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    Clinical Trial Results:
    A multi-center, randomized, double-blind, placebo-controlled, parallel group, polysomnography study to investigate safety and efficacy of the rotigotine transdermal patch in subjects with Restless Legs Syndrome and End-Stage Renal Disease requiring hemodialysis

    Summary
    EudraCT number
    2011-003486-15
    Trial protocol
    DE   FI   AT   IT  
    Global end of trial date
    29 Oct 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    30 Jun 2016
    First version publication date
    02 Apr 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SP0934
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01537042
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB BIOSCIENCES GmbH
    Sponsor organisation address
    Alfred-Nobel-Strasse 10, Monheim, Germany, 40789
    Public contact
    Clinical Trial Registry & Results Disclosure, UCB BIOSCIENCES GmbH, 49 2173 48 1515, clinicaltrials@ucb.com
    Scientific contact
    Clinical Trial Registry & Results Disclosure, UCB BIOSCIENCES GmbH, 49 2173 48 1515, clinicaltrials@ucb.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
    27 Nov 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this trial is to demonstrate superiority of rotigotine against placebo in subjects with Restless Legs Syndrome (RLS) and End Stage Renal Disease (ESRD) requiring hemodialysis.
    Protection of trial subjects
    The study was conducted under the auspices of an IRB/IEC, as defined in local regulations, ICH-GCP, and in accordance with the ethical principles that have their origin in the Declaration of Helsinki. Subject’s informed consent was obtained and documented in accordance with local regulations, ICH-GCP requirements, and the ethical principles that have their origin in the principles of the Declaration of Helsinki.
    Background therapy
    N/A
    Evidence for comparator
    N/A
    Actual start date of recruitment
    25 Apr 2012
    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
    United States: 18
    Country: Number of subjects enrolled
    Finland: 2
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Italy: 1
    Worldwide total number of subjects
    30
    EEA total number of subjects
    12
    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)
    23
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The recruitment for the SP0934 study began in April 2012. It concluded in October 2013. This was a multicenter study with subjects enrolled by 9 sites across Europe and 6 sites across the United States. The subject disposition consists of the Randomized Set (RS), which is all subjects randomized into SP0934.

    Pre-assignment
    Screening details
    The SP0934 study enrolled 49 patients. Out of the 49 patients, 19 were screen failures. Therefore, there were 30 patients randomized into the SP0934 study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Rotigotine
    Arm description
    Rotigotine Transdermal Patch 1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h.
    Arm type
    Experimental

    Investigational medicinal product name
    Rotigotine
    Investigational medicinal product code
    Other name
    Neupro
    Pharmaceutical forms
    Transdermal patch
    Routes of administration
    Transdermal use
    Dosage and administration details
    Transdermal patch; Dose: 1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h. Subjects start with a Rotigotine dose of 1 mg/24 h for 1 week. The dose can be increased weekly during Up-Titration Period until either the optimal or the maximal dose of 3 mg/24 h has been reached. Subjects will maintain the optimal/maximal dose during the 2-week Maintenance Period. Following the Maintenance Period, subjects will be de-escalated from their optimal dose by decreasing the dose by 1 mg/24 h every other day during Taper Period until complete withdrawal.

    Arm title
    Placebo
    Arm description
    Transdermal patch; Patches matching to active treatment patches in size and appearance. Up to 3 weeks of Titration, 2 weeks of Maintenance, up to 4 days of Taper Period.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Transdermal patch
    Routes of administration
    Transdermal use
    Dosage and administration details
    Transdermal patch; Patches matching to active treatment patches in size and appearance. Up to 3 weeks of Titration, 2 weeks of Maintenance, up to 4 days of Taper Period.

    Number of subjects in period 1
    Rotigotine Placebo
    Started
    20
    10
    Completed
    15
    10
    Not completed
    5
    0
         Protocol deviation
    1
    -
         Other
    1
    -
         Lack of efficacy
    1
    -
         SAE, non-fatal
    1
    -
         AE, non-serious non-fatal
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Rotigotine
    Reporting group description
    Rotigotine Transdermal Patch 1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h.

    Reporting group title
    Placebo
    Reporting group description
    Transdermal patch; Patches matching to active treatment patches in size and appearance. Up to 3 weeks of Titration, 2 weeks of Maintenance, up to 4 days of Taper Period.

