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    Summary
    EudraCT Number:2020-003372-41
    Sponsor's Protocol Code Number:TP-0007
    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:2021-06-15
    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 number2020-003372-41
    A.3Full title of the trial
    Assessing the Pharmacokinetics, Safety, Tolerability and Efficacy of Continuous Oral Levodopa via the DopaFuse® Delivery System in Parkinson’s Disease Patients
    Valutazione della farmacocinetica, della sicurezza, della tollerabilità e dell'efficacia del trattamento orale continuato con levodopa mediante il sistema di somministrazione DopaFuse® in pazienti affetti da malattia di Parkinson
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigating the DopaFuse® Delivery System in Parkinson's Disease Patients. Assessing safety, effectiveness, how well it is tolerated, and how the drug is processed by the body.
    Studio del sistema di rilascio DopaFuse® nei pazienti con malattia di Parkinson. Valutarne la sicurezza, l'efficacia, la tollerabilità, e come il farmaco viene elaborato dall'organismo.
    A.3.2Name or abbreviated title of the trial where available
    Study of Continuous Oral Levodopa: SCOL
    Studio sul trattamento orale continuato con levodopa: SCOL
    A.4.1Sponsor's protocol code numberTP-0007
    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 organisationTFS Trial Form Support International AB
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressPO Box 165
    B.5.3.2Town/ cityLund
    B.5.3.3Post codeSE-221 00
    B.5.3.4CountrySweden
    B.5.4Telephone number0046462801800
    B.5.5Fax number0046462801801
    B.5.6E-mailregulatory@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 nameDopaFuse Delivery System
    D.3.2Product code [N04BA]
    D.3.4Pharmaceutical form Oral paste
    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 INNLEVODOPA
    D.3.9.1CAS number 59-92-7
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameLevodopa
    D.3.9.4EV Substance CodeSUB08468MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/h milligram(s)/hour
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number68
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCARBIDOPA
    D.3.9.1CAS number 28860-95-9
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameCarbidopa
    D.3.9.4EV Substance CodeSUB06126MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/h milligram(s)/hour
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number17
    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 Yes
    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
    Motor symptoms in Parkinson's Disease
    Sintomi motori del morbo di Parkinson
    E.1.1.1Medical condition in easily understood language
    motor (movement) symptoms of Parkinson's disease
    Sintomi motori (movimento) della 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 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
    The purpose of this study is to evaluate whether the DopaFuse System can reduce the fluctuation of plasma levodopa levels as compared to participants' standard intermittent doses of oral LD/CD tablets
    (background treatment).
    Lo scopo di questo studio è valutare se il sistema DopaFuse può ridurre la fluttuazione dei livelli plasmatici di levodopa rispetto a dosi intermittenti standard dei partecipanti di compresse orali LD / CD
    (trattamento di fondo).
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess whether the DopaFuse system is safe, well tolerated, and can relieve motor symptoms
    L'obiettivo secondario è valutare se il sistema DopaFuse è sicuro, ben tollerato e può alleviare i sintomi motori
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of Parkinson's Disease consistent with UK Brain Bank Criteria
    2. Age at least 30 years old at time of consent
    3. Male and Female participants (Women of child-bearing potential (WOCB) are eligible for participation if they are not pregnant or breastfeeding and agree to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 30 days after the last dose of study treatment)
    4. Suitable for oral retainer wear
    5. A good response to Levodopa, as assessed by the Investigator
    6. At least 2 hours of wearing OFF time per day, as reported by the
    participant
    7. Predictable early morning OFF periods, in the judgement of the participant and the Investigator
    8. Taking 400-1,200 mg of LD/CD per day in at least 4 doses, with stable dosing for the last 28 days prior to screening.
    9. A modified Hoehn and Yahr of ¿ 3 in the ON state at screening
    10. A stable regimen of anti-PD medications for the last 28 days prior to Screening
    11. A Mini-Mental State Examination (MMSE) Score =26
    12. Capable of giving signed informed consent Approved for entry into the study by the Enrollment
    1. Diagnosi di malattia di Parkinson secondo i criteri della UK Brain Bank
    2. Età pari ad almeno 30 anni al momento del consenso
    3. Partecipanti di sesso maschile e femminile (le donne potenzialmente fertili [Women of Child-Bearing Potential, WOCB] possono partecipare se non sono in gravidanza o in allattamento e accettano di seguire le linee guida sulla contraccezione di cui all'Appendice 3 durante il periodo di trattamento e per almeno 30 giorni dopo l'ultima dose del trattamento in studio)
    4. Pazienti adatti ad indossare un apparecchio di contenzione orale
    5. Buona risposta alla levodopa secondo la valutazione dello sperimentatore
    6. Almeno 2 ore al giorno di tempo di wearing OFF (effetto di fine dose), in base a quanto riportato dal partecipante
    7. Prevedibili periodi di OFF di prima mattina, a giudizio del partecipante e dello sperimentatore
    8. Assunzione di 400-1.200 mg di LD/CD al giorno in almeno 4 dosi, con dosaggio stabile negli ultimi 28 giorni prima dello screening
    9. Punteggio modificato sulla scala Hoehn e Yahr ¿3 nello stato ON allo screening
    10. Regime stabile di farmaci anti-PD negli ultimi 28 giorni prima dello screening
    11. Punteggio MMSE (Mini-Mental State Examination, Mini esame dello stato mentale) =26
    12. Capacità di fornire il consenso informato firmato
    E.4Principal exclusion criteria
    1. Atypical or secondary Parkinson's Disease
    2. Severe Dyskinesia that might interfere with study performance in the judgement of Investigator
    3. Clinically significant dysphagia or sialorrhea that might interfere with administration of study intervention in the judgement of the Investigator
    4. Use of extended release levodopa within 28 days prior to screening
    5. Any clinically significant medical, surgical, or psychiatric condition; laboratory value or ECG result which, in the opinion of the Investigator, makes the participant unsuitable for study entry or potentially unable to complete all aspects of the study.
    6. Presence of clinically significant orthostatic hypotension at screening, in the opinion of Investigator or the EAC
    7. Suicidal ideation within 1 year prior to the Screening Visit as evidenced by answering "yes" to Questions 4 or 5 on the suicidal ideation portion of the Columbia Suicide Severity Rating Scale (C-SSRS) or attempted suicide within the last 5 years.
    8. History of psychosis or hallucinations in the past six months
    9. Any malignancy in the past 5 years (excluding basal cell carcinoma of the skin or cervical carcinoma in situ that have been successfully treated.)
    10. Current or previous diagnosis of malignant melanoma or the presence of any suspicious skin lesion based on physical exam findings
    11. Unable to give blood required for the study
    12. History of allergic reaction to plastics
    13. LD infusion therapy (i.e. Duodopa); current or previous continuous apomorphine infusion treatment.
    14. Participation in any other clinical trial <30 days prior to screening visit.
    15. Presence of two third molars ("wisdom teeth") on the upper dentition
    16. Participants who, for any reason, are judged by the Investigator or the EAC to be inappropriate for this study, including participants who are unable to communicate or cooperate with the Investigator or who have/had a clinically significant illness or abnormal physical examination that may compromise safety of the participant during the trial or affect ability of the participant to adhere to study procedures.
    17. Participants taking non-selective monoamine oxidase (MAO) inhibitors
    18. Participants with known hypersensitivity to the active ingredients (levodopa, carbidopa) or excipients (Benzoic Acid, Disodium Edetate, Medium Chain Triglycerides, Poloxamer 188) of the drug paste
    19. Participants with narrow-angle glaucoma
    1. Malattia di Parkinson atipica o secondaria
    2. Discinesia grave che, secondo il giudizio dello sperimentatore, potrebbe interferire con le prestazioni dello studio
    3. Disfagia o scialorrea clinicamente significativa che, secondo il giudizio dello sperimentatore, potrebbe interferire con la somministrazione del trattamento in studio
    4. Uso di levodopa a rilascio prolungato entro 28 giorni prima dello screening
    5. Qualsiasi condizione medica, chirurgica o psichiatrica clinicamente significativa; valore di laboratorio o risultato ECG che, a parere dello sperimentatore, rende il partecipante non idoneo all'ingresso nello studio o potenzialmente incapace di completare tutti gli aspetti dello studio
    6. Presenza di ipotensione ortostatica clinicamente significativa allo screening, secondo il parere dello sperimentatore o dell'EAC
    7. Ideazione suicidaria entro un anno prima della Visita di screening, come evidenziato dalla risposta “sì” alle domande 4 o 5 della sezione sull’ideazione suicidaria della scala della Columbia University sulla valutazione della gravità del rischio di suicidio (Columbia Suicide Severity Rating Scale, C-SSRS) o da un tentativo di suicidio negli ultimi 5 anni
    8. Storia di psicosi o allucinazioni negli ultimi sei mesi
    9. Qualsiasi neoplasia maligna negli ultimi 5 anni (con l'esclusione del carcinoma cutaneo basocellulare o del carcinoma della cervice in situ trattati efficacemente)
    10. Diagnosi attuale o precedente di melanoma maligno o presenza di qualsiasi lesione cutanea sospetta sulla base dei risultati dell'esame obiettivo
    11. Incapacità di sottoporsi ai prelievi di sangue richiesti per lo studio
    12. Anamnesi di reazione allergica alla plastica
    13. Terapia infusionale a base di LD (ad es. Duodopa); trattamento infusionale attuale o precedente a base di apomorfina
    14. Partecipazione a un altro studio clinico <30 giorni prima della visita di screening
    15. Presenza di due terzi molari (“denti del giudizio”) sulla dentatura superiore
    16. Partecipanti che, per qualsiasi motivo, sono giudicati dallo sperimentatore o dall'EAC inappropriati per questo studio, compresi i partecipanti che non sono in grado di comunicare o collaborare con lo sperimentatore o che hanno/hanno avuto una malattia clinicamente significativa o un risultato anomalo all'esame obiettivo che potrebbe comprometterne la sicurezza durante lo studio o la capacità di aderire alle procedure dello studio
    17. Partecipanti che assumono inibitori non selettivi della monoamino ossidasi (MAO)
    18. Partecipanti con ipersensibilità nota ai principi attivi (levodopa, carbidopa) o agli eccipienti (acido benzoico, edetato disodico, trigliceridi a catena media, poloxamero 188) della pasta contenente il farmaco
    19. Partecipanti con glaucoma ad angolo stretto
    E.5 End points
    E.5.1Primary end point(s)
    PHARMACOKINETICS:
    - Variability in plasma concentration of levodopa as assessed with the Levodopa Fluctuation Index (Cmax-Cmin)/Caverage), comparing Day 2 to Day 1 in steady state (4-12 hours). Fluctuation index will also be calculated by the hour.
    SAFETY AND TOLERABILITY:
    - TEAEs
    - SAEs
    - TEAEs leading to discontinuation
    - Percent of participants that complete study
    EFFICACY:
    - Difference in OFF time between Days 1 and 15, based on in-person investigator ratings
    Farmacocinetica:
    Variabilità della concentrazione plasmatica di levodopa, valutata mediante l'indice di fluttuazione della levodopa (Cmax-Cmin)/Cmedia), confrontando il Giorno 2 con il Giorno 1 allo stato stazionario (4-12 ore). L'indice di fluttuazione sarà calcolato anche in base all'ora
    Sicurezza e tollerabilità
    • TEAE
    • SAE
    • TEAE che causano l'interruzione del trattamento
    • Percentuale di partecipanti che completano lo studio
    Efficacia
    • Differenza nel tempo OFF tra i Giorni 1 e 15, in base alle valutazioni condotte di persona dallo sperimentatore
    E.5.1.1Timepoint(s) of evaluation of this end point
    PK: Day 1 to 2
    Efficacy: Day 1 to Day 15
    Safety: Day 1 to Day 29
    PK: dal giorno 1 al giorno 2
    Efficacia: dal giorno 1 al giorno 15
    Sicurezza: dal giorno 1 al giorno 29
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 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 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 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 participant in the study, OR Last scheduled procedure shown in the Schedule of Activities for the last participant in the trial globally.
    Ultima visita dell'ultimo partecipante allo studio, OPPURE Ultima procedura programmata mostrata nel Programma delle attività per l'ultimo partecipante allo studio a livello globale.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    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: 14
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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 Decision2021-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-25
    P. End of Trial
    P.End of Trial StatusCompleted
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