Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    LATE ONSET PARKINSON’S DISEASE IN SUBJECTS 70 YEARS AND OLDER: POSSIBLE USE OF ROTIGOTINE

    Summary
    EudraCT number
    		 2013-000827-15
    Trial protocol
    		 IT  
    Global end of trial date

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    PARROT
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Osp. Card. G. Panico
    Sponsor organisation address
    Via San Pio X n. 4, Tricase, Italy, 73039
    Public contact
    Elisabetta Pupillo, Istituto di Ricerche Farmacologiche “Mario Negri” di Milano, elisabetta.pupillo@marionegri.it
    Scientific contact
    Elisabetta Pupillo, Istituto di Ricerche Farmacologiche “Mario Negri” di Milano, elisabetta.pupillo@marionegri.it
    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
    Interim
    Date of interim/final analysis
    25 May 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    Primary objective: To assess efficacy and safety of rotigotine in patients with late onset PD, starting at age 70 or later, on motor symptoms.
    Protection of trial subjects
    Safety monitoring for all patients enrolled in the study will include laboratory safety assessments and clinical evaluation, as scheduled in the flow chart. All adverse events (AE) and serious adverse events (SAE) will be recorded.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2013
    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
    Italy: 2
    Worldwide total number of subjects
    2
    EEA total number of subjects
    2
    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)
    0
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 70+y;Idiopathic PD confirmed by at least2of the following signs:resting tremor,bradikynesia,rigidity;Onset of PD symptoms and diagnosis within the last12months;Disease stage I or II according to H&Y scale;Ability to provide written IC Patients willing and able to comply with scheduled visits,treatment plan,lab tests and other study procedures

    Pre-assignment period milestones
    Number of subjects started
    		 2
    Number of subjects completed
    		 2

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 active
    Arm description
    		 Treatment is titrated to optimal dose (that at which investigator and subject felt that motor and non motor impairment are adequately controlled), starting at 2 mg/24 hr and increasing with weekly increments of 2 mg/24 hr up to a maximum of 8 mg/24 hr. The dose is maintained at the optimal or maximal dose for a 8-week period (maintenance period) .
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rotigotine
    Investigational medicinal product code
    Rotigotine
    Other name
    Pharmaceutical forms
    Transdermal patch
    Routes of administration
    Transdermal use
    Dosage and administration details
    Treatment is titrated to optimal dose (that at which investigator and subject felt that motor and non motor impairment are adequately controlled), starting at 2 mg/24 hr and increasing with weekly increments of 2 mg/24 hr up to a maximum of 8 mg/24 hr. The dose is maintained at the optimal or maximal dose for a 8-week period (maintenance period) .

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Transdermal patch
    Routes of administration
    Transdermal use
    Dosage and administration details
    placebo

    Arm title
    		 placebo
    Arm description
    		 placebo, transdermal patch
    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
    placebo

    Number of subjects in period 1
    		active placebo
    Started
    1
    1
    Completed
    1
    1

    Baseline characteristics

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

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 2 2
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 2 2
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 1 1

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    active
    Reporting group description
    		 Treatment is titrated to optimal dose (that at which investigator and subject felt that motor and non motor impairment are adequately controlled), starting at 2 mg/24 hr and increasing with weekly increments of 2 mg/24 hr up to a maximum of 8 mg/24 hr. The dose is maintained at the optimal or maximal dose for a 8-week period (maintenance period) .

    Reporting group title
    placebo
    Reporting group description
    		 placebo, transdermal patch

    Primary: safety

    		 Close Top of page
    End point title
    		 safety
    End point description
    To assess efficacy and safety of rotigotine in patients with late onset PD, starting at age 70 or later, on motor symptoms
    End point type
    Primary
    End point timeframe
    from baseline to week 16
    End point values
    		 active placebo
    Number of subjects analysed
    1
    1
    Units: percentage
    1
    1
    Statistical analysis title
    		 descriptive statistics
    Statistical analysis description
    descriptive statistics for the assessment of the comparability of the two treatment groups and the safety of active treatment and placebo, and the use of ad-hoc statistical tests (univariate and multivariate) for the efficacy analysis.
    Comparison groups
    active v placebo
    Number of subjects included in analysis
    2
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    AE were reported during the treatment period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    3
    Frequency threshold for reporting non-serious adverse events: 1%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: no adverse events recorded

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    25 May 2015
    slow recruitment, study closed prematurely
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 27 01:29:29 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA