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    Summary
    EudraCT Number:2010-019894-13
    Sponsor's Protocol Code Number:PPMI-001
    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:2012-03-02
    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 number2010-019894-13
    A.3Full title of the trial
    The Parkinson's Progression Markers Initiative (PPMI)
    I Marcatori di Progressione della Malattia di Parkinson
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The Parkinson's Progression Markers Initiative (PPMI)
    I Marcatori di Progressione della Malattia di Parkinson
    A.3.2Name or abbreviated title of the trial where available
    PPMI
    PPMI
    A.4.1Sponsor's protocol code numberPPMI-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01141023
    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 SponsorMICHAEL J. FOX FOUNDATION FOR PARKINSON'S RESEARCH
    B.1.3.4CountryUnited States
    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 supportMichael J. Fox Foundation
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportGE Healthcare
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportPfizer Global Research and Development
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportMerck and Company
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportGenetech
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitute for Neurodegenerative Disorders
    B.5.2Functional name of contact pointPPMI Trial Principal Investigator
    B.5.3 Address:
    B.5.3.1Street Address60 Temple Street
    B.5.3.2Town/ cityNew Haven
    B.5.3.3Post code06510
    B.5.3.4CountryUnited States
    B.5.4Telephone number203 401 4323
    B.5.5Fax number203 401 4303
    B.5.6E-mailslash@indd.org
    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 DaTSCAN
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIOFLUPANE (123I)
    D.3.9.1CAS number 155798-07-5
    D.3.9.4EV Substance CodeSUB08221MIG
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number111 to 185
    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 Yes
    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 Disease
    Malattia di Parkinson
    E.1.1.1Medical condition in easily understood language
    Early Parkinson Disease
    Malattia di Parkinson in fase precoce
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To identify clinical, imaging and biologic markers pf Parkinson Disease (PD) progression for use in clinical trials of disease-modifying therapies.
    Identificare marcatori clinici, radiologici e biologici della progressione della Malattia di Parkinson (MP) da utilizzare in studi clinici di terapie modificanti la malattia.
    E.2.2Secondary objectives of the trial
    Establish standardized protocols for acquisition, transfer, analysis of clinical,imaging, biologic data that can be used by the PD research community. Develop a comprehensive and uniformly acquired clinical and imaging dataset and biological samples that can be used to estimate the mean rates of change and the variability around the mean of clinical, imaging and biomic outcomes in early PD patients. Investigate existing and identify novel clinical, imaging, and biomic PD progression markers to identify quantitative individual measures or combination of measures that demonstrate optimum interval change in PD patients in comparison to healthy controls or in sub-sets of PD patients defined by baseline assessments, progression milestones and/or rate of clinical, imaging, or biomic change.Conduct preliminary verification studies on promising biological markers using stored collected samples.
    Stabilire protocolli standardizzati per acquisizione trasferimento analisi di dati clinici radiologici biologici, utilizzabili nell'ambito della comunità scientifica.Sviluppare una completa uniforme raccolta di dati clinici radiologici biologici,per valutare il tasso di variazione e la variabilità rispetto alla media dei risultati clinici radiologici biologici in pazienti con MP precoce. Ricercare noti e nuovi possibili marcatori di progressione di malattia, clinici radiologici biologici, per identificare misure quantitative individuali, o in combinazione, che dimostrino l’intervallo ottimale del cambiamento, in pazienti con MP rispetto ai controlli sani o in sottogruppi con MP, definiti da valutazioni essenziali di progessione e/o tasso di variazione delle caratteristiche cliniche radiologiche biologiche.Condurre studi su marcatori biologici, sui campioni raccolti e conservati.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Parkinson Disease(PD)Subjects: 1.Patients must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia); OR either asymmetric resting tremor or asymmetric bradykinesia. 2.A diagnosis of Parkinson disease for two years or less at Screening. 3.Hoehn and Yahr stage I or II. 4.Confirmation from imaging core that screening DAT scan is consistent with dopamine transporter deficit. 5.Not expected to require PD medication with at least 6 months from Baseline. 6.Male or female age 30 years or older at time of PD diagnosis. Healthy Control (HC)Subjects: 1.Male or female age 30 years or older at Screening. 2.Confirmation from imaging core that screening DAT scan is consistent with no dopamine transporter deficit.
