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    Summary
    EudraCT Number:2014-002295-87
    Sponsor's Protocol Code Number:LDCD-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:2014-09-29
    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 number2014-002295-87
    A.3Full title of the trial
    A Phase IIa study to assess the safety, tolerability, plasma pharmacokinetics and efficacy of intermittent oral administration of standard levodopa/carbidopa vs. semi-continuous intra-oral administration of levodopa/carbidopa in patients with advanced Parkinson’s disease who suffer motor fluctuations.
    Studio di fase IIa per valutare la farmacocinetica, la sicurezza, l’efficacia e la tollerabilità della somministrazione orale intermittente di formulazioni standard di Levodopa/carbidopa verso somministrazione semi- continua intra-orale di levodopa/carbidopa in pazienti con Malattia di Parkinson avanzata affetti da fluttuazioni motorie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase IIa study to assess the safety, tolerability, plasma pharmacokinetics and efficacy of intermittent oral administration of standard levodopa/carbidopa vs. semi-continuous intra-oral administration of levodopa/carbidopa in patients with advanced Parkinson’s disease who suffer motor fluctuations.
    Studio di fase IIa per valutare la farmacocinetica, la sicurezza, l’efficacia e la tollerabilità della somministrazione orale intermittente di formulazioni standard di Levodopa/carbidopa verso somministrazione semi- continua intra-orale di levodopa/carbidopa in pazienti con Malattia di Parkinson avanzata affetti da fluttuazioni motorie
    A.4.1Sponsor's protocol code numberLDCD-001
    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 SponsorSynAgile Corporation
    B.1.3.4CountryUnited States
    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 supportSynAgile Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCIRM
    B.5.2Functional name of contact pointMichela Pilone
    B.5.3 Address:
    B.5.3.1Street AddressViale Zara 81
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20159
    B.5.3.4CountryItaly
    B.5.4Telephone number00390266825289
    B.5.6E-mailmichela.pilone@cirm.net
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 SINEMET 100 mg + 25 mg compresse
    D.2.1.1.2Name of the Marketing Authorisation holderMSD Italia S.r.l.
    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 nameSINEMET 100 mg + 25 mg compresse
    D.3.2Product code NA
    D.3.4Pharmaceutical form Oral suspension
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Parkinson's disease patients who suffer motor fluctuations will
    participate in the study
    Pazienti con Malattia di Parkinson avanzata affetti da fluttuazioni
    motorie.
    E.1.1.1Medical condition in easily understood language
    Parkinson's disease patients who suffer motor fluctuations will
    participate in the study
    Pazienti con Malattia di Parkinson avanzata affetti da fluttuazioni
    motorie.
    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 17.0
    E.1.2Level SOC
    E.1.2Classification code 10029205
    E.1.2Term Nervous system disorders
    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 assess the plasma pharmacokinetics of continuous intra-oral administration of LD/CD vs. intermittent administration of standard oral LD/CD
    Valutare la farmacocinetica plasmatica determinata dalla somministrazione semi-continua intra-orale della LD verso somministrazione intermittente di
    formulazioni standard per determinare se la prima sia in grado di
    garantire livelli plasmatici di LD più costanti.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of continuous intra-oral administration of
    LD/CD
    To assess the effect on PD motor function of continuous intra-oral
    infusion of LD/CD vs. intermittent administration of standard oral LD/CD
    Valutare la safety e la tollerabilità della somministrazione semi- continua intra-orale di
    LD.
    Valutare l'effetto sulle ore di off giornaliere della somministrazione semi- continua
    intra-orale confrontate con la somministrazione intermittente di
    formulazioni standard di LD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. PD diagnosis consistent with UK Brain Bank Criteria
    2. Good response to levodopa with at least 2 hours of wearing off
    episodes in judgment of investigator
    3. Stable doses of levodopa plus/minus other dopaminergic therapy
    (minimum of 4 weeks for each drug)
    4. MMSE score > 26
    5. Capable of providing informed consent
    6. No clinically significant medical, psychiatric or laboratory
    abnormalities in the judgment of the investigator.
    7. No history of psychosis or hallucinations in the past 6 months
    8. Women who are capable of child bearing must have a negative urine
    pregnancy test at screening visit and use an adequate contraceptive
    method throughout the study.
    1. Diagnosi di Malattia di Parkinson idiopatica in accordo con UK Brain
    Bank Criteria
    2. Buona risposta alla LD con almeno due ore di off giornalieri valutati
    dall'investigatore
    3. Dosaggio giornaliero stabile di LD e di tutti gli altri farmaci
    dopaminergici da almeno quattro settimane.
    4. Punteggio MMSE > 26 allo screening.
    5. Soggetti in grado di fornire Consenso Informato.
    6. Assenza di qualsiasi patologia medica o psichiatrica o di qualsiasi
    alterazione dei parametri di laboratorio giudicata rilevante
    dall'investigatore.
    7. Assenza di storia clinica di psicosi e/o allucinazioni nei precedenti 6
    mesi.
    8. Le donne in età fertile dovranno avere un test di gravidanza negativo
    allo screening ed usare un metodo anticoncezionale adeguato durante
    tutto l'arco dello studio.
    E.4Principal exclusion criteria
    1. Atypical or secondary parkinsonism
    2. Severe dyskinesia that might interfere with study performance in
    judgment of investigator
    3. Patient receiving duodopa, apomorphine infusion or DBS
    4. Dysphagia or sialorrhea that might interfere with administration of
    study intervention
    5. Any relevant medical, surgical, or psychiatric condition, laboratory
    value, or concomitant medication which, in the opinion of the
    Investigator, would interfere with performing a pharmacokinetic study
    or would interfere with drug absorption.
    1. Parkinsonismo atipico o secondario
    2. Movimenti involontari di grado severo che possano interferire con lo
    svolgimento dello studio secondo il giudizio dell'investigatore.
    3. Presenza di qualsiasi patologia medica o psichiatrica o di qualsiasi
    alterazione dei parametri di laboratorio giudicata rilevante
    dall'investigatore ed in grado di interferire con lo studio di
    farmacocinetica e con l'assorbimento della LD.
    4. Presenza di disfagia e di scialorrea tali da interferire con
    l'assorbimento della LD somministrata per via intra-orale.
    5. Pazienti in trattamento con duodopa e con infusione di apomorfina
    o che abbiano ricevuto trattamento con DBS (Deep Brain Stimulation).
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetic: The primary outcome measure will be the variability in
    the observed plasma concentration of levodopa as assessed with the
    fluctuation index (Fluctuation index = (Cmax-Cmin)/Caverage).
    Parametri di Farmacocinetica: variabilità osservata nelle concentrazioni
    di levodopa valutate mediante Fluctuation index (Fluctuation index =
    (Cmax-Cmin)/Caverage).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The hourly time points are as follows: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5,
    5, 5.5, 6, 6.5, 7, 7.5, and 8, on Days 2 and 3
    I punti temporali orarie sono le seguenti: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4,
    4.5, 5, 5.5, 6, 6.5, 7, 7.5, and 8, nei giorni 2 e 3
    E.5.2Secondary end point(s)
    Pharmacokinetic: Secondary outcome measures will include assessment
    of variability using the coefficient of variation (CV). Exploratory
    measures will include assessments of levodopa Cmax, Tmax, and AUC.
    Plasma PK of carbidopa, HVA, DOPAC, and 3-OMD will also be assessed.
    Safety: Safety will be assessed by descriptive reporting of adverse
    events (frequency and severity)
    Tolerability: Tolerability will be assessed by percentage of subjects that
    complete the trial on given treatment assignment.
    Efficacy: Efficacy will be measured by the number of off hours in 8-hour
    day as determined by physician evaluations and in the change in the
    UPDRS between the baseline and mean of 2, 4, and 8-hour evaluations
    Parametri di Farmacocinetica: Valutazione della variabilità mediante
    Coefficiente di variazione. Determinazione della farmacocinetica della
    levodopa con calcolo di Cmax, Tmax, e AUC; farmacocinetica plasmatica
    della carbidopa, HVA, DOPAC e 3-OMD.
    Safety: la safety verrà valutata mediante report descrittivo di ogni
    eventuale evento avverso registrato (frequenza e gravità).
    Tollerabilità: la tollerabilità verrà valutata mediante calcolo della
    percentuale di soggetti che avranno completato il trial per ciascun
    trattamento assegnato.
    Efficacia: l'efficacia verrà valutata mediante la determinazione del
    numero delle ore di off, obiettivate dall'investigatore, sulle 8 ore totali
    di osservazione e mediante la variazione del punteggio UPDRS riportato
    al basale e la media dei punteggi UPDRS rportati a 2, 4, and 8 ore di
    osservazione.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Pharmacokinetic :The hourly time points are as follows: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8, on Days 2 and 3
    Safety: descriptively by D2, D3, and D4 and cumulative safety
    Tolerability: Baseline to D2, Baseline to D3 and Baseline to D4
    Efficacy: every half hour over 8 hour period and at hours 2,4, and 8
    Parametri di Farmacocinetica: I punti temporali orarie sono le seguenti: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8, on nei giorni 2 e 3
    Sicurezza: descrittivamente da D2, D3, D4 e la sicurezza e cumulativa
    La tollerabilità: Baseline al D2, Baseline a D3 e Baseline a D4
    Efficacia: ogni mezz'ora su un periodo di 8 ore e ad ore 2,4, e 8
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    stesso farmaco, somministrato in modalità differente
    same drug, administered in different ways
    E.8.2.4Number of treatment arms in the trial2
    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.8.5The 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
    The study has not yet started
    Lo studio non e ancora iniziato
    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 months5
    E.8.9.1In the Member State concerned 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: 13
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 18
    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)
    Plans for treatment or care after the subject has ended his/her participation in the trial
    I piani per il trattamento o la cura dopo che il soggetto ha concluso il suo / la sua partecipazione alla sperimentazione
    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 Decision2014-10-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-10-07
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