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    Clinical Trial Results:
    A Randomised Double-Blinded Placebo-Controlled Trial to Assess the Efficacy and Safety of Scopolamine Compared to Placebo in Individuals with Bipolar Disorder who are Experiencing a Depressive Episode (SCOPE-BD)

    Summary
    EudraCT number
    		 2017-003112-39
    Trial protocol
    		 IE  
    Global end of trial date
    22 Feb 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Mar 2025
    First version publication date
    09 Mar 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    NUIG-2017-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04211961
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Galway
    Sponsor organisation address
    University Road, Galway City, Ireland,
    Public contact
    Dr. Brian Hallahan, Department of Psychiatry, Clinical Science Institute, University of Galway, Galway, Ireland, brian.hallahan@universityofgalway.ie
    Scientific contact
    Dr. Brian Hallahan, Department of Psychiatry, Clinical Science Institute, University of Galway, Galway, Ireland, brian.hallahan@universityofgalway.ie
    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
    22 Aug 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Feb 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Feb 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to investigate the efficacy and safety of IV Scopolamine, compared to placebo, in reducing severity of depression in individuals with bipolar disorder who are experiencing a depressive episode of at least moderate severity.
    Protection of trial subjects
    The SCOPE-BD trial was approved by Galway University Hospital Clinical Research Ethics Committee. This study was conducted in compliance with the protocol, International Conference on Harmonization – Good Clinical Practice (ICH-GCP) and any applicable regulatory requirements including the archiving of essential documents. The PI was responsible for obtaining informed consent from each patient or legal representative and for obtaining the appropriate signatures on the Informed Consent Document (ICD) prior to the performance of any protocol procedures and before administration of study drug. The PI provided a copy of the signed ICD to the patient, and a copy was maintained at the investigative site. A properly executed, signed ICD was obtained from each patient. Eligible patients were only included in the trial after providing written informed consent. Informed consent was obtained prior to conducting any trial specific procedures. Upon providing consent, the informed consent form (ICF) was signed and dated by the subject, and the investigator who administered the ICF. The complete original ICF was filed by the site in the site file, a copy of the ICF was given to the participant and a copy was filed in the patients notes. An additional consent was obtained for bio-banking samples; this was pre-approved by the approving Ethics Committee.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Dec 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Ireland: 55
    Worldwide total number of subjects
    55
    EEA total number of subjects
    55
    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)
    50
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Recruitment Period: 23 March 2021 to 22 February 2024. The study has one location - University Hospital Galway, Galway, Ireland.

    Pre-assignment
    Screening details
    		 Patients were eligible for participation if they carried diagnosis of Bipolar Disorder by DSM-V criteria and were experiencing an episode of depression of at least moderate severity at Visit 1 (Screening) and Visit 2 based on clinical interview by a trained clinician and a Hamilton Depression Rating Scale (HDRS) score ≥ 14.

    Pre-assignment period milestones
    Number of subjects started
    		 55
    Number of subjects completed
    		 50

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Not eligible for randomisation: 5
    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Patients randomised to the Placebo arm received an intravenous infusion of saline at each study visit (Visits 3,4,5)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    100mL saline infused over 15 minutes

    Arm title
    		 Scopolamine
    Arm description
    		 Patients randomised to Scopolamine received an infusion of Scopolamine 4 µg/kg in 100mL saline over 15 minutes at each study visit (Visits 3,4,5)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Scopolamine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    4 µg/kg in 100mL saline infused over 15 minutes

    Number of subjects in period 1 [1]
    		Placebo Scopolamine
    Started
    24
    26
    Completed
    24
    26
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Of the 55 participants who consented, 5 were withdrawn pre-randomisation. Fifty participants were eventually randomised into the SCOPE-BD trial. Enrolled patients underwent a placebo treatment at Visit 2 and were eligible for randomisation at Visit 3 only if their depressive symptoms were still at least moderate in severity.
    Period 2
    Period 2 title
    After last treatment (Visit 6)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    100mL saline infused over 15 minutes

