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    Clinical Trial Results:
    A Randomized, Double-Blind, Four Treatment, Four period, Crossover Study, with Placebo, Tizanidine Immediate Release and Diphenhydramine to Study the Effect of Tizanidine Extended Release on Simulated Driving Performance, Cognitive, and Psychomotor Functioning

    Summary
    EudraCT number
    		 2015-003770-32
    Trial protocol
    		 NL  
    Global end of trial date
    11 Jul 2016

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CLR_14_05
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sun Pharma Advanced Research Company Limited
    Sponsor organisation address
    17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri East., Mumbai, India, 400093
    Public contact
    Head- Clinical development, Sun Pharma Advanced Research Company, 91 2266455645, Clinical.Trials@sparcmail.com
    Scientific contact
    Head- Clinical development, Sun Pharma Advanced Research Company, 91 2266455645, Clinical.Trials@sparcmail.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
    11 Jul 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Jul 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jul 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate effect of tizanidine ER 12 mg on simulated driving performance, cognitive and psychomotor functions compared with placebo and tizanidine IR 8 mg (two 4 mg doses given 6.5 hours apart) and active control (diphenhydramine) and placebo in healthy subjects
    Protection of trial subjects
    At the start of each study day compliance was checked with alcohol breath test, urine drug screen and urine pregnancy test (females). Participants were assigned a participant number. In this cross-over design all participants received all treatments , the order of which was based on a randomization table The treatment codes are stored in a secure environment within TNO and accessible only to the medical expert and the principal investigator. The code was broken at the end of the trial when all participants had completed the study and after all, data was entered into the database, cleaned, and the database locked. After database lock, the results were analyzed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Apr 2016
    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
    Netherlands: 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

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Adequate participants were enrolled to have twenty-four healthy participants (13 males and approximately 11 females) complete the study per protocol requirements. Participants were screened by means of a medical questionnaire and physical examination.

    Pre-assignment
    Screening details
    		 30 participants screened, 27 unique subjects randomized.

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Placebo Baseline
    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
    two doses separated by 6 .5 hours

    Arm title
    		 Active control baseline
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Diphenhydramine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg tablet (single dose) followed by placebo after 6.5 hours

    Arm title
    		 Tizanidine Immediate release Baseline
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tizanidine immediate release tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    8 mg (two 4 mg doses separated by 6.5 hours)

    Arm title
    		 Tizanidine Extended release Baselilne
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tizanidine extended release tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    (single 12 mg dose) followed by placebo dose after 6. 5 hours.

    Number of subjects in period 1
    		Placebo Baseline Active control baseline Tizanidine Immediate release Baseline Tizanidine Extended release Baselilne
    Started
    24
    24
    24
    24
    Completed
    24
    24
    24
    24
    Period 2
    Period 2 title
    Assessment 1
    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
    		 Placebo Assessment 1
    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
    two doses separated by 6 .5 hours

    Arm title
    		 Active control Assessment 1
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Diphenhydramine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg tablet (single dose) followed by placebo after 6.5 hours

    Arm title
    		 Tizanidine Immediate release Assessment 1
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tizanidine immediate release tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    8 mg (two 4 mg doses separated by 6.5 hours)

    Arm title
    		 Tizanidine Extended release Assessment 1
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tizanidine extended release tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    (single 12 mg dose) followed by placebo dose after 6. 5 hours.

    Number of subjects in period 2
    		Placebo Assessment 1 Active control Assessment 1 Tizanidine Immediate release Assessment 1 Tizanidine Extended release Assessment 1
    Started
    24
    24
    24
    24
    Completed
    24
    24
    24
    24
    Period 3
    Period 3 title
    Assessment 2
    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
    		 Placebo Assessment 2
    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
    two doses separated by 6 .5 hours

    Arm title
    		 Active control Assessment 2
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Diphenhydramine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg tablet (single dose) followed by placebo after 6.5 hours

    Arm title
    		 Tizanidine Immediate release Assessment 2
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tizanidine immediate release tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    8 mg (two 4 mg doses separated by 6.5 hours)

    Arm title
    		 Tizanidine Extended release Assessment 2
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tizanidine extended release tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    (single 12 mg dose) followed by placebo dose after 6. 5 hours.

