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    Clinical Trial Results:
    Cabergoline as a Preventive Treatment for Chronic Migraine: an Investigator-Initiated, Randomized Clinical Trial

    Summary
    EudraCT number
    		 2021-005579-38
    Trial protocol
    		 DK  
    Global end of trial date
    13 Jun 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Jun 2024
    First version publication date
    27 Jun 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05525611
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle Juul-Jensens Boulevard 165, Aarhus N, Denmark, 8200
    Public contact
    Jens Otto Lunde Jørgensen, Department of Endorcrinology, +45 20727383, joj@clin.au.dk
    Scientific contact
    Jens Otto Lunde Jørgensen, Department of Endorcrinology, +45 20727383, joj@clin.au.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
    29 Dec 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Jun 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jun 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study the effect of Cabergoline in patients with migraine
    Protection of trial subjects
    The study was monitored by the Good Clinical Practice Unit at Aarhus University Hospital. All participant were ask about adverse events, and could contact the investigator at any time, if adverse events were experienced.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Sep 2022
    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: 36
    Worldwide total number of subjects
    36
    EEA total number of subjects
    36
    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)
    36
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The first patient was enrolled on September 13, 2022, and the last patient completed the study on June 13, 2023. Patients were recruited from the Department of Neurology at Aarhus University Hospital and through the Aarhus University Hospital facebook page.

    Pre-assignment
    Screening details
    		 101 adults were screened for eligibility. Forty-five patients failed to meet inclusion criteria (because of too few migraine days, comorbidities, breastfeeding, use of a dopamine antagonist, not using anticonception, planned medication changes) and 11 declined to participate.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cabergoline
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cabergoline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    0.5 mg once weekly orally

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet once a week orally

    Number of subjects in period 1
    		Cabergoline Placebo
    Started
    18
    18
    Completed
    18
    18
    Period 2
    Period 2 title
    Treatment period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cabergoline
    Arm description
    		 Cabergoline 0.5 mg once weekly as add-on treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cabergoline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    0.5 mg once weekly orally

    Arm title
    		 Placebo
    Arm description
    		 Placebo once weekly as add-on treatment
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet once a week orally

    Number of subjects in period 2
    		Cabergoline Placebo
    Started
    18
    18
    Completed
    18
    18

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cabergoline
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Cabergoline Placebo Total
    Number of subjects
    		 18 18 36
    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)
    		 18 18 36
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 41 ( 10 ) 44 ( 8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 17 16 33
        Male
    		 1 2 3
    Acute headache medication use
    Units: Subjects
        Acute headache medication use
    		 18 18 36
    Migraine-preventive medication use
    Units: Subjects
        No current or previous use
    		 6 7 13
        Previous use only
    		 5 5 10
        Current use
    		 7 6 13
    History of preventive treatment failure
    Units: Subjects
        Lack of efficacy or unacceptable side effects
    		 10 9 19
        No History of preventive treatment failure
    		 7 7 14
        Not recorded
    		 1 2 3
    Age at migraine onset
    Units: year
        arithmetic mean (standard deviation)
    		 17.1 ( 8.7 ) 17.2 ( 6.0 ) -
    Monthly migraine days
    Units: day
        arithmetic mean (standard deviation)
    		 13.6 ( 4.1 ) 14.0 ( 5.3 ) -
    Days of use of acute migraine medication
    Units: day
        arithmetic mean (standard deviation)
    		 10.5 ( 4.5 ) 11.5 ( 3.1 ) -
    HIT-6 score
    Units: score
        arithmetic mean (standard deviation)
    		 64 ( 5.6 ) 63.8 ( 3.4 ) -
    MIDAS grade
    Units: Score
        median (inter-quartile range (Q1-Q3))
    		 47 (27.5 to 85) 43 (27 to 58.5) -

    End points

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

    Reporting group title
    Placebo
    Reporting group description
    		 -
    Reporting group title
    Cabergoline
    Reporting group description
    		 Cabergoline 0.5 mg once weekly as add-on treatment

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo once weekly as add-on treatment