    Arm title
    		 Scopolamine
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Scopolamine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    4 µg/kg in 100mL saline infused over 15 minutes

    Number of subjects in period 2
    		Placebo Scopolamine
    Started
    24
    26
    Completed
    24
    24
    Not completed
    0
    2
         Adverse event, serious fatal
    -
    1
         Consent withdrawn by subject
    -
    1
    Period 3
    Period 3 title
    Followup (Visit 7)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    100mL saline infused over 15 minutes

    Arm title
    		 Scopolamine
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    100mL saline infused over 15 minutes

    Investigational medicinal product name
    Scopolamine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    4 µg/kg in 100mL saline infused over 15 minutes

    Number of subjects in period 3
    		Placebo Scopolamine
    Started
    24
    24
    Completed
    24
    23
    Not completed
    0
    1
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Patients randomised to the Placebo arm received an intravenous infusion of saline at each study visit (Visits 3,4,5)

    Reporting group title
    Scopolamine
    Reporting group description
    		 Patients randomised to Scopolamine received an infusion of Scopolamine 4 µg/kg in 100mL saline over 15 minutes at each study visit (Visits 3,4,5)

    Reporting group values
    		 Placebo Scopolamine Total
    Number of subjects
    		 24 26 50
    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)
    		 22 23 45
        From 65-84 years
    		 2 3 5
        85 years and over
    		 0 0 0
    Age continuous
    Age in years at baseline
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 53 (46 to 57) 42 (37 to 50) -
    Gender categorical
    Units: Subjects
        Female
    		 15 11 26
        Male
    		 9 15 24
    Race
    Units: Subjects
        Asian
    		 0 1 1
        White
    		 23 24 47
        Hispanic/LatinX
    		 1 1 2
    Ocupational status
    Occupational status at baseline
    Units: Subjects
        Employed full-time for pay
    		 4 2 6
        Employed part-time for pay
    		 1 5 6
        Full-tiime student
    		 2 1 3
        Homemaker
    		 2 1 3
        Leave of absence for medical reasons
    		 2 4 6
        Retired
    		 3 1 4
        Unemployed <6months, expects to work
    		 0 2 2
        Unemployed <6months, does not expecct to work
    		 1 1 2
        Unemployed >=6 months, expects to work
    		 2 5 7
        Unemployed >=6months, does not expect to work
    		 7 4 11
    Educational status
    Educational status at baseline
    Units: Subjects
        College graduate
    		 11 5 16
        Graduate professional training (Masters or above)
    		 6 7 13
        High school graduate
    		 3 6 9
        Junioo high school (7th,8th,9th)
    		 0 1 1
        Some college or technical school (at least 1yr)
    		 3 5 8
        Some High School (10th,11th)
    		 1 2 3
    Relationshiop status
    Relationship status at baseline
    Units: Subjects
        Divorced
    		 3 3 6
        Long-term relationship
    		 4 2 6
        Married
    		 7 4 11
        Single
    		 10 17 27
    Socioeconomic status
    Socioeconomic status at baseline
    Units: Subjects
        Machine operators, semiskilled workers
    		 3 9 12
        Major business and professional
    		 1 1 2
        Medium business, minor professioonal, technical
    		 8 6 14
        Skilled craftsmen, clerical, sales workers
    		 7 4 11
        Unskilled labourers, menial service workers
    		 5 6 11
    Handedness
    Units: Subjects
        Right-handed
    		 20 23 43
        Left-handed
    		 3 1 4
        Ambidextrous
    		 1 2 3
    Psychosis
    History of Psychosis at baseline
    Units: Subjects
        Yes
    		 10 13 23
        No
    		 14 13 27
    Rapid cycling
    Units: Subjects
        Yes
    		 2 3 5
        No
    		 22 23 45
    Smoker
    Units: Subjects
        Yes
    		 8 9 17
        No
    		 16 17 33
    Alcohol use
    Units: Subjects
        Yes
    		 7 7 14
        No
    		 17 19 36
    Alcohol dependence
    Units: Subjects
        Yes
    		 3 5 8
        No
    		 21 21 42
    Cannabis use
    Units: Subjects
        Yes
    		 3 3 6
        No
    		 21 23 44

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Patients randomised to the Placebo arm received an intravenous infusion of saline at each study visit (Visits 3,4,5)

    Reporting group title
    Scopolamine
    Reporting group description
    		 Patients randomised to Scopolamine received an infusion of Scopolamine 4 µg/kg in 100mL saline over 15 minutes at each study visit (Visits 3,4,5)
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Scopolamine
    Reporting group description
    		 -
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Scopolamine
    Reporting group description
    		 -

    Primary: Hamilton Depression Rating Scale (HDRS) score

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    End point title
    		 Hamilton Depression Rating Scale (HDRS) score
    End point description
    Score on Hamilton Depression Rating Scale (HDRS)
    End point type
    Primary
    End point timeframe
    At time of last treatment (Visit 6) about 2 weeks after randomisation, and at time of followup (Visit 7) about one month after randomisation
    End point values
    		 Placebo Scopolamine Placebo Scopolamine
    Number of subjects analysed
    24
    24
    24
    23
    Units: units on a scale
        median (inter-quartile range (Q1-Q3))
    12 (7 to 15.5)
    13 (10.8 to 17)
    9 (5 to 14)
    12 (10 to 15)
    Statistical analysis title
    		 Wilcoxin Rank Sum Test
    Comparison groups
    Scopolamine v Placebo
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Wilcoxon Rank Sum Test
    Comparison groups
    Placebo v Scopolamine
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Montgomery and Asberg Depression Scale (MADRS)

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    End point title
    		 Montgomery and Asberg Depression Scale (MADRS)
    End point description
    End point type
    Secondary
    End point timeframe
    At time of last treatment (Visit 6) about 2 weeks after randomisation, and at time of followup (Visit 7) about one month after randomisation
    End point values
    		 Placebo Scopolamine Placebo Scopolamine
    Number of subjects analysed
    24
    24
    24
    23
    Units: units on a scale
        median (inter-quartile range (Q1-Q3))
    14 (9 to 20)
    16 (10 to 27)
    11 (6 to 20)
    14 (12 to 18)
    Statistical analysis title
    		 Wilcoxin Rank Sum Test
    Comparison groups
    Placebo v Scopolamine
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Wilcoxin Rank Sum Test
    Comparison groups
    Placebo v Scopolamine
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Profile of Overall Mood State (POMS)

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    End point title
    		 Profile of Overall Mood State (POMS)
    End point description
    End point type
    Secondary
    End point timeframe
    At time of last infusion (Visit 6)
    End point values
    		 Placebo Scopolamine
    Number of subjects analysed
    22
    23
    Units: units on a scale
        median (inter-quartile range (Q1-Q3))
    27 (9 to 51)
    41 (16 to 93)
    Statistical analysis title
    		 Wilcoxin Rank Sum Test
    Comparison groups
    Placebo v Scopolamine
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Remission of depressive episode

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    End point title
    		 Remission of depressive episode
    End point description
    Remission defined as occurring when individual has HDRS score <=7 and MADRS score <6
    End point type
    Secondary
    End point timeframe
    Assessed at time of last treatment (Visit 6) about 2 weeks after randomisation, and at at time of Followup visit (Visit 7) about one month after randomisation
    End point values
    		 Placebo Scopolamine Placebo Scopolamine
    Number of subjects analysed
    24
    24
    24
    23
    Units: subjects
    2
    2
    4
    1
    Statistical analysis title
    		 Fisher's Exact Test
    Comparison groups
    Placebo v Scopolamine
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.9
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Fisher's Exact Test
    Comparison groups
    Scopolamine v Placebo
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Response of depressive episode

