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    Clinical Trial Results:
    A pharmacological trial with Sativex® and gentamicin for optimized pharmacological treatment of older patients with a focus on appetite stimulation and renal risk drugs

    Summary
    EudraCT number
    		 2021-002318-15
    Trial protocol
    		 DK  
    Global end of trial date
    29 Jan 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Apr 2026
    First version publication date
    04 Apr 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    010921
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Copenhagen University Hospital, Amager and Hvidovre
    Sponsor organisation address
    Kettegård Allé 30, Hvidovre, Denmark, 2650
    Public contact
    Clinical Trial Information, Copenhagen University Hospital, Amager and Hvidovre, Department of Clinical Research , rikke.lundsgaard.nielsen@regionh.dk
    Scientific contact
    Clinical Trial Information, Copenhagen University Hospital, Amager and Hvidovre, Department of Clinical Research , 0045 40461306, rikke.lundsgaard.nielsen@regionh.dk
    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
    01 Oct 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Dec 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jan 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - Study 1: To investigate if Sativex® has appetite stimulating properties defined as increased energy intake compared to placebo
    Protection of trial subjects
    Protocol designed to minimize burden for patients such as duration, supply of food, transportion, ethical approvals, doctor on call, follow up by phone etc
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2021
    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
    Denmark: 73
    Worldwide total number of subjects
    73
    EEA total number of subjects
    73
    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)
    0
    From 65 to 84 years
    63
    85 years and over
    10

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were included at the Emergency Department (ED) at Copenhagen University Hospital, Amager and Hvidovre, Denmark,

    Pre-assignment
    Screening details
    		 screening for poor appetite with snaq performed before inclusion, to ensure poor appetite

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal spray, suspension
    Routes of administration
    Buccal use
    Dosage and administration details
    three sprays at two time points

    Arm title
    		 Sativex
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sativex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oromucosal spray
    Routes of administration
    Buccal use
    Dosage and administration details
    3 sprays at two time points

    Number of subjects in period 1
    		Placebo Sativex
    Started
    17
    17
    Wash out
    17
    17
    Completed
    17
    17

    Baseline characteristics

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    Baseline characteristics reporting groups [1]
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    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: originally designed with three groups. two groupw where removed, a new sample size calculation were perfomed, showing 17 patients were needed
    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 17 17
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 78 (71.2 to 85.9) -
    Gender categorical
    Units: Subjects
        Female
    		 13 13
        Male
    		 4 4

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Sativex
    Reporting group description
    		 -

    Primary: to determine whether a standardized oromucosal spray containing a defined combination of THC and CBD was superior to placebo in improving caloric intake in older patients with poor appetite

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    End point title
    		 to determine whether a standardized oromucosal spray containing a defined combination of THC and CBD was superior to placebo in improving caloric intake in older patients with poor appetite
    End point description
    End point type
    Primary
    End point timeframe
    before and after administration of sativex compared to placebo on two different trial days with a two week wash out period
    End point values
    		 Placebo Sativex
    Number of subjects analysed
    17
    17
    Units: Kcal
        median (inter-quartile range (Q1-Q3))
    575.07 (507.07 to 677.35)
    577.96 (505.90 to 671.38)
    Statistical analysis title
    		 Primary endpoint analysis
    Comparison groups
    Sativex v Placebo
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 5
    Method
    		 t-test, 2-sided
    Parameter type
    		 Median difference (final values)
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During trial days and on follow up phone calls
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Sativex
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Sativex
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 17 (11.76%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    COPD exerbation
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Fall
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Sativex
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 17 (29.41%)
    15 / 17 (88.24%)
    Nervous system disorders
    Tirednes, vertigo, nausea, euphoira
         subjects affected / exposed
    5 / 17 (29.41%)
    15 / 17 (88.24%)
         occurrences all number
    21
    31

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Jul 2022
    The following two protocol amendments have been approved by the Ethics Committee of the Capital Region of Denmark and are registered at ClinicalTrials.gov. Amendment #1: Removal of the secondary endpoint, in substudy 1, concerning eating patterns to relieve participants of extensive data collection. Additionally, the measurement of intraocular pressure in substudy 1 on follow-up days 1, 2, and 7 was removed, and it was specified that the result of the randomization in substudy 1 is not revealed to the project staff. Further, with additional approval from the Danish Medicines Agency, the exclusion criteria were clarified. Handgrip strength and biomarkers of ageing were added to substudy 2. Lastly, the total amount of blood collected in substudy 1 was corrected. Amendment #2: Follow-up visits and phone calls were optimized. The number of PK blood samples was reduced from 12 to 10 and the time points were adjusted. Re-screening with SNAQ was implemented if there were >14 days from discharge until TD1. The dietary diary before TD1 and TD2 was removed. The time-point for the dessert was expedited to fit with a shorter TD1 and TD2. Lastly, funding details and information about trial staff were updated. Amendment #3: Removal of two groups, and change of sample size calculation, n=17 instead of 69

    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.
    Originally designed to include 3 dosings regimen, hence 69 participants, it was changed to one group, and then a new sample size calulation that estimated a sample size of 17 patients
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    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.

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