß Fachinformation für mind. 6 Wochen zum Zeitpunkt des Screenings ohne ein ausreichendes Ansprechen nach der Kriterien des MGH ATRQ. Eine zeitgleiche Behandlung mit weiteren Antidepressiva oder den in antidepressiver Indikation eigesetzten Substanzen Quetiapin oder Aripiprazol in jeglicher Dosierung ist möglich (z. B. zur Schlafinduktion), sämtliche Antidepressiva müssen vor dem Screening für mind. 6 Wochen, davon seit mind. 2 Wochen in konstanter Dosis verabreicht worden sein
    E.4Principal exclusion criteria
    • Presence of a neurodegenerative disease
    • Presence of a neurological disease, within which the depressive symptoms were associated to a depression
    • Presence of any severe, unstable somatic disease, including chronic inflammatory diseases such as rheumatoid arthritis or chronic inflammatory intestine diseases
    • The depressive symptoms can better be explained by possible comorbid psychiatric disorder, especially a personality disorder
    • Improvement by over 50% in the HAMD-17-score during the past 14 days
    • Pregnancy and breast feeding women
    • Substance or alcohol abuse during the past 6 months or a positive urinary drug Screening (Medication with benzodiazepinen is allowed as well as nicotine consumption)
    • Thyroid dysfunctions (if not substituted euthyroit), severe Malfunction of the liver or kidneys
    • Known autoimmune disease (lifetime prevalence) except euthyroid Hashimoto thyroiditis
    • Clinical relevant laboratory abnormalities
    • Current medication with ant-inflammatory substances (NSAID, Corticosteroids)
    • Current medication with Retinoids (Retinol, Retinoic acid or Retinoid-receptor agonists)
    • Any adverse event occurred in the past which was associated with an earlier intake of tetracyclines, including any hypersensitive reactions to tetracyclines and intolerance of tetracyclines
    • Any medication that is known to interact with Minocycline, in the case of requiring such medication, this will lead to break off the therapy with Minocycline
    • Current medication with barbiturates and other drugs with anticonvulsive effects (e.g. Carbamazepin, Diphenylhydantoin und Primidon)
    • Current medication with beta-lactam antibiotics, i.e. penicillines or cephalosporines
    • Current medication with isotretinoin or medication with isotretinoin during the past 4 weeks
    • Current medication with theophylline
    • Current medication with sulfonylurea antidiabetics and anticoagulants of the cumarine-type
    • Current medication with cyclosporine A
    • Current medication with Methotrexate
    • Being put under methoxyflurane anaesthetics or medication with other substances which could cause kidney damage
    • Lacking willingness to allow storage and transfer of pseudonymized medical data within the clinical Trial
    • Simultaneous administration of other psychtropic substances in addition to standard medication. For the therapy of severe agitation and anxiety as well as major sleeping disorder are only allowed Lorazepam (max. 4 mg/day) or Z-Hypnotics (Zolpidem (max. 10 mg/day), Zopicclone (max. 7.5 mg/day))
    • Participation in a clinical trial according to the AMG during the past 8 weeks
    • Involuntary commitment in an institution by warrant of the court or agency
    • Acute suicidal tendency, suicide plan or attempt in the current disease episode or suicide attempt in the last 5 years
    • Vorliegen einer neurodegenerativen Erkrankung
    • Vorliegen einer neurologischen Erkrankung, in deren Rahmen die depressive Symptomatik aufgetreten ist
    • Vorliegen jeglicher schweren, instabilen somatischen Erkrankung, inklusive chronisch entzündlicher Erkrankungen wie z.B. rheumatologisch Erkrankungen oder chronisch-entzündliche Darmerkrankungen
    • Die depressive Symptomatik wird besser durch das Vorliegen einer möglicherweise komorbiden sonstigen psychiatrischen Störung, insbesondere eine Persönlichkeitsstörung, erklärt
    • Verbesserung von über 50% im HAMD-17-Wert während der letzten 14 Tage
    • Schwangerschaft und stillende Frauen
    • Substanz- oder Alkoholmissbrauch innerhalb der letzten 6 Monate oder ein positives Drogenscreening aus dem Urin (Medikation mit Benzodiazepinen erlaubt, ebenso wie Nikotinkonsum)
    • Schilddrüsenfehlfunktion (falls nicht euthyreot substituiert), schwere Leber- oder Nierenfehlfunktion
    • Bekannte Autoimmunerkrankung (Lebenszeitprävalenz), außer euthyreote Hashimoto-Thyreoiditis
    • Klinisch relevante Laborauffälligkeiten
    • Aktuelle Medikation mit Anti-entzündlichen Substanzen (NSARs, Kortikoide)
    • Aktuelle Medikation mit Retinoiden (Retinol, Retinsäure oder Rentinoid-Rezeptor-Agonisten)
    • Jegliche in der Vergangenheit aufgetretene unerwünschte Wirkung die mit einer früheren Einnahmen von Tetrazyklinen einherging, inklusive jeglicher Hypersensitivitätsreaktion auf Tetrazykline und Tetrazyklinunverträglichkeit
    • Jegliche Medikation, die zu bekannten Wechselwirkungen mit Minocyclin führt. Sollte während der Studiendauer eine solche Medikation notwendig werden, führt dies zum Absetzen des Minocyclins.
