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    Summary
    EudraCT Number:2016-000973-19
    Sponsor's Protocol Code Number:SWH-MAOB
    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:2022-01-20
    Trial 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 number2016-000973-19
    A.3Full title of the trial
    OVERNIGHT SWITCH FROM RASAGILINE TO SAFINAMIDE IN FLUCTUATING PATIENTS WITH PARKINSON’S DISEASE: A TOLERABILITY AND SAFETY STUDY
    STUDIO DI SICUREZZA E TOLLERABILITA’ SUL CAMBIO IMMEDIATO (OVERNIGHT) TRA RASAGILINA E SAFINAMIDE IN PAZIENTI FLUTTUANTI CON MALATTIA DI PARKINSON.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to verify safety and tolerability of the immediate switch from rasagiline (irreversible MAO-B inhibitor) and safinamide (reversible inhibitor of MAO-B)
    Studio per verificare la sicurezza e la tollerabilità nel passaggio immediato dal farmaco rasagilina (inibitore MAO-B irreversibile) al farmaco safinamide (inibitore MAO-B reversibile)
    A.3.2Name or abbreviated title of the trial where available
    OVERNIGHT SWITCH FROM RASAGILINE TO SAFINAMIDE
    CAMBIO IMMEDIATO TRA RASAGILINA E SAFINAMIDE
    A.4.1Sponsor's protocol code numberSWH-MAOB
    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 SponsorIRCCS SAN RAFFAELE PISANA GESTITO DA SAN RAFFAELE ROMA SRL
    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 supportIRCCS San Raffaele Pisana
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS SAN RAFFAELE PISANA GESTITO DA SAN RA
    B.5.2Functional name of contact pointClinical Trial Centre
    B.5.3 Address:
    B.5.3.1Street AddressVia della Pisana 235
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00163
    B.5.3.4CountryItaly
    B.5.4Telephone number06.52252311
    B.5.5Fax number06.66058486
    B.5.6E-mailfabrizio.stocchi@sanraffaele.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 XADAGO - 50 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- BLISTER (PVC/PVDC/ALLUMINIO)- 30 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderZAMBON S.P.A.
    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 nameXadago
    D.3.2Product code N04BD03
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Parkinson's Disease
    Malattia di Parkinson
    E.1.1.1Medical condition in easily understood language
    Parkinson's Disease
    Malattia di Parkinson
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10013113
    E.1.2Term Disease Parkinson's
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this study is to verify safety and tolerability of the immediate switch from rasagiline (irreversible MAO-B inhibitor) and safinamide (reversible MAO-B inhibitor) trough monitoring of BP by 24-hour Holter recording.
    The primary objective of the study will be achieved if the mean BP will not increase by >10 mmHg in the studied population.
    The mean blood pressure (MAP) is the average blood pressure in an individual. It is defined as the average arterial pressure during a single cardiac cycle.
    Scopo di questo studio è quello di verificare la sicurezza e la tollerabilità del passaggio immediato da rasagilina (inibitore irreversibile delle MAO-B) a safinamide (inibitore reversibile MAO-B) attraverso il monitoraggio della pressione arteriosa nelle 24 ore (Holter-PA).
    L'obiettivo primario dello studio sarà raggiunto se la pressione arteriosa media non aumenterà di >10 mmHg nella popolazione studiata. La pressione arteriosa media (MAP) è la pressione sanguigna media di un individuo; essa è definita come la pressione media arteriosa durante un singolo ciclo cardiaco.
    E.2.2Secondary objectives of the trial
    Secondary endpoints will be:
    a) clinical change compared to baseline at the following scales:
    - Unified Parkinson's Disease rating scale (total score),
    - Hoehn &Yahr,
    - Montreal Cognitive assessment (MoCA)
    - Abnormal involuntary Movement Scale (AIMS);
    b) variability of MAP that will be correlated with patients’ clinical status (on and off state).
    Gli endpoint secondari saranno:
    - differenza clinica verso visita basale, valutata mediante:
    a) Unified Parkinson’s Disease Rating Scale (UPDRS -punteggio totale),
    b) Hoehn & Yahr,
    c) Montreal Cognitive Assessment (MoCA)
    d) Abnormal Involuntary Moviment Scale (AIMS);
    - la variabilità della pressione arteriosa media, che sarà correlata con lo stato clinico dei pazienti (stato ON-OFF).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Male and female of age between 30 an 80 yrs old.