    Number of subjects in period 3
    		Placebo Assessment 2 Active control Assessment 2 Tizanidine Immediate release Assessment 2 Tizanidine Extended release Assessment 2
    Started
    24
    24
    24
    24
    Completed
    24
    24
    24
    24
    Period 4
    Period 4 title
    Assessment 3
    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
    		 Placebo Assessment 3
    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
    two doses separated by 6 .5 hours

    Arm title
    		 Active control Assessment 3
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Diphenhydramine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg tablet (single dose) followed by placebo after 6.5 hours

    Arm title
    		 Tizanidine Immediate release Assessment 3
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tizanidine immediate release tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    8 mg (two 4 mg doses separated by 6.5 hours)

    Arm title
    		 Tizanidine Extended release Assessment 3
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tizanidine extended release tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    (single 12 mg dose) followed by placebo dose after 6. 5 hours.

    Number of subjects in period 4
    		Placebo Assessment 3 Active control Assessment 3 Tizanidine Immediate release Assessment 3 Tizanidine Extended release Assessment 3
    Started
    24
    24
    24
    24
    Completed
    24
    24
    24
    24
    Period 5
    Period 5 title
    Assessment 4
    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
    		 Placebo Assessment 4
    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
    two doses separated by 6 .5 hours

    Arm title
    		 Active control Assessment 4
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Diphenhydramine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg tablet (single dose) followed by placebo after 6.5 hours

    Arm title
    		 Tizanidine Immediate release Assessment 4
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tizanidine immediate release tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    8 mg (two 4 mg doses separated by 6.5 hours)

    Arm title
    		 Tizanidine Extended release Assessment 4
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tizanidine extended release tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    (single 12 mg dose) followed by placebo dose after 6. 5 hours.

    Number of subjects in period 5
    		Placebo Assessment 4 Active control Assessment 4 Tizanidine Immediate release Assessment 4 Tizanidine Extended release Assessment 4
    Started
    24
    24
    24
    24
    Completed
    24
    24
    24
    24

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 -

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 24 24
    Age categorical
    Units: Subjects
    Age continuous
    mean age
    Units: years
        arithmetic mean (full range (min-max))
    		 32 (22 to 44) -
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 13 13

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Placebo Baseline
    Reporting group description
    		 -

    Reporting group title
    Active control baseline
    Reporting group description
    		 -

    Reporting group title
    Tizanidine Immediate release Baseline
    Reporting group description
    		 -

    Reporting group title
    Tizanidine Extended release Baselilne
    Reporting group description
    		 -
    Reporting group title
    Placebo Assessment 1
    Reporting group description
    		 -

    Reporting group title
    Active control Assessment 1
    Reporting group description
    		 -

    Reporting group title
    Tizanidine Immediate release Assessment 1
    Reporting group description
    		 -

    Reporting group title
    Tizanidine Extended release Assessment 1
    Reporting group description
    		 -
    Reporting group title
    Placebo Assessment 2
    Reporting group description
    		 -

    Reporting group title
    Active control Assessment 2
    Reporting group description
    		 -

    Reporting group title
    Tizanidine Immediate release Assessment 2
    Reporting group description
    		 -

    Reporting group title
    Tizanidine Extended release Assessment 2
    Reporting group description
    		 -
    Reporting group title
    Placebo Assessment 3
    Reporting group description
    		 -

    Reporting group title
    Active control Assessment 3
    Reporting group description
    		 -

    Reporting group title
    Tizanidine Immediate release Assessment 3
    Reporting group description
    		 -

    Reporting group title
    Tizanidine Extended release Assessment 3
    Reporting group description
    		 -
    Reporting group title
    Placebo Assessment 4
    Reporting group description
    		 -

    Reporting group title
    Active control Assessment 4
    Reporting group description
    		 -

    Reporting group title
    Tizanidine Immediate release Assessment 4
    Reporting group description
    		 -

    Reporting group title
    Tizanidine Extended release Assessment 4
    Reporting group description
    		 -

