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    Summary
    EudraCT Number:2020-003063-26
    Sponsor's Protocol Code Number:1634
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2021-11-10
    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 number2020-003063-26
    A.3Full title of the trial
    Personalized Risk-Adapted Therapy in Post-Pubertal Patients with Newly Diagnosed Medulloblastoma (PersoMed-I)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial investigating a personalized treatment, based on age and tumor characteristics , of newly diagnosed medullablastoma in patients that are postpubertal and/or adult consisting of lowering RT,chemotherapy doses and adding an investigative drug.
    A.3.2Name or abbreviated title of the trial where available
    PersoMed-I
    A.4.1Sponsor's protocol code number1634
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04402073
    A.5.4Other Identifiers
    Name:NOANumber:23
    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 SponsorEuropean Organisation for Research and Treatment of
    B.1.3.4CountryBelgium
    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 supportEORTC-BTG
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportSunpharmaceuticals
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOrganisation for Research and Treatment of
    B.5.2Functional name of contact pointRegulatory Affairs Department
    B.5.3 Address:
    B.5.3.1Street AddressAvenue E. Mounier 83/11
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number0032 2 7741597
    B.5.5Fax number00322 7727063
    B.5.6E-mailregulatory@eortc.org
    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 Odomzo
    D.2.1.1.2Name of the Marketing Authorisation holderSun Pharmaceutical Industries Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameSonidegib
    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 INNsonidegib
    D.3.9.1CAS number 956697-53-3
    D.3.9.3Other descriptive nameSONIDEGIB
    D.3.9.4EV Substance CodeSUB123432
    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.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 Yes
    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 nameCisplatin
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPConcentrate for solution for infusion (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCisplatin
    D.3.9.1CAS number 15663-27-1
    D.3.9.2Current sponsor codeCispatin
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    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 nameLomustine
    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 INNLOMUSTINE
    D.3.9.2Current sponsor codeLomustine
    D.3.9.4EV Substance CodeSUB08567MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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 Yes
    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 nameVincristine
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSolution for injection (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVINCRISTINE
    D.3.9.1CAS number 57-22-7
    D.3.9.2Current sponsor codeVincristine
    D.3.9.4EV Substance CodeSUB00059MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Newly Diagnosed Medulloblastoma
    E.1.1.1Medical condition in easily understood language
    A malignant tumor originating from brain cells during embryo phase of life and grows in the area of brain stem.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10027107
    E.1.2Term Medulloblastoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare progression-free survival (PFS) by central review of a personalized intensity-modulated therapy (experimental arm; sonidegib) vs. standard therapy in the SHH-activated subgroup in post-pubertal patients with newly diagnosed standard risk medulloblastoma.
    E.2.2Secondary objectives of the trial
    In experimental versus standard arm and in the 3 clinical subgroups
    separately (SHH, WNT and pooled Group 3 & Group 4) except if
    otherwise stated:
    • To compare PFS by central reviewer in WNT and Group 3 & 4
    subgroups
    • To compare PFS by local investigator
    • To compare overall survival (OS)
    • To evaluate safety and tolerability profile
    • To evaluate short- and long-term health-related quality of life
    (HRQoL) with a particular emphasis on the social functioning scale
    • To evaluate issues linked to survivorship (fear of recurrence, having
    problems with insurance/mortgage, work opportunities, life plans/goals
    and relationships with family or friends)
    • To evaluate short- and long-term neurocognitive function (NCF)
    • To evaluate short- and long-term endocrine function
    • To assess the incidence of second malignancies
    See protocol for the following:
    Exploratory objectives
    Fertility sub-study objectives (in selected centres)
    Translational research objectives
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Fertility sub-study (Version 2.0, January 14, 2021)
    Aims:
    • To determine the uptake and utilisation of oncofertility care,
    complications of fertility preservation and barriers of delivering
    oncofertility care in Medulloblastoma patients.
    • To define the timing and extent of reproductive complications in
    Medulloblastoma patients;
    • To look at the difference in reproductive complications in those
    Medulloblastoma patients who had treatment with the LDE225
    (sonidegib) arm of the study compared with those that had treatment on
    the arms of the study without the SMO inhibitor.
    • To prospectively explore the short term medical, psychological and
    practical fertility concerns that Medulloblastoma cancer patients
    experience.
    • To determine the reproductive risk of LDE225 (sonidegib) using mouse
    models.
    E.3Principal inclusion criteria
    Step 1: Registration
    • Before patient registration/randomization/enrollment, written
    informed consent must be given according to ICH/GCP, and
    national/local regulations. For patients under the age of legal consent,
    consent has to be obtained from the parent(s) or legal representative
    according to ICH/GCP, and national/local regulations.
