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    Clinical Trial Results:
    Beta-agonist Efficacy and Tolerability as Adjuvant therapy in Myasthenia Gravis

    Summary
    EudraCT number
    		 2019-000895-40
    Trial protocol
    		 DK  
    Global end of trial date
    30 Dec 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Mar 2026
    First version publication date
    13 Mar 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BETA-MG-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03914638
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle Juul-Jensens Boulevard, 8200 Aarhus N, Denmark,
    Public contact
    Jan L. S. Thomsen, Aarhus University Hospital, jathms@rm.dk
    Scientific contact
    Jan L. S. Thomsen, Aarhus University Hospital, jathms@rm.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
    20 Oct 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Dec 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Dec 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the efficacy and tolerability of oral Salbutamol as adjuvant therapy in patients with generalized myasthenia gravis on stable medications with residual symptoms.
    Protection of trial subjects
    Follow-up
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2019
    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: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    23
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 June 2019 to august 2024 at Aarhus, Aalborg and Odense

    Pre-assignment
    Screening details
    		 44 screened, 37 assessed for eligibility, 30 eligible.

    Period 1
    Period 1 title
    Period 1 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor
    Blinding implementation details
    Active and placebo encapsulated in identical caps.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Salbutamol
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Salbutamol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    4 mg. three times daily

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1 capsule three times daily

    Number of subjects in period 1
    		Salbutamol Placebo
    Started
    15
    15
    Completed
    13
    15
    Not completed
    2
    0
         Adverse event, non-fatal
    2
    -

    Baseline characteristics

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    End points

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

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: QOL15

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    End point title
    		 QOL15
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to week 8.
    End point values
    		 Salbutamol Placebo
    Number of subjects analysed
    15
    15
    Units: -3,9
        number (confidence interval 95%)
    -4.7 (-6.6 to -2.7)
    -0.8 (-2.8 to 1.2)
    Statistical analysis title
    		 Mixed effects
    Statistical analysis description
    Mixed effects linear regression with treatment, visit, treatment-by-visit interaction, sequence and period as fixed effects and subject as random effect.
    Comparison groups
    Salbutamol v Placebo
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.7
         upper limit
    		 -1.1
    Variability estimate
    Standard deviation

    Secondary: QMG

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    End point title
    		 QMG
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to week 8
    End point values
    		 Salbutamol Placebo
    Number of subjects analysed
    15
    15
    Units: -3,0
        number (confidence interval 95%)
    -2.6 (-3.4 to -1.7)
    0.4 (-0.4 to 1.3)
    No statistical analyses for this end point

    Secondary: MGC

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    End point title
    		 MGC
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to week 8
    End point values
    		 Salbutamol Placebo
    Number of subjects analysed
    15
    15
    Units: -1,9
        number (confidence interval 95%)
    -2.9 (-4.1 to -1.7)
    -1.0 (-2.2 to 0.2)
    No statistical analyses for this end point

    Secondary: MG-ADL

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    End point title
    		 MG-ADL
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to week 8
    End point values
    		 Salbutamol Placebo
    Number of subjects analysed
    15
    15
    Units: -1,0
        number (confidence interval 95%)
    -1.4 (-2.0 to -0.7)
    -0.4 (-1.0 to 0.3)
    No statistical analyses for this end point

    Secondary: Neuro-QoL

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    End point title
    		 Neuro-QoL
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to week 8
    End point values
    		 Salbutamol Placebo
    Number of subjects analysed
    15
    15
    Units: -7,8
        number (confidence interval 95%)
    -8.9 (-12.0 to -5.7)
    -1.1 (-4.2 to 2.1)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Baseline to week 8 in both treatment periods.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Frequency threshold for reporting non-serious adverse events: 5%
    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: See publication on adverse events. This EudraCT system is not set-up to manage cross-over designs. There were no serious adverse events. Palpitations 12 (salbutamol) / 3 (placebo) Hypertension 2(salbutamol) / 5 (placebo) Tremor 16 (salbutamol) / 0 (placebo) Head 7 (salbutamol) / 3 (placebo)

    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? Yes
    Date
    Interruption
    Restart date
    02 Dec 2019
    Covid-19
    -

    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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