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    Clinical Trial Results:
    A randomized, placebo-controlled, multiple dose, double blind, phase IIb, dose guiding trial to explore safety and tolerability of four weeks treatment with sulthiame in patients with moderate to severe obstructive sleep apnea

    Summary
    EudraCT number
    		 2017-004767-13
    Trial protocol
    		 SE  
    Global end of trial date
    19 Dec 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Dec 2020
    First version publication date
    16 Dec 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    STM-026/K
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Desitin Arzneimittel GmbH
    Sponsor organisation address
    Weg beim Jäger 214, Hamburg, Germany, 22335
    Public contact
    Clinical Trial Manager, Desitin Arzneimittel GmbH, info@desitin.de
    Scientific contact
    Clinical Trial Manager, Desitin Arzneimittel GmbH, info@desitin.de
    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
    03 Jun 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Dec 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to explore the safety and tolerability of 4 weeks of treatment with different doses of sulthiame (STM) in patients with obstructive sleep apnea (OSA).
    Protection of trial subjects
    The final clinical study protocol and the final version of the patient information and consent form, were reviewed and approved by an Independent Ethics Committee (IEC) prior to inclusion of patients. The study was conducted in compliance with the protocol, regulatory requirements, good clinical practice (GCP) and the ethical principles of the latest revision of the Declaration of Helsinki as adopted by the World Medical Association. All patients received written and verbal information regarding the study. The given information emphasized that participation in the study was voluntary and that the patients could withdraw from the study at any time and for any reason. All patients were given the opportunity to ask questions about the study and were given sufficient time to decide whether to participate in the study. Before any study-related procedures, the informed consent form was signed and personally dated by the patient and by the person who conducted the informed consent discussion.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Mar 2018
    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
    Sweden: 68
    Worldwide total number of subjects
    68
    EEA total number of subjects
    68
    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)
    40
    From 65 to 84 years
    28
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 81 patients were screened. Eligible patients were 18-75 years old, previously treated with CPAP that was stopped because of non-acceptance or non-tolerability with BMI of ≥20 kg/m2-≤35 kg/m2, AHI ≥15, ESS score ≥6 and able to provide informed consent. Patients with OSA treatment within 4 weeks of baseline or central sleep apnea were excluded.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    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
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered once daily.

    Arm title
    		 200 mg STM
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ospolot
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg and 200 mg. Administered once daily.

    Arm title
    		 400 mg STM
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ospolot
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg and 200 mg. Administered once daily.

    Number of subjects in period 1
    		Placebo 200 mg STM 400 mg STM
    Started
    22
    12
    34
    Completed
    22
    12
    25
    Not completed
    0
    0
    9
         Consent withdrawn by subject
    -
    -
    2
         Adverse event, non-fatal
    -
    -
    6
         Non-compliance
    -
    -
    1

    Baseline characteristics

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

    Reporting group title
    200 mg STM
    Reporting group description
    		 -

    Reporting group title
    400 mg STM
    Reporting group description
    		 -

    Reporting group values
    		 Placebo 200 mg STM 400 mg STM Total
    Number of subjects
    		 22 12 34 68
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60.9 ± 10.5 60.3 ± 11.4 60.6 ± 9.4 -
    Gender categorical
    Units: Subjects
        Female
    		 5 5 11 21
        Male
    		 17 7 23 47

    End points

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

    Reporting group title
    200 mg STM
    Reporting group description
    		 -

    Reporting group title
    400 mg STM
    Reporting group description
    		 -

    Primary: Systolic blood pressure

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    End point title
    		 Systolic blood pressure [1]
    End point description
    End point type
    Primary
    End point timeframe
    At baseline (Visit 2) and 4 weeks (Visit 6).
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary goal of this study was exploratory safety and tolerability, and therefore only exploratory statistics were applied.
    End point values
    		 Placebo 200 mg STM 400 mg STM
    Number of subjects analysed
    22
    12
    34
    Units: mmHg
    arithmetic mean (standard deviation)
        Baseline (Visit 2)
    132.8 ± 11.8
    135.4 ± 14.0
    132.1 ± 12.5
        4 weeks (Visit 6)
    130.5 ± 11.4
    132.5 ± 11.6
    133.4 ± 13.2
    No statistical analyses for this end point

    Primary: Diastolic blood pressure

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    End point title
    		 Diastolic blood pressure [2]
    End point description
    End point type
    Primary
    End point timeframe
    At baseline (Visit 2) and 4 weeks (Visit 6).
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary goal of this study was exploratory safety and tolerability, and therefore only exploratory statistics were applied.
    End point values
    		 Placebo 200 mg STM 400 mg STM
    Number of subjects analysed
    22
    12
    34
    Units: mmHg
    arithmetic mean (standard deviation)
        Baseline (Visit 2)
    79.6 ± 6.0
    84.3 ± 8.3
    79.3 ± 9.0
        4 weeks (Visit 6)
    79.5 ± 6.3
    82.4 ± 10.6
    79.9 ± 8.9
    No statistical analyses for this end point

    Primary: Mean arterial blood pressure

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    End point title
    		 Mean arterial blood pressure [3]
    End point description
    End point type
    Primary
    End point timeframe
    At baseline (Visit 2) and 4 weeks (Visit 6).
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary goal of this study was exploratory safety and tolerability, and therefore only exploratory statistics were applied.
    End point values
    		 Placebo 200 mg STM 400 mg STM
    Number of subjects analysed
    22
    12
    34
    Units: mmHg
    arithmetic mean (standard deviation)
        Baseline (Visit 2)
    97.4 ± 6.6
    101.4 ± 9.4
    97.1 ± 9.5
        4 weeks (Visit 6)
    96.4 ± 6.8
    99.3 ± 10.1
    97.6 ± 9.7
    No statistical analyses for this end point

    Primary: Respiratory rate

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    End point title
    		 Respiratory rate [4]
    End point description
    End point type
    Primary
    End point timeframe
    At baseline (Visit 2) and 4 weeks (Visit 6).
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary goal of this study was exploratory safety and tolerability, and therefore only exploratory statistics were applied.
    End point values
    		 Placebo 200 mg STM 400 mg STM
    Number of subjects analysed
    22
    12
    34
    Units: breaths/min
    arithmetic mean (standard deviation)
        Baseline (Visit 2)
    14.1 ± 2.7
    13.3 ± 1.5
    14.2 ± 2.6
        4 weeks (Visit 6)
    13.9 ± 2.5
    13.1 ± 1.2
    14.5 ± 2.9
    No statistical analyses for this end point

    Primary: Pulse

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    End point title
    		 Pulse [5]
    End point description
    End point type
    Primary
    End point timeframe
    At baseline (Visit 2) and 4 weeks (Visit 6).
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary goal of this study was exploratory safety and tolerability, and therefore only exploratory statistics were applied.
    End point values
    		 Placebo 200 mg STM 400 mg STM
    Number of subjects analysed
    22
    12
    34
    Units: beats/min
    arithmetic mean (standard deviation)
        Baseline (Visit 2)
    69.2 ± 10.6
    70.6 ± 13.4
    72.1 ± 8.5
        4 weeks (Visit 6)
    69.6 ± 11.7
    68.8 ± 12.3
    71.8 ± 8.8
    No statistical analyses for this end point

    Primary: Body weight

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    End point title
    		 Body weight [6]
    End point description
    End point type
    Primary
    End point timeframe
    At baseline (Visit 2) and 4 weeks (Visit 6).
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary goal of this study was exploratory safety and tolerability, and therefore only exploratory statistics were applied.
    End point values
    		 Placebo 200 mg STM 400 mg STM
    Number of subjects analysed
    22
    12
    34
    Units: kg
    arithmetic mean (standard deviation)
        Baseline (Visit 2)
    89.2 ± 11.7
    81.8 ± 11.1
    82.1 ± 14.6
        4 weeks (Visit 6)
    88.2 ± 11.5
    80.8 ± 10.5
    82.4 ± 14.6
    No statistical analyses for this end point

