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    Summary
    EudraCT Number:2021-002572-39
    Sponsor's Protocol Code Number:TargetFlame
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-12-17
    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 number2021-002572-39
    A.3Full title of the trial
    Effects of add-on Celecoxib treatment in patients with schizophrenia spectrum disorders and inflammatory cytokine profile (TargetFlame)
    Evaluation der Effektivität der add-on Behandlung von Celecoxib bei Menschen mit einer Schizophrenie und inflammatorischen Zytokin-Profil
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of add-on Celecoxib treatment in patients with schizophrenia spectrum disorders and inflammatory cytokine profile (TargetFlame)
    Evaluation der Effektivität der add-on Behandlung von Celecoxib bei Menschen mit einer Schizophrenie und inflammatorischen Zytokin-Profil
    A.3.2Name or abbreviated title of the trial where available
    TargetFlame
    TargetFlame
    A.4.1Sponsor's protocol code numberTargetFlame
    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 SponsorBezirkskliniken Schwaben
    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 supportEra PerMed BMBF
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTechnische Universität München, Fakultät für Medizin, Münchner Studienzentrum
    B.5.2Functional name of contact pointDr. med. Christiane Blankenstein
    B.5.3 Address:
    B.5.3.1Street AddressIsmaninger Str. 22
    B.5.3.2Town/ cityMünchen
    B.5.3.3Post code81675
    B.5.3.4CountryGermany
    B.5.4Telephone number00498941406321
    B.5.5Fax number00498941406322
    B.5.6E-mailmuenchner.studienzentrum@mri.tum.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 Celecoxib
    D.2.1.1.2Name of the Marketing Authorisation holderAliud
    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 nameCelecoxib
    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 INNCelecoxib
    D.3.9.1CAS number 169590-42-5
    D.3.9.2Current sponsor codeTargetFlame
    D.3.9.3Other descriptive nameCELECOXIB
    D.3.9.4EV Substance CodeSUB01143MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Schizophrenia
    Schizophrenia
    E.1.1.1Medical condition in easily understood language
    Schizophrenia
    Schizophrenie
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10039626
    E.1.2Term Schizophrenia
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to investigate improvements in psychopathology in patients with schizophrenia spectrum disorders having an inflammatory blood profile randomized to either Celecoxib or placebo
    Der primäre Endpunkt ist die Verbesserung der Psychopathologie bei Patienten mit einer Schizophrenie mit inflammatorischem Zytokin-Profil, die nach Randomisierung entweder Celecoxib oder Placebo erhalten haben.
    E.2.2Secondary objectives of the trial
    Secondary and exploratory objectives include differences in side effects, symptom severity, safety measures and cognitive functions.
    Sekundäre Endpunkte beinhalten Unterschiede in den Nebenwirkungen, in der Symptomschwere, in der Sicherheit der Anwendung und in kognitiven Funktionen in den beiden Gruppen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key inclusion criteria:
    • A DSM-V diagnosis of schizophrenia or schizophrenia-spectrum disorder according to MINI interview
    • PANSS total ≥ 55 at screening
    • An "inflamed" serum profile identified based on the definition provided in this protocol
    • Exclusion of a non-detected rheumatological or HBV/HCV disease following the screening defined in this protocol
    • Any antipsychotic treatment being stable for one week prior to inclusion
    • Inpatients and outpatients
    • Age between 18 and 65 years
    • Written informed consent obtained from the participant prior to performing any protocol-related procedures, including screening evaluations
    • Female participants with reproductive potential must have a negative pregnancy test using a pregnancy test strip as part of the screening visit
    • Female participants with reproductive potential must have a negative serum pregnancy test within seven days prior to randomization
    • Male participants and female participants who are not capable of bearing children or who use a method of contraception that is medically approved by the health authority of the respective country at screening
    This includes:
    • A woman who is not capable of bearing a child is defined as follows: post-menopausal (12 months natural (spontaneous) amenorrhea or 6 months spontaneous amenorrhea with serum-FSH-values (folliclestimulating hormone) of >40 mIU/mL); 6 weeks after a bilateral ovariectomy with or without hysterectomy or sterilization by means of tubal ligation
    • A woman capable of bearing child is defined as follows: a woman who is physiologically capable of becoming pregnant, including women whose occupation, lifestyle or sexual orientation exclude sexual intercourse with a male partner and women whose partners have been sterilized by vasectomy or other measures.
    • Medically-approved acceptable methods of contraception with a low failure rate (i.e. less than 1% per year) when used consistently and correct can include the following: hormonal contraceptives, intrauterine device and double barrier method. Acceptable preventive measures can include total abstinence at the discretion of the investigator, in cases where compliance is ensured because of the study participant’s age, occupation, lifestyle or sexual orientation. Periodical abstinence (e.g. calendar, ovulation, symptothermal methods or abstinence until the 4th day after the ovulation) as well as coitus interruptus are not acceptable methods of contraception.
    • A reliable method of contraception (CTFG guideline) must be used for the entire duration of the study.
    Einschlusskriterien:
    • DSM-V Diagnose einer Schizophrenie oder schizophrenen Spektrum-erkrankung bestätigt durch das das Mini international Neuropsychiatric Interview (MINI)
    • PANSS Total Score ≥ 55 zum Zeitpunkt des Screenings
    • Inflammatorisches Serum-Profil gemäß Protokolldefinition
    • Ausschluss von nicht-erkannter rheumatologischer oder HBV/HCV Erkrankung nach wie in diesem Studienprotokoll erfolgtem Screening
    • Stabilität der antipsychotischen Behandlung für mind. 1 Woche vor Studieneinschluss
    • Stationäres oder ambulantes Behandlungssetting
    • Alter zwischen 18 und 65 Jahren
    • Gültige Einwilligungserklärung vor der Durchführung jeglicher studienspezifischen Tätigkeiten, inklusive der Screening-Untersuchung
    • Weibliche gebährfähige Teilnehmerinnen müssen einen negativen Schwangerschaftstest im Serum innerhalb von 7 Tagen vor Studienbeginn vorweisen
    • Männliche oder weibliche Teilnehmer, die nicht gebährfähig sind bzw., die eine Verhütungsmethode verwenden, welche von der Gesundheitsautorität des jeweiligen Landes medizinisch anerkannt wird zum Zeitpunkt des Screenings
    Dies beinhaltet:
    • Eine Frau, die nicht gebärfähig ist, wird wie folgt definiert:
    Post-menopausal (12 Monate andauernde natürliche (spontane) Amenorrhoe oder 6 Monate spontane Amenorrhoe mit Serum-FSH- (Follikel-stimulierendes Hormon) Werten von >40 mIU/mL); 6 Wochen nach bilateraler Ovarektomie mit oder ohne Hysterektomie oder Sterilisation durch Tubenligatur
    • Eine gebärfähige Frau wird wie folgt definiert:
    Eine Frau, die physiologisch in der Lage ist schwanger zu werden, eingeschlossen Frauen, dessen Beruf, Lebenswandel oder sexuelle Orientierung Geschlechtsverkehr mit einem männlichen Partner ausschließen und Frauen, dessen Partner durch Vasektomie oder andere Verfahren sterilisiert worden sind.
    Medizinisch anerkannte Verhütungsmethoden können wie folgt sein:
    Hormonelle Kontrazeptiva, intrauterine Empfängnisverhütung und double barrier Methode. Anerkannte präventive Maßnahmen inkludieren vollständige Abstinenz im Ermessen des Prüfers in Fällen, in denen die Compliance gesichert ist aufgrund des Alters, des Berufes, des Lebenswandels oder der sexuellen Orientierung des Teilnehmers. Periodische Abstinenz (z.B. Kalendermethode, Ovulation, symptothermale Methoden oder Abstinenz bis zum 4. Tag nach der Ovulation) sowie Coitus Interruptus sind nicht anerkannte Verhütungsmethoden.
    • Eine verlässliche Verhütungsmethode (CTFG Richtlinie) muss für den ganzen Zeitraum der Studie angewendet werden.
    E.4Principal exclusion criteria
    Key exclusion criteria:
    • Patients who are unable to give informed consent;
    • Coercive treatment or forced placement in a psychiatric hospital at the time of study inclusion;
    • Patients who have acute suicidal ideations according to the clinical standard assessment
    • Medical history of an immune-mediated brain disorder;
    • Chronic use of glucocorticosteroids (temporary use is permitted, if stopped at least 1 month before start of treatment trial);
    • Chronic use of non-steroidal anti-inflammatory drugs (temporary use is permitted, if stopped at least 1 month before start of treatment trial; on-demand use is permitted only as topic application);
    • Current use of statins or other lipid-lowering drugs;
    • Current use of tacrolimus or fluconazole;
    • Current use of antihypertensives from the substance class of ACE inhibitors or AT-II antagonists or beta-blockers with the exception of propranolol;
    • Current use of diuretics;
    • Current use of carbamazepin;
    • Chronic use of antiplatelet agents (e.g ASS, clopidogrel), marcumar or Non-vitamin K Antagonist Oral anticoagulants (NOAK);
    • Known history of treatment-resistant hypertension;
    • Known history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease;
    • Known history of congestive heart failure (NYHA II-IV) or current use of digoxin;
    • Known history of type 2 diabetes mellitus;
    • Severe liver disorder(s) (serum albumin <25 g/l or Child-Pugh score >10);
    • Severe kidney disorder(s) (estimated creatinine clearance <30 ml/min);
    • Known history of systemic dermatological disorders;
    • Known history of ulcer disease or gastrointestinal (GI) bleeding;
    • Known history of inflammatory bowel disease;
    • Pregnancy or breast-feeding;
    • For male patients: Pregnancy or breast-feeding of the partner
    • Intolerance to one of the study drugs;
    • Known hypersensitivity to sulphonamides;
    • Known history of asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergictype reactions after taking acetylsalicylic acid(aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2 (cyclooxygenase-2) inhibitors;
    • Known history of hereditary Galactose-intolerance, complete Lactase-deficiency or Glucose-Galactose-malabsorption disorder;
    • Concurrent enrolment in another clinical trial where the participant is receiving an IMP or participation in another clinical trial with IMP during the last 30 days before inclusion or 7 half-lives of previously used IMP, whichever is longer.
    Ausschlusskriterien:
    • Nicht-einwilligungsfähige Patient*innen
    • Zwangsbehandlung oder Zwangsunterbringung in einem psychiatrischen Krankenhaus zum Zeitpunkt des Studieneinschlusses
    • Patient*innen, die nach klinischer Standardeinschätzung akut suizidal sind
    • Immunvermittelte Erkrankung des Gehirns in der medizinischen Vorgeschichte
    • Chronischer Gebrauch von Glucocorticoiden (temporärer Gebrauch ist erlaubt, insofern dieser mind. 1 Monat vor Beginn der Behandlung im Rahmen der Studie beendet wurde)
    • Chronischer Gebrauch von nicht-steroidaler, anti-inflammatorischer Medikation (temporärer Gebrauch ist erlaubt, insofern dieser mind. 1 Monat vor Beginn der Behandlung im Rahmen der Studie beendet wurde, Gebrauch als Bedarfsmedikation ist erlaubt im Rahmen der festgelegten therapeutischen Referenzbereiche
    • Aktuelle Behandlung mit Statinen oder anderen fettsenkenden Substanzen
    • Aktuelle Behandlung mit Tacrolimus oder Fluconazol;
    • Aktuelle Anwendung von Blutdrucksenkern aus der Substanzklasse der ACE-Hemmer oder AT-II-Antagonisten oder Betablockern mit Ausnahme von Propranolol;
    • Aktuelle Anwendung von Diuretika;
    • Aktuelle Anwendung von Carbamazepin;
    • Chronische Einnahme von Thrombozytenaggregationshemmern (z. B. ASS, Clopidogrel), Marcumar oder oralen Antikoagulanzien ohne Vitamin-K-Antagonisten (NOAK);
    • Bekannte Vorgeschichte von behandlungsresistentem Bluthochdruck;
    • Bekannte ischämische Herzerkrankungen, periphere arterielle Erkrankungen und/oder zerebrovaskuläre Erkrankungen in der Vorgeschichte;
    • Bekannte Vorgeschichte von kongestiver Herzinsuffizienz (NYHA II-IV) oder derzeitige Verwendung von Digoxin;
    • Bekannte Vorgeschichte von Diabetes mellitus Typ 2;
    • Schwere Lebererkrankung(en) (Serumalbumin <25 g/l oder Child-Pugh-Score >10);
    • Schwere Nierenfunktionsstörung(en) (geschätzte Kreatinin-Clearance <30 ml/min);
    • Bekannte systemische dermatologische Erkrankungen in der Vorgeschichte;
    • Bekanntes Auftreten von Geschwüren oder gastrointestinalen Blutungen;
    • Bekannte Anamnese von entzündlichen Darmerkrankungen;
    • Schwangerschaft oder Stillen;
    • Männliche Patienten, die schwangere oder stillende Partner haben
    • Unverträglichkeit gegenüber einem der Studienmedikamente;
    • Bekannte Überempfindlichkeit gegenüber Sulfonamiden;
    • Asthma, akute Rhinitis, Nasenpolypen, angioneurotisches Ödem, Urtikaria oder andere allergische Reaktionen nach Einnahme von Acetylsalicylsäure (Aspirin) oder anderen nichtsteroidalen entzündungshemmenden Arzneimitteln (NSAIDs) einschließlich COX-2-Hemmern (Cyclooxygenase-2-Hemmern) in der Vorgeschichte;
    • Bekannte erbliche Galaktose-Intoleranz, kompletter Laktase-Mangel oder Glukose-Galaktose-Malabsorptionsstörung;
    • Gleichzeitige Teilnahme an einer anderen klinischen Studie, in der der Teilnehmer ein IMP erhält, oder Teilnahme an einer anderen klinischen Studie mit einem IMP in den letzten 30 Tagen vor dem Einschluss oder 7 Halbwertszeiten des zuvor verwendeten IMP, je nachdem, was länger ist
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint:
    Reduction in symptom severity in randomized patients following treatment with add-on Celecoxib compared to control patients following treatment with add-on placebo as assessed by total PANSS score changes from baseline to two months (56 days) after treatment initiation
    Primärer Endpunkt:
    Reduktion in Symptomschwere (Veränderungen im PANSS Total Score) von Baseline vs. 2 Monate nach Initiierung der Behandlung in randomisierten Patienten mit entweder add-on Celecoxib oder add-on Placebo (Kontrollgruppe)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Two months (56 days) after treatment initiation
    Zwei Monate (56 Tage) nach Beginn der Behandlung
    E.5.2Secondary end point(s)
    Key secondary endpoint(s):
    • Disease severity in the positive, negative and general psychopathology dimensions assessed using the P-PANSS, N-PANSS and GP-PANSS subscale scores after 2 and 6 months compared to baseline
    • Andreasen Remission criteria after 2 and 6 months compared to baseline
    • Global Assessment of functioning scale (GAF) score after 2 and 6 months compared to baseline
    Assessment of safety:
    • Adverse Events (AEs) at each visit
    • Serious Adverse Events (SAEs) at each visit
    • Study laboratory at each visit. Study laboratory includes standard blood count ("Kleines Blutbild"), creatinine, ASAT, ALAT, albumin, potassium, and sodium
    • Weight and BMI after 2 and 6 months compared to baseline
    • Standard parameters of Electrocardiogram (ECG) at compared to baseline
    Sekundäre Endpunkte:
    • Symptomschwere in den psychopathologischen Dimensionen Positiv-symptomatik, Negativsymptomatik und Allgemeinsymptomatik gemessen mit den Subscores P-PANSS, N-PANSS und GP-PANSS nach 2 und 6 Monaten verglichen mit Baseline
    • Andreasen-Remissions-Kriterien nach 2 und nach 6 Monaten verglichen mit Baseline
    • Globales Funktionsniveau gemäß Global Assessment of functioning (GAF) – Skala nach 2 und nach 6 Monaten verglichen mit Baseline
    Erhebung von Sicherheitsparametern:
    • Unerwünschte Ereignisse / adverse events (AEs) und schwerwiegende unerwünschte Ereignisse / serious adverse events (SAEs) bei jeder Visite
    • Spezifische Laborparameter im Blut (Standard-Blutbild, Kreatinin, ASAT, ALAT, Albumin, Kalium und Natrium) bei jeder Visite
    • Gewicht und Body-mass-index (BMI) nach 2 und nach 6 Monaten verglichen mit Baseline
    • Standardparameter des Elektrokardiogramms (EKG) im Vergleich zu Baseline
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 2 and 6 months
    Nach 2 und 6 Monaten
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 concerned2
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 109
    F.1.3Elderly (>=65 years) No
    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 state109
    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)
    Study medication will be used as an add-on medication. Actual standard medication will be continued during and after the end of study.
    Die Studienmedikation wird als add-on-Medikation zu einer bereits bestehenden Medikation gegeben, die auch nach Ende der Studie weitergeführt wird.
    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 Decision2022-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-30
    P. End of Trial
    P.End of Trial StatusOngoing
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    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
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