    Primary: Standard Deviation of the Lateral Position during highway driving

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    End point title
    		 Standard Deviation of the Lateral Position during highway driving [1]
    End point description
    End point type
    Primary
    End point timeframe
    4 weeks
    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: There was no statisticallly significant difference.
    End point values
    		 Placebo Baseline Placebo Assessment 1 Placebo Assessment 2 Placebo Assessment 3 Placebo Assessment 4 Active control baseline Tizanidine Immediate release Baseline Tizanidine Extended release Baselilne Active control Assessment 1 Tizanidine Immediate release Assessment 1 Tizanidine Extended release Assessment 1 Active control Assessment 2 Tizanidine Immediate release Assessment 2 Tizanidine Extended release Assessment 2 Active control Assessment 3 Tizanidine Immediate release Assessment 3 Tizanidine Extended release Assessment 3 Active control Assessment 4 Tizanidine Immediate release Assessment 4 Tizanidine Extended release Assessment 4
    Number of subjects analysed
    23 [2]
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    Units: centimetres
        arithmetic mean (standard error)
    18.88 ( 1.44 )
    19.73 ( 1.34 )
    22.18 ( 2.52 )
    23.43 ( 2.65 )
    23.09 ( 4.03 )
    18.82 ( 1.16 )
    18.14 ( 1.36 )
    18.52 ( 1.62 )
    26.42 ( 3.09 )
    26.15 ( 2.03 )
    23.75 ( 2.31 )
    27.61 ( 2.68 )
    24.12 ( 2.34 )
    26.81 ( 3.00 )
    28.19 ( 3.13 )
    20.73 ( 1.88 )
    26.00 ( 2.65 )
    23.54 ( 2.36 )
    28.59 ( 4.26 )
    21.81 ( 1.83 )
    Notes
    [2] - Placebo Baseline
    No statistical analyses for this end point

    Primary: Standard Deviation of the Lateral Position during rural road driving

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    End point title
    		 Standard Deviation of the Lateral Position during rural road driving [3]
    End point description
    End point type
    Primary
    End point timeframe
    4 weeks
    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: There was no statisticallly significant difference.
    End point values
    		 Placebo Baseline Placebo Assessment 1 Placebo Assessment 2 Placebo Assessment 3 Placebo Assessment 4 Active control baseline Tizanidine Immediate release Baseline Tizanidine Extended release Baselilne Active control Assessment 1 Tizanidine Immediate release Assessment 1 Tizanidine Extended release Assessment 1 Active control Assessment 2 Tizanidine Immediate release Assessment 2 Tizanidine Extended release Assessment 2 Active control Assessment 3 Tizanidine Immediate release Assessment 3 Tizanidine Extended release Assessment 3 Active control Assessment 4 Tizanidine Immediate release Assessment 4 Tizanidine Extended release Assessment 4
    Number of subjects analysed
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    Units: centimetre
        arithmetic mean (standard error)
    15.81 ( 1.20 )
    17.38 ( 1.33 )
    19.34 ( 2.55 )
    20.91 ( 2.48 )
    19.77 ( 2.43 )
    15.98 ( 1.35 )
    15.48 ( 1.49 )
    16.41 ( 1.64 )
    24.35 ( 2.43 )
    23.18 ( 2.00 )
    23.44 ( 2.84 )
    25.59 ( 2.44 )
    22.88 ( 2.27 )
    28.52 ( 5.00 )
    26.46 ( 2.45 )
    19.90 ( 2.22 )
    25.49 ( 3.03 )
    20.99 ( 2.17 )
    26.98 ( 4.07 )
    21.19 ( 2.21 )
    No statistical analyses for this end point

    Secondary: Standard deviation of speed

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    End point title
    		 Standard deviation of speed
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Placebo Baseline Placebo Assessment 1 Placebo Assessment 2 Placebo Assessment 3 Placebo Assessment 4 Active control baseline Tizanidine Immediate release Baseline Tizanidine Extended release Baselilne Active control Assessment 1 Tizanidine Immediate release Assessment 1 Tizanidine Extended release Assessment 1 Active control Assessment 2 Tizanidine Immediate release Assessment 2 Tizanidine Extended release Assessment 2 Active control Assessment 3 Tizanidine Immediate release Assessment 3 Tizanidine Extended release Assessment 3 Active control Assessment 4 Tizanidine Immediate release Assessment 4 Tizanidine Extended release Assessment 4
    Number of subjects analysed
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    Units: km/h
    arithmetic mean (standard error)
        during highway driving
    3.53 ( 0.24 )
    3.72 ( 0.27 )
    3.76 ( 0.31 )
    4.17 ( 0.33 )
    3.90 ( 0.31 )
    3.66 ( 0.28 )
    3.49 ( 0.23 )
    3.53 ( 0.23 )
    4.79 ( 0.41 )
    4.26 ( 0.28 )
    4.23 ( 0.27 )
    4.38 ( 0.32 )
    4.21 ( 0.29 )
    4.33 ( 0.32 )
    4.34 ( 0.32 )
    3.84 ( 0.23 )
    4.15 ( 0.28 )
    4.10 ( 0.32 )
    4.03 ( 0.34 )
    3.83 ( 0.33 )
        during rural road driving
    3.3993 ( 0.23800 )
    3.74 ( 0.32 )
    3.76 ( 0.29 )
    4.03 ( 0.35 )
    3.50 ( 0.28 )
    3.4239 ( 0.26391 )
    3.3572 ( 0.24878 )
    3.3493 ( 0.25766 )
    4.67 ( 0.38 )
    4.45 ( 0.32 )
    4.33 ( 0.38 )
    4.61 ( 0.35 )
    3.94 ( 0.31 )
    4.15 ( 0.31 )
    4.46 ( 0.28 )
    3.90 ( 0.25 )
    4.53 ( 0.34 )
    3.86 ( 0.35 )
    4.43 ( 0.36 )
    3.82 ( 0.29 )
    No statistical analyses for this end point

    Secondary: Distance Headway in meters

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    End point title
    		 Distance Headway in meters
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Placebo Baseline Placebo Assessment 1 Placebo Assessment 2 Placebo Assessment 3 Placebo Assessment 4 Active control baseline Tizanidine Immediate release Baseline Tizanidine Extended release Baselilne Active control Assessment 1 Tizanidine Immediate release Assessment 1 Tizanidine Extended release Assessment 1 Active control Assessment 2 Tizanidine Immediate release Assessment 2 Tizanidine Extended release Assessment 2 Active control Assessment 3 Tizanidine Immediate release Assessment 3 Tizanidine Extended release Assessment 3 Active control Assessment 4 Tizanidine Immediate release Assessment 4 Tizanidine Extended release Assessment 4
    Number of subjects analysed
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    Units: meters
    arithmetic mean (standard error)
        Mean Distance Headway during highway driving
    58.61 ( 2.09 )
    59.95 ( 3.05 )
    62.55 ( 2.89 )
    61.59 ( 3.48 )
    63.43 ( 3.65 )
    61.92 ( 3.01 )
    58.73 ( 3.65 )
    56.41 ( 3.42 )
    66.04 ( 3.98 )
    63.20 ( 2.65 )
    60.94 ( 4.17 )
    63.57 ( 3.84 )
    63.14 ( 3.80 )
    62.13 ( 3.93 )
    64.87 ( 4.26 )
    58.97 ( 3.20 )
    60.45 ( 4.00 )
    61.89 ( 3.83 )
    63.32 ( 3.30 )
    58.34 ( 3.92 )
        Mean Distance Headway during rural road driving
    44.80 ( 1.56 )
    45.80 ( 2.23 )
    45.06 ( 2.00 )
    45.26 ( 2.08 )
    47.82 ( 2.71 )
    46.44 ( 2.21 )
    44.09 ( 2.04 )
    44.02 ( 2.48 )
    46.25 ( 2.14 )
    47.56 ( 1.89 )
    45.70 ( 3.11 )
    45.43 ( 2.77 )
    45.56 ( 2.21 )
    44.35 ( 2.13 )
    45.22 ( 2.81 )
    43.44 ( 1.98 )
    43.13 ( 2.44 )
    45.53 ( 2.50 )
    44.43 ( 1.78 )
    43.37 ( 2.83 )
    No statistical analyses for this end point

    Secondary: Time to collision

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    End point title
    		 Time to collision
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Placebo Baseline Placebo Assessment 1 Placebo Assessment 2 Placebo Assessment 3 Placebo Assessment 4 Active control baseline Tizanidine Immediate release Baseline Tizanidine Extended release Baselilne Active control Assessment 1 Tizanidine Immediate release Assessment 1 Tizanidine Extended release Assessment 1 Active control Assessment 2 Tizanidine Immediate release Assessment 2 Tizanidine Extended release Assessment 2 Active control Assessment 3 Tizanidine Immediate release Assessment 3 Tizanidine Extended release Assessment 3 Active control Assessment 4 Tizanidine Immediate release Assessment 4 Tizanidine Extended release Assessment 4
    Number of subjects analysed
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    Units: seconds
    arithmetic mean (standard error)
        Minimum Time to collision during highway driving
    10.00 ( 0.00 )
    9.68 ( 0.24 )
    9.86 ( 0.14 )
    9.58 ( 0.36 )
    9.88 ( 0.12 )
    10.00 ( 0.00 )
    9.96 ( 0.04 )
    10.00 ( 0.00 )
    9.83 ( 0.16 )
    10.00 ( 0.00 )
    9.75 ( 0.15 )
    9.68 ( 0.22 )
    9.94 ( 0.06 )
    9.67 ( 0.24 )
    9.79 ( 0.21 )
    9.93 ( 0.07 )
    9.64 ( 0.28 )
    9.59 ( 0.24 )
    9.69 ( 0.23 )
    9.88 ( 0.12 )
        Minimum time to collision during rural road drivi
    9.99 ( 0.01 )
    9.75 ( 0.16 )
    9.68 ( 0.15 )
    9.38 ( 0.35 )
    9.52 ( 0.29 )
    9.71 ( 0.27 )
    9.75 ( 0.21 )
    9.67 ( 0.25 )
    7.94 ( 0.65 )
    9.50 ( 0.30 )
    9.08 ( 0.39 )
    8.59 ( 0.49 )
    9.31 ( 0.31 )
    9.10 ( 0.43 )
    8.35 ( 0.54 )
    9.69 ( 0.14 )
    8.65 ( 0.49 )
    9.07 ( 0.49 )
    9.44 ( 0.23 )
    9.27 ( 0.35 )
    No statistical analyses for this end point

    Secondary: Time Headway

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    End point title
    		 Time Headway
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Placebo Baseline Placebo Assessment 1 Placebo Assessment 2 Placebo Assessment 3 Placebo Assessment 4 Active control baseline Tizanidine Immediate release Baseline Tizanidine Extended release Baselilne Active control Assessment 1 Tizanidine Immediate release Assessment 1 Tizanidine Extended release Assessment 1 Active control Assessment 2 Tizanidine Immediate release Assessment 2 Tizanidine Extended release Assessment 2 Active control Assessment 3 Tizanidine Immediate release Assessment 3 Tizanidine Extended release Assessment 3 Active control Assessment 4 Tizanidine Immediate release Assessment 4 Tizanidine Extended release Assessment 4
    Number of subjects analysed
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    23
    Units: seconds
    arithmetic mean (standard error)
        Mean Time Headway during highway driving
    1.77 ( 0.06 )
    1.81 ( 0.09 )
    1.89 ( 0.09 )
    1.86 ( 0.11 )
    1.91 ( 0.11 )
    1.87 ( 0.09 )
    1.77 ( 0.11 )
    1.70 ( 0.10 )
    2.00 ( 0.12 )
    1.91 ( 0.08 )
    1.84 ( 0.13 )
    1.92 ( 0.12 )
    1.91 ( 0.12 )
    1.87 ( 0.12 )
    1.96 ( 0.13 )
    1.78 ( 0.10 )
    1.83 ( 0.12 )
    1.87 ( 0.12 )
    1.91 ( 0.10 )
    1.76 ( 0.12 )
        Mean Time Headway during rural road driving
    2.03 ( 0.07 )
    2.07 ( 0.10 )
    2.04 ( 0.09 )
    2.05 ( 0.09 )
    2.17 ( 0.12 )
    2.10 ( 0.10 )
    2.00 ( 0.09 )
    1.99 ( 0.11 )
    2.11 ( 0.10 )
    2.16 ( 0.09 )
    2.07 ( 0.14 )
    2.07 ( 0.13 )
    2.07 ( 0.10 )
    2.01 ( 0.10 )
    2.05 ( 0.13 )
    1.97 ( 0.09 )
    1.96 ( 0.11 )
    2.06 ( 0.11 )
    2.02 ( 0.08 )
    1.97 ( 0.13 )
        Standard deviation during highway driving
    0.30 ( 0.02 )
    0.35 ( 0.04 )
    0.40 ( 0.04 )
    0.43 ( 0.05 )
    0.46 ( 0.05 )
    0.38 ( 0.04 )
    0.31 ( 0.04 )
    0.33 ( 0.04 )
    0.53 ( 0.06 )
    0.44 ( 0.04 )
    0.44 ( 0.05 )
    0.47 ( 0.05 )
    0.46 ( 0.05 )
    0.44 ( 0.05 )
    0.51 ( 0.06 )
    0.40 ( 0.04 )
    0.46 ( 0.06 )
    0.45 ( 0.05 )
    0.47 ( 0.06 )
    0.44 ( 0.06 )
        Standard deviation during rural road driving
    0.46 ( 0.04 )
    0.53 ( 0.06 )
    0.50 ( 0.04 )
    0.55 ( 0.05 )
    0.51 ( 0.05 )
    0.47 ( 0.05 )
    0.43 ( 0.04 )
    0.41 ( 0.04 )
    0.66 ( 0.07 )
    0.65 ( 0.06 )
    0.59 ( 0.07 )
    0.63 ( 0.06 )
    0.57 ( 0.06 )
    0.58 ( 0.05 )
    0.61 ( 0.05 )
    0.54 ( 0.06 )
    0.61 ( 0.06 )
    0.59 ( 0.05 )
    0.66 ( 0.06 )
    0.54 ( 0.05 )
    No statistical analyses for this end point

    Secondary: Peripheral Detection Task

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    End point title
    		 Peripheral Detection Task
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Placebo Baseline Placebo Assessment 1 Placebo Assessment 2 Placebo Assessment 3 Placebo Assessment 4 Active control baseline Tizanidine Immediate release Baseline Tizanidine Extended release Baselilne Active control Assessment 1 Tizanidine Immediate release Assessment 1 Tizanidine Extended release Assessment 1 Active control Assessment 2 Tizanidine Immediate release Assessment 2 Tizanidine Extended release Assessment 2 Active control Assessment 3 Tizanidine Immediate release Assessment 3 Tizanidine Extended release Assessment 3 Active control Assessment 4 Tizanidine Immediate release Assessment 4 Tizanidine Extended release Assessment 4
    Number of subjects analysed
    20
    20
    20
    20
    20
    20
    20
    20
    20
    20
    20
    20
    20
    20
    20
    20
    20
    20
    20
    20
    Units: milliseconds
    arithmetic mean (standard error)
        Mean reaction time PDT during highway driving
    415 ( 20 )
    418 ( 22 )
    419 ( 28 )
    438 ( 31 )
    427 ( 29 )
    415 ( 26 )
    397 ( 18 )
    421 ( 23 )
    462 ( 30 )
    452 ( 22 )
    441 ( 17 )
    478 ( 34 )
    443 ( 24 )
    457 ( 25 )
    487 ( 32 )
    434 ( 26 )
    448 ( 19 )
    452 ( 36 )
    471 ( 34 )
    441 ( 23 )
        Mean reaction time PDT during rural road driving
    437 ( 19 )
    457 ( 25 )
    467 ( 37 )
    486 ( 31 )
    462 ( 31 )
    459 ( 30 )
    428 ( 22 )
    455 ( 26 )
    500 ( 31 )
    525 ( 34 )
    500 ( 19 )
    520 ( 33 )
    504 ( 24 )
    523 ( 32 )
    554 ( 31 )
    478 ( 26 )
    525 ( 21 )
    473 ( 30 )
    535 ( 28 )
    500 ( 29 )
        Percentage missed targets PDT during highway drivi
    5.24 ( 2.44 )
    4.93 ( 1.78 )
    4.44 ( 1.42 )
    6.66 ( 2.25 )
    5.29 ( 1.62 )
    5.11 ( 1.90 )
    3.78 ( 1.05 )
    3.72 ( 1.51 )
    7.15 ( 1.92 )
    8.23 ( 2.01 )
    4.54 ( 1.36 )
    7.61 ( 2.07 )
    6.38 ( 1.46 )
    7.12 ( 1.61 )
    8.90 ( 2.27 )
    5.18 ( 1.39 )
    8.15 ( 1.98 )
    8.49 ( 2.40 )
    7.14 ( 1.86 )
    7.85 ( 3.37 )
        Percentage missed targets PDT during rural road dr
    5.52 ( 1.88 )
    7.80 ( 2.19 )
    8.82 ( 3.09 )
    14.44 ( 4.61 )
    9.45 ( 3.01 )
    6.47 ( 1.79 )
    4.56 ( 0.97 )
    5.92 ( 1.99 )
    15.51 ( 3.57 )
    14.35 ( 3.10 )
    12.06 ( 2.35 )
    17.12 ( 3.05 )
    12.60 ( 2.41 )
    15.62 ( 3.14 )
    19.43 ( 3.43 )
    11.88 ( 2.73 )
    18.54 ( 3.24 )
    10.63 ( 3.29 )
    17.47 ( 2.87 )
    13.72 ( 3.28 )
    No statistical analyses for this end point

    Secondary: Psychomotor vigilance test

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    End point title
    		 Psychomotor vigilance test
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Placebo Baseline Placebo Assessment 1 Placebo Assessment 2 Placebo Assessment 3 Placebo Assessment 4 Active control baseline Tizanidine Immediate release Baseline Tizanidine Extended release Baselilne Active control Assessment 1 Tizanidine Immediate release Assessment 1 Tizanidine Extended release Assessment 1 Active control Assessment 2 Tizanidine Immediate release Assessment 2 Tizanidine Extended release Assessment 2 Active control Assessment 3 Tizanidine Immediate release Assessment 3 Tizanidine Extended release Assessment 3 Active control Assessment 4 Tizanidine Immediate release Assessment 4 Tizanidine Extended release Assessment 4
    Number of subjects analysed
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    Units: milliseconds
    arithmetic mean (standard error)
        Mean reaction time
    387 ( 13 )
    403 ( 15 )
    419 ( 14 )
    423 ( 17 )
    443 ( 25 )
    398 ( 16 )
    389 ( 14 )
    396 ( 10 )
    488 ( 31 )
    458 ( 21 )
    421 ( 14 )
    504 ( 30 )
    455 ( 25 )
    468 ( 17 )
    461 ( 18 )
    435 ( 16 )
    475 ( 18 )
    437 ( 19 )
    458 ( 15 )
    471 ( 28 )
        Number of lapses
    10.13 ( 2.43 )
    12.17 ( 2.88 )
    14.67 ( 3.20 )
    15.04 ( 2.90 )
    16.04 ( 3.24 )
    12.00 ( 2.78 )
    11.50 ( 2.43 )
    9.75 ( 1.36 )
    21.54 ( 3.89 )
    19.75 ( 3.03 )
    14.25 ( 2.59 )
    25.75 ( 3.46 )
    17.88 ( 2.91 )
    19.92 ( 2.39 )
    21.04 ( 3.34 )
    17.33 ( 2.90 )
    21.04 ( 2.63 )
    18.96 ( 3.64 )
    21.33 ( 2.91 )
    19.83 ( 3.09 )
    No statistical analyses for this end point

    Secondary: VigTrack

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    End point title
    		 VigTrack
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Placebo Baseline Placebo Assessment 1 Placebo Assessment 2 Placebo Assessment 3 Placebo Assessment 4 Active control baseline Tizanidine Immediate release Baseline Tizanidine Extended release Baselilne Active control Assessment 1 Tizanidine Immediate release Assessment 1 Tizanidine Extended release Assessment 1 Active control Assessment 2 Tizanidine Immediate release Assessment 2 Tizanidine Extended release Assessment 2 Active control Assessment 3 Tizanidine Immediate release Assessment 3 Tizanidine Extended release Assessment 3 Active control Assessment 4 Tizanidine Immediate release Assessment 4 Tizanidine Extended release Assessment 4
    Number of subjects analysed
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    Units: milliseconds
    arithmetic mean (standard error)
        Mean reaction time
    576 ( 14 )
    663 ( 20 )
    659 ( 21 )
    667 ( 19 )
    678 ( 25 )
    609 ( 18 )
    586 ( 16 )
    611 ( 24 )
    718 ( 25 )
    727 ( 23 )
    672 ( 26 )
    734 ( 29 )
    702 ( 19 )
    686 ( 21 )
    718 ( 25 )
    674 ( 21 )
    679 ( 21 )
    692 ( 18 )
    709 ( 20 )
    702 ( 20 )
        Percentage targets missed
    2.53 ( 1.01 )
    5.00 ( 1.62 )
    4.54 ( 0.97 )
    5.61 ( 1.64 )
    6.32 ( 1.52 )
    3.25 ( 0.96 )
    3.32 ( 1.56 )
    6.64 ( 3.82 )
    16.14 ( 3.53 )
    17.03 ( 3.62 )
    9.43 ( 3.56 )
    14.48 ( 2.99 )
    9.11 ( 2.73 )
    12.22 ( 3.74 )
    10.28 ( 2.37 )
    6.49 ( 1.87 )
    11.45 ( 3.45 )
    7.28 ( 1.49 )
    9.84 ( 1.57 )
    11.67 ( 3.25 )
        Trackin score
    72.21 ( 11.00 )
    76.63 ( 11.47 )
    74.20 ( 11.76 )
    75.94 ( 11.55 )
    68.72 ( 7.40 )
    79.88 ( 10.34 )
    74.25 ( 9.48 )
    77.32 ( 14.37 )
    118.73 ( 15.40 )
    123.35 ( 18.57 )
    82.33 ( 13.10 )
    111.66 ( 19.27 )
    90.36 ( 11.44 )
    86.36 ( 13.97 )
    97.24 ( 14.08 )
    79.30 ( 10.22 )
    81.28 ( 12.04 )
    73.58 ( 8.05 )
    84.09 ( 10.97 )
    83.07 ( 12.76 )
    No statistical analyses for this end point

    Secondary: Karolinska Sleepiness Scale

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    End point title
    		 Karolinska Sleepiness Scale
    End point description
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Placebo Baseline Placebo Assessment 1 Placebo Assessment 2 Placebo Assessment 3 Placebo Assessment 4 Active control baseline Tizanidine Immediate release Baseline Tizanidine Extended release Baselilne Active control Assessment 1 Tizanidine Immediate release Assessment 1 Tizanidine Extended release Assessment 1 Active control Assessment 2 Tizanidine Immediate release Assessment 2 Tizanidine Extended release Assessment 2 Active control Assessment 3 Tizanidine Immediate release Assessment 3 Tizanidine Extended release Assessment 3 Active control Assessment 4 Tizanidine Immediate release Assessment 4 Tizanidine Extended release Assessment 4
    Number of subjects analysed
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    24
    Units: mean scores
        arithmetic mean (standard error)
    3.75 ( 0.35 )
    4.13 ( 0.23 )
    4.17 ( 0.29 )
    4.17 ( 0.29 )
    4.38 ( 0.31 )
    3.75 ( 0.33 )
    3.96 ( 0.30 )
    3.71 ( 0.20 )
    5.46 ( 0.40 )
    5.63 ( 0.39 )
    4.38 ( 0.29 )
    6.29 ( 0.37 )
    5.58 ( 0.31 )
    5.46 ( 0.37 )
    5.25 ( 0.41 )
    4.46 ( 0.30 )
    4.96 ( 0.32 )
    5.04 ( 0.34 )
    5.38 ( 0.38 )
    5.25 ( 0.34 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    4 weeks (one day per week)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Non serious adverse events
    Reporting group description
    		 -

    Serious adverse events
    		 Non serious adverse events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Non serious adverse events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 24 (75.00%)
    Surgical and medical procedures
    Sleepiness/Tired
         subjects affected / exposed
    17 / 24 (70.83%)
         occurrences all number
    62
    Cardiac disorders
    Cold
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences all number
    5
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 24 (25.00%)
         occurrences all number
    10
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    3 / 24 (12.50%)
         occurrences all number
    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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    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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