    Pazienti affetti da malattia di Parkinson: 1.Pazienti con almeno due dei seguenti sintomi: tremore a riposo, bradicinesia, rigidità (deve essere presente tremore a riposo o bradicinesia); OPPURE tremore a riposo asimmetrico o bradicinesia asimmetrica; 2.Diagnosi di malattia di Parkinson da 2 anni o meno, alla visita di Screening 3.Stadio Hoehn & Yahr I o II; 4.Conferma, dalla struttura centrale di lettura Imaging, del deficit dopaminergico all’esame radiologico DAT-Scan alla visita di Screening; 5.Pazienti per i quali non si prevede trattamento farmacologico per la MP, per almeno 6 mesi dalla visita basale; 6.Maschi o femmine di età uguale o superiore a 30 anni al momento della diagnosi di malattia di Parkinson. Soggetti sani: 1.Maschi o femmine di età uguale o superiore a 30 anni alla visita di Screening 2.Conferma, dalla struttura centrale di lettura Imaging, di assenza del deficit dopaminergico all’esame radiologico DAT-Scan alla visita di Screening.
    E.4Principal exclusion criteria
    Parkinson Disease (PD) Subjects: 1.Currently taking levodopa, dopamine agonists, MAO-B inhibitors, amantadine or other PD medication. 2.Has taken levodopa, dopamine agonists, MAO-B inhibitors or amantadine within 60 days of Baseline. 3.Has taken levodopa or dopamine agonists prior to Baseline for more than a total of 60 days. 4.Received any of the following drugs that might interfere with DAT imaging: Neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of Screening. 5.Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture. 6.Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia. 7.Use of investigational drugs or devices within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary,e.g., coenzyme Q10). Healthy Control (HC) Subjects: 1.Current or active neurological disorder. 2.First degree relative with idiopathic PD (parent, sibling, child). 3.MoCA score ≤ 26. 4.Received any of the following drugs that might interfere with DAT imaging: Neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 6 months of Screening. 5.Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture. 6.Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia. 7.Use of investigational drugs or devices within 60 days prior to baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).
    Pazienti affetti da malattia di Parkinson: 1.Pazienti in corrente terapia con L-dopa, dopaminoagonisti, inibitori-MAO-B, amantadina o altri farmaci per la malattia di Parkinson. 2.Pazienti che hanno effettuato terapia con L-dopa, dopaminoagonisti, inibitori-MAO-B o amantadina, entro 60 giorni dalla visita Basale. 3.Pazienti che assunto L-dopa, dopaminoagonisti prima della visita Basale per un totale maggiore di 60 giorni. 4.Pazienti che hanno assunto i seguenti farmaci che possono interferire con l’esame SPECT DAT-scan (neurolettici, metoclopramide, alfa-metildopa, metilfenidato, reserpina o derivati anfetaminici) entro 6 mesi dalla visita di Screening. 5.Pazienti in corrente trattamento con anticoagulanti (per es. coumadin, eparina) che possono precludere il completamento in sicurezza della puntura lombare 6.Condizioni che precludono la sicurezza di esecuzione della normale puntura lombare (malformazione della colonna lombare, diatesi emorragica, o coagulopatia clinicamente significativa o trombocitopenia). 7.Pazienti in trattamento con farmaci o dispositivi medici sperimentali, entro i 60 giorni precedenti la visita Basale (trattamenti dietetici assunti al di fuori di uno studio clinico non sono da considerare criterio di esclusione, ad esempio il Coenzima Q10). Soggetti sani: 1.Presenza corrente o attiva di malattie neurologiche. 2.Parenti di primo grado affetti da malattia di Parkinson (genitore, fratello/sorella, figlio). 3.MoCA score inferiore o uguale a 26. 4.Soggetti che hanno assunto i seguenti farmaci che possono interferire con l’esame radiologico DAT-scan (neurolettici, metoclopramide, alfa-metildopa, metilfenidato, reserpina o derivati anfetaminici), entro 6 mesi dalla visita di Screening. 5.Pazienti in trattamento corrente con anticoagulanti (per es. coumadin, eparina) che possono precludere il completamento in sicurezza della puntura lombare 6.Condizioni che precludono la sicurezza di esecuzione della normale puntura lombare (malformazione della colonna lombare, diatesi emorragica, o coagulopatia clinicamente significativa o trombocitopenia). 7.Pazienti in trattamento con farmaci o dispositivi medici sperimentali, entro i 60 giorni precedenti la visita Basale (trattamenti dietetici assunti al di fuori di uno studio clinico non sono da considerare criterio di esclusione, ad esempio il Coenzima Q10).