    Primary: Body mass index (BMI)

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    End point title
    		 Body mass index (BMI) [7]
    End point description
    End point type
    Primary
    End point timeframe
    At baseline (Visit 2) and 4 weeks (Visit 6).
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary goal of this study was exploratory safety and tolerability, and therefore only exploratory statistics were applied.
    End point values
    		 Placebo 200 mg STM 400 mg STM
    Number of subjects analysed
    22
    12
    34
    Units: kg/m2
    arithmetic mean (standard deviation)
        Baseline (Visit 2)
    28.9 ± 3.0
    27.7 ± 3.1
    26.7 ± 3.1
        4 weeks (Visit 6)
    28.6 ± 3.0
    27.3 ± 2.9
    26.2 ± 3.0
    No statistical analyses for this end point

    Primary: Waist-hip ratio

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    End point title
    		 Waist-hip ratio [8]
    End point description
    End point type
    Primary
    End point timeframe
    At baseline (Visit 2) and 4 weeks (Visit 6).
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary goal of this study was exploratory safety and tolerability, and therefore only exploratory statistics were applied.
    End point values
    		 Placebo 200 mg STM 400 mg STM
    Number of subjects analysed
    22
    12
    34
    Units: unitless
    arithmetic mean (standard deviation)
        Baseline (Visit 2)
    1.0 ± 0.1
    1.0 ± 0.1
    0.9 ± 0.1
        4 weeks (Visit 6)
    1.0 ± 0.1
    0.9 ± 0.1
    0.9 ± 0.1
    No statistical analyses for this end point

    Primary: Electrocardiogram (ECG)

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    End point title
    		 Electrocardiogram (ECG) [9]
    End point description
    End point type
    Primary
    End point timeframe
    At baseline (Visit 2) and 4 weeks (Visit 6).
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary goal of this study was exploratory safety and tolerability, and therefore only exploratory statistics were applied.
    End point values
    		 Placebo 200 mg STM 400 mg STM
    Number of subjects analysed
    22
    12
    25
    Units: patients
        Baseline (Visit 2) - Normal
    16
    10
    18
        Baseline (Visit 2) - Abnormal NCS
    5
    1
    7
        Baseline (Visit 2) - Abnormal CS
    1
    1
    0
        4 weeks (Visit 6) - Normal
    18
    11
    16
        4 weeks (Visit 6) - Abnormal NCS
    2
    0
    9
        4 weeks (Visit 6) - Abnormal CS
    2
    1
    0
    No statistical analyses for this end point

