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    Clinical Trial Results:
    Rasagiline treatment for Sleep disorders in Parkinson´s disease

    Summary
    EudraCT number
    		 2010-023756-82
    Trial protocol
    		 DE  
    Global end of trial date
    30 Apr 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Jan 2024
    First version publication date
    03 Jan 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    TUD-RaSPar-051
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01442610
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Technische Universität Dresden
    Sponsor organisation address
    Helmholtzstraße 10, Dresden, Germany, 01069
    Public contact
    Koordinierungszentrum für Klinische Studien, Medizinische Fakultät C. G. Carus, kks@ukdd.de
    Scientific contact
    Koordinierungszentrum für Klinische Studien, Medizinische Fakultät C. G. Carus, kks@ukdd.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    31 Dec 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Apr 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Reduction of sleep disturbances
    Protection of trial subjects
    Patients were closely monitored by the trial group members with regard to safety during the course of the trial. This included a systematically documentation of (S)AEs.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2011
    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
    Germany: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    7
    From 65 to 84 years
    23
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Inclusion of patients with confirmed Parkinson's disease and sleep disturbance according to Pittsburgh Sleep Quality Index (PSQI; > 5 points).

    Period 1
    Period 1 title
    Placebo run-in
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Arm title
    		 All subjects
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet; once daily for 2 weeks

    Number of subjects in period 1
    		All subjects
    Started
    30
    Completed
    30
    Period 2
    Period 2 title
    Treatment
    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
    		 Rasagiline
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rasagiline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet (1mg Rasagiline), once daily for 8 weeks

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet, once daily for 8 weeks

    Number of subjects in period 2
    		Rasagiline Placebo
    Started
    20
    10
    Completed
    20
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    All subjects
    Reporting group description
    		 -

    Reporting group values
    		 All subjects Total
    Number of subjects
    		 30 30
    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)
    		 70 ( 6.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 14 14
        Male
    		 16 16
    Subject analysis sets

    Subject analysis set title
    Rasagiline: Start of treatment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects of the Rasagiline group for baseline visit, whose data are presented in the full analysis.

    Subject analysis set title
    Rasagiline: EoT
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects of the Rasagiline group after 8 weeks of treatment (EoT), whose data are presented in the full analysis.

    Subject analysis set title
    Placebo: Start of treatment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects of the Placebo group for baseline visit, whose data are presented in the full analysis.

    Subject analysis set title
    Placebo: EoT
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects of the Placebo group after 8 weeks of treatment (EoT), whose data are presented in the full analysis.

    Subject analysis sets values
    		 Rasagiline: Start of treatment Rasagiline: EoT Placebo: Start of treatment Placebo: EoT
    Number of subjects
    18
    18
    7
    7
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    69.9 ( 6.9 )
    69.9 ( 6.9 )
    70.2 ( 7.3 )
    70.2 ( 7.3 )
    Gender categorical
    Units: Subjects
        Female
    9
    9
    3
    3
        Male
    9
    9
    4
    4

    End points

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    End points reporting groups
    Reporting group title
    All subjects
    Reporting group description
    		 -
    Reporting group title
    Rasagiline
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Subject analysis set title
    Rasagiline: Start of treatment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects of the Rasagiline group for baseline visit, whose data are presented in the full analysis.

    Subject analysis set title
    Rasagiline: EoT
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects of the Rasagiline group after 8 weeks of treatment (EoT), whose data are presented in the full analysis.

    Subject analysis set title
    Placebo: Start of treatment
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects of the Placebo group for baseline visit, whose data are presented in the full analysis.

    Subject analysis set title
    Placebo: EoT
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects of the Placebo group after 8 weeks of treatment (EoT), whose data are presented in the full analysis.

    Primary: Sleep efficacy (% sleep partial time (SPT)) after 8 weeks of treatment with Rasagiline

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    End point title
    		 Sleep efficacy (% sleep partial time (SPT)) after 8 weeks of treatment with Rasagiline
    End point description
    End point type
    Primary
    End point timeframe
    between V2 (end of placebo run-in-phase) and V3 (end of 8 weeks Rasagiline treatment phase)
    End point values
    		 Rasagiline: Start of treatment Rasagiline: EoT
    Number of subjects analysed
    18
    18
    Units: percent
        arithmetic mean (standard deviation)
    62.1 ( 11.9 )
    70.6 ( 13.9 )
    Statistical analysis title
    		 paired samples t-test
    Comparison groups
    Rasagiline: Start of treatment v Rasagiline: EoT
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.024
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Parkinson’s Disease Sleepiness Scale 2 (PDSS-2 ) after 8 weeks of treatment with Rasagiline

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    End point title
    		 Parkinson’s Disease Sleepiness Scale 2 (PDSS-2 ) after 8 weeks of treatment with Rasagiline
    End point description
    End point type
    Primary
    End point timeframe
    between V2 (end of placebo run-in-phase) and V3 (end of 8 weeks Rasagiline treatment phase)
    End point values
    		 Rasagiline: Start of treatment Rasagiline: EoT
    Number of subjects analysed
    17
    17
    Units: points
        arithmetic mean (standard deviation)
    20.2 ( 9.6 )
    20.8 ( 8.9 )
    Statistical analysis title
    		 paired samples t-test
    Comparison groups
    Rasagiline: Start of treatment v Rasagiline: EoT
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.749
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Sleep efficacy (% time in bed (TIB)) after 8 weeks of treatment with Rasagiline

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    End point title
    		 Sleep efficacy (% time in bed (TIB)) after 8 weeks of treatment with Rasagiline
    End point description
    between V2 (end of placebo run-in-phase) and V3 (end of 8 weeks Rasagiline treatment phase)
    End point type
    Primary
    End point timeframe
    8 weeks
    End point values
    		 Rasagiline: Start of treatment Rasagiline: EoT
    Number of subjects analysed
    18
    18
    Units: percent
        arithmetic mean (standard deviation)
    58.1 ( 14.0 )
    63.5 ( 15.4 )
    Statistical analysis title
    		 paired samples t-test
    Comparison groups
    Rasagiline: Start of treatment v Rasagiline: EoT
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.097
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Sleep efficacy (% sleep partial time (SPT)) after 8 weeks of treatment with Placebo

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    End point title
    		 Sleep efficacy (% sleep partial time (SPT)) after 8 weeks of treatment with Placebo
    End point description
    End point type
    Primary
    End point timeframe
    between V2 (end of placebo run-in-phase) and V3 (end of 8 weeks Placebo treatment phase)
    End point values
    		 Placebo: Start of treatment Placebo: EoT
    Number of subjects analysed
    7
    7
    Units: percent
        arithmetic mean (standard deviation)
    82.3 ( 12.3 )
    79.1 ( 11.9 )
    Statistical analysis title
    		 paired samples t-test
    Comparison groups
    Placebo: Start of treatment v Placebo: EoT
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.489
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Parkinson’s Disease Sleepiness Scale 2 (PDSS-2) after 8 weeks of treatment with Placebo

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    End point title
    		 Parkinson’s Disease Sleepiness Scale 2 (PDSS-2) after 8 weeks of treatment with Placebo
    End point description
    End point type
    Primary
    End point timeframe
    between V2 (end of placebo run-in-phase) and V3 (end of 8 weeks Placebo treatment phase)
    End point values
    		 Placebo: Start of treatment Placebo: EoT
    Number of subjects analysed
    7
    7
    Units: Points
        arithmetic mean (standard deviation)
    22.2 ( 9.2 )
    20.0 ( 9.3 )
    Statistical analysis title
    		 paired samples t-test
    Comparison groups
    Placebo: EoT v Placebo: Start of treatment
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.663
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Sleep efficacy (% time in bed (TIB)) after 8 weeks of treatment with Placebo

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    End point title
    		 Sleep efficacy (% time in bed (TIB)) after 8 weeks of treatment with Placebo
    End point description
    End point type
    Primary
    End point timeframe
    between V2 (end of placebo run-in-phase) and V3 (end of 8 weeks Placebo treatment phase)
    End point values
    		 Placebo: Start of treatment Placebo: EoT
    Number of subjects analysed
    7
    7
    Units: percent
        arithmetic mean (standard deviation)
    76.7 ( 12.9 )
    69.6 ( 8.6 )
    Statistical analysis title
    		 paired samples t-test
    Comparison groups
    Placebo: Start of treatment v Placebo: EoT
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.181
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Proportion of light sleep stage N1 (%) after 8 weeks of treatment with Rasagiline

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    End point title
    		 Proportion of light sleep stage N1 (%) after 8 weeks of treatment with Rasagiline
    End point description
    End point type
    Secondary
    End point timeframe
    between V2 (end of placebo run-in-phase) and V3 (end of 8 weeks Rasagiline treatment phase)
    End point values
    		 Rasagiline: Start of treatment Rasagiline: EoT
    Number of subjects analysed
    18
    18
    Units: percent
        arithmetic mean (standard deviation)
    22.0 ( 12.2 )
    17.2 ( 9.8 )
    Statistical analysis title
    		 paired samples t-test
    Comparison groups
    Rasagiline: Start of treatment v Rasagiline: EoT
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.036
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Wake time after sleep (from TIB (min)) after 8 weeks of treatment with Rasagiline

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    End point title
    		 Wake time after sleep (from TIB (min)) after 8 weeks of treatment with Rasagiline
    End point description
    End point type
    Secondary
    End point timeframe
    between V2 (end of placebo run-in-phase) and V3 (end of 8 weeks Rasagiline treatment phase)
    End point values
    		 Rasagiline: Start of treatment Rasagiline: EoT
    Number of subjects analysed
    18
    18
    Units: minutes
        arithmetic mean (standard deviation)
    206.2 ( 72.9 )
    175.8 ( 74.3 )
    Statistical analysis title
    		 paired samples t-test
    Comparison groups
    Rasagiline: Start of treatment v Rasagiline: EoT
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.048
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Arousal-Index (n/h) after 8 weeks of treatment with Rasagiline

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    End point title
    		 Arousal-Index (n/h) after 8 weeks of treatment with Rasagiline
    End point description
    End point type
    Secondary
    End point timeframe
    between V2 (end of placebo run-in-phase) and V3 (end of 8 weeks Rasagiline treatment phase)
    End point values
    		 Rasagiline: Start of treatment Rasagiline: EoT
    Number of subjects analysed
    18
    18
    Units: number
        arithmetic mean (standard deviation)
    49.9 ( 19.1 )
    43.6 ( 18.1 )
    Statistical analysis title
    		 paired samples t-test
    Comparison groups
    Rasagiline: Start of treatment v Rasagiline: EoT
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.019
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Proportion of deep sleep stage N3 (%) after 8 weeks of treatment with Rasagiline

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    End point title
    		 Proportion of deep sleep stage N3 (%) after 8 weeks of treatment with Rasagiline
    End point description
    End point type
    Secondary
    End point timeframe
    between V2 (end of placebo run-in-phase) and V3 (end of 8 weeks Rasagiline treatment phase)
    End point values
    		 Rasagiline: Start of treatment Rasagiline: EoT
    Number of subjects analysed
    18
    18
    Units: percent
        arithmetic mean (standard deviation)
    18.2 ( 10.9 )
    20.6 ( 11.9 )
    Statistical analysis title
    		 paired samples t-test
    Comparison groups
    Rasagiline: Start of treatment v Rasagiline: EoT
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.194
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Proportion of dream (REM) sleep stage (%) after 8 weeks of treatment with Rasagiline

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    End point title
    		 Proportion of dream (REM) sleep stage (%) after 8 weeks of treatment with Rasagiline
    End point description
    End point type
    Secondary
    End point timeframe
    between V2 (end of placebo run-in-phase) and V3 (end of 8 weeks Rasagiline treatment phase)
    End point values
    		 Rasagiline: Start of treatment Rasagiline: EoT
    Number of subjects analysed
    18
    18
    Units: percent
        arithmetic mean (standard deviation)
    6.8 ( 5.7 )
    8.9 ( 6.0 )
    Statistical analysis title
    		 paired samples t-test
    Comparison groups
    Rasagiline: Start of treatment v Rasagiline: EoT
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.131
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Total sleep time (min) after 8 weeks of treatment with Rasagiline

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    End point title
    		 Total sleep time (min) after 8 weeks of treatment with Rasagiline
    End point description
    End point type
    Secondary
    End point timeframe
    between V2 (end of placebo run-in-phase) and V3 (end of 8 weeks Rasagiline treatment phase)
    End point values
    		 Rasagiline: Start of treatment Rasagiline: EoT
    Number of subjects analysed
    18
    18
    Units: minutes
        arithmetic mean (standard deviation)
    286.6 ( 77.2 )
    310.2 ( 85.0 )
    Statistical analysis title
    		 paired samples t-test
    Comparison groups
    Rasagiline: Start of treatment v Rasagiline: EoT
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.197
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Sleep latency (min) after 8 weeks of treatment with Rasagiline

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    End point title
    		 Sleep latency (min) after 8 weeks of treatment with Rasagiline
    End point description
    End point type
    Secondary
    End point timeframe
    between V2 (end of placebo run-in-phase) and V3 (end of 8 weeks Rasagiline treatment phase)
    End point values
    		 Rasagiline: Start of treatment Rasagiline: EoT
    Number of subjects analysed
    18
    18
    Units: minutes
        arithmetic mean (standard deviation)
    19.9 ( 18.6 )
    26.4 ( 49.0 )
    Statistical analysis title
    		 paired samples t-test
    Comparison groups
    Rasagiline: Start of treatment v Rasagiline: EoT
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.482
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: REM sleep latency (min) after 8 weeks of treatment with Rasagiline

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    End point title
    		 REM sleep latency (min) after 8 weeks of treatment with Rasagiline
    End point description
    End point type
    Secondary
    End point timeframe
    between V2 (end of placebo run-in-phase) and V3 (end of 8 weeks Rasagiline treatment phase)
    End point values
    		 Rasagiline: Start of treatment Rasagiline: EoT
    Number of subjects analysed
    14
    14
    Units: minutes
        arithmetic mean (standard deviation)
    223.3 ( 124.0 )
    214.2 ( 107.8 )
    Statistical analysis title
    		 paired samples t-test
    Comparison groups
    Rasagiline: Start of treatment v Rasagiline: EoT
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.745
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Nocturnal mobility (n) after 8 weeks of treatment with Rasagiline

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    End point title
    		 Nocturnal mobility (n) after 8 weeks of treatment with Rasagiline
    End point description
    End point type
    Secondary
    End point timeframe
    between V2 (end of placebo run-in-phase) and V3 (end of 8 weeks Rasagiline treatment phase)
    End point values
    		 Rasagiline: Start of treatment Rasagiline: EoT
    Number of subjects analysed
    18
    18
    Units: number
        arithmetic mean (standard deviation)
    11.7 ( 6.5 )
    12.7 ( 8.8 )
    Statistical analysis title
    		 paired samples t-test
    Comparison groups
    Rasagiline: EoT v Rasagiline: Start of treatment
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.533
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Epworth Sleepiness Scale (EES) after 8 weeks of treatment with Rasagiline

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    End point title
    		 Epworth Sleepiness Scale (EES) after 8 weeks of treatment with Rasagiline
    End point description
    End point type
    Secondary
    End point timeframe
    between V2 (end of placebo run-in-phase) and V3 (end of 8 weeks Rasagiline treatment phase)
    End point values
    		 Rasagiline: Start of treatment Rasagiline: EoT
    Number of subjects analysed
    16
    16
    Units: points
        arithmetic mean (standard deviation)
    9.4 ( 4.5 )
    8.5 ( 4.5 )
    Statistical analysis title
    		 paired samples t-test
    Comparison groups
    Rasagiline: Start of treatment v Rasagiline: EoT
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.016
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Pittsburgh Sleep Quality Index (PSQI) after 8 weeks of treatment with Rasagiline

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    End point title
    		 Pittsburgh Sleep Quality Index (PSQI) after 8 weeks of treatment with Rasagiline
    End point description
    End point type
    Secondary
    End point timeframe
    between V2 (end of placebo run-in-phase) and V3 (end of 8 weeks Rasagiline treatment phase)
    End point values
    		 Rasagiline: Start of treatment Rasagiline: EoT
    Number of subjects analysed
    18
    18
    Units: points
        arithmetic mean (standard deviation)
    9.4 ( 2.7 )
    9.3 ( 2.6 )
    Statistical analysis title
    		 paired samples t-test
    Comparison groups
    Rasagiline: Start of treatment v Rasagiline: EoT
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.752
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Parkinsons’ Daily Quality of Life-39 (PDQ-39) after 8 weeks of treatment with Rasagiline

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    End point title
    		 Parkinsons’ Daily Quality of Life-39 (PDQ-39) after 8 weeks of treatment with Rasagiline
    End point description
    End point type
    Secondary
    End point timeframe
    between V2 (end of placebo run-in-phase) and V3 (end of 8 weeks Rasagiline treatment phase)
    End point values
    		 Rasagiline: Start of treatment Rasagiline: EoT
    Number of subjects analysed
    13
    13
    Units: points
        arithmetic mean (standard deviation)
    31.2 ( 19.8 )
    31.0 ( 23.0 )
    Statistical analysis title
    		 paired samples t-test
    Comparison groups
    Rasagiline: Start of treatment v Rasagiline: EoT
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.927
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Total Unified Parkinson’s disease rating scale (UPDRS) after 8 weeks of treatment with Rasagiline

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    End point title
    		 Total Unified Parkinson’s disease rating scale (UPDRS) after 8 weeks of treatment with Rasagiline
    End point description
    End point type
    Secondary
    End point timeframe
    between V2 (end of placebo run-in-phase) and V3 (end of 8 weeks Rasagiline treatment phase)
    End point values
    		 Rasagiline: Start of treatment Rasagiline: EoT
    Number of subjects analysed
    16
    16
    Units: points
        arithmetic mean (standard deviation)
    30.1 ( 13.7 )
    29.3 ( 10.4 )
    Statistical analysis title
    		 paired samples t-test
    Comparison groups
    Rasagiline: Start of treatment v Rasagiline: EoT
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.709
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Unified Parkinson’s disease rating scale I (UPDRS I) after 8 weeks of treatment with Rasagiline

