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    Clinical Trial Results:
    Evaluation in patients affected by middle of the night (MONT) awakenings using different dosages of triazolam

    Summary
    EudraCT number
    		 2013-000078-30
    Trial protocol
    		 IT  
    Global end of trial date
    09 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Aug 2021
    First version publication date
    04 Aug 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MB0612/1860/02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Valeas Spa
    Sponsor organisation address
    Via Vallisneri 10, Milano, Italy,
    Public contact
    Medical Direction, Valeas SpA, +39 2236901, dir.medica@valeas.it
    Scientific contact
    Medical Direction, Valeas SpA, +39 2236901, dir.medica@valeas.it
    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 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of different triazolam dosage in patients affected by difficulty returning to sleep following a nocturnal awakening
    Protection of trial subjects
    None
    Background therapy
    		 None
    Evidence for comparator
    		 None
    Actual start date of recruitment
    08 Jan 2014
    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: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    24
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Adult men and women, aged 18–64, meeting diagnostic criteria for primary insomnia according to the Diagnostic and Statistical Manual of Mental Disorder were enrolled in Italy. 40 patients were assessed for eligibility; 16 were excluded because they did not meet inclusion criteria (15) or declined to participate (1).

    Pre-assignment
    Screening details
    		 Key exclusion criteria for the study included clinical significant ongoing medical/neurologic conditions; any sleep disorder other than insomnia as determined by sleep history, or regular night shift worker within the past 6 months prior to screening; history of psychiatric disorder; use of any other central nervous system medication.

    Period 1
    Period 1 title
    T0
    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
    		 T0 - 0.0625 mg
    Arm description
    		 0.0625 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Triazolam
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral drops, solution
    Routes of administration
    Oral use
    Dosage and administration details
    0.0625 mg Eligible patients underwent a 7-day washout period, if necessary, and then a two-night PSG evaluation was performed. After the first adaption night in the sleep laboratory, two consecutive nights were evaluated by means of PSG and actigraphy. During the first night (T0), after the awakening, patients received placebo drops (single-blind), whereas after awakening during the second night (T1), one of the three randomized dosages of triazolam was given (in single-dose containers).

    Arm title
    		 T0 - 0.125 mg
    Arm description
    		 0.125 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Triazolam
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral drops, solution
    Routes of administration
    Oral use
    Dosage and administration details
    0.125 mg Eligible patients underwent a 7-day washout period, if necessary, and then a two-night PSG evaluation was performed. After the first adaption night in the sleep laboratory, two consecutive nights were evaluated by means of PSG and actigraphy. During the first night (T0), after the awakening, patients received placebo drops (single-blind), whereas after awakening during the second night (T1), one of the three randomized dosages of triazolam was given (in single-dose containers).

    Arm title
    		 T0 - 0.250 mg
    Arm description
    		 0.250 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Triazolam
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral drops, solution
    Routes of administration
    Oral use
    Dosage and administration details
    0.250 mg Eligible patients underwent a 7-day washout period, if necessary, and then a two-night PSG evaluation was performed. After the first adaption night in the sleep laboratory, two consecutive nights were evaluated by means of PSG and actigraphy. During the first night (T0), after the awakening, patients received placebo drops (single-blind), whereas after awakening during the second night (T1), one of the three randomized dosages of triazolam was given (in single-dose containers).

    Number of subjects in period 1
    		T0 - 0.0625 mg T0 - 0.125 mg T0 - 0.250 mg
    Started
    8
    8
    8
    Completed
    8
    8
    8
    Period 2
    Period 2 title
    T1
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 T1 - 0.0625 mg
    Arm description
    		 0.0625 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Triazolam
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral drops, solution
    Routes of administration
    Oral use
    Dosage and administration details
    0.0625 mg Eligible patients underwent a 7-day washout period, if necessary, and then a two-night PSG evaluation was performed. After the first adaption night in the sleep laboratory, two consecutive nights were evaluated by means of PSG and actigraphy. During the first night (T0), after the awakening, patients received placebo drops (single-blind), whereas after awakening during the second night (T1), one of the three randomized dosages of triazolam was given (in single-dose containers).