    • FFPE tumor tissue from surgical resection and whole blood for central
    pathology review must be available.
    Step 2: Enrollment/randomization
    • Newly diagnosed, histologically proven, genetically classified,
    centrally confirmed medulloblastoma
    • Molecular subtype: medulloblastoma, SHH-activated and TP53-
    wildtype, M0-1; medulloblastoma, WNT-activated, M0-1;
    medulloblastoma, Group 3 & Group 4, M0-1
    • Histologic subtype: medulloblastoma, classic (CMB);
    medulloblastoma, desmoplastic/nodular (DNMB); medulloblastoma, with
    extensive nodularity (MBEN); medulloblastoma, large cell/anaplastic
    (LCA)
    • Post-pubertal patients (<18y of age), or adults (18 y of age and
    above) in SHH-activated medulloblastoma.
    • Adults (≥ 18 years) in the WNT-activated, Group 3 & Group 4
    medulloblastoma.
    • Patients (<18 years) must have completed puberty.
    • Patients (<18 years) must have a radiologically confirmed bone age
    of minimum 15 years for females and 17 years for males.
    Non-SHH dependent patients under the age of 18 and SHH-activated
    patients under the age of 18 with M1 disease or above should be
    transferred to a paediatric site for inclusion in a pediatric site for
    inclusion in a pediatric trial that fits that population.
    • Clinical status within 2 weeks of randomization/enrollment:
    Karnofsky 50-100
    • NANO-score 0 to 9 (allowing full-blown cerebellar symptoms)
    • Clinically standard-risk (centrally assessed MRI review on pre- and
    postoperative MRI) defined as:
    - Adult patients: total or subtotal surgical resection defined as at least
    80% reduction of the contrast enhancing tumour and/or less than or
    equal to 1.5 cm2 (measured in axial plane) of residual tumour on early
    post-operative MRI, without and with contrast.
    - Post-pubertal patients: total or near total surgical resection with less
    than or equal to 1.5 cm2 (measured in axial plane) of residual tumour on
    early post-operative MRI, without and with contrast
    - No CNS metastasis on MRI (cranial and spinal)
    - Chang stage <M2
    • No evidence of extra-CNS metastasis
    • Full recovery from surgery or any post-surgical complication (e.g.
    bleeding, infections etc.)
    • Baseline MRI as the following:
    o Brain MRI: pre- and post- surgery (within 72h) MRI is mandatory.
    o Spine MRI: preferably pre-operative. If not available, post-operative
    is acceptable.
    • Normal liver, renal and haematological function within 2 weeks of
    randomization/enrollment.
    • WBC ≥ 3×10^9/L
    • ANC ≥ 1.5×10^9/L
    • Platelet count of ≥ 100×10^9/L independent of transfusion
    • Hemoglobin ≥ 10 g/dl
    • Total Bilirubin ≤ 1.5 × ULN
    • ALT (SGPT), AST (SGOT), alkaline phosphatase (ALP) ≤ 2.5 × ULN
    • Serum creatinine < 1.5 × ULN or creatinine clearance (CrCl) >60
    mL/min (the estimated GFR should be in mL/min/1.73m² unit, using the
    MDRD formula)
    • According to CTFG recommendations related to contraception and
    pregnancy testing during clinical trials, a negative serum or urine
    pregnancy test within 7 days before randomization/enrollment for
    women of childbearing / reproductive potential (WOCBP).
    • WOCBP must use two methods of adequate birth control, including a
    highly effective method and a barrier method. Birth control during the
    study treatment period and for at least 20 months after the last study
    treatment is mandatory for patients who receive sonidegib For all other
    patients, this period is 12 months after the last study treatment. A highly
    effective method of birth control is defined as those which result in low
    failure rate (i.e. less than 1% per year) when used consistently and
    correctly.
    • Male patients even those who have had a vasectomy must always use
    a condom during treatment and for 12 months after last treatment. Men
    should not donate semen during treatment and for 12 months after
    ending treatment (donation of semen for the semen analyses in the 1 b
    fertility project is allowed)
    • Female subjects who are breast feeding must discontinue nursing
    prior to the first dose of study treatment and until 20 months after the
    last study treatment.
    E.4Principal exclusion criteria
    Step 2: Enrollment/randomization
    • Prior treatment for medulloblastoma
    • Unavailability of central review pathology results
    • Post-pubertal patients with known negative prognostic markers
    (MYC/MYCN amplification and/or TP53 germline alteration in the SHH
    subgroup)
    • Inability to start radiotherapy within 56 days after surgery.
    • Significant sensorineural hearing deficit as defined by pure tone
    audiometry with bone conduction or air conduction and normal
    tympanogram showing impairment ≥ 20 dB at 1-3 kHz
    • Any medical contraindication to radiotherapy or chemotherapy
    • Hypersensitivity to contrast medium for MRI.