    Primary: Clinical chemistry

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    End point title
    		 Clinical chemistry [10]
    End point description
    End point type
    Primary
    End point timeframe
    At baseline (Visit 2) and 4 weeks (Visit 6)
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary goal of this study was exploratory safety and tolerability, and therefore only exploratory statistics were applied.
    End point values
    		 Placebo 200 mg STM 400 mg STM
    Number of subjects analysed
    22
    12
    34
    Units: unit(s)
    arithmetic mean (standard deviation)
        Albumin (g/L) - Baseline (Visit 2)
    42.9 ± 2.7
    40.9 ± 2.5
    42.6 ± 2.9
        Albumin (g/L) - 4 weeks (Visit 6)
    42.9 ± 3.5
    39.8 ± 3.1
    43.7 ± 3.1
        Alkaline phosphatase (ukat/L) - Baseline (Visit 2)
    1.2 ± 0.3
    1.3 ± 0.4
    1.2 ± 0.3
        Alkaline phosphatase (ukat/L) - 4 weeks (Visit 6)
    1.1 ± 0.2
    1.2 ± 0.3
    1.2 ± 0.4
        Alanine aminotransf. (ukat/L) - Baseline (Visit 2)
    0.6 ± 0.3
    0.7 ± 0.3
    0.5 ± 0.2
        Alanine aminotransf. (ukat/L) - 4 weeks (Visit 6)
    0.5 ± 0.3
    0.6 ± 0.4
    0.4 ± 0.2
        Aspartate aminotransf.(ukat/L)- Baseline (Visit 2)
    0.4 ± 0.1
    0.6 ± 0.1
    0.4 ± 0.1
        Aspartate aminotransf.(ukat/L) - 4 weeks (Visit 6)
    0.4 ± 0.2
    0.4 ± 0.2
    0.3 ± 0.1
        Bilirubin (umol/L) - Baseline (Visit 2)
    11.0 ± 4.1
    10.9 ± 5.9
    10.4 ± 5.7
        Bilirubin (umol/L) - 4 weeks (Visit 6)
    11.1 ± 5.5
    10.9 ± 5.7
    10.8 ± 4.9
        Calcium (mmol/L) - Baseline (Visit 2)
    2.4 ± 0.1
    2.4 ± 0.1
    2.4 ± 0.1
        Calcium (mmol/L) - 4 weeks (Visit 6)
    2.4 ± 0.1
    2.3 ± 0.1
    2.4 ± 0.1
        Chloride (mmol/L) - Baseline (Visit 2)
    103.0 ± 2.0
    102.7 ± 2.2
    102.8 ± 2.3
        Chloride (mmol/L) - 4 weeks (Visit 6)
    102.8 ± 2.2
    104.4 ± 2.4
    106.3 ± 1.9
        Creatinine (umol/L) - Baseline (Visit 2)
    80.0 ± 11.2
    90.1 ± 25.3
    80.8 ± 14.5
        Creatinine (umol/L) - 4 weeks (Visit 6)
    83.6 ± 11.0
    91.7 ± 27.4
    92.7 ± 14.1
        Potassium (mmol/L) - Baseline (Visit 2)
    4.3 ± 0.1
    4.3 ± 0.3
    4.3 ± 0.2
        Potassium (mmol/L) - 4 weeks (Visit 6)
    4.3 ± 0.3
    4.0 ± 0.3
    4.2 ± 0.3
        Phosphate (mmol/L) - Basline (Visit 2)
    1.1 ± 0.2
    1.0 ± 0.1
    1.1 ± 0.1
        Phosphate (mmol/L) - 4 weeks (Visit 6)
    1.0 ± 0.2
    1.0 ± 0.2
    1.0 ± 0.1
        Sodium (mmol/L) - Baseline (Visit 2)
    141.2 ± 1.6
    141.3 ± 1.2
    141.4 ± 1.7
        Sodium (mmol/L) - 4 weeks (Visit 6)
    141.5 ± 1.6
    141.7 ± 1.6
    142.0 ± 1.9
    No statistical analyses for this end point

