Clinical Trial Results:
Evaluation in patients affected by middle of the night (MONT) awakenings using different dosages of triazolam
Summary
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EudraCT number |
2013-000078-30 |
Trial protocol |
IT |
Global end of trial date |
09 Dec 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
04 Aug 2021
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First version publication date |
04 Aug 2021
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
MB0612/1860/02
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Valeas Spa
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Sponsor organisation address |
Via Vallisneri 10, Milano, Italy,
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Public contact |
Medical Direction, Valeas SpA, +39 2236901, dir.medica@valeas.it
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Scientific contact |
Medical Direction, Valeas SpA, +39 2236901, dir.medica@valeas.it
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
17 Feb 2015
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
09 Dec 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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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
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Protection of trial subjects |
None
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Background therapy |
None | ||
Evidence for comparator |
None | ||
Actual start date of recruitment |
08 Jan 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Italy: 24
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Worldwide total number of subjects |
24
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EEA total number of subjects |
24
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
24
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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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
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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
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Period 1 title |
T0
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||
Roles blinded |
Investigator, Subject | ||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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T0 - 0.0625 mg | ||||||||||||
Arm description |
0.0625 mg | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Triazolam
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral drops, solution
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Routes of administration |
Oral use
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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).
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Arm title
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T0 - 0.125 mg | ||||||||||||
Arm description |
0.125 mg | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Triazolam
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Investigational medicinal product code |
|||||||||||||
Other name |
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Pharmaceutical forms |
Oral drops, solution
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Routes of administration |
Oral use
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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).
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Arm title
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T0 - 0.250 mg | ||||||||||||
Arm description |
0.250 mg | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Triazolam
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Investigational medicinal product code |
|||||||||||||
Other name |
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Pharmaceutical forms |
Oral drops, solution
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Routes of administration |
Oral use
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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).
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Period 2
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Period 2 title |
T1
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Is this the baseline period? |
No | ||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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T1 - 0.0625 mg | ||||||||||||
Arm description |
0.0625 mg | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Triazolam
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Investigational medicinal product code |
|||||||||||||
Other name |
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Pharmaceutical forms |
Oral drops, solution
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Routes of administration |
Oral use
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||||||||||||
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).
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Arm title
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T1 - 0.125 mg | ||||||||||||
Arm description |
0.125 mg | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Triazolam
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Investigational medicinal product code |
|||||||||||||
Other name |
|||||||||||||
Pharmaceutical forms |
Oral drops, solution
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||||||||||||
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).
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Arm title
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T1 - 0.250 mg | ||||||||||||
Arm description |
0.250 mg | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Triazolam
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Investigational medicinal product code |
|||||||||||||
Other name |
|||||||||||||
Pharmaceutical forms |
Oral drops, solution
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Routes of administration |
Oral use
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||||||||||||
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).
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Baseline characteristics reporting groups
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Reporting group title |
T0 - 0.0625 mg
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Reporting group description |
0.0625 mg | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
T0 - 0.125 mg
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Reporting group description |
0.125 mg | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
T0 - 0.250 mg
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Reporting group description |
0.250 mg | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
T0 - 0.0625 mg
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Reporting group description |
0.0625 mg | ||
Reporting group title |
T0 - 0.125 mg
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Reporting group description |
0.125 mg | ||
Reporting group title |
T0 - 0.250 mg
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Reporting group description |
0.250 mg | ||
Reporting group title |
T1 - 0.0625 mg
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Reporting group description |
0.0625 mg | ||
Reporting group title |
T1 - 0.125 mg
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Reporting group description |
0.125 mg | ||
Reporting group title |
T1 - 0.250 mg
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Reporting group description |
0.250 mg |
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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).
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End point type |
Primary
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End point timeframe |
Second night in the hospital
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Statistical analysis title |
T test | ||||||||||||||||||||||||||||
Statistical analysis description |
Difference between baseline and T1
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Comparison groups |
T0 - 0.0625 mg v T1 - 0.0625 mg
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Number of subjects included in analysis |
16
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||||||||||||||||||
P-value |
= 0.009 | ||||||||||||||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||||||||||||||
Confidence interval |
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Statistical analysis title |
T test | ||||||||||||||||||||||||||||
Statistical analysis description |
Difference between baseline and T1
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Comparison groups |
T0 - 0.125 mg v T1 - 0.125 mg
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Number of subjects included in analysis |
16
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||||||||||||||||||
P-value |
= 0.009 | ||||||||||||||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||||||||||||||
Confidence interval |
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Statistical analysis title |
T test | ||||||||||||||||||||||||||||
Statistical analysis description |
Difference between baseline and T1
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Comparison groups |
T0 - 0.250 mg v T1 - 0.250 mg
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Number of subjects included in analysis |
16
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||||||||||||||||||
P-value |
= 0.007 | ||||||||||||||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||||||||||||||
Confidence interval |
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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).
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End point type |
Primary
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End point timeframe |
Second night in the hospital
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Statistical analysis title |
T test | ||||||||||||||||||||||||||||
Comparison groups |
T0 - 0.0625 mg v T1 - 0.0625 mg
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Number of subjects included in analysis |
16
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||||||||||||||||||
P-value |
= 0.036 | ||||||||||||||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||||||||||||||
Confidence interval |
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Statistical analysis title |
T test | ||||||||||||||||||||||||||||
Comparison groups |
T0 - 0.125 mg v T1 - 0.125 mg
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Number of subjects included in analysis |
16
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Analysis specification |
Pre-specified
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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
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Number of subjects included in analysis |
16
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||||||||||||||||||
P-value |
= 0.006 | ||||||||||||||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||||||||||||||
Confidence interval |
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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).
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End point type |
Primary
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End point timeframe |
Second night in the hospital
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Statistical analysis title |
T test | ||||||||||||||||||||||||||||
Comparison groups |
T0 - 0.0625 mg v T1 - 0.0625 mg
|
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Number of subjects included in analysis |
16
|
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Analysis specification |
Pre-specified
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||||||||||||||||||||||||||||
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
|
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Analysis specification |
Pre-specified
|
||||||||||||||||||||||||||||
Analysis type |
other | ||||||||||||||||||||||||||||
P-value |
= 0.01 | ||||||||||||||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||||||||||||||
Confidence interval |
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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).
|
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End point type |
Primary
|
||||||||||||||||||||||||||||
End point timeframe |
Second night in the hospital
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
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 |
|
|||||||||||||||||||||||||||||
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
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
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 |
|
|||||||||||||||||
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
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
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
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||
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 |
|
|||
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 |