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    Summary
    EudraCT Number:2018-003557-21
    Sponsor's Protocol Code Number:LixiBrain01
    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:2018-10-17
    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 number2018-003557-21
    A.3Full title of the trial
    Effect of insulin glargine and lixisenatide versus insulin glargine on brain insulin sensitivity in patients with type 2 diabetes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of insulin glargine and lixisenatide versus insulin glargine on brain insulin sensitivity in patients with type 2 diabetes
    A.4.1Sponsor's protocol code numberLixiBrain01
    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 supportSanofi-Aventis Deutschland GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Tuebingen
    B.5.2Functional name of contact pointInternal Medicine IV
    B.5.3 Address:
    B.5.3.1Street AddressOtfried-Müller Str. 10
    B.5.3.2Town/ cityTuebingen
    B.5.3.3Post code72076
    B.5.3.4CountryGermany
    B.5.4Telephone number+497071 29 80687
    B.5.6E-mailcorinna.sailer@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 Yes
    D.2.1.1.1Trade name Suliqua®
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis
    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.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInsulin Glargin
    D.3.9.2Current sponsor codeiGlarLixi
    D.3.9.4EV Substance CodeSUB08196MIG
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlixisenatide
    D.3.9.1CAS number 320367-13-3
    D.3.9.3Other descriptive nameLIXISENATIDE
    D.3.9.4EV Substance CodeSUB32251
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Lantus®
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Deutschland GmbH
    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 nameLantus
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINSULIN GLARGINE
    D.3.9.1CAS number 160337-95-1
    D.3.9.2Current sponsor codeGlargine
    D.3.9.4EV Substance CodeSUB08196MIG
    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 No
    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 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.3.9.2Current sponsor codehuman nasal insulin
    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 No
    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.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    E.1.1.1Medical condition in easily understood language
    Female and male subjects with type 2 diabetes
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Objective: To assess whether treatment with insulin glargine + lixisenatide (iGlarLixi) versus insulin glargine changes regional brain insulin sensitivity and thereby glucose metabolism, eating behaviour, and cognition in patients with type 2 diabetes insufficiently controlled with oral antidiabetic drugs (OAD).
    E.2.2Secondary objectives of the trial
    o Effect of 12 weeks treatment with iGlarLixi or Glargine on resting state brain activity and on brain response to food pictures and control pictures as assessed by functional magnetic resonance imaging. Food intake and food preference will be monitored during an ad libitum buffet.
    o Effect of 12 weeks treatment with iGlarLixi or Glargine on cognitive function assessed by
    established neurocognitive tests (CANTAB[Cambridge Neuropsychological Test Automated
    Battery]containing Motor Screening Task (MOT),Reaction Time (RTI) Paired Associates Learning
    (PAL), Spatial Working Memory (SWM), PatternRecognition Memory (PRM), Delayed Matching
    to Sample (DMS), Rapid Visual InformationProcessing (RVP) tests).
    o Effect of 12 weeks treatment with iGlarLixi or Glargine on glycemic control (HbA1c change
    from baseline to week 12).
    o Effect of 12 weeks treatment with iGlarLixi or Glargine on body weight and body fat distribution
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects meeting all of the following criteria will be considered
    for admission to the trial:
    • Must be between 18 and 65 years at the time of signing
    the informed consent.
    • BMI 25-45 kg/m²
    • Understand and voluntarily sign an informed consent
    document prior to any study related
    assessments/procedures.
    • Ability to adhere to the study visit schedule and other
    protocol requirements.
    • Patients with type 2 diabetes mellitus diagnosed for at
    least 1 year before the screening visit (visit 1) treated for
    at least 3 months prior to visit 1 with only metformin or
    metformin and a sodium glucose co-transporter 2
    inhibitor, and patients who are not adequately controlled
    with this treatment.
    • Females of childbearing potential (FCBP) must agree
     to utilize a highly effective forms of contraception
    (Pearl index < 1) or practice complete abstinence
    from heterosexual contact while participating in
    the study (including dose interruptions), and for
    at least 28 days after study treatment
    discontinuation and must agree to pregnancy
    testing during this timeframe
     to abstain from breastfeeding during study
    participation and 28 days after study drug
    discontinuation.
    • Males must agree
     to use a latex condom during any sexual contact
    with FCBP while participating in the study and for
    28 days following discontinuation from this study,
    even if he has undergone a successful vasectomy
     to refrain from donating semen or sperm while
    participating in this study and for 28 days after
    discontinuation from this study treatment.
    • All subjects must agree to refrain from donating blood
    while on study drug and for 28 days after discontinuation
    from this study treatment.
    • All subjects must agree not to share medication.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following criteria will not be included in the trial:
    • HbA1c at screening visit less than 7.5% or more than 12% for patients previously treated with metformin alone or with metformin and a second oral anti-diabetic treatment.• Women during pregnancy and lactation.• History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal products. This includes iGlarLixi, insulin glargine, and human nasal insulin.
    • Use of oral glucose-lowering agents other than those stated in the inclusion criteria or any injectable glucoselowering
    agents during 3 months before screening • History of discontinuation of a previous treatment with a GLP-1 receptor agonist (GLP-1 RA) due to safety/tolerability issue or lack of efficacy. • Patient who has previously participated in any clinical trial with lixisenatide or the insulin glargine +lixisenatide fixed ratio combination or has previously received lixisenatide.
    • Any contraindication to metformin use, according to local labeling. • Use of weight loss drugs within 3 months prior to screening visit. • Within the last 6 months prior to screening visit: myocardial infarction, unstable angina, or heart failure
    requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures to be
    performed during the study period. • History of stroke. • History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy was already performed), chronic pancreatitis, pancreatitis during a previous treatment with incretin therapies, pancreatectomy, stomach/gastric surgery. • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes). • Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 160 mmHg or diastolic blood pressure above 90 mmHg) at screening visit. • At screening visit, Body Mass Index (BMI) less than or equal to 25 or above 45 kg/m². • At screening visit ALT or AST more than 3 ULN. • At screening visit calcitonin above or equal to 20 pg/mL (5.9 pmol/L). • Exclusion Criteria for randomization at the end of the screening period: o HbA1c less than 7.5% or above 12%. o Amylase and/or lipase more than 3 ULN. o Calcitonin above or equal to 20 pg/mL (5.9pmol/L). • Participation in other clinical trials or observation period of competing trials up to 30 days prior to this study. • Known malformation of the central nervous system• Persons working nightshift• Treatment with drugs with central nervous actions or systemic steroid therapy • Any relevant (according to investigator’s judgment) cardiovascular disease, e.g. myocardial infarction, acute coronary syndrome, unstable angina pectoris,PTCA, heart failure (NYHA II-IV), planned coronary,carotid or peripheral artery revascularisation procedures to be performed during the study period.
    • Indication of liver disease, as per medical history or defined by serum levels of either Alanine,Aminotransferase (ALT [SGPT]), Aspartate Aminotransferase (AST [SGOT]), or Alkaline Phosphatase above 3 x upper limit of normal (ULN) as determined during screening.• Alcohol abuse, defined as more than 20 gr/day • Impaired renal function, defined as estimated Glomerular Filtration Rate (eGFR) ≤ 60 ml/min (MDRD formula) as determined during screening. • Known structural and functional urogenital abnormalitiesthat that predispose for urogenital infections. • Subjects with a haemoglobin (Hb) between 14 and 18g/dl (for males) and Hb between 12 and 16 g/dl (forfemales) at screening.• Bariatric surgery within the past two years and other
    gastrointestinal surgeries that induce chronic malabsorption within the last 5 years. • Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.• Treatment with anti-obesity drugs 3 months prior to
    informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight. • Known autoimmune disease (except autoimmune disease of the thyroid gland) or chronic inflammatory condition.• Claustrophobia • Any other clinically significant major organ system disease at screening such as relevant gastrointestinal,neurologic, psychiatric, endocrine (i.e. pancreatic),hematologic, malignant, infection or other major
    systemic diseases making implementation of the protocol or interpretation of the study results difficult.
    Presence of any contraindication for the conduct of an MRI investigation. Any other clinical condition, Refusal to get informed of unexpected detected pathological MRI findings • History of diabetic ketoacidosis • Severe gastric or bowel disease (including
    gastroparesis)[..]for further details please check the prtocol-Section Exclusion Criteria
    E.5 End points
    E.5.1Primary end point(s)
    o Effect of 12 weeks treatment with iGlarLixi or Glargine on brain insulin sensitivity assessed by functional magnetic resonance imaging (fMRI) as change in regional cerebral blood flow (rCBF) from before to 30 minutes after nasal insulin spray application.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 2 and visit 7 ( week 0 and 12)
    E.5.2Secondary end point(s)
    o Effect of 12 weeks treatment with iGlarLixi or Glargine on resting state brain activity and on brain response to food pictures and control pictures as assessed by functional magnetic resonance imaging. Food intake and food preference will be monitored during an ad libitum buffet.
    o Effect of 12 weeks treatment with iGlarLixi or Glargine on cognitive function assessed by established neurocognitive tests (HVLT [Hopkins Verbal Learning Test]; TMT-A&B [Trail Making Test-A&B], MMSE ; MOCA + Digit Symbol Substitution Test [SDMT ]; CANTAB [Cambridge Neuropsychological Test Automated Battery] Tests).
    o Effect of 12 weeks treatment with iGlarLixi or Glargine on glycemic control (HbA1c change from baseline to week 12 ).
    o Effect of 12 weeks treatment with iGlarLixi or Glargine on body weight and body fat distribution
    E.5.2.1Timepoint(s) of evaluation of this end point
    Effect of 12 weeks treatment with iGlarLixi or Glargine on resting state brain activity and on brain response to food pictures: Week 0 and Week 12 (Visit 0 and Visit 7)

    Effect of 12 weeks treatment with iGlarLixi or Glargine on cognitive function assessed by established neurocognitive tests: Week 0 and Week 12 (Visit 0 and Visit 7)

    Effect of 12 weeks treatment with iGlarLixi or Glargine on glycemic control (HbA1c change from baseline to week 12 ): Week 0 and Week 12 (Visit 0 and Visit 7)

    Effect of 12 weeks treatment with iGlarLixi or Glargine on body weight and body fat distribution: Week 0 and Week 12 (Visit 0 and Visit 7)
    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) 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    • Serious Aadverse Drug Reactions (SADR)/not justifiable toxicity
    • Substantial changes in risk-benefit considerations
    • New insights from other trials
    • Insufficient recruitment rate
    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
    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: 40
    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 state40
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    There is no plan for further treatment in this study. Further treatment should be by discretion of the patients’ physician.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-06
    P. End of Trial
    P.End of Trial StatusCompleted
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