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    Summary
    EudraCT Number:2012-005394-31
    Sponsor's Protocol Code Number:12/0219
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-09-05
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-005394-31
    A.3Full title of the trial
    MS-SMART: A Multi-Arm Phase IIb Randomised, Double Blind Placebo-Controlled Clinical Trial Comparing The Efficacy of Three Neuroprotective Drugs in Secondary Progressive Multiple Sclerosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MS-SMART: A Trial of Efficacy (usefulness) of 3 Neuroprotective Drugs in SPMS
    A.3.2Name or abbreviated title of the trial where available
    MS-SMART: Multiple Sclerosis Secondary Progressive Multi-Arm Randomisation Trial
    A.4.1Sponsor's protocol code number12/0219
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN28440672
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01912059
    A.5.4Other Identifiers
    Name:CinicalTrials.govNumber:NCT01910259
    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 SponsorUCL
    B.1.3.4CountryUnited Kingdom
    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 supportThe Efficacy and Mechanism Evaluation (EME) Programme, MRC
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportSanofi Genzyme
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEdinburgh Clinical Trials Unit
    B.5.2Functional name of contact pointMoira Ross
    B.5.3 Address:
    B.5.3.1Street AddressOPD2, Western General Hospital, Crewe Road
    B.5.3.2Town/ cityEdinburgh
    B.5.3.3Post codeEH4 2XU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01315372553
    B.5.6E-mailmoira.ross@ed.ac.uk
    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 Rilutek
    D.2.1.1.2Name of the Marketing Authorisation holderAventis Pharma S.A.
    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 nameRilutek
    D.3.4Pharmaceutical form Capsule
    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 INNRiluzole
    D.3.9.1CAS number 1744-22-5
    D.3.9.4EV Substance CodeAS1
    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: 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 Amiloride
    D.2.1.1.2Name of the Marketing Authorisation holderActavis UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameAmiloride
    D.3.4Pharmaceutical form 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 INNAmiloride
    D.3.9.1CAS number 2016-88-8
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.2.1.1.1Trade name Fluoxetine
    D.2.1.1.2Name of the Marketing Authorisation holderActavis UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameFluoxetine
    D.3.4Pharmaceutical form Capsule
    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 INNFluoxetine hydrochloride
    D.3.9.4EV Substance CodeAS4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    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
    Mutliple Sclerosis (Secondary Progressive)
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis (Secondary Progressive)
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Secondary Progressive Multiple Sclerosis (SPMS) results from progressive nerve death or neuro-degeneration that causes accumulating and irreversible disability characterised by a range of devastating problems affecting walking, balance, vision, cognition, pain control, bladder and bowel function.

    MS-SMART will test 3 leading drugs to determine if any are effective at slowing the rate of brain shrinkage compared to placebo. Brain volume loss will be measured using MRI brain scans, which will also advance our understanding of how the drugs are providing neuroprotection in SPMS patients.
    E.2.2Secondary objectives of the trial
    The clinical effects of neuroprotection will be measured by various clinician and patient reported outcomes and disability assessments.

    Advanced MRI scans will be used to work out what are the anti-inflammatory and neuro-protective mechanisms of the drugs being tested.

    Cerebrospinal fluid (CSF) neurofilament levels will be measured to assess neuroprotection.

    Markers (substances in CSF, blood and urine samples) will also be looked at. In the future these markers may help us develop effective ways of predicting which people with secondary progressive Multiple Sclerosis are more likely to respond to the neuroprotective drugs under investigation in the MS-SMART study.

    CSF lymphocyte phenotyping -
    In addition the lymphocytes present in the CSF (which are collected automatically at the same time) will be purified, analysed and phenotyped. Techniques such as deep sequencing will be used to understand lymphocyte repertoires which will enable us to examine the current status of i
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. Advanced MRI Sub-Study, Protocol Appendices 1st June 2014

    OBJECTIVES
    Advanced MRI scans to investigate the anti-inflammatory and neuro-protective mechanisms of the drugs being tested.

    The purpose of the sub-study is to acquire a number of additional MRI outcome measures in order to gain a deeper insight in to the pathological evolution of secondary progressive MS (by evaluating serial changes in the placebo arm) and to explore whether the imaging outcome measures are modified by any of the 3 active treatments (thereby providing insights in to therapeutic mechanisms). Data on the longitudinal sensitivity and clinical correlation of the imaging measures will also inform their utility as outcome measures for future trials in secondary progressive MS.

    2. CSF Neurofilament Sub-study, Protocol Appendices 1st June 2014

    OBJECTIVES
    i. Does Amiloride, Riluzole and Fluoxetine prevent axonal damage in SPMS? The primary outcome will be the impact on CSF Neurofilament levels.
    ii. Does Amiloride, Riluzole and Fluoxetine favorably affect the profile of other CSF biomarkers? In addition to CSF Neurofilament levels we proposed measuring putative markers of neuronal sprouting and synaptogenesis and gliosis; these include NCAM, GAP43 and GFAP. In addition, the effects of these drugs on a panel of inflammatory biomarkers will also be assessed.

    In addition the lymphocytes present in the CSF (which are collected automatically at the same time) will be purified, analysed and phenotyped. Techniques such as deep sequencing will be used to understand lymphocyte repertoires which will enable us to examine the current status of immune activity, as well as to gain further understanding as to the aetiology of MS.

    3. Optical Coherence Tomography Sub-Study, Protocol Appendices 1st June 2014

    OBJECTIVES
    To use OCT to measure retinal nerve fibre layer thickness and retinal ganglion cell layer thickness; to evaluate the sensitivity of OCT to detect on-going retinal neuroaxonal loss in secondary progressive MS, and whether such loss can be prevented by Amiloride, Fluoxetine or Riluzole.


    E.3Principal inclusion criteria
    • Confirmed diagnosis of SPMS. Steady progression rather than relapse must be the major cause of increasing disability in the preceding 2 years. Progression can be evident from either an increase of at least one point in EDSS or clinical documentation of increasing disability in patients notes
    • EDSS 4.0-6.5
    • Aged 25 to 65 inclusive
    • Women and men with partners of childbearing potentialage must be using an appropriate method of contraception to avoid any unlikely teratogenic effects of the 3 drugs from time of consent, to 6 weeks after treatment inclusive
    • Women must have a negative pregnancy test within 7 days prior to the baseline visit) unless not of child bearing potential (e.g. have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy or they are postmenopausal)
    • Willing and able to comply with the trial protocol (e.g. can tolerate MRI and fulfils the requirements for MRI, e.g. not fitted with pacemakers or permanent hearing aids) ability to understand and complete questionnaires
    • Written informed consent
    E.4Principal exclusion criteria
    • Pregnancy or breast feeding females
    • Baseline MRI scan not of adequate quality for analysis (e.g. too much movement artefact)
    • Significant organ co-morbidity (e.g. malignancy or renal or hepatic failure)
    • Relapse within 3 months of baseline visit
    • •Patients who have been treated with iv or oral steroids for an MS relapse/progression within 3 months of baseline visit (these patients can undergo future screening visits once the 3 month window has expired), patients on steroids for another medical condition may enter as long as the steroid prescription is not for multiple sclerosis (relapse or progression)

    Use of Simvastatin at 80mg dose within 3 months of baseline visit (lower doses of Simvastatin and other statins are permissible)

    • Commencement of fampridine within 6 months of baseline visit
    • Use of immunosupressants (e.g. azathioprine, methotrexate, cyclosporine) or first generation disease modifying treatments (β-interferons, glatiramer) within 6 months of baseline visit
    • Use of fingolimod/fumarate/teriflunomide/laquinomod/or other experimental disease modifying treatment (including research in an investigational medicinal product) within 12 months of baseline visit
    • Use of mitoxantrone/natalizumab/alemtuzumab/daclizumab if treated within 12 months of baseline visit
    • Primary progressive MS
    • Relapsing-remitting MS
    • Known hypersensitivity to the active substances and their excipients to any of the active drugs for this trial
    • Use of an SSRI- within 6 months of the baseline visit
    • Current use of tamoxifen
    • Current use of herbal treatments containing St. John’s Wort
    • Patients with a history of bleeding disorders or currently on anticoagulants
    • Use of monoamine oxidase inhibitors, phenytoin, L-tryptophan) and/or neuroleptic drugs within 6 months of the baseline visit
    • Use of: lithium, chlorpropamide, triamterene, spironolactone, within 6 months of the baseline visit
    • Current use of potassium supplements
    • Significant signs of depression
    • Bipolar disorder
    • A Beck Depression Index score of 19 or higher
    • Epilepsy/seizures
    • Receiving or previously received Electroconvulsive therapy ECT treatment
    • Glaucoma
    • Routine screening blood values (LFT) >/ 3 x upper limit of normal (ULN) of site reference ranges (AST/ALT, bilirubin, ˠGT)
    • Potassium <2.8mmol/l or >5.5mmol/l
    • Sodium <125mmol/l
    • Creatinine >130µmol/l
    • WBCs <3x109/l
    • Lymphocytes <0.8 x 109/l
    • Neutrophil count <1.0 x109 /l
    • Platelet count <90 x109 /l
    • Haemoglobin <8.0g/l

    E.5 End points
    E.5.1Primary end point(s)
    Percentage Brain Volume Change (PBVC)

    A decrease in brain volume is seen at all stages of Multiple Sclerosis, and especially in patients with Secondary Progressive MS. Brain atrophy will be measured as a percentage brain volume change using the registration-based SIENA technique.

    PBVC measured using the SIENA technique has therefore been chosen as the primary outcome measure for our trial.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, 24 weeks & 96 weeks
    E.5.2Secondary end point(s)
    Secondary Objectives -
    •To establish that a multi-arm trial strategy is an efficient way of screening drugs in SPMS and can become the template for future work.
    •To explore any anti-inflammatory drug activity using the count of new and enlarging T2 lesions.
    •Examining for evidence of pseudo-atrophy (to ensure reliability of the primary outcome measure).
    •To examine the clinical effect of neuroprotection as measured by clinician (EDSS, MSFC, SDMT, SLCVA, relapse rate) and patient reported outcome measures (MSIS29, MSWS, Pain [NPRS, NPS and BPI] and Fatigue (NFI).
    •To collect basic health economic data (EQ-5D) to inform future phase III trials.
    Mechanistic Objectives
    •Persistent new T1 hypointense lesion count to assess neuroprotection in new lesions
    •Grey matter volume change to assess cortical neuroprotection
    •MR spectroscopy (MRS) to measure N-acetyl aspartate (reversal of neuronal mitochondrial dysfunction), myoinositol (prevention of glial cell inflammation) and glutamate (prevention of excitotoxicity)
    •Magnetic Transfer Ratio (MTR) to evaluate myelination
    •Composite MRI/disability scores to increase sensitivity and study interaction of treatment mechanisms.
    •Quantification of Cerebrospinal fluid (CSF) neurofilament levels to measure neuroprotection.
    CSF lymphocyte phenotyping
    •Optical Coherence Tomography (OCT)-measured Retinal nerve Fibre Layer thickness as a measure of neuroprotection.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, 24, 36, 48 and 96 weeks.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group 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 trial3
    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 concerned12
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit of the last participant.
    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 months0
    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 months0
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 440
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state440
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 440
    F.4.2.2In the whole clinical trial 440
    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)
    Participants will return to routine clinical care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-07-04
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