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    Clinical Trial Results:
    An Open-Label, Long-Term, Follow-Up Study To Determine The Safety, Tolerability, and Efficacy of Rotigotine Transdermal System As Monotherapy in Adolescents with Restless Legs Syndrome

    Summary
    EudraCT number
    2016-000635-40
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    07 Dec 2015

    Results information
    Results version number
    v2(current)
    This version publication date
    23 Dec 2016
    First version publication date
    19 Jun 2016
    Other versions
    v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    SP1005
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01498120
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB BIOSCIENCES, Inc.
    Sponsor organisation address
    8010 Arco Corporate Drive, Raleigh, United States, NC 27617
    Public contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, 40789 +49 2173 4815 15, clinicaltrials@ucb.com
    Scientific contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, 40789 +49 2173 48 15 15, 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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Mar 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to assess the long-term safety and tolerability of rotigotine treatment in adolescents with idiopathic restless legs syndrome (RLS).
    Protection of trial subjects
    During the conduct of the study all subjects were closely monitored.
    Background therapy
    Background therapy was permitted as defined in the study protocol.
    Evidence for comparator
    -
    Actual start date of recruitment
    21 Jan 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: 14
    Worldwide total number of subjects
    14
    EEA total number of subjects
    0
    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)
    14
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This study started to enroll subjects in USA in January 2012 and concluded in December 2015.

    Pre-assignment
    Screening details
    Participant Flow refers to the Safety Set (SS) which consists of all subjects who were randomized in this study and received at least 1 dose of study medication.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    Rotigotine
    Arm description
    Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
    Arm type
    Experimental

    Investigational medicinal product name
    Neupro
    Investigational medicinal product code
    Rotigotine
    Other name
    Pharmaceutical forms
    Transdermal patch
    Routes of administration
    Transdermal use
    Dosage and administration details
    Subjects received the patch according to the following schedules and doses: 0.5 mg/24 h, 1 mg/24 h, 2 mg/24 h and 3 mg/24 h.

    Number of subjects in period 1
    Rotigotine
    Started
    14
    Completed
    1
    Not completed
    13
         Unspecified
             4
         AE, non-serious non-fatal
             3
         Consent withdrawn by subject
             5
         Lost to follow-up
             1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Rotigotine
    Reporting group description
    Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).

    Reporting group values
    Rotigotine Total
    Number of subjects
    14 14
    Age Categorical
    Units: Subjects
        Adolescents (12-17 years)
    14 14
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    15.4 ± 1.2 -
    Gender Categorical
    Units: Subjects
        Male
    4 4
        Female
    10 10

    End points

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    End points reporting groups
    Reporting group title
    Rotigotine
    Reporting group description
    Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).

    Subject analysis set title
    Rotigotine (Safety Set)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    The Safety Set (SS) which consists of all subjects who were randomized in this study and received at least 1 dose of study medication. Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).

    Primary: Number of subjects withdrawn Due to An Adverse Event (AE) From Visit 1 (Day 1) Through End of Study

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    End point title
    Number of subjects withdrawn Due to An Adverse Event (AE) From Visit 1 (Day 1) Through End of Study [1]
    End point description
    An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
    End point type
    Primary
    End point timeframe
    Visit 1 (Day 1) through End of Study (approximately 2 years)
    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: The analysis of the primary endpoint being exploratory in nature, no statistical test was performed.
    End point values
    Rotigotine (Safety Set)
    Number of subjects analysed
    14
    Units: subjects
        Subjects withdrawn due to AEs
    3
    No statistical analyses for this end point

    Primary: Number of Subjects with At Least One Adverse Event (AE) From Visit 1 (Day 1) to End of Study

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    End point title
    Number of Subjects with At Least One Adverse Event (AE) From Visit 1 (Day 1) to End of Study [2]
    End point description
    An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
    End point type
    Primary
    End point timeframe
    From Visit 1 (Day 1) through End of Study (approximately 2 years)
    Notes
    [2] - 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: The analysis of the primary endpoint being exploratory in nature, no statistical test was performed.
    End point values
    Rotigotine (Safety Set)
    Number of subjects analysed
    14
    Units: subjects
        Subjects with AE(s)
    10
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (up to 25 months).
    Adverse event reporting additional description
    All enrolled subjects who received at least 1 dose of study medication were included in the SS.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    9.1
    Reporting groups
    Reporting group title
    Rotigotine (Safety Set)
    Reporting group description
    The Safety Set (SS) which consists of all subjects who were randomized in this study and received at least 1 dose of study medication. Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).

    Serious adverse events
    Rotigotine (Safety Set)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 14 (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
    Rotigotine (Safety Set)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 14 (71.43%)
    Vascular disorders
    Orthostatic hypotension
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    General disorders and administration site conditions
    Application site pruritus
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Febrile disorders
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Oedema peripheral
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Joint sprain
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Sunburn
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Road traffic accident
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Contusion
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Investigations
    Electrocardiogram QT corrected interval prolonged
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Blood sodium increased
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Toxicology laboratory analyses
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Drug screen positive
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Sinus tachycardia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Syncope vasovagal
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    3
    Presyncope
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Sudden onset of sleep
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    2
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    4 / 14 (28.57%)
         occurrences all number
    7
    Food poisoning
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    6
    Renal and urinary disorders
    Enuresis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Haematuria
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Dermal cyst
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Arthralgia
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Infections and infestations
    Ear infection
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Streptococcal infection
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Sinusitis
         subjects affected / exposed
    1 / 14 (7.14%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 14 (21.43%)
         occurrences all number
    3
    Urinary tract infection
         subjects affected / exposed
    2 / 14 (14.29%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Jul 2011
    The main purpose of this substantial amendment was to include the suicidality risk assessment (Columbia-Suicide Severity Rating Scale [C-SSRS]). In accordance with the recently issued US Food and Drug Administration (FDA) draft Guidance for Industry, which went into effect on 29 Oct 2010, the C-SSRS has been added to all ongoing and new interventional protocols in order to prospectively assess the occurrence of treatment-emergent suicidality in clinical studies of drug and biological products (FDA, Guidance for Industry, 2010). In addition, a list of Anticipated serious adverse events (SAEs) was included in this amendment in compliance with the US FDA guidance on safety reporting requirements for studies conducted under an open Investigational New Drug Application (effective 28 Mar 2011; FDA, Guidance for Industry and Investigators, 2010). The Beck Depression Inventory II and the Beck Anxiety Inventory were removed from the study assessments. Other changes included in this amendment were as follows: -Added the timeframe at which the efficacy and other variables were analyzed. -Added the version number of the Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale. -Updated the storage requirements for the rotigotine patch. -Clarified the subject eligibility for SP1005 based on the dosing requirements from the previous rotigotine study (ie, SP1004). -Permitted the use of a topical anesthetic prior to the needle stick. -Added safety parameters (12-lead electrocardiogram [ECG] and laboratory tests) to be performed at the investigator’s discretion at the Unscheduled Visit. -Removed reference to patch size from all sections, except in Section 7.1 of the Protocol, Description of investigational medicinal product. -Revised the preparation and handling of the blood and saliva samples and clearly identified the PK sampling visits. -Updated sponsor clinical project manager contact information. -Corrected typographic errors and made changes of an editorial nature.
    02 May 2012
    The main purpose of this substantial amendment was to ensure consistency between the protocol and the US FDA Pediatric Development Plan for the RLS indication in subjects 13 years and older. Since the subject’s dosing was no longer dependent on body weight, the dosing schedules for each study period were revised. In addition, PK saliva sampling was removed from the study. Data from a completed PK study (RL0002) suggested that saliva concentrations of rotigotine could not be used as a surrogate for plasma concentrations of rotigotine. Other changes included in this amendment were as follows: -Updated the contact information for SAE reporting and procedures for reporting SAEs to be consistent with the current protocol template. -Updated the regulatory status of rotigotine for the treatment of RLS in adults in the US. -Clarified that the sample size may be increased if adolescent subjects with RLS were to roll over into this study from other future rotigotine studies. -Removed the requirement for PK blood samples to be centrifuged at a controlled temperature. -Corrected typographic errors and minor inconsistencies of an editorial nature.

    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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