    • Hypersensitivity towards the active substance of any of study drugs
    or their excipients
    • Current use of BCRP substrates such as mitoxantrone, methotrexate,
    topotecan, imatinib or irinotecan or if patient is within 5 times the halflife
    of these medications
    • Concurrent severe or uncontrolled medical disease (e.g., active
    systemic infection, diabetes, psychiatric disorder) that, in the opinion of
    the investigator, would compromise the safety of the patient or
    compromise the ability of the patient to complete the study.
    • Prior or second invasive malignancy, except non-melanoma skin
    cancer, completely resected cervical carcinoma in situ, low risk prostate
    cancer (cT1-2a N0 and Gleason score ≤ 6 and PSA < 10 ng/mL), either
    totally resected or irradiated with curative intent (with PSA of less than
    or equal to 0.1 ng/mL) or under active surveillance as per ESMO
    guidelines. Other cancers for which the subject has completed
    potentially curative treatment more than 5 years prior to diagnosis of
    medulloblastoma study entry are allowed.
    • Known history or current evidence of active Hepatitis B (e.g., positive
    HBV surface antigen) or C (e.g., HCV RNA [qualitative] is detected)
    • Known or current evidence of Human Immunodeficiency Virus (HIV)
    infection (positive HIV-1/2 antibodies)
    • Presence of any psychological, familial, sociological, or geographical
    condition potentially hampering compliance with the study protocol and
    follow-up schedule; those conditions should be discussed with the
    patient before registration in the trial.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-Free Survival (PFS) according to RAPNO assessed by central
    reviewer of a personalized intensity-modulated therapy (experimental
    arm; sonidegib) compared to standard therapy in SHH-activated patients
    in post-pubertal patients with newly diagnosed standard risk
    medulloblastoma.
    E.5.1.1Timepoint(s) of evaluation of this end point
    [ Time Frame: 91 months after the date of recruitment of the first patient ]
    Compare progression-free survival (PFS) by central review of a personalized intensity-modulated therapy (experimental arm; sonidegib) vs. standard therapy in the SHH-activated subgroup in post-pubertal patients with newly diagnosed standard risk medulloblastoma

    E.5.2Secondary end point(s)
    In experimental versus standard arm in 3 subgroups separately (SHH,
    WNT and pooled Group 3 & Group 4) except if otherwise stated:
    • PFS by central reviewer in WNT and Group 3 & Group 4 subgroups
    • PFS by local investigator
    • OS
    • Frequencies and percentages of worst adverse events (AEs) or
    laboratory event; grades according to CTCAE v.5 (with neurological,
    kidney, auditory, endocrine and radiotherapy associated as AE of special
    interest)
    • Patient reported outcomes:
    - Health-related Quality of life (HRQol): EORTC QLQ-C30 and BN20, social
    functioning as scale of special interest
    - Survivorship outcomes (five items from EORTC QLQ-SURV111)
    • Neurocognitive function (NCF): Hopkins Verbal Learning Test,
    Controlled Oral Word Association Trail Making Test Part A, Trail Making
    Test Part B, cerebellar cognitive affective/Schmahmann syndrome scale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. (PFS) [ when 43 PFS events are observed estimated to occur 91 months after the date of recruitment of 1st patient]
    2. (OS) [ when 43 PFS events are observed estimated to occur 91 m after the date of recruitment of 1st patient]
    3.safety and tolerability profile: CTCAE v5 [ when 43 PFS events are observed estimated to occur 91 months after the date of recruitment of 1st patient]
    4. (HRQoL) [ when 43 PFS events are observed estimated to occur 91 m after the date of recruitment of 1st patient]
    The primary HRQoL endpoint that is considered relevant for this study is social functioning. The other scales from the QLQ-C30 and BN20 considered as exploratory in nature.
    5.OS[when 43 PFS events are observed estimated to occur 91 M after the date of recruitment of 1st patient
    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 Yes
    E.6.13.1Other scope of the trial description
    Radiotherapy, QOL, radiogenomics, neurocognitive function, long term effects, impact on fertility, biobanking
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) 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 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 concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Switzerland
    Australia
    United Kingdom
    Austria
    Denmark
    France
    Germany
    Italy
    Netherlands
    Spain
    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
    End of study occurs when all of the following criteria have been satisfied:
    • 5 months after all patients have stopped protocol treatment.
    • The trial is mature for the analysis of the primary endpoint as defined in the protocol.
    • The database has been fully cleaned and frozen for this analysis.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days83
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days83
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 37
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 37
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 164
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 163
    F.4.2.2In the whole clinical trial 205
    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)
    According to the discretion of the treating physician
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation University of Munich
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-03
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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