    Reporting group values
    Rotigotine Placebo Total
    Number of subjects
    20 10 30
    Age categorical
    The baseline analysis population consisted of the Safety Set (SS), which is all subjects who were randomized and had at least 1 patch applied during the Treatment Period.
    Units: Subjects
        Adults (18-64 years)
    15 8 23
        From 65-84 years
    5 2 7
    Age continuous
    The baseline analysis population consisted of the Safety Set (SS), which is all subjects who were randomized and had at least 1 patch applied during the Treatment Period.
    Units: years
        arithmetic mean (standard deviation)
    50.7 ± 16.3 57.2 ± 12.6 -
    Gender categorical
    The baseline analysis population consisted of the Safety Set (SS), which is all subjects who were randomized and had at least 1 patch applied during the Treatment Period.
    Units: Subjects
        Female
    7 3 10
        Male
    13 7 20
    Race Group
    The baseline analysis population consisted of the Safety Set (SS), which is all subjects who were randomized and had at least 1 patch applied during the Treatment Period.
    Units: Subjects
        American Indian/ Alaska Native
    0 0 0
        Asian
    0 0 0
        Black
    6 2 8
        Native Hawaiian or Other Pacific Islander
    0 0 0
        White
    13 4 17
        Other/mixed
    0 1 1
        Missing
    1 3 4
    Ethnicity
    The baseline analysis population consisted of the Safety Set (SS), which is all subjects who were randomized and had at least 1 patch applied during the Treatment Period.
    Units: Subjects
        Hispanic or Latino
    3 2 5
        Not Hispanic or Latino
    16 5 21
        Missing
    1 3 4
    Region
    The baseline analysis population consisted of the Safety Set (SS), which is all subjects who were randomized and had at least 1 patch applied during the Treatment Period.
    Units: Subjects
        US
    12 6 18
        EU
    8 4 12
    Weight
    The baseline analysis population consisted of the Safety Set (SS), which is all subjects who were randomized and had at least 1 patch applied during the Treatment Period.
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    89.42 ± 15.34 85.38 ± 20.99 -
    Height
    The baseline analysis population consisted of the Safety Set (SS), which is all subjects who were randomized and had at least 1 patch applied during the Treatment Period.
    Units: Centimeters
        arithmetic mean (standard deviation)
    171.5 ± 11.99 171.77 ± 8.59 -
    BMI
    The baseline analysis population consisted of the Safety Set (SS), which is all subjects who were randomized and had at least 1 patch applied during the Treatment Period.
    Units: kilogram(s)/square meter
        arithmetic mean (standard deviation)
    30.405 ± 4.262 28.85 ± 6.182 -

    End points

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    End points reporting groups
    Reporting group title
    Rotigotine
    Reporting group description
    Rotigotine Transdermal Patch 1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h.

    Reporting group title
    Placebo
    Reporting group description
    Transdermal patch; Patches matching to active treatment patches in size and appearance. Up to 3 weeks of Titration, 2 weeks of Maintenance, up to 4 days of Taper Period.

    Primary: Ratio from Baseline to the end of the 2-week Maintenance Period in Periodic Limb Movement Index (PLMI)

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    End point title
    Ratio from Baseline to the end of the 2-week Maintenance Period in Periodic Limb Movement Index (PLMI)
    End point description
    The PLMI is defined as Periodic Limb Movements (PLMs)/ total time in bed in hours. PLMs are measured by Polysomnography (PSG). The reduction of the PLMI is reflected in terms of the ratio from Baseline to the end of the Maintenance Period and was calculated as [PLMI at end of Maintenance Period (MP)] / [PLMI at Baseline]. A PLMI Ratio <1 indicates an improvement from Baseline to the end of the 2-week MP.
    End point type
    Primary
    End point timeframe
    From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period.
    End point values
    Rotigotine Placebo
    Number of subjects analysed
    15
    10
    Units: Ratio
        least squares mean (confidence interval 95%)
    0.51 (0.33 to 0.8)
    1.16 (0.68 to 1.99)
    Statistical analysis title
    Primary Outcome Statistical Analysis
    Comparison groups
    Rotigotine v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    other [1]
    P-value
    = 0.0232
    Method
    ANCOVA
    Parameter type
    Treatment Ratio
    Point estimate
    0.44
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.22
         upper limit
    0.88
    Notes
    [1] - An analysis of covariance (ANCOVA) was performed for the log-transformed PLMI ratio with treatment and region as factors and Baseline as a covariate.

    Secondary: Change from Baseline in the Periodic Limb Movements Index (PLMI) to the end of the Maintenance Period

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    End point title
    Change from Baseline in the Periodic Limb Movements Index (PLMI) to the end of the Maintenance Period
    End point description
    The PLMI is defined as Periodic Limb Movements (PLMs)/ total time in bed in hours. PLMs are measured by Polysomnography (PSG). A negative value in change from Baseline indicates an improvement from Baseline to the end of the Maintenance Period.
    End point type
    Secondary
    End point timeframe
    From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period.
    End point values
    Rotigotine Placebo
    Number of subjects analysed
    15
    10
    Units: movement/ hour
        arithmetic mean (standard deviation)
    -23.7 ± 38.7
    10.3 ± 21
    No statistical analyses for this end point

    Secondary: Change from Baseline in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) sum score to the end of the Maintenance Period

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    End point title
    Change from Baseline in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) sum score to the end of the Maintenance Period
    End point description
    The IRLS is a subject based scale that consists of 10 items to evaluate the severity of major RLS symptoms and the impact of the disease on subjects' functioning in daytime activities. Each of the 10 items is measured on a scale that ranges from 0 (not present) to 4 (severe). A sum score between 0 (no RLS symptoms present at all) and 40 (maximum severity in all symptoms) across all 10 items will be calculated. A negative value in Change from Baseline indicates an improvement from Baseline in IRLS.
    End point type
    Secondary
    End point timeframe
    From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period.
    End point values
    Rotigotine Placebo
    Number of subjects analysed
    15
    10
    Units: units on a scale
        arithmetic mean (standard deviation)
    -15.9 ± 9.1
    -8.6 ± 7.2
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Restless Legs-6 (RLS-6) Rating Scale 1 to the end of the Maintenance Period

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    End point title
    Change from Baseline in the Restless Legs-6 (RLS-6) Rating Scale 1 to the end of the Maintenance Period
    End point description
    The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 1 measures satisfaction with sleep during the last seven nights on an 11-point scale that ranges between 0 (completely satisfied) to 10 (completely dissatisfied). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline.
    End point type
    Secondary
    End point timeframe
    From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
    End point values
    Rotigotine Placebo
    Number of subjects analysed
    15
    10
    Units: units on a scale
        arithmetic mean (standard deviation)
    -2.8 ± 3.2
    -1.1 ± 3.5
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Restless Legs-6 (RLS-6) Rating Scale 2 to the end of the Maintenance Period

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    End point title
    Change from Baseline in the Restless Legs-6 (RLS-6) Rating Scale 2 to the end of the Maintenance Period
    End point description
    The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 2 measures the severity of RLS symptoms during the last 7 nights in the situation of falling asleep. This is measured on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline.
    End point type
    Secondary
    End point timeframe
    From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
    End point values
    Rotigotine Placebo
    Number of subjects analysed
    15
    10
    Units: units on a scale
        arithmetic mean (standard deviation)
    -4.4 ± 2.9
    -2.8 ± 2.9
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Restless Legs-6 (RLS-6) Rating Scale 3 to the end of the Maintenance Period

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    End point title
    Change from Baseline in the Restless Legs-6 (RLS-6) Rating Scale 3 to the end of the Maintenance Period
    End point description
    The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 3 measures the severity of RLS symptoms during the last seven nights on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline.
    End point type
    Secondary
    End point timeframe
    From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
    End point values
    Rotigotine Placebo
    Number of subjects analysed
    15
    10
    Units: units on a scale
        arithmetic mean (standard deviation)
    -4.7 ± 3.1
    -3.2 ± 2.6
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Restless Legs-6 (RLS-6) Rating Scale 4 to the end of the Maintenance Period

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    End point title
    Change from Baseline in the Restless Legs-6 (RLS-6) Rating Scale 4 to the end of the Maintenance Period
    End point description
    The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 4 measures the severity of RLS symptoms during the last seven days at rest on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline.
    End point type
    Secondary
    End point timeframe
    From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
    End point values
    Rotigotine Placebo
    Number of subjects analysed
    15
    10
    Units: units on a scale
        arithmetic mean (standard deviation)
    -2.6 ± 2.2
    -1.6 ± 3.2
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Restless Legs-6 (RLS-6) Rating Scale 5 to the end of the Maintenance Period

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    End point title
    Change from Baseline in the Restless Legs-6 (RLS-6) Rating Scale 5 to the end of the Maintenance Period
    End point description
    The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 5 measures the severity of RLS symptoms during the last seven days engaged in activities on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline.
    End point type
    Secondary
    End point timeframe
    From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
    End point values
    Rotigotine Placebo
    Number of subjects analysed
    15
    10
    Units: units on a scale
        arithmetic mean (standard deviation)
    -1.6 ± 2.7
    -1.6 ± 2.1
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Restless Legs-6 (RLS-6) Rating Scale 6 to the end of the Maintenance Period

