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    Clinical Trial Results:
    A Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Amifampridine Phosphate in Patients with MuSK Antibody Positive Myasthenia Gravis, and a Sample of AChR Antibody Positive Myasthenia Gravis Patients

    Summary
    EudraCT number
    2017-004018-25
    Trial protocol
    IT  
    Global end of trial date
    24 Apr 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    03 May 2021
    First version publication date
    03 May 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MSK-002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03304054
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    IND: 106263
    Sponsors
    Sponsor organisation name
    Catalyst Pharmaceuticals, Inc.
    Sponsor organisation address
    355 Alhambra Circle, Suite 1250, Coral Gables, United States, 33134
    Public contact
    Gary Ingenito, Catalyst Pharmaceuticals Inc., 001 3054203200, gingenito@catalystpharma.com
    Scientific contact
    Gary Ingenito, Catalyst Pharmaceuticals Inc., 001 3054203200, gingenito@catalystpharma.com
    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
    17 Feb 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Apr 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To characterize the overall safety and tolerability of amifampridine phosphate compared with placebo in patients with MuSK antibody positive myasthenia gravis. To assess the clinical efficacy of amifampridine phosphate compared with placebo in patients with MuSK antibody positive myasthenia gravis based on change in Myasthenia Gravis Activities of Daily Living Score (MG-ADL)
    Protection of trial subjects
    In the event of an emergency, any needed medications could be prescribed without prior approval, however, the medical monitor was notified of the use of any contraindicated medications immediately thereafter. The measures of safety used in this study were routine clinical and laboratory procedures. The efficacy measures used a variety of approaches to evaluate changes in neuromuscular function and muscle strength. These standardized tests have been previously used for the determination of response to therapeutic intervention in patients with MG and in other indications and, thus, were relevant for use in this study in patients with MG.
    Background therapy
    None
    Evidence for comparator
    None
    Actual start date of recruitment
    01 Jun 2018
    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
    Italy: 27
    Country: Number of subjects enrolled
    Serbia: 9
    Country: Number of subjects enrolled
    United States: 53
    Worldwide total number of subjects
    89
    EEA total number of subjects
    27
    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)
    74
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The recruitment started on 1 June 2018, in 26 sites in the USA and Europe (Italy and Serbia). Approximately 60 male and female MuSK-MG subjects and 10 AChR-MG subjects were planned to be recruited.

    Pre-assignment
    Screening details
    After signing the informed consent, patients were screened and conducted at the start of the Run-in period. During the Run-in a stable dose and frequency of amifampridine phosphate were established for at least 7 days, and at least a 2-point improvement in MG-ADL score was achieved. 70 patients were recruited, 19 were screen failures.

    Pre-assignment period milestones
    Number of subjects started
    89
    Number of subjects completed
    70

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Screening failure: 19
    Period 1
    Period 1 title
    Study period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator
    Blinding implementation details
    This was a double-blind, treatment withdrawal study where both the patient and Investigator were blinded to the treatment assignment.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Amifampridine phosphate
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    3,4-pyridinediamine, phosphate (1:1) diamino-3,4-pyridine, phosphate salt
    Investigational medicinal product code
    Other name
    3,4-diaminopyridine phosphate
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The selection and timing of doses for each subject were determined at the discretion of the investigator within the bounds of a total daily dose of 30 mg to 80 mg, divided into doses taken 3 to 4 times per day, based on optimal neuromuscular benefit. The maximum single dose was 20 mg.

    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
    Each tablet contains microcrystalline cellulose, colloidal anhydrous silica, and calcium stearate. Placebo was provided as tablets indistinguishable from amifampridine phosphate.

