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    Summary
    EudraCT Number:2005-001031-29
    Sponsor's Protocol Code Number:920´104
    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:2005-04-21
    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 number2005-001031-29
    A.3Full title of the trial
    Wirkung einer einmaligen Einnahme eines alkoholischen Baldrian/Hopfen Flüssigextraktes (Dormeasan® -Tropfen) im Vergleich zu Placebo auf das Schlafverhalten von Patienten mit Ein- bzw. Durchschlafstörungen.
    (Effects of a single-dose intake of an alcoholic liquid extract Valerian/Hops (Dormeasan drops) in comparison to placebo on the sleep of patients with slight sleep disturbances).
    A.3.2Name or abbreviated title of the trial where available
    Baldrian/Hopfen/Schlafstörungen
    A.4.1Sponsor's protocol code number920´104
    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 SponsorBioforce GmbH
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Dormeasan
    D.2.1.1.2Name of the Marketing Authorisation holderBioforce AG, CH - Roggwil
    D.2.1.2Country which granted the Marketing AuthorisationSwitzerland
    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 nameDormeasan
    D.3.2Product code SPC 0015.e03
    D.3.4Pharmaceutical form Oral drops*
    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.3.8INN - Proposed INNBaldrian / Hopfen Extrakt - Tropfen
    D.3.9.2Current sponsor codeNCAG 1304
    D.3.9.3Other descriptive nameDormeasan
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral drops*
    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
    volunteers with non-organic slight insomnia (DSM IIII R primary insomnia).
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Information not present in EudraCT
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Sleep duration (min) Basis: validated sleep depth index SFx (developed by Dimpfel, 1998) in comparison to placebo.
    E.2.2Secondary objectives of the trial
    A) on the neurophysiological site the parameter extracted from polysomnography (Todorova et al., 1997):
    A1) sum of times where absolute delta- and theta-power is present over the tested night (quantitative EEG parameter).
    A2) REM sleep latency,
    A3) sleep efficiency (related to total time in bed) [%],
    A4) total time of deep sleep [min],
    A5) total time of being awake [min],
    A6) counts of awakening events during the night sleep.

    B) on the clinical site, subjectively by the volunteer estimated:
    B1) sleep quality
    B2) feeling of recovery (GES, Basis SF-A).
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    * both sexes,
    * age between 30 and 70 years (each inclusive),
    * only slight sleep disturbance with inconspicuous history and clinical findings,
    *objective findings - during polysomnographic recording - of sleep disturbances (total sleep time < 6,5h and/or sleep efficiency (related to total bed time) < 83% and/or sleep latency (up to reaching the sleeping stage II) > 30min and/or percentage of toatl awaking time >10% realted to total bed time],
    * negative finding of alcohol at the time of screening-investigation and at the evening of test night,
    * written informed consent to participate at the study (informed consent).
    * protection to get pregnant in woman in childbearing ages.
    E.4Principal exclusion criteria
    * clinical relevant acute or chronical diseases,
    * clinical relevant sleep disturbances need to be treated (e.g. sleep apnea,
    parasomnia),
    * clinical relevant pathological findings from clinical or laboratoty results,
    * clinical pathological EEG-findings,
    * clinical relevant Allergies,
    * drug or alcohol abuse,
    * positive finding of alcohol at Screening-investigation,
    * clinical relevant drugs taken in in the last 3 days before the first test night (visit1),
    and during active study phase,
    * clinical relevant drugs to be taken continuously,
    * body weight < 50 kg und > 115 kg,
    * abuse of coffee, tee or tobacco,
    /smoking within 2 h before arrival at the trial centre and start of the
    polysomnographic recording (PSG).
    /coffein 4 h before arrival at the trial centre and start of the PSG.
    /alcohol 24 h before arrival at the trial centre and start of the PSG.
    * missing written informed consent,
    * participation in another clinical study within 60 days before start of the study.
    * pregnancy or breastfeeding period.
    E.5 End points
    E.5.1Primary end point(s)
    One confirmatoric goal parameter (total sleeping time (S-Dauer)) over the total re-corded period of 8 h (10.00 p.m. at evening to 6:00 a.m. at the following morning)*. The validated SFx-Parameter (dependent from time) will be used:

    S-Dauer =: Integral (from 0 to 480 min*) over time f(SFx(t)) dt.
    whereby f(SFx(t)) = min (1, (max (0, (80 - SFx(t))/3)).
    (min = Minimum, max = Maximum).

    S-Dauer describes the time duration of the sleep*.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 Information not present in EudraCT
    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
    Study duration/volunteer : 2 nights (active participation day 1 / day 2).
    day 0 Screening-investigation up to 8 weeks before day 1.
    day 1 polysomnographic adaptation / diagnostic night.
    day 2 test night (after intake of trial medication).
    day 3 final investigation / end of study / volunteer (latest 4-6 weeks after day 2).
    Study duration total: 8 months after receiving positive ethical vote and vote of the BfArM and reseipt of trial medication.
    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 months8
    E.8.9.1In the Member State concerned days
    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) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-04-21. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state40
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 40
    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)
    symptomatically
    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 Decision2005-08-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-03-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-08-01
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