Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42568   clinical trials with a EudraCT protocol, of which   7009   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-000262-30
    Sponsor's Protocol Code Number:EXN-32-CD-002
    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:2020-11-04
    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 number2017-000262-30
    A.3Full title of the trial
    Efficacy, Safety, Tolerability and Pharmacokinetics of EXN-32 and EXN-44 in patients with Parkinson¿s Disease experiencing motor fluctuations
    Efficacy, Safety, Tolerability and Pharmacokinetics of EXN-32 and EXN-44 in patients with Parkinson¿s Disease experiencing motor fluctuations
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy, Safety, Tolerability and Pharmacokinetics of EXN-32 and EXN-44 in patients with Parkinson¿s Disease experiencing motor fluctuations
    ¿Efficacia, sicurezza, tollerabilit¿ e farmacocinetica di EXN-32 e EXN-44 in pazienti con malattia di Parkinson¿s con fluttuazioni motorie¿
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberEXN-32-CD-002
    A.5.4Other Identifiers
    Name:NANumber:NA
    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 SponsorDR. REDDY’S LABORATORIES LIMITED
    B.1.3.4CountryIndia
    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 supportDr. Reddy's Laboratories Limited
    B.4.2CountryIndia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTFS Trial Form Support
    B.5.2Functional name of contact pointClinical Operation
    B.5.3 Address:
    B.5.3.1Street AddressVia Lucrezio Caro, 63
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00193
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 068076072
    B.5.5Fax number+39 068076085
    B.5.6E-mailpaola.tiradritti@tfscro.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 No
    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 nameEXN-44(LEVODOPA)
    D.3.2Product code EXN-44
    D.3.4Pharmaceutical form Oral suspension
    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.3.9.1CAS number 59-92-7
    D.3.9.2Current sponsor codena
    D.3.9.4EV Substance CodeSUB08468MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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.IMP: 2
    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
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Limited
    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 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.3.9.1CAS number 28860-95-9
    D.3.9.2Current sponsor codecarbipoda
    D.3.9.4EV Substance CodeSUB06126MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 59-92-7
    D.3.9.2Current sponsor codeEXN-44
    D.3.9.4EV Substance CodeSUB08468MIG
    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.IMP: 3
    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 No
    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 nameEXN-32 (CARBIDOPA E LEVODOPA)
    D.3.2Product code EXN-32
    D.3.4Pharmaceutical form Oral 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.3.9.1CAS number 38821-49-7
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB06126MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 59-92-7
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB08468MIG
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    Parkinson's Desease (PD)
    Malattia di Parkinson.
    E.1.1.1Medical condition in easily understood language
    Parkinson's Desease (PD)
    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 21.1
    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
    To evaluate following pharmacodynamic properties of EXN-32 and EXN-44, and compare them with SINEMET¿.
    ¿ Time to resolution of ¿OFF¿ period following administration of EXN-32 and EXN-44.
    ¿ Duration of ¿ON¿ period following dosing.
    ¿ Proportion of patients evaluated to be in the ¿ON¿ state at 05, 15, 30, 60, 90, and 120 minutes after administration of EXN-32, and EXN-44.
    ¿ UPDRS Part III motor score at 10, 20, 30, 60, 90, and 120 minutes after each dose of study medication in each period.
    ¿ To estimate the pharmacokinetic profiles of levodopa and carbidopa.
    ¿ Maximum plasma concentration (Cmax).
    ¿ Time to reach maximum plasma concentration (Tmax).
    ¿ Area under the concentration-time curve from time zero to last measured concentration (AUC0-t).
    ¿ Valutare le propriet¿ farmacodinamiche di EXN-32 ed EXN-44 indicate di seguito, e confrontarle con quelle di SINEMET¿:
    ¿ Tempo di risoluzione del periodo "OFF" dopo la somministrazione di EXN-32 ed EXN-44;
    ¿ Durata del periodo "ON" dopo la somministrazione della dose;
    ¿ Percentuale di pazienti secondo la valutazione, si trovano in stato ¿ON¿ dopo 5, 15, 30, 60, 90 e 120 minuti dalla somministrazione di EXN-32 ed EXN-44.
    ¿ punteggio UPDRS III (parte motoria) a 10, 20, 30, 60, 90 e 120 minuti dopo ogni somministrazione della dose del farmaco in studio in ciascun periodo.
    ¿ Valutare i profili farmacocinetici di levodopa e carbidopa:
    ¿ Massima concentrazione plasmatica (Cmax);
    ¿ Tempo al raggiungimento della massima concentrazione plasmatica (Tmax);
    ¿ Area sotto la curva concentrazione-tempo, dal tempo zero all'ultima concentrazione misurata (AUC0-t).
    E.2.2Secondary objectives of the trial
    - The secondary study objective of the trial are as follows:
    - Pharmacokinetic / Pharmacodynamic relationship.
    - Safety and tolerability.
    Gli obiettivi secondari dello studio sono i seguenti:
    ¿ Valutare il rapporto farmacocinetica-farmacodinamica;
    ¿ Valutare la sicurezza e la tollerabilit¿.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Diagnosis of Idiopathic Parkinson’s Disease (according to modified Hoehn and Yahr Criteria Stages I - IV) (may allow stage IV in and “ON” period).
    ¿ Patients’ receiving stable regimen of levodopa for at least one month before screening with or without concomitant therapy with dopamine agonists, COMT inhibitors, MAO-B inhibitors, or amantadine.
    ¿ Patient suffering from at least three “OFF” periods on an average per day for last one months (including one in the morning).
    ¿ Subjects, male and female, aged 40 years or higher.
    ¿ Provide written informed consent.
    ¿ Be willing and able to comply with the study procedures.
    • Diagnosi di Malattia di Parkinson Idiopatica (con uno stadio I-IV secondo la stadiazione di Hoehn e Yahr modificata, lo stadio IV potrebbe essere ammesso in un periodo "ON");
    • Pazienti trattati con un regime stabile di levodopa per almeno un mese prima dello screening in associazione o meno a una terapia concomitante con agonisti della dopamina, inibitori della COMT, inibitori delle MAO-B o amantadina
    • Pazienti che manifestino almeno tre periodi di "OFF" in media al giorno nell'ultimo mese (compreso uno al mattino);
    • Soggetti di sesso maschile e femminile di età pari o superiore a 40 anni;
    • Firma del consenso informato ;
    • Disponibilità e capacità di aderire alle procedure dello studio.
    E.4Principal exclusion criteria
    ¿ Atypical or secondary Parkinsonism.
    ¿ Lack of response to levodopa.
    ¿ Any dopamine receptor-blocking agent or non-selective MAO inhibitors.
    ¿ Dyskinesia disability score > 3 from UPDRS.
    ¿ Previous stereotactic surgery.
    ¿ Any participation in a clinical trial in the previous 6 months.
    ¿ Current or previous (within last 12 months) history of alcohol or substance abuse.
    ¿ Malignant melanoma or suspicious undiagnosed skin lesion.
    ¿ Narrow-angle glaucoma.
    ¿ Hypersensitivity to levodopa.
    ¿ Myocardial infarction with residual problems, abnormal kidney function, or abnormal liver transaminase values.
    Contraception requirements (in case of female subjects of child bearing potential):
    Females must either be postmenopausal with no menses for at least 12 months or surgically sterile (hysterectomy or tubal ligation) or agree to use a highly effective method of contraception with a pearl index of <1% up to 1 month after last dose. Contraception methods with low user dependency should preferably be used, in particular when
    contraception is introduced as a result of participation in this clinical study. Highly effective’ methods of birth control include*:
    ¿ combined (estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation:
    o oral
    o intravaginal
    o transdermal
    ¿ progesterone-only hormonal contraception associated with inhibition of ovulation*:
    o oral
    o injectable
    o implantable†
    ¿ intra-uterine device (IUD)†
    ¿ intra-uterine hormone releasing system (IUS)†
    ¿ bilateral tubular occlusion†
    ¿ vasectomy of sexual partner that was performed at least 90 days prior to Baseline, and has been medically assessed as successful†
    ¿ sexual abstinence
    o Note: Sexually inactive female subjects may be enrolled at the investigator’s discretion provided that they are counselled to refrain from heterosexual intercourse for the duration of the study and for one month after the last dose, and understand the possible risks involved in getting pregnant during the study.
    *Hormonal methods: If on hormonal contraceptives, must have been on the same hormonal contraceptive product for 3 months (90 days) prior to Baseline
    and continued on same method and dose throughout the duration of the study.
    If subject had used hormonal birth control and had stopped, this should have occurred more than 6 months prior to Baseline. Female subjects on low dose oral contraceptives (containing =35 µg of ethinyl estradiol or equivalent dose of other estrogens) must use a second form of contraceptive during the study.
    †Contraception methods that are considered to have low user dependency.
    • Parkinsonismo atipico o secondario;
    • Assenza di risposta alla levodopa;
    • Terapia con qualsiasi agente bloccante dei recettori dopaminergici o inibitori delle MAO non selettivi;
    • Punteggio di disabilità dovuta alla discinesia >3 in base alla scala UPDRS;
    • Precedente intervento chirurgico stereotassico;
    • Partecipazione ad una sperimentazione clinica nei 6 mesi precedenti;
    • Anamnesi attuale o precedente (negli ultimi 12 mesi) di alcolismo o tossicodipendenza;
    • Melanoma maligno o lesione cutanea sospetta non diagnosticata;
    • Glaucoma ad angolo chiuso;
    • Ipersensibilità a levodopa;
    • Infarto del miocardio associato a problemi residui, funzione renale anomala o valori anomali delle transaminasi epatiche.
    Requisiti di contraccezione (in caso di soggetti femminili in età fertile):
    Le donne devono essere in postmenopausa, senza mestruazioni da almeno 12 mesi o chirurgicamente sterili (isterectomia o legatura delle tube), oppure disposte a utilizzare un metodo contraccettivo altamente efficace con un indice di Pearl pari a <1%, fino a 1 mese dopo l'ultima dose. È preferibile utilizzare metodi di contraccezione a bassa dipendenza dall’utilizzatore, in particolare quando la contraccezione viene introdotta come conseguenza della partecipazione a questo studio clinico. I metodi “altamente efficaci” di controllo delle nascite includono*:
    • contraccezione ormonale combinata (contenente estrogeni e progestinici) associata a inibizione dell’ovulazione:
    o orali
    o intravaginali
    o transdermici
    • contraccezione ormonale a base di solo progesterone associata a inibizione dell’ovulazione*:
    o orali
    o iniettabili
    o impiantabile†
    • dispositivo intrauterino (IUD)†
    • sistema intrauterino a rilascio ormonale (IUS)†
    • chiusura bilaterale delle tube†
    • vasectomia del partner sessuale eseguita almeno 90 giorni prima del basale, e considerata dal punto di vista medico come riuscita†
    • astinenza sessuale
    Nota: I soggetti femminili sessualmente non attivi possono essere arruolati a discrezione dello sperimentatore, a condizione che sia loro consigliata l’astensione dal rapporto eterosessuale per tutta la durata dello studio e per un mese dopo l'ultima dose, e che comprendano i possibili rischi correlati a una gravidanza durante lo studio.
    *Metodi ormonali: Se utilizza contraccettivi ormonali, deve aver utilizzato lo stesso prodotto contraccettivo ormonale per 3 mesi (90 giorni) prima del basale, e proseguito con lo stesso metodo e la stessa dose per tutta la durata dello studio. Qualora il soggetto abbia usato la contraccezione ormonale e l’abbia interrotta, questo deve essere avvenuto più di 6 mesi prima del basale. I soggetti di sesso femminile che utilizzano contraccettivi orali a bassa dose (contenenti =35 µg di etinilestradiolo o dose equivalente di altri estrogeni) devono adottare una seconda forma di contraccezione durante lo studio.
    †Metodi contraccettivi considerati a bassa dipendenza dall’utilizzatore.
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacodynamic / Efficacy endpoints:
    The following pharmacodynamics endpoints will be evaluated for EXN-32, EXN-44, or SINEMET®:
    ¿ Time to resolution of “OFF” period following administration of EXN-32 and EXN-44.
    ¿ Duration of “ON” period following dosing.
    ¿ UPDRS III scores.
    Pharmacodynamic assessments: Baseline and at 05, 15, 30, 60, 90, and 120 minutes following each dose, except UPDRS Part III which will be assessed at pre-dose, 10, 20, 30, 60, 90, and 120 minutes after each
    dose of study treatment.
    Pharmacokinetic endpoints:
    The following pharmacokinetic parameters will be calculated for levodopa and carbidopa in plasma:
    ¿ AUC0-t
    ¿ Cmax
    ¿ Tmax
    Verranno valutati i seguenti endpoint di farmacodinamica relativi a EXN-32, EXN-44 o SINEMET®:
    • Tempo di risoluzione del periodo "OFF" dopo la somministrazione di EXN-32 ed EXN-44;
    • Durata del periodo "ON" dopo la somministrazione della dose;
    • Punteggi alla scala UPDRS parte III.
    Valutazioni di farmacodinamica: al basale e 5, 15, 30, 60, 90 e 120 minuti dopo la somministrazione di ciascuna dose, fatto salvo il punteggio alla Parte III della scala UPDRS che verrà valutato prima della somministrazione della dose e 10, 20, 30, 60, 90 e 120 minuti dopo ciascuna somministrazione della dose del trattamento in studio.
    Endpoint di farmacocinetica:
    Verranno calcolati i seguenti parametri di farmacocinetica relativi a levodopa e carbidopa:
    • AUC0-t
    • Cmax
    • Tmax
    E.5.1.1Timepoint(s) of evaluation of this end point
    Pharmacodynamic assessments: Baseline and at 05, 15, 30, 60, 90, and 120 minutes following each dose, except UPDRS Part III which will be assessed at pre-dose, 10, 20, 30, 60, 90, and 120 minutes after each dose of study treatment.
    Valutazioni di farmacodinamica: al basale e 5, 15, 30, 60, 90 e 120 minuti dopo la somministrazione di ciascuna dose, fatto salvo il punteggio alla Parte III della scala UPDRS che verrà valutato prima della somministrazione della dose e 10, 20, 30, 60, 90 e 120 minuti dopo ciascuna somministrazione della dose del trattamento in studio.
    E.5.2Secondary end point(s)
    ¿ Pharmacokinetic / Pharmacodynamic relationship.
    Safety endpoints:
    ¿ Vital Signs (blood pressure [BP], temperature, pulse rate, and respiration rate).
    ¿ Clinical laboratory tests (hematology, clinical chemistry).
    ¿ Urine analysis
    ¿ Adverse events.; ¿ Pharmacokinetic / Pharmacodynamic relationship.
    Safety endpoints:
    ¿ Vital Signs (blood pressure [BP], temperature, pulse rate, and respiration rate).
    ¿ Clinical laboratory tests (hematology, clinical chemistry).
    ¿ Urine analysis
    ¿ Adverse events.
    ¿ Pharmacokinetic / Pharmacodynamic relationship.
    Safety endpoints:
    ¿ Vital Signs (blood pressure [BP], temperature, pulse rate, and respiration rate).
    ¿ Clinical laboratory tests (hematology, clinical chemistry).
    ¿ Urine analysis
    ¿ Adverse events.; ¿ Rapporto farmacocinetica-farmacodinamica.
    Endpoint di sicurezza:
    ¿ Segni vitali (pressione arteriosa [PA], temperatura, frequenza cardiaca e frequenza respiratoria);
    ¿ Test clinici di laboratorio (ematologia e chimica clinica);
    ¿ Analisi delle urine;
    ¿ Eventi avversi.
    E.5.2.1Timepoint(s) of evaluation of this end point
    screening period: -14 to -1
    treatment period: day 1 - day 10 - day 19
    follow up: day 27; ¿ Screening Period (Day -14 to -1)
    ¿ Treatment period (Day 1 to 19)
    ¿ Follow-up Period (Day 27)
    periodo di screening: -14 to -1
    periodo di trattamento: giorno 1 - giorno 10 - giorno 19
    follow up: giorno 27; ¿ Periodo di screening (dal Giorno -14 al Giorno -1)
    ¿ Periodo di trattamento (dal Giorno 1 al Giorno 19)
    ¿ Periodo di follow-up (Giorno 27)
    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 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 Yes
    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 Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Prospective randomized open blinded end¿point (PROBE) study
    Prospective randomized open blinded end¿point (PROBE) study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned3
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA3
    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 months8
    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 months8
    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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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)
    None
    Nessuno
    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 Decision2017-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-22
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA