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    Clinical Trial Results:
    Clinical Trial to Explore Treatment Effects of Ginkgo biloba Extract EGb 761® in Patients with Different Types of Vertigo and Effect Modification by Type of Vertigo, Chronicity and Concomitant Pathologies

    Summary
    EudraCT number
    2016-000316-15
    Trial protocol
    PL  
    Global end of trial date
    12 Jun 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    12 Oct 2019
    First version publication date
    12 Oct 2019
    Other versions
    Summary report(s)
    523079.01.114 Summary of results for Eudra CT database V1.0 2019_09_25

    Trial information

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    Trial identification
    Sponsor protocol code
    523079.01.114
    Additional study identifiers
    ISRCTN number
    ISRCTN83227991
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Dr. Willmar Schwabe GmbH & Co. KG
    Sponsor organisation address
    Willmar-Schwabe-Str. 4, Karlsruhe, Germany, 76227
    Public contact
    Head Clinical Research Department, Dr. Willmar Schwabe GmbH & Co. KG, 0049 7214005573,
    Scientific contact
    Head Clinical Research Department, Dr. Willmar Schwabe GmbH & Co. KG, 0049 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
    23 Jul 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Jun 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To explore whether causes, risk factors, chronicity of vertigo and accompanying features influence the treatment effect of EGb 761® in terms of improvement and response rates • To identify groups of patients that benefit most of EGb 761®
    Protection of trial subjects
    Possibility to withdraw informed consent. Monitoring of adverse events and laboratory parameters.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    28 Oct 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
    Poland: 206
    Worldwide total number of subjects
    206
    EEA total number of subjects
    206
    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)
    160
    From 65 to 84 years
    46
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects were recruited in twelve investigational sites in Poland.

    Pre-assignment
    Screening details
    Twenty seven patients did not receive the investigational product since they were classified as screening failures.

    Pre-assignment period milestones
    Number of subjects started
    206
    Number of subjects completed
    179

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Screening Failures: 27
    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    Baseline
    Arm description
    Baseline before starting treatment with EGb 761®
    Arm type
    Baseline

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    EGb 761®
    Arm description
    Investigational medical product containing EGb 761®, two film-coated tablets of 120 mg Ginkgo biloba extract
    Arm type
    Experimental

    Investigational medicinal product name
    EGb 761®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 film-coated tablet 2 times per day for 12 consecutive weeks.

    Number of subjects in period 1
    Baseline EGb 761®
    Started
    179
    179
    Completed
    179
    169
    Not completed
    0
    10
         Adverse event, non-fatal
    -
    1
         Laboratory results at baseline
    -
    2
         Consent withdrawn by subject
    -
    4
         Lost to follow-up
    -
    3

    Baseline characteristics

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    Baseline characteristics reporting groups [1]
    Reporting group title
    Treatment period (overall period)
    Reporting group description
    In total, 179 subjects received the investigational treatment.

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Some patients were not included into the analysis set due to drop out without havinbg tretament
    Reporting group values
    Treatment period (overall period) Total
    Number of subjects
    179 179
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    137 137
        From 65-84 years
    42 42
        85 years and over
    0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    52.2 ± 14.5 -
    Gender categorical
    Units: Subjects
        Female
    139 139
        Male
    40 40
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The full analysis set (FAS) includes all patients who took EGb 761® treatment and have at least one value of one of the most important variables to describe treatment effects assessed after baseline.

    Subject analysis set title
    Safety Evaluation Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The safety evaluable set (SES) comprises all patients having taken at least one tablet of EGb 761®.

    Subject analysis sets values
    Full Analysis Set Safety Evaluation Set
    Number of subjects
    174
    179
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    133
    137
        From 65-84 years
    41
    42
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    52.2 ± 14.5
    52.2 ± 14.5
    Gender categorical
    Units: Subjects
        Female
    135
    139
        Male
    39
    40

    End points

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    End points reporting groups
    Reporting group title
    Baseline
    Reporting group description
    Baseline before starting treatment with EGb 761®

    Reporting group title
    EGb 761®
    Reporting group description
    Investigational medical product containing EGb 761®, two film-coated tablets of 120 mg Ginkgo biloba extract

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The full analysis set (FAS) includes all patients who took EGb 761® treatment and have at least one value of one of the most important variables to describe treatment effects assessed after baseline.

    Subject analysis set title
    Safety Evaluation Set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The safety evaluable set (SES) comprises all patients having taken at least one tablet of EGb 761®.

    Primary: Primary end point

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    End point title
    Primary end point [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
    Week 0 - week 12
    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 into the database, the outcome variable presented here have been chosen to this purpose. Statistical analyses were conducted descriptively for all end points. Please refer to the attached summary of results for details.
    End point values
    Baseline EGb 761®
    Number of subjects analysed
    174
    174
    Units: points
        median (inter-quartile range (Q1-Q3))
    9999.99 (9999.99 to 9999.99)
    9999.99 (9999.99 to 9999.99)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    15 weeks
    Adverse event reporting additional description
    Non-serious adverse events occurred in 33 patients. However, no incidence of preferred terms of adverse events was higher than the threshold of 5%.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    After risk phase
    Reporting group description
    After risk phase

    Reporting group title
    Between begin of study and begin of 1st study period
    Reporting group description
    Before Tretament

    Reporting group title
    Treatment with EGb 761® 240 mg
    Reporting group description
    Study Drug

    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: No adverse events (AE) with an incidence higher than the threshold of 5% occurred during the trial.
    Serious adverse events
    After risk phase Between begin of study and begin of 1st study period Treatment with EGb 761® 240 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 179 (0.00%)
    1 / 179 (0.56%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Tibia fracture
         subjects affected / exposed
    0 / 179 (0.00%)
    0 / 179 (0.00%)
    1 / 179 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood sodium increased
         subjects affected / exposed
    1 / 179 (0.56%)
    0 / 179 (0.00%)
    0 / 179 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    After risk phase Between begin of study and begin of 1st study period Treatment with EGb 761® 240 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 179 (0.00%)
    0 / 179 (0.00%)
    0 / 179 (0.00%)

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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
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