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    End point title
    		 Unified Parkinson’s disease rating scale I (UPDRS I) after 8 weeks of treatment with Rasagiline
    End point description
    UPDRS I: Cognition, mood, behavior
    End point type
    Secondary
    End point timeframe
    between V2 (end of placebo run-in-phase) and V3 (end of 8 weeks Rasagiline treatment phase)
    End point values
    		 Rasagiline: Start of treatment Rasagiline: EoT
    Number of subjects analysed
    18
    18
    Units: points
        arithmetic mean (standard deviation)
    2.1 ( 1.4 )
    3.2 ( 2.1 )
    Statistical analysis title
    		 paired samples t-test
    Comparison groups
    Rasagiline: Start of treatment v Rasagiline: EoT
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.01
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Unified Parkinson’s disease rating scale II (UPDRS II) after 8 weeks of treatment with Rasagiline

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    End point title
    		 Unified Parkinson’s disease rating scale II (UPDRS II) after 8 weeks of treatment with Rasagiline
    End point description
    UPDRS II: Activities of daily living
    End point type
    Secondary
    End point timeframe
    between V2 (end of placebo run-in-phase) and V3 (end of 8 weeks Rasagiline treatment phase)
    End point values
    		 Rasagiline: Start of treatment Rasagiline: EoT
    Number of subjects analysed
    18
    18
    Units: points
        arithmetic mean (standard deviation)
    7.5 ( 4.5 )
    7.8 ( 4.8 )
    Statistical analysis title
    		 paired samples t-test
    Comparison groups
    Rasagiline: EoT v Rasagiline: Start of treatment
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.674
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Unified Parkinson’s disease rating scale III (UPDRS III) after 8 weeks of treatment with Rasagiline

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    End point title
    		 Unified Parkinson’s disease rating scale III (UPDRS III) after 8 weeks of treatment with Rasagiline
    End point description
    UPDRS III: motor score
    End point type
    Secondary
    End point timeframe
    between V2 (end of placebo run-in-phase) and V3 (end of 8 weeks Rasagiline treatment phase)
    End point values
    		 Rasagiline: Start of treatment Rasagiline: EoT
    Number of subjects analysed
    16
    16
    Units: points
        arithmetic mean (standard deviation)
    17.8 ( 8.5 )
    15.8 ( 4.8 )
    Statistical analysis title
    		 paired samples t-test
    Comparison groups
    Rasagiline: Start of treatment v Rasagiline: EoT
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.205
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Modified Hoehn & Yahr Scale after 8 weeks of treatment with Rasagiline

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    End point title
    		 Modified Hoehn & Yahr Scale after 8 weeks of treatment with Rasagiline
    End point description
    End point type
    Secondary
    End point timeframe
    between V2 (end of placebo run-in-phase) and V3 (end of 8 weeks Rasagiline treatment phase)
    End point values
    		 Rasagiline: Start of treatment Rasagiline: EoT
    Number of subjects analysed
    15
    15
    Units: points
        arithmetic mean (standard deviation)
    2.0 ( 0.7 )
    1.9 ( 0.8 )
    Statistical analysis title
    		 paired samples t-test
    Comparison groups
    Rasagiline: Start of treatment v Rasagiline: EoT
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.173
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Schwab & England Scale ADL after 8 weeks of treatment with Rasagiline

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    End point title
    		 Schwab & England Scale ADL after 8 weeks of treatment with Rasagiline
    End point description
    End point type
    Secondary
    End point timeframe
    between V2 (end of placebo run-in-phase) and V3 (end of 8 weeks Rasagiline treatment phase)
    End point values
    		 Rasagiline: Start of treatment Rasagiline: EoT
    Number of subjects analysed
    14
    14
    Units: points
        arithmetic mean (standard deviation)
    85.7 ( 8.5 )
    83.6 ( 13.9 )
    Statistical analysis title
    		 paired samples t-test
    Comparison groups
    Rasagiline: Start of treatment v Rasagiline: EoT
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.512
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From screening visite to telephone follow up visit 4; approx. 25 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    Rasagiline
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Rasagiline Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Rasagiline Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 20 (60.00%)
    4 / 10 (40.00%)
    Surgical and medical procedures
    Bladder operation
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Maxillary operation
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Dyskinesia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Dystonia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Cognitive deterioration
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Flu like symptoms
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Tinnitus
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Vomiting
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Pseudohallucination
         subjects affected / exposed
    3 / 20 (15.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Insomnia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Libido disorder
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Arthralgia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0

    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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