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    The EU Clinical Trials Register currently displays   37504   clinical trials with a EudraCT protocol, of which   6153   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2012-000928-18
    Sponsor's Protocol Code Number:PROMESA
    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:2013-06-28
    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 number2012-000928-18
    A.3Full title of the trial
    Double blind, randomised, prospective placebo controlled parallel group phase III study to investigate the Effect of EGCG supplementation on disease progression of patients with Multiple System Atrophy (MSA)
    Doppelblinde, randomisierte, prospektive, placebo-kontrollierte Parallel-gruppen Phase III- Studie zur Untersuchung des Effekts der Einnahme von EGCG auf das Fortschreiten der Krankheit bei Patienten mit Multi-systematrophie (MSA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Double blind, randomised, prospective placebo controlled parallel group phase III study to investigate the Effect of EGCG supplementation on disease progression of patients with Multiple System Atrophy (MSA)
    Doppelblinde, randomisierte, prospektive, placebo-kontrollierte Parallel-gruppen Phase III- Studie zur Untersuchung des Effekts der Einnahme von EGCG auf das Fortschreiten der Krankheit bei Patienten mit Multi-systematrophie (MSA)
    A.3.2Name or abbreviated title of the trial where available
    Progression Rate of MSA under EGCG Supplementation as anti-Aggregation-Approach
    A.4.1Sponsor's protocol code numberPROMESA
    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 SponsorHospital of the Ludwig-Maximilians-University of Munich
    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 supportDeutsche Parkinson Vereinigung (DZNE)
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportDeutsche Stiftung Neurologie
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportDr. med. Arthur Arnstein Stiftung, Berlin
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportInternationale Parkinson Fonds Deutschland gGmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital of the Ludwig-Maximilians-University of Munich
    B.5.2Functional name of contact pointSponsor delegated person: Dr. Levin
    B.5.3 Address:
    B.5.3.1Street AddressMarchioninistr. 15
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code81377
    B.5.3.4CountryGermany
    B.5.4Telephone number+4989440074812
    B.5.5Fax number+4989440073677
    B.5.6E-mailjlevin@med.uni-muenchen.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 Sunphenon EGCg
    D.2.1.1.2Name of the Marketing Authorisation holderTaiyo international
    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 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 INNEGCG
    D.3.9.1CAS number 989-51-5
    D.3.9.2Current sponsor codeEGCG
    D.3.9.3Other descriptive nameGREEN TEA LEAF
    D.3.9.4EV Substance CodeSUB32750
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number800 to 1200
    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 Yes
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    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
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Progression of patients with Multiple System Atrophy (MSA)
    fortgeschrittene Erkrankung bei Patienten mit Multi-System-Atrophie (MSA)
    E.1.1.1Medical condition in easily understood language
    patients with progressive neurodegenerative disorder
    Patienten mit fortgeschrittener neurodegenerative Erkrankung
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of EGCG vs. Placebo to reduce the progression in the motor examination (ME) of the Unified MSA Rating Scale (UMSARS-ME) from V1 to V7, (80% power, 5% P-level, 50% effect size, i.e. an expected mean yearly UMSARS-ME increase of 3.9 under verum treatment compared to 7.8 ± 6.8 (mean ± standard deviation) under Placebo-treatment.
    E.2.2Secondary objectives of the trial
    Clinical safety and tolerability of EGCG (physical and neurological examination, laboratory parameters, adverse events, vital signs, drop-out rates, survival rates and survival time).
    To assess the efficacy of EGCG vs. Placebo to reduce the progression from V1 to V7 the following parameters are of interest:
    - UMSARS total score
    - clinical global impression (CGI)
    - global and regional cerebral atrophy (3D MPRAGE MRI volumetry).
    - global and regional cerebral iron deposition in pons and striatum (T2* MRI).
    To assess any effect of ECGC vs. Placebo on the evolution of the above men-tioned parameters during the wash-out phase (from V6 to V7) to explore pos-sible symptomatic effects
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Clinical signs of MSA. Diagnosis will be made for patients with „clinical possible“ or „clinical prob-able“ Multiple System Atrophy (MSA) according to the diagnostic criteria of Gilman et al. (Neurology 2008).
    2. Stadium Hoehn & Yahr I – III
    3. A stable regimen for at least 1 month prior to V1 and willingness / no foreseeable need to change the regimen throughout the the 52 week follow-up period for
    a. drugs acting against Parkinsonism (e.g. Levodopa, Dopamine-Agonists, Amantadine and MAO-B-Inhibitors)
    b. other CNS-active substances including antidepressants and antidementive drugs.
    c. drugs acting against autonomic dysfunction (e.g. ephedrin, midodrin, fludrucortison, octreo-tide, desmopresin, oxybutinine).
    4.Capability and willingness to give written signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
    5. No regular consumption of green tea or EGCG
    6. Not more than maximum of two cups black tea /day
    E.4Principal exclusion criteria
    1. Clinical signs of MSA exceeding Stadium Hoehn and Yahr III (loss of postural reflexes, no independent walking possible, inability to stand unassisted, wheelchair-bound)
    2. Neurodegenerative diseases other than MSA
    3. Severe liver disease with elevation of transaminases above 5folds of the upper normal level or the in-take of hepatotoxic drugs
    4. Known hypersensitivity to EGCG or substances with a similar chemical structure
    5. Participation in another clinical trial involving administration of an investigational medicinal product within 30 days prior to V0.
    6. Known or persistent abuse of medication, drugs or alcohol
    7. Subjects with a physical or psychiatric condition that may put the subject at risk, confound trial results or may interfere with the subject’s participation in this clinical trial
    8. Consumption of more than 500ml grapefruit juice/day (leading to inhibition of cytochrome P-450 isoen-zyme 3A4, which may be involved in degradation of EGCG)
    9. Intake of COMT-Inhibitors (e.g. Entacapone, Tolcapone)
    12. Current or planned therapy with bortezomib and/ or history of plasmocytoma
    13. Anemia at Screening Visit (Hb < 10g/dl)
    E.5 End points
    E.5.1Primary end point(s)
    The change from V1 to V7 in UMSARS-ME comparing placebo vs. verum-treated patients
    E.5.1.1Timepoint(s) of evaluation of this end point
    The change from V1 to V7
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:
    • Changes from V1 to V7 in the total UMSARS score comparing placebo vs. verum treated patients
    • Changes from V1 to V7 in CGI comparing placebo vs. verum treated patients
    • Changes from V1 to V7 in MRI parameters (global and regional atrophy / iron deposition) comparing placebo- vs. verum treated patients
    • Changes in UMSARS-ME, total UMSARS, GCI score, and MRI parameters (global and regional at-rophy / iron-deposition) from V6 to V7 comparing placebo- vs. verum-treated patients, to identify possible symptomatic effects.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Changes from V1 to V7 in the total UMSARS score comparing placebo vs. verum treated patients
    • Changes from V1 to V7 in CGI comparing placebo vs. verum treated patients
    • Changes from V1 to V7 in MRI parameters (global and regional atrophy / iron deposition) comparing placebo- vs. verum treated patients
    • Changes in UMSARS-ME, total UMSARS, GCI score, and MRI parameters (global and regional at-rophy / iron-deposition) from V6 to V7 comparing placebo- vs. verum-treated patients, to identify possible symptomatic effects.
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS December 2016
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months32
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months29
    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: 86
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 86
    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 state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 11
    F.4.2.2In the whole clinical trial 86
    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 Decision2013-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-09-16
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