    E.5 End points
    E.5.1Primary end point(s)
    The mean rates of change and the variability around the mean of clinical, imaging and biomic outcomes in early PD patients, and where appropriate the comparison of these rates between PD patient subsets and between PD and healthy subjects at study intervals from 3 months to 36 months. Specific examples of outcomes include MDS-UPDRS, DAT striatal uptake, and serum and CSF alpha-synuclein. PD patient subsets may be defined by baseline assessments, progression milestones and/or rate of clinical, imaging, or biomic change.
    Gli indici medi di variazione e la variabilità intorno alla media dei risultati clinici, radiologici e biologici nei pazienti con MP in fase precoce, e dove possibile il confronto di questi risultati tra sottogruppi di pazienti con MP e tra pazienti con MP e soggetti sani, agli intervalli dello studio da 3 a 36 mesi. Specifici esempi di outcome includono MDS-UPDRS, la captazione striatale del DAT-scan e livelli di alfa-sinucleina sierica e nel liquor . Sottogruppi di pazienti con MP possono essere definiti da valutazioni basali, criteri essenziali di progressione e/o grado di cambiamento delle caratteristiche cliniche, radiologiche o biologiche.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Intermittently throughout the study. The Clinical Study Oversight Committee reviews data every six months.
    Periodicamente nel corso dello studio. La Commissione Clinica di Vigilanza dello studio valuterà i dati ogni 6 mesi.
    E.5.2Secondary end point(s)
    a)Correlations between the rates of change in the mean of clinical, imaging and biomic outcomes in early PD patient subsets and between PD and healthy subjects at study intervals from 3 months to 36 months. b) Prevalence of measures of clinical, imaging and biomic outcomes in early PD patients and healthy subjects at study intervals from baseline to 36 months. c) To establish the predictive value of early clinical non-motor features, baseline imaging and biomic outcomes for future course of disease.
    1.Correlazioni tra i gradi medi di variazione dei risultati clinici, radiologici e biologici nei sottogruppi di pazienti con MP in fase precoce e tra pazienti con MP e soggetti sani, agli intervalli dello studio da 3 a 36 mesi. 2.Prevalenza delle valutazioni dei risultati clinici, radiologici e biologici in pazienti con MP in fase precoce e soggetti sani, agli intervalli dello studio, dal basale a 36 mesi. 3. Stabilire il valore predittivo delle caratteristiche cliniche non-motorie iniziali, la radiologia basale e i risultati biologici, per il decorso futuro della malattia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Intermittently throughout the study. The Clinical Study Oversight Committee reviews data every six months.
    Periodicamente nel corso dello studio. La Commissione Clinica di Vigilanza dello studio valuterà i dati ogni 6 mesi.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Biomarkers
    Biomarkers
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Studio caso-controllo
    Case-control study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Studio caso-controllo
    Case-control study
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    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 years5
    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 years5
    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.1.1Number of subjects for this age range: 0
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 600
    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)
    This is not a treatment trial.
    Questo non è uno studio con un trattamento.
    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 Decision2012-02-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-17
    P. End of Trial
    P.End of Trial StatusCompleted
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