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    Summary
    EudraCT Number:2012-001245-40
    Sponsor's Protocol Code Number:FARM9X59Y4
    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:2013-05-17
    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 number2012-001245-40
    A.3Full title of the trial
    CLINICAL AND PHARMACOKINETICS STUDY TO EVALUATE THE THERAPEUTIC EQUIVALENCE AND BIOEQUIVALENCE OF LEVODOPA BENSERAZIDE GENERIC FORMULATION (TEVA ITALIA) VERSUS THE ORIGINATOR (MADOPAR®)
    STUDIO CLINICO E FARMACOCINETICO PER VALUTARE L'EQUIVALENZA TERAPEUTICA E LA BIOEQUIVALENZA DEL GENERICO LEVODOPA- BENSERAZIDE (TEVA ITALIA) VERSO L'ORIGINATOR (MADOPAR ®).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CLINICAL AND PHARMACOLOGICAL STUDY TO EVALUATE THE THERAPEUTIC EQUIVALENCE AND BIOEQUIVALENCE OF LEVODOPA BENSERAZIDE GENERIC FORMULATION (TEVA ITALIA) VERSUS THE ORIGINATOR (MADOPAR®)
    STUDIO CLINICO E FARMACOCINETICO PER VALUTARE L'EQUIVALENZA TERAPEUTICA E BIOCHIMICA DEL FARMACO ANTIPARKINSONIANO GENERICO LEVODOPA- BENSERAZIDE (TEVA ITALIA) VERSO IL FARMACO ORIGINALE (MADOPAR ®).
    A.4.1Sponsor's protocol code numberFARM9X59Y4
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    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 Madopar 200+50 mg
    D.2.1.1.2Name of the Marketing Authorisation holderRoche spa
    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.3.4Pharmaceutical 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 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.IMP: 2
    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 LEVODOPA / BENSERAZIDE 200 + 50 MG
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA ITALIA SRL
    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.3.4Pharmaceutical 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 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
    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 16.0
    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 primary objective of the study will be achieved if non-inferiority in improving motor symptoms (therapeutic equivalence) and bioequivalence in the primary pharmacokinetic parameters (total Area Under the Curve) of the generic levodopa/benserazide compared with originator will be demonstrated. The therapeutic equivalence will be measured with the Unified Parkinson's Disease rating scale (UPDRS) part III (total motor score). A reduction in UPDRS motor score indicates an improvement in the motor symptoms of Parkinson's disease. The bioequivalence will be assessed with the pharmacokinetic study taking the total Area Under the Curve (AUC) as the primary parameter.
    L'obiettivo primario e' quello di valutare l'equivalenza terapeutica, mediante scala UPDRS parte motoria (III), e la bioequivalenza, mediante studio del parametro farmacocinetico AUC, del generico della levodopa-benserazide (Teva Italia)
    confrontandolo con l'originator (Madopar) nei pazienti con malattia di Parkinson. L'obiettivo primario dello studio sarà raggiunto se sarà ottenuta una non inferiorità alla scala UPDRS (valutazione clinica) e una bioequivalenza nel parametro primario di farmacocinetica (AUC).
    E.2.2Secondary objectives of the trial
    Secondary clinical endpoints will the proportion of patients with a score of 1 or 2 (‘very much improved' or ‘much improved') on the Patient Clinical Global Impression - Global Improvement (CGI-I) scale. Secondary PK endpoints will be the bioequivalence in the following parameters: minimum concentration (Cmin), maximum concentration (Cmax), time to maximum concentration (Tmax) and the half life (t 1/2) after the last dose.
    Obiettivo secondario sarà quello di valutare con un questionario
    (CGI) l'indice di gradimento da parte dei pazienti. Obiettivo secondario di farmacocinetica Sarà quello di valutare la bioequivalenza nei seguenti end points secondari: concentrazione minima (Cmin),la concentrazione massima (Cmax),l'area sotto la curva (AUC), il tempo per raggiungere la concentrazione massima (Tmax) e l'emivita plasmatica dopo l'ultima dose (t1/2).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Population: 60 out-patients with a diagnosis of idiopathic Parkinson's disease for at least 5 years, receiving L-dopa, will be enrolled to participate into the study. The study will be performed in hospital setting using the facilities of the clinical trial centre in both sites involved in the study. The patients will be recruited within the patient population using the hospitals out-patients clinics. Recruitment timing will be 12 months.
    Inclusion Criteria:
    ° Subject must be >=30 and <=75 years of age, of either sex and of any race.
    ° Diagnosis of Parkinson's disease
    ° Subjects must be in Hoehn and Yahr stages 2 to 4.
    ° Subject must have good response to levodopa (>=30% improvement in the UPDRS score).
    ° Subject must have been on a stable regimen of L-dopa for at least 4 month before Screening.
    ° A female subject must be postmenopausal, or sterile or use a medically accepted method of contraception.
    Popolazione: Saranno arruolati nello studio 60 pazienti con malattia di Parkinson idiopatica da almeno 5 anni, rispondenti alla levodopa. Maschi o femmine di ogni etnia, di eta' tra i 30 e i 75 anni. Diagnosi clinica di Morbo di Parkinson (presenza di almeno 2 dei 3 sintomi cardinali - bradicinesia, rigidita', tremore e buona risposta alla levodopa >30% di miglioramento alla UPDRS). Hoehn & Yahr stadi da 2 a 4. Chiara risposta alla levodopa. Dosi stabili di levodopa (Madopar) da almeno 4 mesi prima di entrare nello studio. Pazienti donne in post-menopausa, oppure non in grado di avere una gravidanza o in terapia con anticoncezionali. Pazienti non dementi in grado di capire e dare il loro consenso informato allo studio.
    E.4Principal exclusion criteria
    ° Atypical Parkinsonism
    ° Subjects with very severe motor fluctuations and/or dyskinesias.
    ° Significant internal-medicine or psychiatric diseases.
    ° Subject's clinical laboratory tests outside the normal ranges.
    ° History of previous rabdomiolysis.
    ° Subjects in therapy with COMT-inhibitor.
    ° Subjects who participated in any other clinical trial in the 4 months before the screening.
    ° Any subject who is pregnant or breastfeeding.
    ° Subjects demented or not able to give informed consent to trial
    Parkinsonismo atipico. Pazienti con gravi fluttuazioni motorie e/o discinesie. Significanti malattie internistiche o psichiatriche. Valori di laboratorio alterati clinicamente significanti. Storia di episodi di rabdomiolisi. Pazienti in trattamento con inibitori delle COMT. Pazienti che hanno partecipato ad un protocollo clinico nelle ultime 6 settimane. Donne in gravidanza o allattamento. Pazienti dementi o non in grado di dare il loro consenso informato.
    E.5 End points
    E.5.1Primary end point(s)
    Change in UPDRS scores has been used as a primary outcome in a large number of clinical trial. In the present study part III (motor score) will be used as the primary outcome because the motor part is more sensitive to immediate changes and score all the motor symptoms of PD. The bioequivalence will be evaluated with the pharmacokinetic study taking the total Area Under the Curve (AUC) as the primary parameter.
    La variabile primaria di efficacia clinica sara' il cambiamento medio nel punteggio motorio (parte III) della scala UPDRS valutata alla fine dei periodi di trattamento, settimana 4 e 8 verso il periodo basale. La variabile primaria di bioequivalenza sara' nello studio di PK l’area sotto la curva totale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the study
    Alla fine dello studio
    E.5.2Secondary end point(s)
    Secondary PK endpoints will be the bioequivalence in the following parameters: minimum concentration (Cmin), Maximum concentration (Cmax), time to maximum concentration (Tmax) and the half life (t 1/2) after the last dose. Secondary clinical endpoints will the proportion of patients with a score of 1 or 2 (‘very much improved' or ‘much improved') on the Patient Clinical Global Impression-Global Improvement (CGI-I) scale and total UPDRS score.
    I parametri secondari di bioequivalenza saranno la concentrazione minima (Cmin), la concentrazione massima (Cmax), il tempo per raggiungere la concentrazione massima (Tmax) e l'emivita plasmatica dopo l'ultima dose (t1/2). La variabilita' nei livelli plasmatici durante la giornata sara' calcolata con la formula Cmax-Cmin. La variabile secondaria, gradimento del trattamento, sara' valutata mediante il questionario di CGI auto compilato dal paziente.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the study
    Alla 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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence Yes
    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 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 No
    E.8.1.6Cross over Yes
    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
    Originator verso generico
    Originator versus generic drug
    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 concerned2
    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 Yes
    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
    Ultima Visita dell'ultimo soggetto
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state60
    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)
    Choise of more effective treatment
    Scelta del trattamento più efficace
    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 Decision2013-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-18
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