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    Summary
    EudraCT Number:2010-022114-12
    Sponsor's Protocol Code Number:MW012
    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:2010-09-14
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-022114-12
    A.3Full title of the trial
    Multizentrische prospektive randomisierte kontrollierte offene Phase IV Studie zur Evaluation von Synergien zwischen WS® 1070 und strukturiertem Stressmanagement bei Patienten mit nachlassender Leistungs- und Konzentrationsfähigkeit sowie Müdigkeits- und Schwächegefühl bei subjektiv erlebter Stressbelastung

    Multicenter, pospective, randomized, controlled, open phase IV study to evaluate synergies between WS® 1070 and a structured stress management in patients with asthenia and decreased concentration capacity as well as fatigue and feeling of weakness along with subjective stress.
    A.3.2Name or abbreviated title of the trial where available
    WS® 1070 und Stressmanagement
    A.4.1Sponsor's protocol code numberMW012
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDr. Willmar Schwabe GmbH & Co. KG
    B.1.3.4CountryGermany
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Eleutherococcus Schwabe Kapseln
    D.2.1.1.2Name of the Marketing Authorisation holderDr. Willmar Schwabe GmbH & Co. KG
    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.3.2Product code WS(R) 1070
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeWS(R) 1070
    D.3.9.3Other descriptive nameEleutherococcus senticosus dry extract
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Asthenia and decreased concentration capacity as well as fatigue and feeling of weakness along with subjective stress
    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
    The clinical trial is an explorative study. There won't be a distinction between primary and secondary objectives.

    Evaluation of synergies between treatment with WS(R) 1070 and structured stress management in patients with asthenia and decreased concentration capacity as well as fatigue and feeling of weakness along with subjective stress.
    Tolerability and safety of WS(R) 1070 alone and in combination with structured stress management in patients with asthenia and decreased concentration capacity as well as fatigue and feeling of weakness along with subjective stress.
    E.2.2Secondary objectives of the trial
    see above
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria
    1. Men and Women aged between 30 and 50 years
    2. Written informed consent
    3. Fatigue and feeling of weakness proven by a result of more than 6 points in at least 1 sub scale of the “Multidimensional Fatigue Inventory” (MFI-20)
    4. Asthenia and decreased concentration capacity proven by a result of more than 8 points in the ASS-SYM questionnaire, sub scale capacity
    5. Subjective stress proven by a t-value > 60 in at least 2 scales of the “Trierer Inventar zum Chronischen Stress” (TICS) questionnaire
    6. Consultion of all screening results by a medical specialist and attestation that there were no indications of a physical or psychiatric disease as reason for patients afflictions to be found, which required further diagnostics or treatment.
    7. In Women of child-bearing potential exclusion of pregnancy and practicing a highly effective method of birth control prior and during study participation:as
    a) implants or injectables
    b) combined oral contraceptives
    c) hormonal IUDs
    d) two-sided vasectomised partner
    e) sexual abstinence
    8. Willingness and ability to participate in all study specific actions, including the participation in the two-day stress management seminar and the neuropsychological testing at screening, treatment and final visit.
    E.4Principal exclusion criteria
    Exclusion criteria
    1. History of hypersensitivity to one ingredient of the study drug
    2. Participation in another clinical trial within 12 weeks prior to study start
    3. Pregnancy or breast feeding
    4. Diseases, which can affect the absorption of the study drug
    5. Severe or acute illnesses within 4 weeks prior to study start
    6. Acute or chronic psychiatric (“DSM IV Achse I Störung”) or neurological disorder within 12 months prior to study start
    7. Suicidal tendency
    8. History of or current substance/ drug abuse
    9. Psychotherapy within 12 months prior to study start
    10. Concurrent treatment with one substance out of the following substance categories
    a) Psychotropic drugs
    b) Hypnotics
    c) Antiepileptics
    d) Anti Parkinson drugs
    e) Anesthetics
    f) Central active analgesics
    g) Muscle relaxants
    h) Herbal medicines or dietary supplements
    i) Vitamine B compound
    j) Central active antihypertensives
    k) Central nervous system antihistamines or antiemetics
    11. Clinically significant changes of ECG or laboratory results
    12. Clinically significant internistic diseases
    13. Planned hospitalization
    14. Planned holiday of more than 5 days within study participation
    15. Other factors, which could affect study participation (e.g. lack of understanding of study matter and consequences, insufficient language understanding)
    16. Treatment with cardio active glycosides
    17. Hypertension (RR>140 Hg systolic or >90mm Hg diastolic or antihypertensive treatment)
    18. Insulin dependent diabetes mellitus
    19. Contraindications for the application of progressive muscle relaxation
    a) Acute lumbago
    b) Inflammatory or painful muscle diseases (e.g. myositis)
    c) Acute arthritides
    d) Heart failure
    Other cardiovascular diseases prohibiting the “Valsava-Manöver” (e.g. aortic aneurysm).
    E.5 End points
    E.5.1Primary end point(s)
    The clinical trial is an explorative study. There won't be a distinction between primary and secondary endpoints.

    • cognitive capacity
    • physiological stress parameter
    • subjektive stress
    • fatigue and feeling of weakness
    • Alertness, restlessness and mood
    • quality of life
    • quality of sleep
    • physical complaints and activity
    • therapy contentment
    • adverse events and health related events
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    stress management seminar (non drug therapy)
    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 concerned5
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    please refer to the protocol (chapter 3.3.1)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    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 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.1.3Elderly (>=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 state135
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 135
    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)
    please refer to the protocol (chapter 5.8)
    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 Decision2010-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-07-19
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