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    Summary
    EudraCT Number:2018-004145-16
    Sponsor's Protocol Code Number:Z7219K01
    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:2021-01-21
    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 number2018-004145-16
    A.3Full title of the trial
    A 12-weeks, multicentre, randomized, double-blind, placebo-controlled, exploratory, pilot study to evaluate the safety and efficacy of safinamide 200 mg once daily, as add-on therapy, in patients with possible or probable parkinsonian variant of multiple system atrophy.
    Studio pilota, di 12 settimane, multicentrico, randomizzato, in doppio cieco, controllato con placebo, esplorativo, per valutare la sicurezza e l’efficacia di safinamide 200 mg una volta al giorno, come terapia aggiuntiva, in pazienti con possibile o probabile variante parkinsoniana dell’atrofia multisistemica.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study evaluating the safety and efficacy of safinamide for patients with Multiple System Atrophy
    Studio per valutare la sicurezza e l’efficacia di safinamide per pazienti con atrofia multisistemica
    A.3.2Name or abbreviated title of the trial where available
    Safinamide for Multiple System Atrophy
    Safinamide per Atrofia multisistemica
    A.4.1Sponsor's protocol code numberZ7219K01
    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 SponsorZAMBON SPA
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportZambon SpA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationZambon SpA
    B.5.2Functional name of contact pointClinical Development
    B.5.3 Address:
    B.5.3.1Street AddressVia Lillo del Duca 10
    B.5.3.2Town/ cityBresso, Milano
    B.5.3.3Post code20091
    B.5.3.4CountryItaly
    B.5.4Telephone number02665241
    B.5.5Fax number000000
    B.5.6E-mailclinicaltrials@zambongroup.com
    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
    D.2.1.1.2Name of the Marketing Authorisation holderZambon SpA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 [Z7219]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSAFINAMIDE METANSOLFONATO
    D.3.9.1CAS number 133865-89-1
    D.3.9.2Current sponsor codeZ7219
    D.3.9.3Other descriptive nameSAFINAMIDE
    D.3.9.4EV Substance CodeSUB32946
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Parkinsonian variant of Multiple System Atrophy
    Variante parkinsoniana dell’atrofia multisistemica
    E.1.1.1Medical condition in easily understood language
    Multiple System Atrophy
    Atrofia multisistemica
    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 PT
    E.1.2Classification code 10064060
    E.1.2Term Multiple system atrophy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and tolerability of safinamide, 200 mg od, compared with placebo
    Valutare la sicurezza e la tollerabilità di safinamide, 200 mg una volta al giorno, rispetto al placebo
    E.2.2Secondary objectives of the trial
    To evaluate the potential efficacy of safinamide 200 mg od, as add-on therapy, on motor function and/or quality of life
    Valutare la potenziale efficacia di safinamide 200 mg una volta al giorno, come terapia aggiuntiva, sulla funzione motoria e/o sudlla qualità ella vita
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all of the following criteria apply:
    Age
    1. Participant must be 30 to 80 years of age inclusive, at the time of signing the informed consent.
    Type of Participant and Disease Characteristics
    2. Participants who are diagnosed (with MRI confirmation) with possible or probable parkinsonian variant of Multiple System Atrophy
    less than 2 years ago.
    3. Participants with an anticipated survival of at least 3 years in the opinion of the investigator.
    Sex
    4. Male or female
    • A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies (see Appendix 4):
    i. Not a woman of childbearing potential (WOCBP)
    OR
    ii. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 30 days after the last dose of study intervention.
    Informed Consent
    5. Capable of giving signed informed consent
    I partecipanti possono essere inclusi nello studio solo se si applicano tutti i seguenti criteri:
    Età
    1. Il partecipante deve avere un'età compresa tra 30 e 80 anni, al momento della firma del consenso informato.
    Tipologia di partecipanti e caratteristiche della malattia
    2. Partecipanti cui è stata disgnosticata meno di 2 anni fa (con conferma MRI) una possibile o probabile variante parkinsoniana di atrofia multisistemica.
    3. Partecipanti con una sopravvivenza prevista di almeno 3 anni secondo il parere dello sperimentatore.
    Sesso
    4. Maschio o femmina
    • Le donne possono partecipare se non incinta, non allattano al seno e applicano almeno una delle seguenti condizioni (vedi Appendice 4):
    i. Non potenzialmente fertile
    O
    ii. Donna fertile che accetta di seguire le indicazioni relative alla contraccezione durante il periodo di trattamento e per almeno 30 giorni dopo l'ultima dose di farmaco in studio.
    Consenso informato
    5. In grado di dare il consenso informato firmato
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    Medical Conditions
    1. History of neurosurgical procedure, including stereotactic surgery.
    2. History of Deep Brain Stimulation (DBS)
    3. History of bipolar disorder, severe depression, schizophrenia or other psychotic disorder.
    4. History of drug and/or alcohol abuse within 12 months prior to screening as defined by the current edition of the Diagnostic and
    Statistical Manual of Mental Disorders
    5. History of dementia (DSM-V criteria)
    6. Ophthalmologic history including any of the following conditions: albinism, uveitis, retinitis pigmentosa, retinal degeneration, active retinopathy, severe progressive diabetic retinopathy, inherited retinopathy or family history of hereditary retinal disease.
    7. Active hepatitis B or C
    8. History of human immunodeficiency virus (HIV) infection
    9. Subjects not able to swallow oral medications
    10. Subjects with severe orthostatic symptoms
    11. Impaired ambulation, i.e. falling more than once per week, bedridden patients or confined to a wheelchair during the whole day.
    12. Subjects with active malignant neoplasms.
    13. Movement disorders other than MSA (e.g. Parkinson Disease, dementia with Lewy bodies, essential tremor, progressive supranuclear palsy, pharmacological or post-encephalic parkinsonism).
    14. Any clinically significant or unstable medical or surgical condition that, in the opinion of the investigator, might preclude safe completion
    of the study or might affect the results of the study.
    Prior/Concomitant Therapy
    15. Not on a stable regime, for at least 4 weeks prior to the randomization (baseline visit), of
    a. oral levodopa (including controlled release [CR], immediate release [IR] or a combination of CR/IR), with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor
    or
    b. dopamine agonist, anticholinergic and/or amantadine.
    Prior/Concurrent Clinical Study Experience
    16. Patients should not have received treatment with monoamine oxidase inhibitors in the 2 weeks prior to the randomization visit, nor treatment with levodopa infusion, pethidine, opiates, opioids, fluoxetine, fluvoxamine in the 4 weeks prior to the randomization visit.
    17. Patients should not have received treatment with an oral or depot neuroleptic within 12 weeks prior to the randomization visit.
    18. Use of any investigational drug within 30 days prior to screening or 5 half-lives, whichever is the longest.
    Diagnostic assessments
    19. Montreal Cognitive Assessment (MoCA) = 20
    20. Laboratory assessments showing moderate or severe hepatic impairment (2x ULN)
    Other Exclusions
    21. Allergy/sensitivity or contraindications to the investigational
    I partecipanti sono esclusi dallo studio se si applica uno dei seguenti criteri:
    Condizioni mediche
    1. Storia della procedura neurochirurgica, compresa la chirurgia stereotassica.
    2. Storia di Deep Brain Stimulation (DBS)
    3. Storia di disturbo bipolare, grave depressione, schizofrenia o altri disturbi psicotici.
    4. Anamnesi di abuso di droghe e / o alcol nei 12 mesi precedenti lo screening come definito dall'attuale edizionedel Diagnostic and
    Statistical Manual of Mental Disorders
    5. Storia della demenza (criteri DSM-V)
    6. Storia oftalmologica compresa una delle seguenti condizioni: albinismo, uveite, retinite pigmentosa, degenerazione retinica, retinopatia attiva, retinopatia diabetica progressiva grave, retinopatia ereditaria o storia familiare di malattia retinica ereditaria.
    7. Epatite attiva B o C
    8. Storia di infezione da virus dell'immunodeficienza umana (HIV)
    9. Soggetti non in grado di deglutire i farmaci orali
    10. Soggetti con sintomi ortostatici gravi
    11. Ambivalenza alterata, cioè caduta più di una volta alla settimana, pazienti costretti a letto o costretti su una sedia a rotelle durante l'intera giornata.
    12. Soggetti con neoplasie maligne attive.
    13. Disturbi del movimento diversi dalla MSA (ad esempio morbo di Parkinson, demenza con corpi di Lewy, tremore essenziale, paralisi sopranucleare progressiva, parkinsonismo farmacologico o postencefalico).
    14. Qualsiasi condizione medica o chirurgica clinicamente significativa o instabile che, secondo il parere dello sperimentatore, potrebbe precludere il completamento in sicurezza dello studio o potrebbe influenzare i risultati dello studio.
    Terapia preventiva / concomitante
    15. Non inregime stabile, per almeno 4 settimane prima della randomizzazione (visita basale), con levodopa orale (incluso rilascio controllato [CR], rilascio immediato [IR] o una combinazione di CR / IR), con o senza benserazide / carbidopa, con o senza aggiunta di un inibitore della catetolo O-metiltransferasi (COMT)
    o
    b. agonista della dopamina, anticolinergico e / o amantadina.
    Inclusione in uno studio clinico precedente / concomitante
    16. I pazienti non devono aver ricevuto un trattamento con inibitori della monoamino ossidasi nelle 2 settimane precedenti la visita di randomizzazione, né il trattamento con infusione di levodopa, petidina, oppiacei, oppioidi, fluoxetina, fluvoxamina nelle 4 settimane precedenti la visita di randomizzazione.
    17. I pazienti non devono aver ricevuto un trattamento con un neurolettico orale o di deposito entro 12 settimane prima della visita di randomizzazione.
    18. Uso di qualsiasi farmaco sperimentale entro 30 giorni prima dello screening o 5 emivite, qualunque sia la più lunga.
    Valutazioni diagnostiche
    19. Montreal Cognitive Assessment (MoCA) = 20
    20. Valutazioni di laboratorio con insufficienza epatica moderata o grave (2x ULN)
    Altre esclusioni
    21. Allergia / sensibilità o controindicazioni al farmaco sperimentale
    E.5 End points
    E.5.1Primary end point(s)
    • The nature, frequency, severity, relationship (to study drug), actions taken, and outcome of TEAEs and SAEs.
    • Changes in physical and neurological examination findings.
    • Changes in vital sign (heart rate, systolic and diastolic blood pressure) values, including occurrence of abnormalities.
    • Changes in 12-lead ECG parameter measures, including occurrence of abnormalities.
    • Changes in clinical chemistry and hematology values, including shifts from Baseline and occurrence of abnormalities.
    • Number of withdrawals (and reason if given).
    • La natura, la frequenza, la gravità, il rapporto (con il farmaco in studio), le azioni intraprese e l’esito degli eventi avversi emergenti dal trattamento (TEAE) e degli eventi avversi seri (SAE).
    • Variazioni dei risultati degli esami obiettivi e neurologici.
    • Variazioni dei valori dei segni vitali (frequenza cardiaca, pressione sanguigna sistolica e diastolica), compreso il verificarsi di anomalie.
    • Variazioni delle misurazioni dei parametri dell’ECG a 12 derivazioni, compreso il verificarsi di anomalie.
    • Variazioni dei valori di chimica clinica ed ematologia, comprese le variazioni dal valore basale e il verificarsi di anomalie.
    • Numero di ritiri (e motivazione, se indicata).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Outcome will be assessed after 12 weeks of treatment, when progression is unlikely to be a confounder of change.
    Il risultato sarà valutato dopo 12 settimane di trattamento, quando è improbabile che la progressione sia un fattore di confondimento del cambiamento.
    E.5.2Secondary end point(s)
    • The change from baseline to week 12 in the goniometric measurement for "lateral" displacement
    • Change from baseline at week 12 in Unified MSA Rating Scale, MSA Health-Related Quality of Life (MSA-QoL) scale, Montreal Cognitive Assessment (MoCA) scale, Unified Dystonia Rating Scale (UDRS).
    • La variazione dal valore basale alla settimana 12 nella misurazione goniometrica per lo spostamento “laterale”.
    • Variazione dal valore basale alla settimana 12 nella scala di valutazione unificata della MSA, nella scala della qualità della vita correlata alla salute relativa a MSA (MSA-QoL), nella scala di valutazione cognitiva di Montreal (MoCa), nella scala di valutazione unificata della distonia (UDRS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Outcome will be assessed after 12 weeks of treatmen
    Il risultato sarà valutato dopo 12 settimane di trattamento
    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 No
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 48
    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)
    Standard of Care
    Standard di cura
    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 Decision2019-08-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-05
    P. End of Trial
    P.End of Trial StatusCompleted
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