    • Aktuelle Medikation mit Barbituraten und anderen antikonvulsiv wirkenden Arzneimittel (z. B. Carbamazepin, Diphenylhydantoin und Primidon)
    • Aktuelle Medikation mit Betalaktam-Antibiotika, wie z. B. Penicillinen oder Cefalosporinen
    • Aktuelle Medikation mit Isotretinoin oder Medikation mit Isoretionin in den letzten 4 Wochen
    • Aktuelle Medikation mit Theophyllin
    • Aktuelle Medikation mit Sulfonylharnstoff-Antidiabetika und Antikoagulanzien vom Cumarin-Typ
    • Aktuelle Medikation mit Ciclosporin A
    • Aktuelle Medikation mit Methotrexat
    • Durchführung einer Methoxyfluran-Narkose oder Medikation mit anderen Stoffen, die die Niere schädigen können
    • Fehlende Bereitschaft zur Speicherung und Weitergabe pseudonymisierter Krankheitsdaten im Rahmen der klinischen Prüfung
    • Gleichzeitige Einnahme sonstiger psychotroper Substanzen neben der antidepressiven Standardmedikation. Ausschließlich zur Therapie akuter Erregungs-/ Angstzustände oder schwerer Schlafstörungen sind Lorazepam (max. 4 mg/ Tag) oder Z-Hypnotika (Zolpidem (max. 10 mg/ Tag), Zopiclon (max. 7,5 mg/ Tag)) erlaubt
    • Teilnahme an einer klinischen Prüfung nach dem AMG innerhalb der letzten 8 Wochen
    • Unterbringung in einer Anstalt auf gerichtliche oder behördliche Anordnung
    • Akute Suizidalität, Suizidpläne oder -versuche in der aktuellen Erkrankungsepisode, oder Suizidversuch innerhalb der letzten 5 Jahre
    E.5 End points
    E.5.1Primary end point(s)
    Primary end point is changes in the MADRS score from starting point (week 1) to (week 7)
    Primärer Endpunkt ist Änderung im MADRS-Wert vom Startzeitpunkt (Woche 1) zu Woche 7.
    E.5.1.1Timepoint(s) of evaluation of this end point
    end of trial
    Es sind keine Zwischenauswertungen geplant. Nach Studienende
    E.5.2Secondary end point(s)
    • Remission; remission is define as reduction of MADRS value is smaller than 9
    • Response to therapy (response is define as reduction of MADRS value more than 50 % in comparison to week 1)
    • Evaluation of CGI-S, BDI, HAMD-17 and SCL-90R,
    TMT-A and B (determination time point CGI-S, BDI, HAMD-17: at the time of screening, during the conduct of the clinical trial in week 1 to 6 and last visit (week 7) as well as in 1FU and 2 FU ((6 Months after end of trial) (not BDI-S)); TMT A and B, SCL 90R: at screening, during the study conduct in week 4 (only SCL 90R) and last visit (week 7) as well as in 1 FU (6 week after end of trial)
    Measurement of the expression levels in peripheral blood mononuclear cell (PBMC) (week 1 and 7) and serum concentration of different Cytokine, cell-type specifically marker, neurotrophic as well as inflammatory processes and cell metabolism determination-factors in week 1, 4 and week 7
    • Genotype-determination therapy-Bestimmung therapie-affecting genetic variation (f.e. rs2032583, rs2235015, rs2235040, rs1045642, rs2032582, rs1128503 in the ABCB1-gene) (week 1)
    • Remission; Remission ist definiert als Reduktion des MADRS-Wertes auf kleiner 9
    • Ansprechen auf die Therapie (Ansprechen ist definiert als Reduktion des MADRS um mehr als 50% im Vergleich zu Woche 1)
    • Erhebung von CGI-S, BDI, HAMD-17 und SCL-90R,
    TMT A und B (Bestimmungszeitpunkte CGI-S, BDI, HAMD-17: je zum Zeitpunkt des Screenings, während der Studie in je Woche 1-6 und zum Studienende (Woche 7) sowie je 6 Wochen und 6 Monate nach Studienende (nicht BDI-S)); TMT A und B, SCL 90R: je zum Zeitpunkt des Screenings, während der Studie in Woche 4 (nur SCL-90R) und zum Studienende (Woche 7) sowie in der 1. Nachuntersuchung (6 Wochen nach Studienende)
    • Messung der Expressionslevel in peripheren mononukleären Blutzellen (PBMCs) und der Serumkonzentration diverser Zytokine, zelltypspezifischer Marker, neurotropher sowie an inflammatorischen Prozessen und am Zellmetabolismus beteiligter Faktoren Bestimmungszeitpunkt je Woche 1, 4 und Woche 7 (nach Studienende)
    • Genotyp-Bestimmung therapiebeeinflussender genetischer Varianten (z.B. rs2032583, rs2235015, rs2235040, rs1045642, rs2032582, rs1128503 im ABCB1-Gen) (Woche 1)
    E.5.2.1Timepoint(s) of evaluation of this end point
    end of trial
    Es sind keine Zwischenauswertungen geplant. Nach Studienende
    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 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.8.2.4Number 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 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
    Last Patient Last Visit = Last Treatment (week 7)
    letzter Patient letzte Visite= letzte Behandlung (Woche 7)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    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: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state160
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 160
    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)
    After completing the treatment and visits per protocol, patients will continue with regular visits according to usual practice of the treatment. The patients and dropouts will be invited to participate in two follow-up visits.
    Weiteres Vorgehen nach dem Ausscheiden
    Patienten erhalten bei Therapieabbruch genau wie nach Beendigung der Studie weiterhin eine Behandlung im Rahmen der Routineversorgung nach dem gleichen Schema wie nach regulärem Therapie-Ende untersucht werden. Sie werden, soweit möglich, zudem an den regulären Nachsorgeuntersuchungen untersucht.

    Weiteres Vorgehen nach dem Abschluss
    Nach Abschluss der Studie werden die Patienten weiterhin im Rahmen der Routineversorgung weiter behandelt.
    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 Decision2015-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-08-07
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