    Number of subjects in period 1 [1]
    Amifampridine phosphate Placebo
    Started
    34
    36
    Completed
    34
    35
    Not completed
    0
    1
         Adverse event, non-fatal
    -
    1
    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: The worldwide number enrolled in the trial includes also patients who failed the pre-screening phase.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Amifampridine phosphate
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Reporting group values
    Amifampridine phosphate Placebo Total
    Number of subjects
    34 36 70
    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
        arithmetic mean (standard deviation)
    53.1 ± 14.92 53.5 ± 12.61 -
    Gender categorical
    Units: Subjects
        Female
    24 8 32
        Male
    10 28 38
    Race
    Units: Subjects
        American Indian or Alaska Native
    0 0 0
        Asian
    0 0 0
        Black or African American
    3 2 5
        Native Hawaiian or Other Pacific Islander
    0 0 0
        White
    31 34 65
        Other
    0 0 0
        Not recorded
    0 0 0
    Weight
    Units: Kg
        arithmetic mean (standard deviation)
    84.6 ± 21.11 84.3 ± 27.27 -
    Height
    Units: cm
        arithmetic mean (standard deviation)
    164.7 ± 7.64 163.5 ± 10.75 -
    MG-ADL total score
    MG-ADL total score at baseline for MuSK subjects (n=27 in the Amifampridine group and n=28 in the placebo group)
    Units: Score
        arithmetic mean (standard deviation)
    4.96 ± 2.915 3.86 ± 2.103 -
    MG-ADL Total Score for AChR subjects
    MG-ADL Total Score for AChR (n=7 in the Amifampridine group and n=8 in the placebo group)
    Units: Score
        arithmetic mean (standard deviation)
    6.14 ± 3.388 7.00 ± 4.175 -
    QMG Total Score for MuSK subjects
    At baseline n=27 in the Amfridine group and n=28 in the placebo group.
    Units: Score
        arithmetic mean (standard deviation)
    10.00 ± 3.873 8.64 ± 3.744 -

    End points

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    End points reporting groups
    Reporting group title
    Amifampridine phosphate
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Primary: Change in MG-ADL score from Day 0 to Day 10_MuSK-MG

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    End point title
    Change in MG-ADL score from Day 0 to Day 10_MuSK-MG
    End point description
    The primary efficacy variable was the change in MG-ADL score from Day 0 (Baseline) to Day 10 for MuSK-MG subjects treated with amifampridine phosphate and placebo. The MG-ADL is a self-report scale designed to assess the patient’s MG symptoms and functional performance of activities of daily living. The MG-ADL consists of 8 items (derived from symptom-based components of the original 13-item Quantitative Myasthenia Gravis test) to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. Each of the 8 items is rated using a response scale ranging from 0 (normal) to 3 (most severe). Lower scores indicate better functional performance. Data of patients diagnosed with MuSK-MG were reported.
    End point type
    Primary
    End point timeframe
    From Day 0 (baseline) to Day 10
    End point values
    Amifampridine phosphate Placebo
    Number of subjects analysed
    27
    28
    Units: Score
        arithmetic mean (standard deviation)
    1.04 ± 2.980
    2.25 ± 2.00
    Statistical analysis title
    Change in MG-ADL score from Day 0 to Day 10
    Statistical analysis description
    Observed significance level (p-value) for Wilcoxon-Mann-Whitney Test of Equality of CFB distributions
    Comparison groups
    Amifampridine phosphate v Placebo
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.2196 [1]
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [1] - These results were not statistically significant (p = 0.2196) and provided no support for the alternative hypothesis.

    Secondary: Change in QMG score from Day 0 to Day 10_MuSK-MG

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    End point title
    Change in QMG score from Day 0 to Day 10_MuSK-MG
    End point description
    The QMG score was used to assess the patient’s general body strength and fatigability. The QMG was administered at the protocol-specified time points by the same evaluator throughout the study.
    End point type
    Secondary
    End point timeframe
    From Day 0 to Day 10
    End point values
    Amifampridine phosphate Placebo
    Number of subjects analysed
    26
    25
    Units: Score
        arithmetic mean (standard deviation)
    1.19 ± 3.990
    1.80 ± 3.948
    Statistical analysis title
    Change in QMG score from Day 0 to Day 10
    Comparison groups
    Amifampridine phosphate v Placebo
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [2]
    P-value
    = 0.3736
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [2] - Observed significance level (p-value) for Wilcoxon-Mann-Whitney Test of Equality of CFB distributions

    Secondary: Change in QMG score from Day 0 to Day 10_AChR

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    End point title
    Change in QMG score from Day 0 to Day 10_AChR
    End point description
    The QMG score was used to assess the patient’s general body strength and fatigability. The QMG was administered at the protocol-specified time points by the same evaluator throughout the study.
    End point type
    Secondary
    End point timeframe
    From Day 0 to Day 10
    End point values
    Amifampridine phosphate Placebo
    Number of subjects analysed
    7
    8
    Units: Score
        arithmetic mean (standard deviation)
    10.57 ± 3.359
    14.13 ± 4.155
    No statistical analyses for this end point

    Secondary: Proportion of subjects with a change of 2 or more in MG-ADL score from Baseline to Day 10

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    End point title
    Proportion of subjects with a change of 2 or more in MG-ADL score from Baseline to Day 10
    End point description
    End point type
    Secondary
    End point timeframe
    From Day 0 to Day 10
    End point values
    Amifampridine phosphate Placebo
    Number of subjects analysed
    27
    28
    Units: subject
        Less Than 2 Points
    21
    25
        2 or More Points
    6
    3
    Statistical analysis title
    MG-ADL Score Shift of at Least 2 Points
    Statistical analysis description
    Six (6) subjects (22.2%) randomized to treatment with amifampridine phosphate were observed to have a change in MG-ADL score of 2 or more while three (3) subjects (10.7%) randomized to treatment with placebo were observed to have a change in MG-ADL score of 2 or more.
    Comparison groups
    Amifampridine phosphate v Placebo
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [3]
    P-value
    = 0.2955
    Method
    Fisher exact
    Confidence interval
    Notes
    [3] - While more subjects in the amifampridine treatment group had a change in MG-ADL score of 2 or more compared to the placebo treatment group, these differences were not statistically significant.

    Secondary: Proportion of a subjects with a change of 3 or more in QMG score from Baseline to Day 10 for MuSK-MG subjects

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    End point title
    Proportion of a subjects with a change of 3 or more in QMG score from Baseline to Day 10 for MuSK-MG subjects
    End point description
    Three (3) subjects (11.5%) randomized to treatment with amifampridine phosphate were observed to have a change in QMG score of 3 or more while one (1) subject (4.0%) randomized to treatment with placebo was observed to have a change in QMG score of 3 or more.
    End point type
    Secondary
    End point timeframe
    From Day 0 to Day 10
    End point values
    Amifampridine phosphate Placebo
    Number of subjects analysed
    26
    25
    Units: subject
        Less Than 3 Points
    23
    24
        3 or More Points
    3
    1
    Statistical analysis title
    QMG Score Shift
    Comparison groups
    Amifampridine phosphate v Placebo
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [4]
    P-value
    = 0.6098
    Method
    Fisher exact
    Confidence interval
    Notes
    [4] - While more subjects in the amifampridine treatment group had a change in QMG score of 3 or more compared to the placebo treatment group, these differences were not statistically significant.

    Other pre-specified: Change in MG-ADL score from Day 0 to Day 10_AChR

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    End point title
    Change in MG-ADL score from Day 0 to Day 10_AChR
    End point description
    The MG-ADL is a self-report scale designed to assess the patient’s MG symptoms and functional performance of activities of daily living. The MG-ADL consists of 8 items (derived from symptom-based components of the original 13-item Quantitative Myasthenia Gravis test) to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. Each of the 8 items is rated using a response scale ranging from 0 (normal) to 3 (most severe). Lower scores indicate better functional performance. Data of AChR subjects were reported.
    End point type
    Other pre-specified
    End point timeframe
    From Day 0 to Day 10
    End point values
    Amifampridine phosphate Placebo
    Number of subjects analysed
    7
    8
    Units: Score
        arithmetic mean (standard deviation)
    -1.43 ± 2.225
    3.38 ± 2.825
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the enrollment to the end of the study.
    Adverse event reporting additional description
    Safety was assessed through the incidence of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs). Vital signs, 12-lead electrocardiograms (ECGs), clinical laboratory tests, physical examinations, and concomitant medications were also evaluated.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Safety population
    Reporting group description
    The Safety population consisted of all subjects who were enrolled in the study and had received at least one dose of amifampridine phosphate. (Subjects who began the run-in period belonged to the Safety population whether they were randomized to a treatment or not).

    Serious adverse events
    Safety population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 86 (2.33%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    Myasthenia gravis
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Myasthenia gravis crisis
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Safety population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    80 / 86 (93.02%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Pituitary tumor benign
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Fall
         subjects affected / exposed
    2 / 86 (2.33%)
         occurrences all number
    2
    Nervous system disorders
    Burning sensation
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    9 / 86 (10.47%)
         occurrences all number
    9
    Dropped head syndrome
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Dysgeusia
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Facial paresis
         subjects affected / exposed
    11 / 86 (12.79%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    11 / 86 (12.79%)
         occurrences all number
    11
    Hypoaesthesia
         subjects affected / exposed
    4 / 86 (4.65%)
         occurrences all number
    4
    Hypogeusia
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Myasthenia gravis
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Myasthenia gravis crisis
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Paraesthesia
         subjects affected / exposed
    35 / 86 (40.70%)
         occurrences all number
    35
    Sensory disturbance
         subjects affected / exposed
    3 / 86 (3.49%)
         occurrences all number
    3
    Sinus headache
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Speech disorder
         subjects affected / exposed
    2 / 86 (2.33%)
         occurrences all number
    2
    Tremor
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 86 (3.49%)
         occurrences all number
    3
    Chest discomfort
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    10 / 86 (11.63%)
         occurrences all number
    10
    Feeling cold
         subjects affected / exposed
    3 / 86 (3.49%)
         occurrences all number
    3
    Feeling hot
         subjects affected / exposed
    2 / 86 (2.33%)
         occurrences all number
    2
    Feeling jittery
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Influenza like illness
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Medical device site discharge
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Pain
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Temperature regulation disorder
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    5 / 86 (5.81%)
         occurrences all number
    5
    Abdominal distention
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Abdominal pain
         subjects affected / exposed
    3 / 86 (3.49%)
         occurrences all number
    3
    Abdominal pain upper
         subjects affected / exposed
    8 / 86 (9.30%)
         occurrences all number
    8
    Diarrhoea
         subjects affected / exposed
    12 / 86 (13.95%)
         occurrences all number
    12
    Dyspepsia
         subjects affected / exposed
    7 / 86 (8.14%)
         occurrences all number
    7
    Dysphagia
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Eructation
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Hypoaesthesia oral
         subjects affected / exposed
    9 / 86 (10.47%)
         occurrences all number
    9
    Nausea
         subjects affected / exposed
    14 / 86 (16.28%)
         occurrences all number
    14
    Paraesthesia oral
         subjects affected / exposed
    37 / 86 (43.02%)
         occurrences all number
    37
    Tongue coated
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    3 / 86 (3.49%)
         occurrences all number
    3
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Cough
         subjects affected / exposed
    2 / 86 (2.33%)
         occurrences all number
    2
    Dyspnoea
         subjects affected / exposed
    3 / 86 (3.49%)
         occurrences all number
    3
    Epistaxis
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Oropharyngeal pain
         subjects affected / exposed
    3 / 86 (3.49%)
         occurrences all number
    3
    Productive cough
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Rhinitis allergic
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Sinus congestion
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Rash maculo-papular
         subjects affected / exposed
    2 / 86 (2.33%)
         occurrences all number
    2
    Psychiatric disorders
    Adjustment disorder with depressed mood
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Anxiety
         subjects affected / exposed
    2 / 86 (2.33%)
         occurrences all number
    2
    Disorientation
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    2 / 86 (2.33%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Back pain
         subjects affected / exposed
    3 / 86 (3.49%)
         occurrences all number
    3
    Muscle spasms
         subjects affected / exposed
    6 / 86 (6.98%)
         occurrences all number
    6
    Muscular weakness
         subjects affected / exposed
    2 / 86 (2.33%)
         occurrences all number
    2
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Musculoskeletal pain
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Neck pain
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    4 / 86 (4.65%)
         occurrences all number
    4
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Ear infection
         subjects affected / exposed
    2 / 86 (2.33%)
         occurrences all number
    2
    Influenza
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    3 / 86 (3.49%)
         occurrences all number
    3
    Oral herpes
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Otitis media
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Sinusitis
         subjects affected / exposed
    2 / 86 (2.33%)
         occurrences all number
    2
    Urinary tract infection
         subjects affected / exposed
    3 / 86 (3.49%)
         occurrences all number
    3
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    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.
    The COVID-19 Pandemic occurred at the end of the study. Four enrolled subjects were impacted by the COVID-19 Pandemic. There were no statistically significant impacts on the results of the study due to the COVID-19 Pandemic.
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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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