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    End point title
    		 Response of depressive episode
    End point description
    Response defined as a 50% reduction in MADRS score at assessment visit, compared to Visit 3 (randomisation visit)
    End point type
    Secondary
    End point timeframe
    At time of last treatment visit (Visit 6), about two weeks after randomisation, and at time of Followup (visit 7) about a month after randomisation.
    End point values
    		 Placebo Scopolamine Placebo Scopolamine
    Number of subjects analysed
    24
    24
    24
    23
    Units: subjects
    9
    7
    7
    6
    Statistical analysis title
    		 Chi-Squared test
    Comparison groups
    Placebo v Scopolamine
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Chi-Squared test
    Comparison groups
    Placebo v Scopolamine
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Psychiatric inpatient admission

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    End point title
    		 Psychiatric inpatient admission
    End point description
    End point type
    Secondary
    End point timeframe
    During study participation (Visits 2 through 7)
    End point values
    		 Placebo Scopolamine
    Number of subjects analysed
    24
    23
    Units: subjects
    1
    2
    Statistical analysis title
    		 Fisher's Exact Test
    Comparison groups
    Placebo v Scopolamine
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.9
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Introduction of new antidepressant

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    End point title
    		 Introduction of new antidepressant
    End point description
    End point type
    Secondary
    End point timeframe
    During study participation, about a month.
    End point values
    		 Placebo Scopolamine
    Number of subjects analysed
    24
    23
    Units: subjects
    2
    3
    Statistical analysis title
    		 Fisher's Exact Test
    Comparison groups
    Placebo v Scopolamine
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.9
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Increase in dose of existing antidepressant

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    End point title
    		 Increase in dose of existing antidepressant
    End point description
    End point type
    Secondary
    End point timeframe
    At any time during study participation, about a month.
    End point values
    		 Placebo Scopolamine
    Number of subjects analysed
    24
    23
    Units: subjects
    4
    4
    Statistical analysis title
    		 Fisher's Exact Test
    Comparison groups
    Placebo v Scopolamine
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.9
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Occurrence of (hypo)manic episode

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    End point title
    		 Occurrence of (hypo)manic episode
    End point description
    Defined as score of >6 on the Young Mania Rating Scale (YMRS)
    End point type
    Secondary
    End point timeframe
    At any time during Randomisation (Visit 3) through Followup (Visit 7) about a month after randomisation
    End point values
    		 Placebo Scopolamine
    Number of subjects analysed
    24
    23
    Units: subjects
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Any time from randomisation to followup visit, about a month
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Scopolamine
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Scopolamine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 24 (4.17%)
    3 / 26 (11.54%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    1
    Psychiatric disorders
    Depressed Mood leading to hospitalisation
    Additional description: Depressed Mood leading to hospitalisation
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suspected suicide
    Additional description: Suspected suicide
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hospitalisation - due to psychosocial stressors
    Additional description: Hospitalisation - due to psychosocial stressors
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 26 (3.85%)
         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: 0%
    Non-serious adverse events
    		 Placebo Scopolamine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 24 (58.33%)
    25 / 26 (96.15%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Bruise from venipuncture
    Additional description: Bruise from venipuncture
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Fatigue
    Additional description: Fatigue
         subjects affected / exposed
    5 / 24 (20.83%)
    3 / 26 (11.54%)
         occurrences all number
    5
    3
    Knot in throat
    Additional description: Knot in throat
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Spaciness
    Additional description: Feeling 'spacey'
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Shivering
    Additional description: Shivering
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Thirst
    Additional description: Thirst
         subjects affected / exposed
    0 / 24 (0.00%)
    4 / 26 (15.38%)
         occurrences all number
    0
    6
    Reproductive system and breast disorders
    Pain from endometriosis
    Additional description: Pain from endometriosis
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Pain in tissue beside hip
    Additional description: Pain in tissue beside hip
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dry throat
    Additional description: Dry throat
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Sore throat
    Additional description: Sore throat
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Pain on Side of throat
    Additional description: Pain on Side of throat
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Respiratory Problems
    Additional description: Respiratory Problems
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    Wheeziness
    Additional description: Wheeziness
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Anxiety
    Additional description: Anxiety
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    feeling panicky
    Additional description: feeling panicky
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Feeling "on edge"
    Additional description: Feeling "on edge"
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Feeling "confused and scattered"
    Additional description: Feeling "confused and scattered"
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Investigations
    Colonoscopy
    Additional description: Colonoscopy
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Elevated blood sugar levels
    Additional description: Elevated blood sugar levels
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dizziness
    Additional description: Dizziness
         subjects affected / exposed
    1 / 24 (4.17%)
    19 / 26 (73.08%)
         occurrences all number
    1
    25
    Drowsiness
    Additional description: Drowsiness
         subjects affected / exposed
    0 / 24 (0.00%)
    8 / 26 (30.77%)
         occurrences all number
    0
    11
    Headache
    Additional description: Headache
         subjects affected / exposed
    5 / 24 (20.83%)
    7 / 26 (26.92%)
         occurrences all number
    7
    7
    Giddiness
    Additional description: Giddiness
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Shakiness
    Additional description: Shakiness
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Restless legs syndrome
    Additional description: Restless legs syndrome
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Light-Headedness
         subjects affected / exposed
    0 / 24 (0.00%)
    4 / 26 (15.38%)
         occurrences all number
    0
    4
    Tremors pre-infusion in hands/fingers
    Additional description: Tremors pre-infusion in hands/fingers
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Tingling in legs
    Additional description: Tingling in legs
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    Eye disorders
    Blurred Vision
    Additional description: Blurred Vision
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    2
    Intermittent blurred vision
    Additional description: Intermittent blurred vision
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Right eye discolouration, left eye red, some soren
    Additional description: Right eye discolouration, left eye red, some soren
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Nausea
    Additional description: A little nausea
         subjects affected / exposed
    3 / 24 (12.50%)
    8 / 26 (30.77%)
         occurrences all number
    4
    10
    Diarrhea
    Additional description: Diarrhea
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Dry Mouth
    Additional description: Dry Mouth
         subjects affected / exposed
    3 / 24 (12.50%)
    15 / 26 (57.69%)
         occurrences all number
    3
    18
    Intermittent nausea
    Additional description: Intermittent nausea
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Stomach pain
    Additional description: Stomach pain
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Midline hernia
    Additional description: Midline hernia
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    mouth ulcers
    Additional description: mouth ulcers
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Tooth Ache
    Additional description: Tooth Ache
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Vomiting
    Additional description: Vomiting
         subjects affected / exposed
    3 / 24 (12.50%)
    1 / 26 (3.85%)
         occurrences all number
    3
    1
    Skin and subcutaneous tissue disorders
    Boils on face and chest
    Additional description: Boils on face and chest
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Acne
    Additional description: Acne
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Dry Skin
    Additional description: Dry Skin
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Hives
    Additional description: Hives
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Bone pain
    Additional description: Aches and pains in bones
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Oedema
    Additional description: Complaint regarding legs, ankle swelling
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Hip pain
    Additional description: Hip pain
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Muscle pain in neck
    Additional description: Muscle pain in neck
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Infections and infestations
    Gingival abscess
    Additional description: bottom gum abscess
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Chest infection (resp.tract infection - Upper)
    Additional description: Chest infection (resp.tract infection - Upper)
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Thrush (vaginal)
    Additional description: Thrush (vaginal)
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Worms
    Additional description: Worms
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Diabetes type 2 diagnosed
    Additional description: Diabetes type 2 diagnosed
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0

    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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    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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