    Arm title
    		 T1 - 0.125 mg
    Arm description
    		 0.125 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Triazolam
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral drops, solution
    Routes of administration
    Oral use
    Dosage and administration details
    0.125 mg Eligible patients underwent a 7-day washout period, if necessary, and then a two-night PSG evaluation was performed. After the first adaption night in the sleep laboratory, two consecutive nights were evaluated by means of PSG and actigraphy. During the first night (T0), after the awakening, patients received placebo drops (single-blind), whereas after awakening during the second night (T1), one of the three randomized dosages of triazolam was given (in single-dose containers).

    Arm title
    		 T1 - 0.250 mg
    Arm description
    		 0.250 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Triazolam
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral drops, solution
    Routes of administration
    Oral use
    Dosage and administration details
    0.250 mg Eligible patients underwent a 7-day washout period, if necessary, and then a two-night PSG evaluation was performed. After the first adaption night in the sleep laboratory, two consecutive nights were evaluated by means of PSG and actigraphy. During the first night (T0), after the awakening, patients received placebo drops (single-blind), whereas after awakening during the second night (T1), one of the three randomized dosages of triazolam was given (in single-dose containers).

    Number of subjects in period 2
    		T1 - 0.0625 mg T1 - 0.125 mg T1 - 0.250 mg
    Started
    8
    8
    8
    Completed
    8
    8
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    T0 - 0.0625 mg
    Reporting group description
    		 0.0625 mg

    Reporting group title
    T0 - 0.125 mg
    Reporting group description
    		 0.125 mg

    Reporting group title
    T0 - 0.250 mg
    Reporting group description
    		 0.250 mg

    Reporting group values
    		 T0 - 0.0625 mg T0 - 0.125 mg T0 - 0.250 mg Total
    Number of subjects
    		 8 8 8 24
    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)
    		 41.13 ± 10.12 40.63 ± 11.94 41.25 ± 10.62 -
    Gender categorical
    Units: Subjects
        Female
    		 5 2 3 10
        Male
    		 3 6 5 14
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 67.4 ± 4.7 69.5 ± 3.9 65.6 ± 3.1 -
    Height
    Units: meter
        arithmetic mean (standard deviation)
    		 1.7 ± 0.0 1.7 ± 0.0 1.7 ± 0.0 -
    Body Mass Index
    Units: kg/m
        arithmetic mean (standard deviation)
    		 23.0 ± 1.0 23.0 ± 0.9 22.7 ± 0.9 -
    Total Sleep Time
    Units: Minutes
        arithmetic mean (standard deviation)
    		 353.41 ± 28.27 364.35 ± 27.48 343.87 ± 25.12 -
    Sleep Latency
    Units: Minutes
        arithmetic mean (standard deviation)
    		 10.20 ± 2.12 17.00 ± 5.12 13.08 ± 3.77 -
    Wake after sleep onset
    Units: minutes
        arithmetic mean (standard deviation)
    		 97.90 ± 20.92 74.90 ± 20.71 98.37 ± 15.57 -
    Sleep Efficiency
    Units: percent
        arithmetic mean (standard deviation)
    		 76.01 ± 4.94 80.42 ± 5.67 75.44 ± 4.03 -
    Number of awakenings
    Units: Number
        arithmetic mean (standard deviation)
    		 18.64 ± 2.13 14.85 ± 2.55 20.45 ± 4.57 -
    Stage 1 NREM
    Units: percent
        arithmetic mean (standard deviation)
    		 9.81 ± 1.44 7.14 ± 1.38 9.31 ± 1.54 -
    Stage 2 NREM
    Units: percent
        arithmetic mean (standard deviation)
    		 47.77 ± 2.56 48.57 ± 3.54 42.75 ± 2.51 -
    Slow-wave Sleep
    Units: percent
        arithmetic mean (standard deviation)
    		 24.34 ± 2.07 26.77 ± 3.68 26.44 ± 2.32 -
    REM
    Units: percent
        arithmetic mean (standard deviation)
    		 16.88 ± 2.54 17.88 ± 1.67 21.57 ± 1.13 -

    End points

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    End points reporting groups
    Reporting group title
    T0 - 0.0625 mg
    Reporting group description
    		 0.0625 mg

    Reporting group title
    T0 - 0.125 mg
    Reporting group description
    		 0.125 mg

