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    Summary
    EudraCT Number:2018-004112-21
    Sponsor's Protocol Code Number:VorDE-PD
    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:2021-06-04
    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 number2018-004112-21
    A.3Full title of the trial
    TOLERABILITY, SAFETY AND EFFICACY OF VORTIOXETINE FOR TREATMENT OF DEPRESSION IN PARKINSON’S DISEASE: A 16 WEEK OPEN LABEL STUDY
    STUDIO IN APERTO PER VALUTARE TOLLERABILITA’, SICUREZZA ED EFFICACIA DEL TRATTAMENTO CON VORTIOXETINA NEI PAZIENTI PARKINSONIANI AFFETTI DA DEPRESSIONE.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TOLERABILITY, SAFETY AND EFFICACY OF VORTIOXETINE FOR TREATMENT OF DEPRESSION IN PARKINSONIAN PATIENTS
    TOLLERABILITA’, SICUREZZA ED EFFICACIA DELLA VORTIOXETINA NELLA CURA DELLA DEPRESSIONE NEI PAZIENTI PARKINSONIANI
    A.3.2Name or abbreviated title of the trial where available
    VorDE-PD
    VorDE-PD
    A.4.1Sponsor's protocol code numberVorDE-PD
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS San Raffaele Pisana
    B.5.2Functional name of contact pointDirezione Scientifica
    B.5.3 Address:
    B.5.3.1Street AddressVia di Val Cannuta 247
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00166
    B.5.3.4CountryItaly
    B.5.4Telephone number0652253405
    B.5.6E-mailastrid.vanrijn@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 BRINTELLIX - 20 MG/ML - GOCCE ORALI, SOLUZIONE - USO ORALE - FLACONE (VETRO) 15 ML - 1 FLACONE
    D.2.1.1.2Name of the Marketing Authorisation holderH. LUNDBECK A/S
    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 nameBrintellix
    D.3.2Product code [N06AX26]
    D.3.4Pharmaceutical form Oral drops, solution
    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 INNVORTIOXETINA BROMIDRATO
    D.3.9.1CAS number 508233-74-7
    D.3.9.2Current sponsor codeVORTIOXETINA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Depression in Parkinson's disease
    Depressione in malattia di Parkinson
    E.1.1.1Medical condition in easily understood language
    Depression in Parkinson's disease
    Depressione in 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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10034007
    E.1.2Term Parkinson's disease NOS
    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 primary endpoint of this study will be to verify safety and tolerability of vortioxetine in the treatment of sustained depression in Parkinson's disease. Safety will be assessed through the recording of treatment emergent adverse events (TEAE) and vital signs in each study visits and laboratory tests, ECG, physical and neurological examination at baseline and End of study. The non worsening of motor disability evaluated through Unified Parkinson’s Disease Rating Scale (UPDRS) will be the tolerability end point.
    L'obiettivo primario di questo studio IIT è verificare la sicurezza e la tollerabilità della vortioxetina nei pazienti parkinsoniani affetti da depressione.
    E.2.2Secondary objectives of the trial
    The secondary endpoint will be to demonstrate the efficacy on depression: efficacy measures will include Hamilton Depression Rating Scale (HAM-D-17), Beck Depression Inventory (BDI), CGI-S and CGI-I.
    L’obiettivo secondario sarà quello di valutare l’efficacia del trattamento sull’assetto cognitivo e sulla depressione.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male and female of every ethnic group, age 30 to 80 years
    • Diagnosis of Parkinson’s disease according UK Brain Bank Criteria
    • Hoehn &Yahr: stage 1 to 3
    • Patients with diagnosis of sustained depression
    • Hamilton Depression Rating Scale score (HAM-D-17) = 14
    • Beck Depression Inventory score (BDI)=13
    • Stable doses of antiparkinsonian drugs for at least 4 weeks.
    • Patients able to understand and provide written informed consent
    • 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 PD in accordo ai criteri della UK Brain Bank
    • Hoehn&Yahr: stadi da 1 a 3.
    • Pazienti con diagnosi didepressione diagnosticata in accordo con il Manuale diagnostico e statistico dei disturbi mentali, Quinta Edizione (DSM-V).
    • Punteggio alla Hamilton Depression Rating Scale (HAM-D-17) = 14
    • Punteggio totale alla Beck Depression Inventory (BDI)=13
    • Dosi stabili di farmaci antiparkinsoniani da 4 settimane.
    • Pazienti donne in post-menopausa, oppure non in grado di avere una gravidanza o in terapia con anticoncezionali.
    • Pazienti in grado di comprendere e fornire consenso informato
    E.4Principal exclusion criteria
    • Atypical Parkinsonism.
    • Subjects at risk of suicide (with a score = 3 at the Item 3 of the HAM-D-17)
    • Any significant psychiatric, metabolic and systemic significant concomitant disease
    • Patients with clinically significant out of range laboratory values
    • Patients with history of epileptic seizures
    • Subjects with Dopa Dysregulation Syndrome (DDS)
    • Subjects treated with irreversible IMAO and IMAO-A
    • Use of vortioxetine in the past 30 days
    • Patient treated with oral anticoagulant
    • 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
    • Parkinsonismo atipico.
    • Malattie psichiatriche significative.
    • Pazienti a rischio di suicidio o che hanno riportato uno score = 3 all’Item 3 della HAM-D-17
    • Valori di laboratorio significativamente alterati
    • Patologia internistiche clinicamente rilevanti e non stabili.
    • Pazienti che hanno una storia di convulsioni o pazienti con epilessia.
    • Pazienti con DDS (Dopa Dysregulation syndrome)
    • Uso di vortioxetina nei passati 30 giorni
    • Pazienti che hanno partecipato ad un protocollo clinico nelle ultime 6 settimane.
    • Pazienti donne in gravidanza o allattamento.
    • Pazienti con declino cognitivo di grado moderato-severo non in grado di fornire consenso informato.
    • Pazienti in terapia con anticoagulanti
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study will be to verify safety and tolerability of vortioxetine in the treatment of sustained depression in PD. Safety will be assessed through the recording of treatment emergent adverse events (TEAE) and vital signs in each study visits and laboratory tests, ECG, physical and neurological examination at baseline and End of study. The non worsening of motor disability evaluated through Unified Parkinson’s Disease Rating Scale (UPDRS) will be the tolerability end point.
    L'obiettivo primario di questo studio IIT è verificare la sicurezza e la tollerabilità della vortioxetina nei pazienti parkinsoniani affetti da depressione.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of study. The treatment period will be in 16 weeks per patients
    Fine studio. La durata complessiva dello studio prevista è 16 settimane per ogni paziente
    E.5.2Secondary end point(s)
    The secondary endpoint will be to demonstrate the efficacy on depression: efficacy measures will include Hamilton Depression Rating Scale (HAM-D-17), Beck Depression Inventory (BDI), CGI-S and CGI-I.
    L’obiettivo secondario sarà quello di valutare l’efficacia del trattamento sull’assetto cognitivo e sulla depressione.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of study. The treatment period will be in 16 weeks per patients,
    Fine studio. La durata complessiva dello studio prevista è 16 settimane per ogni paziente
    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 No
    E.6.5Efficacy No
    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 No
    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.8.2.4Number of treatment arms in the trial1
    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.8.6 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
    last visit of the last subject: LVLS
    ultima visita dell'ultimo soggetto: 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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)
    At the end of the study the patients will continue to be followed in the usual procedures of clinical practice. the treatment can be continued as necessary
    Alla fine dello studio i pazienti continueranno ad essere seguiti nelle abituali procedure della pratica clinica. il trattamento potrà essere continuato secondo necessità
    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 Decision
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-17
    P. End of Trial
    P.End of Trial StatusCompleted
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