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    The EU Clinical Trials Register currently displays   41189   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
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    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2013-000827-15
    Sponsor's Protocol Code Number:PARROT
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-03-15
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-000827-15
    A.3Full title of the trial
    LATE ONSET PARKINSON’S DISEASE IN SUBJECTS 70 YEARS AND OLDER: POSSIBLE USE OF ROTIGOTINE
    Insorgenza tardiva della malattia di Parkinson in pazienti con più di 70 anni di età: possibile utilizzo di Rotigotina
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    LATE ONSET PARKINSON’S DISEASE IN SUBJECTS 70 YEARS AND OLDER: POSSIBLE USE OF ROTIGOTINE
    Utilizzo di Rotigotina in pazienti con malattia di Parkinson che insorge dopo i 70 anni di età.
    A.3.2Name or abbreviated title of the trial where available
    PARROT
    PARROT
    A.4.1Sponsor's protocol code numberPARROT
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUnità Malattie Neurodegenerative, Ospedale Cardinale Giovanni Panico, Tricase
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUCB PHARMA S.A.
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto di Ricerche Farmacologiche “Mario Negri” di Milano
    B.5.2Functional name of contact pointElisabetta Pupillo
    B.5.3 Address:
    B.5.3.1Street AddressVia La masa 19
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20156
    B.5.3.4CountryItaly
    B.5.6E-mailelisabetta.pupillo@marionegri.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Rotigotine
    D.2.1.1.2Name of the Marketing Authorisation holderNeupro
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameneurpro
    D.3.2Product code SPM962
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTransdermal use
    Topical use (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTransdermal patch
    D.8.4Route of administration of the placeboTransdermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Parkinson disease
    Malattia di Parkinson
    E.1.1.1Medical condition in easily understood language
    Parkinson
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective
    Primary objective: To assess efficacy and safety of rotigotine in patients with late onset PD, starting at age 70 or later, on motor symptoms.
    E.2.2Secondary objectives of the trial
    Secondary objectives
    Secondary objective: To assess efficacy and safety of rotigotine in patients with late onset PD, starting at age 70 or later, on selected non motor symptoms :
    • sleep quality
    • depression
    • cognitive function
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Age ≥70 years
    -Idiopathic PD confirmed by at least two of the following signs: resting tremor, bradikynesia, rigidity
    -Diagnosis of PD within the last 12 months and onset of symptoms within 12 months from diagnosis
    -Disease stage I or II according to Hoehn and Yahr Scale
    -Ability to provide written informed consent
    -Patients willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
    E.4Principal exclusion criteria
    -Disease duration more than 12 months since diagnosis and/or duration of symptoms at diagnosis for more than 12 months
    -Hoehn & Yahr stage ≥3
    -Atypical or secondary parkinsonism
    -Patient currently on L-dopa, DA or other PD medication at baseline
    -Centrally acting dopaminergic agents, MAOIs, tolcapone, budipine, neuroleptics taken within the 28 days preceding the baseline visit
    -History of deep brain stimulation
    -History of severe cardiac disease/heart failure in the last 3 years
    -History of repeated falls
    -History of sulfite sensitivity
    -Arterial hypotension
    -Stroke or a transient ischemic attack within the last 12 months
    -Previous or current treatment with rotigotine (at any time)
    -Diagnosis of dementia according to DSM-IV-R
    -Mini mental State Examination (MMSE) total score <24 at screening visit
    -History of psychosis
    - Clinically relevant hepatic dysfunction and/or transaminase levels 5+ times higher than upper normal value
    -Experimental treatments within the antecedent 3 months
    -History of drug or alcohol dependency
    -Poor compliance with treatment
    -Inability to comply with protocol
    E.5 End points
    E.5.1Primary end point(s)
    Comparison of the two treatment groups in the percentage of responders at 4 months. Responders is the improvement of at least 20% in the sum of scores UPDRS part 2 and 3
    Confronto dei due gruppi di trattamento nella percentuale di responders a 4 Mesi. Responders è il miglioramento di almeno 20% nella somma degli scores UPDRS parte 2 e 3
    E.5.1.1Timepoint(s) of evaluation of this end point
    16 week
    16 settimane
    E.5.2Secondary end point(s)
    Comparison between the two treatment groups in the percentage of responders to visit 4 and 6 in scores of stairs PDSS-2 and GDS
    Confronto tra i due gruppi di trattamento nella percentuale di responders alla visita 4 e 6 negli scores delle scale PDSS-2 e GDS
    E.5.2.1Timepoint(s) of evaluation of this end point
    baseline, V4 and v6
    Baseline, V4, V6
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Nessuno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-02-17
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