    Primary: Change in monthly migraine days

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    End point title
    		 Change in monthly migraine days
    End point description
    End point type
    Primary
    End point timeframe
    Change in monthly migraine days from baseline to the last month of the treatment phase
    End point values
    		 Cabergoline Placebo
    Number of subjects analysed
    17
    16
    Units: day
        median (inter-quartile range (Q1-Q3))
    -5 (-9 to -3)
    -3.7 (-5.5 to -1.5)
    Statistical analysis title
    		 Mann Whitney U test/unpaired t-test
    Statistical analysis description
    Primary and secondary outcomes were analysed using a linear regression model with heteroscedasticity-robust standard errors, computed via the HC1 method, or unpaired t-test and presented as mean ± SE, if data were normally distributed. Non-normally distributed data were analysed using Mann Whitney U test and presented as medians (IQR).
    Comparison groups
    Cabergoline v Placebo
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Confidence interval

    Secondary: ≥50% Reduction from baseline in monthly migraine days

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    End point title
    		 ≥50% Reduction from baseline in monthly migraine days
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to last month of treatment phase
    End point values
    		 Cabergoline Placebo
    Number of subjects analysed
    17
    16
    Units: number
    8
    4
    No statistical analyses for this end point

    Secondary: Patient Global Impression of Change (PGIC)

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    End point title
    		 Patient Global Impression of Change (PGIC)
    End point description
    End point type
    Secondary
    End point timeframe
    Last visit (after completion of treatment period)
    End point values
    		 Cabergoline Placebo
    Number of subjects analysed
    17
    16
    Units: likert scale
        median (inter-quartile range (Q1-Q3))
    8 (6 to 9)
    5 (5 to 6.25)
    No statistical analyses for this end point

    Secondary: Change in acute migraine-specific medication from baseline

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    End point title
    		 Change in acute migraine-specific medication from baseline
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to last month of treatment phase
    End point values
    		 Cabergoline Placebo
    Number of subjects analysed
    17
    16
    Units: number
        median (inter-quartile range (Q1-Q3))
    -3 (-7 to 0)
    -2.5 (-4.5 to -0.75)
    No statistical analyses for this end point

    Secondary: Change in HIT-6 score from baseline

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    End point title
    		 Change in HIT-6 score from baseline
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to end of treatment phase
    End point values
    		 Cabergoline Placebo
    Number of subjects analysed
    17
    16
    Units: score
        median (inter-quartile range (Q1-Q3))
    -3.8 (-7.5 to 1)
    -2.6 (-4 to 1)
    No statistical analyses for this end point

    Secondary: Change in MIDAS score from baseline

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    End point title
    		 Change in MIDAS score from baseline
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to end of treatment phase
    End point values
    		 Cabergoline Placebo
    Number of subjects analysed
    17
    16
    Units: score
        median (inter-quartile range (Q1-Q3))
    -9 (-27.5 to -2.75)
    -10 (-32.5 to -2.5)
    No statistical analyses for this end point

    Secondary: Change in serum prolactin

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    End point title
    		 Change in serum prolactin
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline to end of treatment phase
    End point values
    		 Cabergoline Placebo
    Number of subjects analysed
    17
    16
    Units: IU/l
        median (inter-quartile range (Q1-Q3))
    -112 (-183 to -95)
    -0.5 (-44.8 to 37.8)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were recorded for each patient from inclusion in the trial until four weeks following completion.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ICD
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Cabergoline
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Cabergoline Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 18 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Cabergoline Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 18 (38.89%)
    4 / 18 (22.22%)
    Cardiac disorders
    Chest pain
    Additional description: Stabbing chest pain
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 18 (22.22%)
    3 / 18 (16.67%)
         occurrences all number
    4
    3
    Dizziness
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 18 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 18 (22.22%)
    0 / 18 (0.00%)
         occurrences all number
    4
    0
    sweating
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Weight gain
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    2 / 18 (11.11%)
    1 / 18 (5.56%)
         occurrences all number
    2
    1
    Loss of appetite
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    1

    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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