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    Summary
    EudraCT Number:2015-002876-25
    Sponsor's Protocol Code Number:178-CL-206A
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-02-02
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2015-002876-25
    A.3Full title of the trial
    An Open-label, Baseline-controlled, Multicenter, Phase 3 Dose-titration Study Followed by a Fixed-dose Observation Period to Evaluate Efficacy, Safety and Pharmacokinetics of Mirabegron in Children and Adolescents From 3 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO) on Clean Intermittent Catheterization (CIC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate how effective and safe the study medication ‘mirabegron’ is and how long it stays in the body in children and adolescents aged 3 to less than 18 years with symptoms of an overactive bladder with a neurologic cause.

    A.3.2Name or abbreviated title of the trial where available
    Crocodile Study
    A.4.1Sponsor's protocol code number178-CL-206A
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/056/2017
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstellas Pharma Europe B.V.
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstellas Pharma Europe B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Europe B.V. - Global Development Operations
    B.5.2Functional name of contact pointService Desk
    B.5.3 Address:
    B.5.3.1Street AddressSylviusweg 62
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 BE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31715455878
    B.5.5Fax number+31715455224
    B.5.6E-mailcontact@nl.astellas.com
    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 Betmiga
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma 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 nameMirabegron
    D.3.4Pharmaceutical form Prolonged-release tablet
    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 INNMIRABEGRON
    D.3.9.1CAS number 223673-61-8
    D.3.9.3Other descriptive nameMIRABEGRON
    D.3.9.4EV Substance CodeSUB32690
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.2.1.1.1Trade name Betmiga
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma 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 nameMirabegron
    D.3.4Pharmaceutical form Prolonged-release tablet
    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 INNMIRABEGRON
    D.3.9.1CAS number 223673-61-8
    D.3.9.3Other descriptive nameMIRABEGRON
    D.3.9.4EV Substance CodeSUB32690
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 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 namemirabegron
    D.3.2Product code YM178
    D.3.4Pharmaceutical form Granules for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNMIRABEGRON
    D.3.9.1CAS number 223673-61-8
    D.3.9.2Current sponsor codeYM178
    D.3.9.3Other descriptive nameMIRABEGRON
    D.3.9.4EV Substance CodeSUB32690
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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
    Neurogenic detrusor overactivity (NDO)
    E.1.1.1Medical condition in easily understood language
    -not being able to control urination (incontinence)
    -strong urge to urinate
    E.1.1.2Therapeutic area Body processes [G] - Biological Phenomena [G16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10012547
    E.1.2Term Detrusor hyperreflexia
    E.1.2System Organ Class 100000014604
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10059617
    E.1.2Term Overactive bladder
    E.1.2System Organ Class 100000014604
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of mirabegron after multiple-dose administration in the pediatric population.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of mirabegron after multiple-dose administration in the pediatric population.
    To evaluate the pharmacokinetics of mirabegron after multiple-dose administration in the pediatric population.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Independent Ethics Committee (IEC)/Institutional Review Board (IRB)-approved written Informed Consent and privacy language as per national regulations must be obtained from the subject and/or from the subject’s parent(s) or legal guardian(s) prior to any study-related procedures (including discontinuation of prohibited medication, if applicable); assent by the subject is given as required by local law.
    2. Subject is male or female from 3 to less than 18 years of age.
    3. Subject has a body weight of ≥ 11 kg.
    4. Subject suffers from NDO confirmed by urodynamic investigation at baseline. The diagnosis of NDO must be confirmed by the presence of at least 1 involuntary destrusor contraction > 15 cm H2O from baseline destrusor pressure, and/or a decrease in compliance leading to an increase in baseline detrusor pressure of > 20 cm H2O.
    5. Subject has been using CIC for at least 4 weeks prior to visit 1/screening.
    6. Subject has a current indication for drug therapy to manage NDO.
    7. Subject is able to take the study drugs in accordance with the protocol.
    8. Female subject must either:
    Be of nonchildbearing potential:
    - Clearly premenarchal or in the judgment of the investigator is premenarchal,
    - Documented surgically sterile,
    or, if of childbearing potential:
    - Agree not to try to become pregnant during the study and for 28 days after the final study drug administration,
    - And have a negative pregnancy test at visit 1/screening and at visit 3/baseline,
    - And, if sexually active must agree to use a highly effective method of birth control, which includes established use of oral, injected or implanted hormonal methods of contraception, OR placement of an intrauterine device (IUD) or intrauterine system (IUS). Birth control must be practiced from visit 1/screening and continuing throughout the study period, and for 28 days after the final study drug administration.
    9. Male subject and their female spouse/partner who are of childbearing potential must be using a highly effective method of birth control, which includes established use of oral, injected or implanted hormonal methods of contraception, placement of an IUD or IUS. Birth control must be practiced from visit 1/screening and continuing throughout the study period, and for 28 days after the final study drug administration.
    10. Female subject must not be breastfeeding from visit 1/screening until 28 days after last study drug administration.
    11. Subject and subject’s parent(s)/legal guardian(s) agree that the subject will not participate in another interventional study while participating in the study.
    12. Subject and subject’s parent(s)/legal guardian(s) are willing and able to comply with the study requirements and with the concomitant medication restrictions.


    E.4Principal exclusion criteria
    1. Subject has a known genitourinary condition (other than NDO) that may cause overactive
    contractions or incontinence (e.g., bladder extrophy, urinary tract obstruction, urethral
    diverticulum or fistula) or kidney/bladder stones or another persistent urinary tract
    pathology that may cause urinary symptoms.
    2. Subject has one of following gastrointestinal problems: partial or complete obstruction, decreased motility such as paralytic ileus, subject at risk of gastric retention.
    3. Subject has a urinary indwelling catheter within 4 weeks prior to visit 1/screening.
    4. Subject has a surgically treated underactive urethral sphincter.
    5. Subject has vesico-ureteral reflux grade 3 to 5.
    6. Subject has undergone bladder augmentation surgery.
    7. Subject receives electrostimulation therapy, if started within 30 days before visit 1/screening or is expected to start during the study period. Subjects who are on an established regimen may remain on this for the duration of the study.
    8. Subject suffers from a symptomatic urinary tract infection (UTI) at baseline (symptomatic is defined as pain, fever, hematuria, new onset foul-smelling urine). If present at visit 1/screening or diagnosed between visit 1/screening and visit 3/baseline, the UTI should be treated successfully (clinical recovery) prior to baseline. If a symptomatic UTI is present at baseline, all baseline assessments are allowed to be postponed for a maximum of 7 days until the UTI is successfully treated (clinical recovery).
    9. Subject has a (mean) resting pulse rate >99th percentile.
    10. Subject has an established hypertension and systolic or diastolic blood pressure greater than the 99 th percentile of the normal range determined by sex, age, and height, plus mmHg.
    11. Subject has a risk of QT prolongation (e.g., hypokalemia, long QT syndrome [LQTS]; or family history of LQTS, exercise-induced syncope).
    12. Subject has severe renal impairment (estimated glomerular filtration rate [eGFR] according to Larsson equation < 30 mL/min).
    13. Subject’s aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is greater than or equal to 2 times the upper limit of normal (ULN) or total bilirubin greater than or equal to 1.5 times the ULN according to age and sex.
    14. Subject has a history or presence of any malignancy prior to visit 1/screening.
    15. Subject has known or suspected hypersensitivity to mirabegron, any of the excipients used in the current formulations or previous severe hypersensitivity to any drug.
    16. Subject has participated in another clinical trial (and/or has taken an investigational drug within 30 days (or 5 half-lives of the drug, or the limit set by national law, whichever is longer) prior to visit 1/screening.
    17. Subject uses any of the following prohibited medications (after start of washout):
    • Any medication, other than the study drug, used for the management of NDO;
    • Any drugs that are sensitive cytochrome (CYP) 2D6 substrates with a narrow therapeutic index or sensitive P-glycoprotein (P-gp) substrates
    • Any strong cytochrome P450 (CYP) 3A4 inhibitors if the subject has a mild to moderate renal impairment (eGFR 30 – 89 mL/min).
    18. Subject has been administered intravesical botulinum toxin; except if given > 4 months prior to visit 1/screening and the subject experiences symptoms comparable to those existing prior to the botulinum toxin injections.
    19. Subject has any other condition, which in the opinion of the Investigator, precludes the subject’s participation in the study.
    20. Subject’s parent/legal guardian is an employee of the Astellas Group, the Contract Research Organization (CRO) involved, or the investigator site executing the study.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy: Change from baseline in maximum cystometric capacity (MCC) after 24 weeks of treatment (based on filling urodynamics)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy: Visit 8, week 24 of efficacy treatment period
    E.5.2Secondary end point(s)
    Efficacy
    Based on filling urodynamics:
    Change from baseline at visit 5/week 4 and visit 8/week 24 in:
    • MCC (only visit 5/week 4)
    • Bladder compliance (∆V/∆P)
    • Number of overactive detrusor contractions (> 15 cm H20) until end of filling
    • Detrusor pressure at end of filling
    • Filling volume until first overactive detrusor contraction (> 15 cm H20)
    Based on e-diary:
    Change from baseline at visit 4/week 2, visit 5/week 4, visit 6/week 8, visit 7/week 12, visit 8/week 24, visit 9/week 36 and visit 10/ week 52 (EOT/EOS) in:
    • Average catheterized volume per catheterization
    • Maximum catheterized volume
    • Maximum catheterized daytime volume
    • Average morning catheterized volume (based on first catheterization after subject woke up)
    • Mean number of leakage episodes per day (day and night time)
    • Number of dry (leakage-free) days/7 days (day and night time)
    Based on questionnaires:
    • Change from baseline at visit 8/week 24 and visit 10/week 52 (EOT/EOS) in Pediatric Incontinence Questionnaire (PIN-Q)
    • Change from baseline at visit 8/week 24 and visit 10/week 52 (EOT/EOS) in Patient Global Impression of Severity Scale (PGI-S)
    • Acceptability questionnaire at visit 5/week 4, visit8/week 24 and visit 10/week 52 (EOT/EOS)
    • Clinician Global Impression of Change (CGI-C) at visit 8/week 24 and visit 10/week 52 (EOT/EOS)
    Safety
    ● Incidence and severity of treatment-emergent adverse events (TEAEs)
    ● Change from baseline in vital signs (clinic measurements): systolic blood pressure, diastolic blood pressure, pulse rate and temperature at visit 5/week 4, visit 7/week 12, visit 8/week 24 and visit 10/week 52 (EOT/EOS)
    ● Change from baseline in vital signs (self blood pressure measurement SBPM): systolic blood pressure, diastolic blood pressure, pulse rate at visit 4/week 2, visit 5/week 4, visit 6/week 8, visit 7/week 12, visit 8/week 24, visit 9/week 36 and visit 10/week 52 (EOT/EOS) and on 2 consecutive days at around 1 and 2 weeks after start of dosing with PED25 (day 1) and after up titration to PED50 (visit 4/week 2, visit 5/week 4 or visit 6/week 8), if not already covered by the scheduled visit 4/week 2 and/or visit 5/week 4 SBPM.
    ● Change from baseline in hematology and biochemistry tests at visit 7/week 12 and visit 10/week 52 (EOT/EOS) and urinalysis tests at visit 5/week 4, visit 7/week 12, visit 8/week 24 and visit 10/week 52 (EOT/EOS)
    ● Change from baseline in ECG parameters at visit 5/week 4 and visit 10/week 52 (EOT/EOS)
    ● Change from baseline to visit 10/week 52 (EOT/EOS) in upper urinary tract ultrasound assessment
    ● Change from baseline in eGFR at visit 7/week 12 and visit 10/week 52 (EOT/EOS)
    Pharmacokinetic parameters will be determined at visit 5/week 4, visit 6/week 8, visit 7/week 12, visit 8/week 24 and/or visit 9/week 36: Cmax, tmax, AUC24, Ctrough, CL/F and Vz/F. Additional pharmacokinetic parameters may be calculated based on the model used.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For Efficacy and Safety end-points - See E.5.2
    Pharmacokinetics: PK samples will be taken at 2 visits between visit 5/week 4 and visit 10/week 52 (EOT/EOS), when steady state has been reached
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Compared to parameter values at baseline
    E.8.2.4Number of treatment arms in the trial1
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Australia
    Belgium
    Brazil
    Colombia
    Croatia
    Denmark
    Egypt
    Israel
    Jordan
    Korea, Republic of
    Latvia
    Lithuania
    Malaysia
    Mexico
    Norway
    Philippines
    Poland
    Romania
    Serbia
    Singapore
    Slovakia
    Sweden
    Taiwan
    Turkey
    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
    The last subject’s last protocol-defined assessment will mark the end of the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    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: 63
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 30
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 33
    F.1.2Adults (18-64 years) No
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 63
    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)
    None
    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 Decision2016-02-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-05-06
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