Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Proof of concept trial to evaluate the effectiveness of combined treatment with Valerian extract (Euvegal®) and Lavender oil (Lasea®) in patients suffering from inability to fall or stay asleep

    Summary
    EudraCT number
    		 2015-003265-29
    Trial protocol
    		 DE  
    Global end of trial date
    14 Aug 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jan 2020
    First version publication date
    05 Jan 2020
    Other versions
    Summary report(s)
    		 750598.01.003_SummaryofResultsEudraCTDatabase_2019_12_20

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    750598.01.003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dr. Willmar Schwabe GmbH & Co. KG
    Sponsor organisation address
    Willmar-Schwabe Straße 4, Karlsruhe, Germany, 76227
    Public contact
    Clinical Research Department, Dr. Willmar Schwabe GmbH & Co. KG, +49 7214005573,
    Scientific contact
    Clinical Research Department, Dr. Willmar Schwabe GmbH & Co. KG, +49 7214005573,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 Sep 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Aug 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of the trial is to assess the effectiveness of a combined treatment with Valerian extract (Euvegal®) and Lavender oil (Lasea®) in patients with inability to fall or stay asleep.
    Protection of trial subjects
    Possibility to withdraw informed consent. Monitoring of adverse events and laboratory parameters.
    Background therapy
    		 -
    Evidence for comparator
    		 Active substances contained in Synalan.
    Actual start date of recruitment
    30 Aug 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 94
    Worldwide total number of subjects
    94
    EEA total number of subjects
    94
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    94
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 A total 175 patients were screened for eligibility. Two of these patients were re-screened due to scheduling conflicts. 32 subjects were randomized. 1 drop out subject was replaced.

    Pre-assignment
    Screening details
    		 32 subjects were randomised to one of six treatment sequences (Silexan - Synalan - Valeriana/Silexan - Valeriana - Synalan/Synalan - Silexan - Valeriana/Synalan - Valeriana - Silexan/Valeriana - Silexan - Synalan/Valeriana - Synalan - Silexan) in a 3-period, 3-way cross-over design.

    Pre-assignment period milestones
    Number of subjects started
    		 94
    Number of subjects completed
    		 94

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Data analyst, Subject, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Silexan
    Arm description
    		 WS® 1265 1x80mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Silexan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    WS® 1265 1x80 mg + WS® 1014 Placebo 1x1

    Arm title
    		 Synalan
    Arm description
    		 WS® 1265 1x80 mg + WS® 1014 1x500 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Synalan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    WS® 1265 1x80 mg + WS® 1014 1x500mg

    Arm title
    		 Valerian
    Arm description
    		 WS® 1014 1x500 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Valerian
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    WS® 1265 Placebo 1x1 + WS® 1014 1x500mg

    Number of subjects in period 1
    		Silexan Synalan Valerian
    Started
    31
    32
    31
    Completed
    31
    31
    31
    Not completed
    0
    1
    0
         Adverse event, non-fatal
    -
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Silexan
    Reporting group description
    		 WS® 1265 1x80mg

    Reporting group title
    Synalan
    Reporting group description
    		 WS® 1265 1x80 mg + WS® 1014 1x500 mg

    Reporting group title
    Valerian
    Reporting group description
    		 WS® 1014 1x500 mg

    Reporting group values
    		 Silexan Synalan Valerian Total
    Number of subjects
    		 31 32 31 94
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 31 32 31 94
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 34.81 ( 7.78 ) 34.63 ( 7.72 ) 34.81 ( 7.78 ) -
    Gender categorical
    Units: Subjects
        Female
    		 18 19 18 55
        Male
    		 13 13 13 39
    Subject analysis sets

    Subject analysis set title
    Silexan
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects, which received Silexan in period I or period II or period III. The full analysis set (FAS) included all patients of the safety analysis who completed at least one treatment period including the Polysomnographic sleep measures (PSG) night.

    Subject analysis set title
    Synalan
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects, which received Synalan in period I or period II or period III. The full analysis set (FAS) included all patients of the safety analysis who completed at least one treatment period including the Polysomnographic sleep measures (PSG) night.

    Subject analysis set title
    Valerian
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects, which received Valerian in period I or period II or period III. The full analysis set (FAS) included all patients of the safety analysis who completed at least one treatment period including the Polysomnographic sleep measures (PSG) night.