    Primary: Hematology

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    End point title
    		 Hematology [11]
    End point description
    End point type
    Primary
    End point timeframe
    At baseline (Visit 2) and 4 weeks (Visit 6).
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary goal of this study was exploratory safety and tolerability, and therefore only exploratory statistics were applied.
    End point values
    		 Placebo 200 mg STM 400 mg STM
    Number of subjects analysed
    22
    12
    34
    Units: unit(s)
    arithmetic mean (standard deviation)
        Basophils (10^9/L) - Baseline (Visit 2)
    0.1 ± 0.0
    0.1 ± 0.1
    0.0 ± 0.1
        Basophils (10^9/L) - 4 weeks (Visit 6)
    0.1 ± 0.1
    0.0 ± 0.0
    0.0 ± 0.1
        Eosinophils (10^9/L) - Baseline (Visit 2)
    0.2 ± 0.1
    0.3 ± 0.1
    0.2 ± 0.1
        Eosinophils (10^9/L) - 4 weeks (Visit 6)
    0.2 ± 0.1
    0.2 ± 0.1
    0.2 ± 0.1
        Hematocrit (L/L) - Baseline (Visit 2)
    0.5 ± 0.0
    0.5 ± 0.0
    0.5 ± 0.0
        Hematocrit (L/L) - 4 weeks (Visit 6)
    0.5 ± 0.0
    0.5 ± 0.0
    0.5 ± 0.0
        Hemoglobin (g/L) - Baseline (Visit 2)
    148.7 ± 10.6
    156.9 ± 16.0
    148.6 ± 11.3
        Hemoglobin (g/L) - 4 weeks (Visit 6)
    147.9 ± 10.7
    145.5 ± 15.4
    147.8 ± 13.6
        Lymphocytes (10^9/L) - Baseline (Visit 2)
    1.9 ± 0.5
    2.1 ± 0.8
    1.9 ± 0.6
        Lymphocytes (10^9/L) - 4 weeks (Visit 6)
    2.0 ± 0.6
    1.9 ± 0.4
    1.8 ± 0.6
        MCH (pg) - Baseline (Visit 2)
    30.1 ± 1.2
    30.7 ± 1.0
    30.4 ± 1.4
        MCH (pg) - 4 weeks (Visit 6)
    30.3 ± 1.3
    30.0 ± 1.0
    30.8 ± 1.3
        MCHC (g/L) - Baseline (Visit 2)
    325.5 ± 8.2
    326.9 ± 11.4
    323.7 ± 8.9
        MCHC (g/L) - 4 weeks (Visit 6)
    325.8 ± 7.4
    316.9 ± 9.1
    319.8 ± 7.1
        MCV (fL) - Baseline (Visit 2)
    92.8 ± 2.8
    94.0 ± 3.0
    94.0 ± 4.4
        MCV (fL) - 4 weeks (Visit 6)
    93.2 ± 3.9
    94.8 ± 3.1
    96.4 ± 4.3
        Monocytes (10^9) - Baseline (Visit 2)
    0.4 ± 0.2
    0.5 ± 0.2
    0.4 ± 0.1
        Monocytes (10^9) - 4 weeks (Visit 6)
    0.4 ± 0.1
    0.4 ± 0.1
    0.4 ± 0.1
        Neutrophils (10^9/L) - Baseline (Visit 2)
    3.1 ± 0.9
    3.1 ± 0.8
    3.0 ± 0.9
        Neutrophils (10^9/L) - 4 weeks (Visit 6)
    3.4 ± 1.3
    3.2 ± 0.8
    3.5 ± 2.3
        Platelet count (10^9/L) - Baseline (Visit 2)
    235.0 ± 44.3
    228.8 ± 43.1
    252.7 ± 67.5
        Platelet count (10^9/L) - 4 weeks (Visit 6)
    241.9 ± 39.3
    230.0 ± 45.8
    260.0 ± 69.7
        Erythrocytes (10^12/L) - Baseline (Visit 2)
    4.9 ± 0.3
    5.1 ± 0.5
    4.9 ± 0.4
        Erythrocytes (10^12/L) - 4 weeks (Visit 6)
    4.9 ± 0.4
    4.9 ± 0.5
    4.8 ± 0.5
        White blood cells (10^9/L) - Baseline (Visit 2)
    5.6 ± 0.9
    6.0 ± 1.4
    5.5 ± 1.1
        White blood cells (10^9/L) - 4 weeks (Visit 6)
    6.0 ± 1.7
    5.8 ± 1.1
    5.8 ± 2.2
    No statistical analyses for this end point

    Primary: Lipid panel

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    End point title
    		 Lipid panel [12]
    End point description
    End point type
    Primary
    End point timeframe
    At baseline (Visit 2) and 4 weeks (Visit 6)
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary goal of this study was exploratory safety and tolerability, and therefore only exploratory statistics were applied.
    End point values
    		 Placebo 200 mg STM 400 mg STM
    Number of subjects analysed
    22
    12
    34
    Units: unit(s)
    arithmetic mean (standard deviation)
        Total cholesterol (mmol/mol) - Baseline (Visit 2)
    5.6 ± 0.9
    5.4 ± 0.9
    5.5 ± 1.0
        Total cholesterol (mmol/mol) - 4 weeks (Visit 6)
    5.4 ± 1.1
    4.8 ± 0.7
    5.1 ± 0.9
        HDL cholesterol (mmol/mol) - Baseline (Visit 2)
    1.5 ± 0.4
    1.4 ± 0.4
    1.5 ± 0.4
        HDL cholesterol (mmol/mol) - 4 weeks (Visit 6)
    1.5 ± 0.3
    1.3 ± 0.4
    1.4 ± 0.4
        LDL cholesterol (mmol/mol) - Baseline (Visit 2)
    3.8 ± 0.9
    3.6 ± 0.9
    3.8 ± 0.8
        LDL cholesterol (mmol/mol) - 4 weeks (Visit 6)
    3.7 ± 1.2
    3.2 ± 0.8
    3.5 ± 0.7
        Triglycerides (mmol/mol) - Baseline (Visit 2)
    1.4 ± 0.4
    1.5 ± 0.5
    1.3 ± 0.5
        Triglycerides (mmol/mol) - 4 weeks (Visit 6)
    1.3 ± 0.5
    1.3 ± 0.5
    1.1 ± 0.5
    No statistical analyses for this end point

    Primary: Glycemic variables

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    End point title
    		 Glycemic variables [13]
    End point description
    End point type
    Primary
    End point timeframe
    At baseline (Visit 2) and 4 weeks (Visit 6).
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary goal of this study was exploratory safety and tolerability, and therefore only exploratory statistics were applied.
    End point values
    		 Placebo 200 mg STM 400 mg STM
    Number of subjects analysed
    22
    12
    34
    Units: unit(s)
    arithmetic mean (standard deviation)
        P-glucose (mmol) - Baseline (Visit 2)
    6.2 ± 0.9
    5.8 ± 1.0
    5.8 ± 1.1
        P-glucose (mmol) - 4 weeks (Visit 6)
    5.9 ± 0.8
    5.7 ± 1.1
    5.6 ± 0.9
        HbA1c (mmol/mol) - Baseline (Visit 2)
    36.0 ± 3.4
    36.3 ± 3.6
    35.9 ± 4.5
        HbA1c (mmol/mol) - 4 weeks (Visit 6)
    36.0 ± 4.7
    35.6 ± 3.8
    35.4 ± 4.7
        Insulin (mIE/L) - Baseline (Visit 2)
    16.1 ± 18.2
    16.4 ± 16.4
    12.0 ± 6.7
        Insulin (mIE/L) - 4 weeks (Visit 6)
    14.3 ± 10.0
    20.6 ± 25.5
    11.3 ± 8.0
    No statistical analyses for this end point

    Primary: Venous blood gas

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    End point title
    		 Venous blood gas [14]
    End point description
    End point type
    Primary
    End point timeframe
    At baseline (Visit 2) and 4 weeks (Visit 6).
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary goal of this study was exploratory safety and tolerability, and therefore only exploratory statistics were applied.
    End point values
    		 Placebo 200 mg STM 400 mg STM
    Number of subjects analysed
    22
    12
    34
    Units: unit(s)
    arithmetic mean (standard deviation)
        Base excess (mmol/L) - Baseline (Visit 2)
    1.4 ± 1.5
    0.9 ± 3.1
    2.2 ± 1.7
        Base excess (mmol/L) - 4 weeks (Visit 6)
    1.4 ± 1.5
    -1.1 ± 1.7
    -1.3 ± 1.4
        Bicarbonate (mmol/L) - Baseline (Visit 2)
    26.0 ± 1.9
    25.4 ± 3.4
    26.9 ± 1.8
        Bicarbonate (mmol/L) - 4 weeks (Visit 6)
    26.0 ± 1.8
    23.5 ± 1.9
    23.6 ± 1.6
        pH (unitless) - Baseline (Visit 2)
    7.4 ± 0.0
    7.4 ± 0.0
    7.4 ± 0.0
        pH (unitless) - 4 weeks (Visit 6)
    7.4 ± 0.0
    7.4 ± 0.0
    7.4 ± 0.0
    No statistical analyses for this end point

    Secondary: Apnea hypopnea index (AHI)

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    End point title
    		 Apnea hypopnea index (AHI)
    End point description
    End point type
    Secondary
    End point timeframe
    At baseline (Visit 2) and 4 weeks (Visit 6).
    End point values
    		 Placebo 200 mg STM 400 mg STM
    Number of subjects analysed
    22
    12
    34
    Units: events/hour
    arithmetic mean (standard deviation)
        Baseline (Visit 2)
    53.92 ± 21.11
    61.15 ± 24.21
    55.25 ± 22.26
        4 weeks (Visit 6)
    50.90 ± 24.21
    40.71 ± 24.06
    33.11 ± 16.44
    Statistical analysis title
    		 Estimated difference between 200mg STM and placebo
    Statistical analysis description
    Change from baseline in apnea/hypopnea index analysed by ANCOVA for difference between 200 mg STM and placebo.
    Comparison groups
    Placebo v 200 mg STM
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [15]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24.3
         upper limit
    		 -7.7
    Notes
    [15] - Analysis performed on all randomized patients with post-baseline assessment, inlcuding 12 patients in the 200mg STM group and 22 patients in the placebo group.
    Statistical analysis title
    		 Estimated difference between 400mg STM and placebo
    Statistical analysis description
    Change from baseline in apnea/hypopnea index analysed by ANCOVA for difference between 400 mg STM and placebo.
    Comparison groups
    400 mg STM v Placebo
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [16]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -18.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.6
         upper limit
    		 -12.1
    Notes
    [16] - Analysis performed on all randomized patients with post-baseline assessment, inlcuding 25 patients in the 400mg STM group and 22 patients in the placebo group.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    200 mg STM
    Reporting group description
    		 -

    Reporting group title
    400 mg STM
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo 200 mg STM 400 mg STM
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 12 (0.00%)
    1 / 34 (2.94%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 12 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo 200 mg STM 400 mg STM
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 22 (59.09%)
    11 / 12 (91.67%)
    30 / 34 (88.24%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    Muscle rupture
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 12 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    Upper limb fracture
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 12 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1
    Nervous system disorders
    Balance disorder
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    Cognitive disorder
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    0
    Dizziness
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 12 (8.33%)
    2 / 34 (5.88%)
         occurrences all number
    1
    1
    2
    Dysgeusia
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    1
    Headache
         subjects affected / exposed
    3 / 22 (13.64%)
    3 / 12 (25.00%)
    11 / 34 (32.35%)
         occurrences all number
    3
    3
    14
    Migraine
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 12 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    Paraesthesia
         subjects affected / exposed
    4 / 22 (18.18%)
    8 / 12 (66.67%)
    27 / 34 (79.41%)
         occurrences all number
    6
    10
    32
    Poor quality sleep
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 12 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    Somnolence
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 12 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 12 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    Fatigue
         subjects affected / exposed
    3 / 22 (13.64%)
    2 / 12 (16.67%)
    5 / 34 (14.71%)
         occurrences all number
    3
    2
    5
    Pyrexia
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 12 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 12 (8.33%)
    1 / 34 (2.94%)
         occurrences all number
    1
    1
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 12 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 12 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    0
    2
    Nausea
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 12 (0.00%)
    4 / 34 (11.76%)
         occurrences all number
    0
    0
    4
    Paraesthesia oral
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 12 (0.00%)
    3 / 34 (8.82%)
         occurrences all number
    0
    0
    3
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 12 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    Cough
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 12 (0.00%)
    4 / 34 (11.76%)
         occurrences all number
    1
    0
    4
    Dyspnoea exertional
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 12 (0.00%)
    3 / 34 (8.82%)
         occurrences all number
    0
    0
    3
    Dyspnoea
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 12 (0.00%)
    7 / 34 (20.59%)
         occurrences all number
    0
    0
    7
    Epistaxis
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 12 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 12 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 22 (13.64%)
    0 / 12 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    4
    0
    1
    Back pain
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 12 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    Muscle rigidity
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 12 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 12 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    Neck pain
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 12 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 22 (9.09%)
    1 / 12 (8.33%)
    3 / 34 (8.82%)
         occurrences all number
    2
    1
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 12 (8.33%)
    2 / 34 (5.88%)
         occurrences all number
    0
    1
    2

    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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