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    End point title
    Change from Baseline in the Restless Legs-6 (RLS-6) Rating Scale 6 to the end of the Maintenance Period
    End point description
    The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 6 measures the severity of daytime tiredness/ sleepiness on an 11-point scale that ranges between 0 (not at all) to 10 (very severe). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline.
    End point type
    Secondary
    End point timeframe
    From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
    End point values
    Rotigotine Placebo
    Number of subjects analysed
    15
    10
    Units: units on a scale
        arithmetic mean (standard deviation)
    -3.4 ± 2.3
    -1.6 ± 2
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Periodic Limb Movement during Sleep Arousal Index (PLMSAI) to the end of the Maintenance Period

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    End point title
    Change from Baseline in the Periodic Limb Movement during Sleep Arousal Index (PLMSAI) to the end of the Maintenance Period
    End point description
    The Periodic Limb Movement during Sleep Arousal Index (PLMSAI) reflects the influence of the PLM on subject's sleep. Arousal is defined as sudden change in the Electroencephalogram (EEG) activity and the index illustrates to what degree the PLMs contribute to arousal from sleep. A negative value in Change from Baseline indicates an improvement from Baseline.
    End point type
    Secondary
    End point timeframe
    From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
    End point values
    Rotigotine Placebo
    Number of subjects analysed
    15
    10
    Units: movement per hour
        arithmetic mean (standard deviation)
    -1.609 ± 14.412
    4.634 ± 7.162
    No statistical analyses for this end point

    Secondary: Change from Baseline in sleep efficiency to the end of the Maintenance Period

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    End point title
    Change from Baseline in sleep efficiency to the end of the Maintenance Period
    End point description
    Sleep stages and time spent in each sleep stage are determined from Electroencephalogram (EEG) readings. Sleep stage data will be used to calculate sleep efficiency. Sleep efficiency will be presented as percentages. Sleep efficiency is the percentage of time in bed spent asleep. A positive value in Change from Baseline indicates an improvement from Baseline.
    End point type
    Secondary
    End point timeframe
    From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
    End point values
    Rotigotine Placebo
    Number of subjects analysed
    15
    10
    Units: sleep time/ total time in bed
        arithmetic mean (standard deviation)
    7.668 ± 12.317
    -2.85 ± 10.347
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Restless Legs-Quality of Life (RLS-QoL) total score to the end of the Maintenance Period

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    End point title
    Change from Baseline in the Restless Legs-Quality of Life (RLS-QoL) total score to the end of the Maintenance Period
    End point description
    The RLS-QoL is a disease-specific questionnaire to evaluate quality of life. It consists of 12 items. A total score will be calculated from all of the 12 items. The overall sum score can be from 0 (highest QoL) to 60 (lowest QoL). A negative value in Change from Baseline indicates an improvement from Baseline.
    End point type
    Secondary
    End point timeframe
    From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
    End point values
    Rotigotine Placebo
    Number of subjects analysed
    15
    9
    Units: scores on a scale
        arithmetic mean (standard deviation)
    -10.7 ± 10.9
    -10.2 ± 10.8
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Short-Form-36 (SF-36) item questionnaire Mental Component Summary (MCS) to the end of the Maintenance Period

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    End point title
    Change from Baseline in the Short-Form-36 (SF-36) item questionnaire Mental Component Summary (MCS) to the end of the Maintenance Period
    End point description
    The SF-36 is a 36 item generic human research quality of life instrument that uses a recall period of 4 weeks. Items are grouped into 8 domains as follows: Physical Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 items), and a further unscaled single item (question 2) for perceived stability or change in health (Health Transition) during the last year. The norm based scores (based on the US general population) were used for analysis. For the MCS, the lowest and highest possible scores are -9 and 82 (rounded). The SF-36 domains (subscores) are scored so that a higher score indicates a better health state.
    End point type
    Secondary
    End point timeframe
    From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
    End point values
    Rotigotine Placebo
    Number of subjects analysed
    14
    9
    Units: units on a scale
        arithmetic mean (standard deviation)
    2.2 ± 10.1
    6.4 ± 6.6
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Short-Form-36 (SF-36) item questionnaire Physical Component Summary (PCS) to the end of the Maintenance Period

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    End point title
    Change from Baseline in the Short-Form-36 (SF-36) item questionnaire Physical Component Summary (PCS) to the end of the Maintenance Period
    End point description
    The SF-36 is a 36 item generic human research quality of life instrument that uses a recall period of 4 weeks. Items are grouped into 8 domains as follows: Physical Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 items), and a further unscaled single item (question 2) for perceived stability or change in health (Health Transition) during the last year. The norm-based scores (based on the US general population) were used for analysis. For the PCS, the lowest and highest possible scores are 1 and 81 (rounded). The SF-36 domains (subscores) are scored so that a higher score indicates a better health state.
    End point type
    Secondary
    End point timeframe
    From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period
    End point values
    Rotigotine Placebo
    Number of subjects analysed
    14
    9
    Units: units on a scale
        arithmetic mean (standard deviation)
    3.8 ± 6.3
    -0.3 ± 8.7
    No statistical analyses for this end point

    Secondary: Change from Baseline in Clinical Global Impressions (CGI) Item 1 score (Visit 2)

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    End point title
    Change from Baseline in Clinical Global Impressions (CGI) Item 1 score (Visit 2)
    End point description
    The CGI Item 1 score measures the severity of illness on a scale that ranges from 0 (Not assessed) to 7 (Among the most extremely ill).
    End point type
    Secondary
    End point timeframe
    Visit 2 (Baseline)
    End point values
    Rotigotine Placebo
    Number of subjects analysed
    15
    10
    Units: participants
        Not assessed
    0
    0
        Normal, not ill at all
    0
    0
        Borderline ill
    0
    0
        Mildly ill
    0
    0
        Moderately ill
    3
    3
        Markedly ill
    5
    9
        Severely ill
    2
    2
        Among the most extremely ill subjects
    0
    1
    No statistical analyses for this end point

    Secondary: Change from Baseline in Clinical Global Impressions (CGI) Item 1 score (Visit 6)

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    End point title
    Change from Baseline in Clinical Global Impressions (CGI) Item 1 score (Visit 6)
    End point description
    The CGI Item 1 score measures the severity of illness on a scale that ranges from 0 (Not assessed) to 7 (Among the most extremely ill).
    End point type
    Secondary
    End point timeframe
    Visit 6 (End of Maintenance Period)
    End point values
    Rotigotine Placebo
    Number of subjects analysed
    15
    10
    Units: participants
        Not assessed
    0
    0
        Normal, not ill at all
    5
    1
        Borderline ill
    4
    1
        Mildly ill
    3
    3
        Moderately ill
    1
    5
        Markedly ill
    2
    0
        Severely ill
    0
    0
        Among the most extremely ill subjects
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events were recorded during the course of the SP0934 study, which began in April 2012 and concluded in October 2013.
    Adverse event reporting additional description
    Adverse Events reporting refers to the Safety Set (SS). All subjects who are randomized and have at least 1 patch applied during the Treatment Period were included in the SS.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Rotigotine
    Reporting group description
    Adverse Event, Non-Serious Adverse Event and Serious Adverse Event reporting refers to the Safety Set (SS). All subjects who are randomized and have at least 1 patch applied during the Treatment Period were included in the SS.

    Reporting group title
    Placebo
    Reporting group description
    Adverse Event, Non-Serious Adverse Event and Serious Adverse Event reporting refers to the Safety Set (SS). All subjects who are randomized and have at least 1 patch applied during the Treatment Period were included in the SS.

    Serious adverse events
    Rotigotine Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 20 (15.00%)
    1 / 10 (10.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Foot 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
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastrointestinal infection
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Rotigotine Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 20 (60.00%)
    4 / 10 (40.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Injury, poisoning and procedural complications
    Back injury
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Dialysis device complication
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Electrocardiogram PR prolongation
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Electrocardiogram ST segment abnormal
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Sleep apnoea syndrome
         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
    3
    0
    Paraesthesia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Somnolence
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Eye haemorrhage
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Application site pruritus
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Depression
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Dysphoria
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 10 (20.00%)
         occurrences all number
    1
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    4 / 20 (20.00%)
    0 / 10 (0.00%)
         occurrences all number
    5
    0
    Vomiting
         subjects affected / exposed
    3 / 20 (15.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Fluid overload
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Hyperglycaemia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Oct 2011
    The protocol was amended in order to add the CGI Item 1 to Day 14 of the Maintenance Period (Visit 6) and to specify options for post-study treatment of RLS.
    18 Nov 2011
    The protocol was amended in order to clarify that subjects who switched to commercially available rotigotine (Neupro) or who entered the NPP would not be scheduled for a Safety Follow-Up Visit.
    14 Jan 2013
    The primary purpose of this protocol amendment was to revise the inclusion and exclusion criteria, based on the recommendations of the investigators, to make them less restrictive and to adapt them to the specific needs of the target patient population for the study.

    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.
    N/A
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