    •Patients able to comprehend and provide consent form
    •Patients with idiopathic Parkinson's disease diagnosed according to the UK Brain Bank criteria
    •Patients in mid-to late stage of the disease (Hoehn & Yahr: between the stage 2 and 4 in on state).
    •Patients suffering from motor fluctuations
    •Patiens must have a good response to levodopa in the opinion of the investigators (evaluated as improvement = 30% of the UPDRS scores)
    •Stable dosage of antiparkinsonian medication for at least 4 weeks prior to study enrolment
    •Female patients in post-menopausal state with at least one year absence of vaginal bleeding or spotting or be surgically sterile
    •Women of childbearing potential must use an acceptable method of contraception
    •men with a potentially fertile partner must have had a vasectomy or be willing to use an acceptable method of contraception for the duration of the study
    ° Maschi o femmine di ogni etnia, di età compresa tra i 30 e i 80 anni.
    ° Diagnosi clinica di malattia di Parkinson in accordo ai criteri della UK Brain Bank
    ° Buona risposta alla levodopa con un miglioramento = 30% del punteggio alla scala di valutazione UPDRS
    ° Hoehn & Yahr: stadi da 2 a 4 in stato di on.
    ° Pazienti con fluttuazioni motorie
    ° Dosi stabili di farmaci da 4 settimane.
    ° Pazienti donne in post-menopausa da almeno un anno o in menopausa chirurgica
    ° Pazienti donne in età fertile che usino metodi anticoncezionali validi
    ° Uomini con patner in età fertile che abbiano subito una vasectomia o che usino metodi anticoncezionali validi per la durata dello studio
    ° Pazienti in grado di comprendere e fornire consenso informato
    E.4Principal exclusion criteria
    •Atypical Parkinsonism
    •Any significant psychiatric, metabolic and systemic significant concomitant disease
    •Patients with Liver failure
    •Patients with clinically significant out of range laboratory values in the anamnesis
    •Patients participating in a clinical trial in the last 6 weeks
    •Patients with moderate-severe cognitive decline not able to provide consent form
    •Patients currently lactating or pregnant or planning to become pregnant during the duration of the study
    •Patients for whom Xadago is contraindicated according to the current SmPC
    ° Parkinsonismo atipico.
    ° Malattie internistiche o psichiatriche significative.
    ° Insufficienza epatica
    ° Valori di laboratorio alterati clinicamente significanti in anamnesi
    ° Pazienti che hanno partecipato ad un protocollo clinico nelle ultime 6 settimane.
    ° Pazienti in cui sussistano controindicazioni all’utilizzo di Xadago (come riportato in foglietto illustrativo)
    ° Donne in gravidanza o allattamento.
    ° Pazienti con declino cognitivo di grado moderato-severo non in grado di fornire consenso informato
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of the study will be achieved if the mean BP will not increase by >10 mmHg in the studied population.
    The mean blood pressure (MAP) is the average blood pressure in an individual. It is defined as the average arterial pressure during a single cardiac cycle.
    L'obiettivo primario dello studio sarà raggiunto se la pressione arteriosa media non aumenterà di >10 mmHg nella popolazione studiata. La pressione arteriosa media (MAP) è la pressione sanguigna media di un individuo; essa è definita come la pressione media arteriosa durante un singolo ciclo cardiaco.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of study
    Fine dello studio
    E.5.2Secondary end point(s)
    Secondary endpoints will be:
    a) clinical change compared to baseline at the following scales:
    - Unified Parkinson's Disease rating scale (total score),
    - Hoehn &Yahr,
    - Montreal Cognitive assessment (MoCA)
    - Abnormal involuntary Movement Scale (AIMS);
    b) variability of MAP that will be correlated with patients’ clinical status (on and off state).
    Gli endpoint secondari saranno:
    - differenza clinica verso visita basale, valutata mediante:
    a) Unified Parkinson’s Disease Rating Scale (UPDRS -punteggio totale),
    b) Hoehn & Yahr,
    c) Montreal Cognitive Assessment (MoCA)
    d) Abnormal Involuntary Moviment Scale (AIMS);
    - la variabilità della pressione arteriosa media, che sarà correlata con lo stato clinico dei pazienti (stato ON-OFF).
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of study
    Fine dello studio
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 Information not present in EudraCT
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    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) Yes
    F.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    Routine Clinical Practice
    Comune pratica clinica
    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 Decision2017-09-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
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