    Reporting group title
    T0 - 0.250 mg
    Reporting group description
    		 0.250 mg
    Reporting group title
    T1 - 0.0625 mg
    Reporting group description
    		 0.0625 mg

    Reporting group title
    T1 - 0.125 mg
    Reporting group description
    		 0.125 mg

    Reporting group title
    T1 - 0.250 mg
    Reporting group description
    		 0.250 mg

    Primary: Change in Wake after sleep onset

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    End point title
    		 Change in Wake after sleep onset
    End point description
    The data recorded by polysomnography during the 3 days spent in the hospital by the patient, i.e. the night T-1 (night of adaptation), the night T0 (the night when he took Placebo (P)), and the night T1 (the night when he took the experimental drug).
    End point type
    Primary
    End point timeframe
    Second night in the hospital
    End point values
    		 T0 - 0.0625 mg T0 - 0.125 mg T0 - 0.250 mg T1 - 0.0625 mg T1 - 0.125 mg T1 - 0.250 mg
    Number of subjects analysed
    8
    8
    8
    8
    8
    8
    Units: minute
        arithmetic mean (standard error)
    97.90 ± 20.92
    74.90 ± 20.71
    98.37 ± 15.57
    43.14 ± 13.96
    19.50 ± 4.51
    41.30 ± 8.32
    Statistical analysis title
    		 T test
    Statistical analysis description
    Difference between baseline and T1
    Comparison groups
    T0 - 0.0625 mg v T1 - 0.0625 mg
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.009
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 T test
    Statistical analysis description
    Difference between baseline and T1
    Comparison groups
    T0 - 0.125 mg v T1 - 0.125 mg
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.009
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 T test
    Statistical analysis description
    Difference between baseline and T1
    Comparison groups
    T0 - 0.250 mg v T1 - 0.250 mg
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.007
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Change in the Number of nightime awakenings

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    End point title
    		 Change in the Number of nightime awakenings
    End point description
    The data recorded by polysomnography during the 3 days spent in the hospital by the patient, i.e. the night T-1 (night of adaptation), the night T0 (the night when he took Placebo (P)), and the night T1 (the night when he took the experimental drug).
    End point type
    Primary
    End point timeframe
    Second night in the hospital
    End point values
    		 T0 - 0.0625 mg T0 - 0.125 mg T0 - 0.250 mg T1 - 0.0625 mg T1 - 0.125 mg T1 - 0.250 mg
    Number of subjects analysed
    8
    8
    8
    8
    8
    8
    Units: unit(s)
        arithmetic mean (standard error)
    18.64 ± 2.13
    14.85 ± 2.55
    20.45 ± 4.57
    10.64 ± 2.31
    6.81 ± 1.60
    9.61 ± 2.70
    Statistical analysis title
    		 T test
    Comparison groups
    T0 - 0.0625 mg v T1 - 0.0625 mg
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.036
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 T test
    Comparison groups
    T0 - 0.125 mg v T1 - 0.125 mg
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.036
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 T test
    Comparison groups
    T0 - 0.250 mg v T1 - 0.250 mg
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.006
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Change in Sleep Efficiency

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    End point title
    		 Change in Sleep Efficiency
    End point description
    The data recorded by polysomnography during the 3 days spent in the hospital by the patient, i.e. the night T-1 (night of adaptation), the night T0 (the night when he took Placebo (P)), and the night T1 (the night when he took the experimental drug).
    End point type
    Primary
    End point timeframe
    Second night in the hospital
    End point values
    		 T0 - 0.0625 mg T0 - 0.125 mg T0 - 0.250 mg T1 - 0.0625 mg T1 - 0.125 mg T1 - 0.250 mg
    Number of subjects analysed
    8
    8
    8
    8
    8
    8
    Units: percent
        arithmetic mean (standard error)
    76.01 ± 4.94
    80.42 ± 5.67
    75.44 ± 4.03
    89.31 ± 3.23
    93.12 ± 1.66
    89.28 ± 2.01
    Statistical analysis title
    		 T test
    Comparison groups
    T0 - 0.0625 mg v T1 - 0.0625 mg
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.012
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 T test
    Comparison groups
    T0 - 0.125 mg v T1 - 0.125 mg
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.017
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 T test
    Comparison groups
    T0 - 0.250 mg v T1 - 0.250 mg
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.01
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Change in Total Sleep Time

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    End point title
    		 Change in Total Sleep Time
    End point description
    The data recorded by polysomnography during the 3 days spent in the hospital by the patient, i.e. the night T-1 (night of adaptation), the night T0 (the night when he took Placebo (P)), and the night T1 (the night when he took the experimental drug).
    End point type
    Primary
    End point timeframe
    Second night in the hospital
    End point values
    		 T0 - 0.0625 mg T0 - 0.125 mg T0 - 0.250 mg T1 - 0.0625 mg T1 - 0.125 mg T1 - 0.250 mg
    Number of subjects analysed
    8
    8
    8
    8
    8
    8
    Units: minute
        arithmetic mean (standard error)
    353.41 ± 28.27
    364.35 ± 27.48
    343.87 ± 25.12
    428.84 ± 17.04
    447.22 ± 8.84
    412.36 ± 8.86
    Statistical analysis title
    		 T test
    Comparison groups
    T0 - 0.0625 mg v T1 - 0.0625 mg
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.009
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 T test
    Comparison groups
    T0 - 0.125 mg v T1 - 0.125 mg
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.005
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 T test
    Comparison groups
    T0 - 0.250 mg v T1 - 0.250 mg
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.017
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Change in DSST

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    End point title
    		 Change in DSST
    End point description
    The DSST (Digit symbol substitution test) is a pencil-and-paper test of psychomotor performance. The test consists of filling as many empty boxes as possible with a symbol matching each number.
    End point type
    Primary
    End point timeframe
    Second night in the hospital
    End point values
    		 T0 - 0.0625 mg T0 - 0.125 mg T0 - 0.250 mg T1 - 0.0625 mg T1 - 0.125 mg T1 - 0.250 mg
    Number of subjects analysed
    8
    8
    8
    8
    8
    8
    Units: score
        arithmetic mean (standard deviation)
    53.75 ± 11.65
    61.38 ± 12.49
    54.13 ± 13.81
    58.25 ± 10.42
    63.25 ± 15.03
    58.63 ± 11.50
    Statistical analysis title
    		 T test
    Comparison groups
    T0 - 0.0625 mg v T1 - 0.0625 mg
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 > 0.05 [1]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [1] - Not significant
    Statistical analysis title
    		 T test
    Comparison groups
    T0 - 0.125 mg v T1 - 0.125 mg
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 > 0.05 [2]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [2] - Not significant
    Statistical analysis title
    		 T test
    Comparison groups
    T0 - 0.250 mg v T1 - 0.250 mg
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 > 0.05 [3]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [3] - Not significant

    Secondary: Change in ESS

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    End point title
    		 Change in ESS
    End point description
    Following the two PSG/actigraphy recording nights, patients continued the 2-week treatment with one of the three dosages assigned at T2 at home. During this time, patients had to wear an actigraph and to complete every morning a visual analog scale for the assessment of vigilance, as well as a sleep log in order to control, in particular, the number of awakenings and drug assumption. The ESS (Epworth Sleepiness scale) questionnaire was used to evaluate the quality of sleep.
    End point type
    Secondary
    End point timeframe
    At the end of the 2-week treatment
    End point values
    		 T0 - 0.0625 mg T0 - 0.125 mg T0 - 0.250 mg
    Number of subjects analysed
    8
    8
    8
    Units: score
        arithmetic mean (standard error)
    4.00 ± 2.98
    2.88 ± 2.36
    4.38 ± 3.70
    No statistical analyses for this end point

    Secondary: Change in ISI

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    End point title
    		 Change in ISI
    End point description
    The ISI (insomnia severity index) questionnaire assesses insomnia severity
    End point type
    Secondary
    End point timeframe
    At the end of the 2-week treatment
    End point values
    		 T0 - 0.0625 mg T0 - 0.125 mg T0 - 0.250 mg
    Number of subjects analysed
    8
    8
    8
    Units: score
        arithmetic mean (standard error)
    11.38 ± 4.07
    11.50 ± 3.51
    7.88 ± 4.49
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From screening to the final visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    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: No adverse events were reported in the study

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28584913
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