    Subject analysis sets values
    		 Silexan Synalan Valerian
    Number of subjects
    31
    31
    31
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
        Adults (18-64 years)
    31
    31
    31
        From 65-84 years
    0
    0
    0
        85 years and over
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    34.81 ( 7.78 )
    34.81 ( 7.78 )
    34.81 ( 7.78 )
    Gender categorical
    Units: Subjects
        Female
    18
    18
    18
        Male
    13
    13
    13

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Silexan
    Reporting group description
    		 WS® 1265 1x80mg

    Reporting group title
    Synalan
    Reporting group description
    		 WS® 1265 1x80 mg + WS® 1014 1x500 mg

    Reporting group title
    Valerian
    Reporting group description
    		 WS® 1014 1x500 mg

    Subject analysis set title
    Silexan
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects, which received Silexan in period I or period II or period III. The full analysis set (FAS) included all patients of the safety analysis who completed at least one treatment period including the Polysomnographic sleep measures (PSG) night.

    Subject analysis set title
    Synalan
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects, which received Synalan in period I or period II or period III. The full analysis set (FAS) included all patients of the safety analysis who completed at least one treatment period including the Polysomnographic sleep measures (PSG) night.

    Subject analysis set title
    Valerian
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects, which received Valerian in period I or period II or period III. The full analysis set (FAS) included all patients of the safety analysis who completed at least one treatment period including the Polysomnographic sleep measures (PSG) night.

    Primary: Polysomnographic endpoints

    		 Close Top of page
    End point title
    		 Polysomnographic endpoints [1]
    End point description
    This document in its section "End points" specifies commercially confidential information of Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe referred to in Article 81 Section (4) b) Regulation (EU) 536/2014 that is a trade secret and released by the holder for purposes of Regulation (EU) 536/2014 only under the condition of confidence. Trade secrets may not - even in part - be published or released to third parties other than to competent authorities without express permission of the trade secret holder.
    End point type
    Primary
    End point timeframe
    Day 3
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: See document for a complete description of the statistical methods and results. There were no primary end points defined for analysis. Because at least one primary end point is required to be entered study results into the database, the parameters presented here have been chosen to this purpose.
    End point values
    		 Silexan Synalan Valerian
    Number of subjects analysed
    31
    31
    31
    Units: minutes
        median (inter-quartile range (Q1-Q3))
    9999.99 (9999.99 to 9999.99)
    9999.99 (9999.99 to 9999.99)
    9999.99 (9999.99 to 9999.99)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    3 Days
    Adverse event reporting additional description
    5 adverse events occurred in 32 patients treated with Synalan, 1 adverse events occurred in 31 patients treated with valeriana, 1 adverse events occurred in 31 patients treated with Silexan.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Synalan
    Reporting group description
    		 Synalan

    Reporting group title
    Valeriana
    Reporting group description
    		 Valerian

    Reporting group title
    Silexan
    Reporting group description
    		 Silexan

    Serious adverse events
    		 Synalan Valeriana Silexan
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Synalan Valeriana Silexan
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Overall, 6 of the randomized 32 subjects experienced non-serious adverse events during treatment phase. This number was not be entered into the database, because each adverse event occurred with a frequency which did not exceed the frequency threshold of 5% for reporting non-serious adverse events. Therefore, the number of subjects with non-serious adverse events resulted in 0 when considering the 5% frequency threshold.

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Jul 2016
    The determination of the creatinine clearance was replaced by the determination of the glomerular filtration rate. The allowed time for the Digit-symbol substitution test (DSST) has been prolonged from 90 to 120 seconds. The use of a patient diary had not been described in the clinical trial protocol by error. Therefore, its use was added by this amendment.
    06 Dec 2016
    The time window of up to 7 days between screening visit and the polysomnography, polysomnographic sleep measures (PSG) screening nights was too short for several patients. Therefore, the period was changed to 14 days. The inclusion criteria Wake-time during sleep, Total sleep time (TST) and Insomnia Severity Index (ISI) were adapted.
    17 Mar 2017
    The exclusion criterion regarding concomitant diseases was changed.
    30 Jun 2017
    The exclusion criterion regarding concomitant diseases was changed.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 03 11:12:14 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA