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    Summary
    EudraCT Number:2020-003372-41
    Sponsor's Protocol Code Number:TP-0007
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-09
    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 ConcernedSpain - AEMPS
    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
    Evaluación de la farmacocinética, la seguridad, la tolerabilidad y la eficacia de levodopa oral continua a través del sistema de administración DopaFuse en pacientes con enfermedad de 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.
    Investigación del sistema de administración de DopaFuse® en pacientes con la enfermedad de Parkinson. Evaluar la seguridad, la eficacia, la tolerancia y la forma en que el organismo procesa el medicamento.
    A.3.2Name or abbreviated title of the trial where available
    Study of Continuous Oral Levodopa: SCOL
    Estudio de levodopa oral continua (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
    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 number+46462801800
    B.5.5Fax number+46462801801
    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.3.4Pharmaceutical 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.3.9.3Other 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.3.9.3Other 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 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 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.
    Síntomas motrices en la enfermedad de Parkinson.
    E.1.1.1Medical condition in easily understood language
    motor (movement) symptoms of Parkinson’s disease
    Síntomas motrices (de movimiento) de la enfermedad de 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).
    El objetivo de este estudio es evaluar si el sistema DopaFuse puede reducir la fluctuación de los niveles plasmáticos de levodopa en comparación con las dosis intermitentes estándar de comprimidos orales de LD/CD de los participantes (tratamiento de 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.
    El objetivo secundario es evaluar si el sistema DopaFuse es seguro, bien tolerado y puede aliviar los síntomas motrices.
    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 Levodopa/Carbidopa or Levodopa/Benserazide (LD/BZD) per day in at least 4 doses, with stable dosing for the last 28 days prior to screening. (Participants will be required to switch from LD/BZD to LD/CD no later than the morning of Day 1/Baseline (visit 4).)
    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.Diagnóstico de la enfermedad de Parkinson en consonancia con los criterios del Banco de Cerebros del Reino Unido (UK Brain Bank).
    2.Tener al menos 30 años en el momento del consentimiento.
    3.Participantes de ambos sexos (las mujeres con capacidad de procrear son elegibles para participar si no están embarazadas o amamantando y aceptan seguir las directrices sobre anticoncepción recogidas en el Apéndice 3 durante el periodo de tratamiento y durante al menos 30 días después de la última dosis del tratamiento del estudio).
    4.Pacientes aptos para el uso de retenedores bucales.
    5.Una buena respuesta a la levodopa, según la evaluación del investigador.
    6.Al menos 2 horas de tiempo OFF al día, según lo comunicado por el participante
    7.Periodos OFF previsibles a primera hora de la mañana, a juicio del participante y del investigador.
    8.En tratamiento con 400-1200 mg de Levodopa/Carbidopa o Levodopa/Benserazide (LD/BZD) al día repartidos en al menos 4 tomas, con una dosis estable durante los últimos 28 días antes de la selección. (Los participantes deberán cambiar de LD/BZD a LD/CD a mas tardar la mañana del dia 1/Basal (visita 4)
    9.Puntuación en la escala de Hoehn y Yahr modificada de 3 en el estado ON en la selección.
    10.Tratamiento estable con medicación contra la EP durante los últimos 28 días antes de la selección.
    11.Puntuación en el miniexamen cognoscitivo (Mini-Mental State Examination, MMSE) ≥ 26.
    12.Capaces de dar su consentimiento informado firmado.
    Aprobados para su incorporación al estudio por el Comité de autorización de inclusiones
    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.Enfermedad de Parkinson atípica o secundaria.
    2.Discinesia intensa que podría interferir en la realización del estudio a juicio del investigador.
    3.Disfagia o sialorrea clínicamente significativa que podría interferir en la administración de la intervención del estudio a juicio del investigador.
    4.Uso de levodopa de liberación prolongada en los 28 días anteriores a la selección.
    5.Cualquier afección médica, quirúrgica o psiquiátrica clínicamente significativa; valor de laboratorio o resultado de ECG que, en opinión del investigador, haga que el participante no sea apto para incorporarse al estudio o que sea potencialmente incapaz de completar todos los aspectos del estudio.
    6.Presencia de hipotensión ortostática clínicamente significativa en la selección, en opinión del investigador o del CAI.
    7.Ideas suicidas en el año anterior a la visita de selección, como se evidencia al responder «sí» a las preguntas 4 o 5 en la parte de ideación suicida de la Escala de Columbia para evaluar el riesgo de suicidio (C-SSRS) o intento de suicidio en los últimos 5 años.
    8.Antecedentes de psicosis o alucinaciones en los últimos seis meses.
    9.Cualquier neoplasia maligna en los últimos 5 años (excluyendo el carcinoma de células basales de la piel o el carcinoma de cuello uterino in situ que se hayan tratado con éxito).
    10.Diagnóstico actual o previo de melanoma maligno o presencia de cualquier lesión cutánea sospechosa según los hallazgos de la exploración física.
    11.No pueden donar la sangre necesaria para el estudio.
    12.Antecedentes de reacción alérgica a los plásticos.
    13.Tratamiento con infusión de LD (es decir, Duodopa); tratamiento con infusión continua de apomorfina ahora o en el pasado
    14.Participación en cualquier otro ensayo clínico < 30 días antes de la visita de selección.
    15.Presencia de dos terceros molares («muelas del juicio») en la dentadura superior.
    16.Los participantes que, por cualquier motivo, el investigador o el CAI considere inapropiados para este estudio, incluidos los participantes que no puedan comunicarse o cooperar con el investigador o que tengan/hayan tenido una enfermedad clínicamente significativa o alguna anomalía en la exploración física que puede comprometer la seguridad del participante durante el ensayo o afectar a la capacidad del participante para respetar los procedimientos del estudio.
    17.Participantes que toman inhibidores no selectivos de la monoaminooxidasa (MAO).
    18.Participantes con hipersensibilidad conocida a los principios activos (levodopa, carbidopa) o a los excipientes (ácido benzoico, edetato disódico, triglicéridos de cadena media, poloxámero 188) de la pasta del fármaco.
    19.Participantes con glaucoma de ángulo estrecho.
    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
    FARMACOCINÉTICA:
    -Variabilidad en la concentración plasmática de levodopa evaluada con el índice de fluctuación de la levodopa (Cmáx-Cmín)/Cpromedio), comparando el día 2 con el día 1 en estado de equilibrio (4-12 horas). El índice de fluctuación también se calculará por hora.

    SEGURIDAD Y TOLERABILIDAD:
    -AAT
    -AAG
    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: Día 1 a 2
    Eficacia: Día 1 al Día 15
    Seguridad: Día 1 al Día 29
    E.5.2Secondary end point(s)
    PHARMACOKINETICS:
    - Coefficient of variation (CV) for plasma levodopa. This will be calculated between 4 and 12 hours on Days 1 and 2 comparing DopaFuse and oral levodopa tablets.
    - Variability in plasma concentration of levodopa as assessed with the Levodopa Fluctuation Index (Cmax-Cmin)/Caverage), comparing Day 3 to Day 1, as well as Day 2 (0-12 hours) to Day 1. Fluctuation index will also be calculated by the hour.
    - Levodopa and Carbidopa Cmax, Tmax, and AUC
    - Variability in plasma levodopa comparing Dopafuse and oral levodopa tablets based on fluctuation index and CV in participants who are H. pylori negative/positive

    SAFETY AND TOLERABILITY:
    - QUIP-RS
    - C-SSRS

    EFFICACY:
    - Change in OFF time between Day 1 and Day 3
    - Change in ON time without troublesome dyskinesia between Days 1, 3 and 15
    - Change in on time with troublesome (severe) dyskinesia between Days 1, 3 and 15
    - Change in UPDRS III at 6 hours after morning dose between Days 1, 3 and 15
    - A comparison of the subgroups who are H. pylori positive and negative will be performed as an exploratory analysis.
    FARMACOCINÉTICA:
    -Coeficiente de variación (CV) de las concentraciones plasmáticas de levodopa. Se calculará entre 4 y 12 horas los días 1 y 2 comparando DopaFuse y los comprimidos orales de levodopa.
    -Variabilidad en la concentración plasmática de levodopa evaluada con el índice de fluctuación de levodopa (Cmáx-Cmín)/Cpromedio), comparando el día 3 con el día 1, así como el día 2 (0-12 horas) con el día 1. El índice de fluctuación también se calculará por hora.
    -Cmáx, Tmáxy AUC de levodopa y carbidopa
    -Variabilidad en la concentración plasmática de levodopa al comparar DopaFuse y los comprimidos orales de levodopa según el índice de fluctuación y el CV en participantes que son H. pylori negativos/positivos
    E.5.2.1Timepoint(s) of evaluation of this end point
    PK: Day 1 to Day 3
    Safety&Tolerability: Day 15 and Day 29
    Efficacy: Day 1-15
    PK: Día 1 a Día 3
    Seguridad y tolerabilidad: Día 15 y Día 29
    Eficacia: Día 1 a 15
    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) Yes
    E.7.1.1First administration to humans Yes
    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 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 No
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    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.
    Última visita del último participante en el estudio, o
    Último procedimiento programado que figura en el calendario de actividades del último participante en el ensayo de forma global.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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 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
    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 Decision2021-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-08-02
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