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    Summary
    EudraCT Number:2020-005073-28
    Sponsor's Protocol Code Number:ParKMetil/001
    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 number2020-005073-28
    A.3Full title of the trial
    Double-blind, randomized, crossover design for evaluation of efficacy and safety of methylphenidate in cognition in patients with Parkinson's disease using electrophysiological measures
    Ensayo clínico doble ciego, aleatorizado, diseño cruzado, evaluación de eficacia y seguridad del metilfenidato en la cognición en pacientes con enfermedad de Parkinson mediante medidas electrofisiológicas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial for evaluation of efficacy and safety of methylfenidate in cognition in Parkinsons disease patients through electroencephalographic measures
    Ensayo clínico para evaluación de eficacia y seguridad de metilfenidato en cognición en pacientes con enfermedad de Parkinson a traves de medidas de electroencefalograma.
    A.3.2Name or abbreviated title of the trial where available
    ParKMetil/001
    ParKMetil/001
    A.4.1Sponsor's protocol code numberParKMetil/001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversidad Rey Juan Carlos
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMinisterio de Ciencia, Innovación y Universidades
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversidad Rey Juan Carlos
    B.5.2Functional name of contact pointSponsor
    B.5.3 Address:
    B.5.3.1Street AddressCalle Tulipan s/n
    B.5.3.2Town/ cityMóstoles / Madrid
    B.5.3.3Post code28933
    B.5.3.4CountrySpain
    B.5.6E-mailnfogelson@gmail.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 Yes
    D.2.1.1.1Trade name Methylphenidate
    D.2.1.1.2Name of the Marketing Authorisation holderRUBIFEN
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameRubifen
    D.3.2Product code N06B A04
    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.3.8INN - Proposed INNMETHYLPHENIDATE HYDROCHLORIDE
    D.3.9.1CAS number 298-59-9
    D.3.9.4EV Substance CodeSUB03254MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Cognition
    Cognición
    E.1.1.1Medical condition in easily understood language
    Cognition
    Cognición
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Differences in reaction time and precision to predictive and random stimulus with and without Methilphenidate.
    The latency and amplitude of the potentials related to events N1, N2 and P3b will be evaluated for different conditions : predictive and random conditions.
    1. Diferencias de tiempo de reacción a estímulos predefinidos y aleatorios con o sin metlfenidato .
    2. Latencia y amplitud de potenciales relacionados con eventos N1, N2 y P3b para diferentes condiciones: predecibles o aleatorias.
    E.2.2Secondary objectives of the trial
    Motor status change after methylphenidate through MDS-UPDRS III
    Cambios en el estado motor tras metilfenidato usando MDS UPDRS III
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The subject is informed about the study, has enough time to read the IC and the opportunity to think about her participation in the study, asks questions and resolves doubts, after which she gives her informed consent.
    2. The subject is willing to comply with the requirements of the study (visits, taking medication, procedures)
    3. The subject is a male or female older than or equal to 30 years and younger than 75 years at the time of recruitment.
    4. The subject has been diagnosed with Parkinson's disease according to the UK EPSSBC criteria (Annex 2) in the last 6 years.
    5. Subject should receive stable anti-parkinsonian therapy within 6 weeks prior to randomization.
    6. The subject must be in the ON situation at the time of taking medication.
    1. El sujeto es informados del estudio, tiene tiempo suficiente de lectura del CI y oportunidad de pensar acerca de su participación en el estudio, pregunta y resuelve dudas, tras lo cual da su consentimiento informado.
    2. El sujeto está dispuesto a cumplir con los requerimientos del estudio ( visitas, toma de medicación, procedimientos)
    3. El sujeto es varón o mujer mayor o igual a 30 años y menor a 75 años en el momento del reclutamiento.
    4. El sujeto está diagnosticado de Enfermedad de Parkinson según los criterios de la UK EPSSBC (anexo 2) en los últimos 6 años.
    5. El sujeto debe recibir tratamiento anti-parkinsoniano estable en las 6 semanas previas a la aleatorización.
    6. El sujeto debe encontrarse en situación ON en el momento de la toma de medicación.
    E.4Principal exclusion criteria
    1. The subject has consumed methylphenidate in the 30 days prior to inclusion.
    2. Subject is participating in another clinical trial with a medical research product or has participated in the 30 days prior to randomization
    3. The subject has an atypical parkinsonian syndrome or secondary parkinsonism.
    4. The subject has cognitive impairment expressed through MoCA <26
    5. The subject has presented or presents hallucinations / delusions / psychosis in the last 3 months
    6. The subject has presented or presents clinically significant major depression in the last 6 months.
    7. The subject has had a suicide attempt throughout his life (includes an active, interrupted or aborted attempt) or has had suicidal ideation in the last 6 months, as indicated by “Yes” to questions 4 or 5 of the CSSRS of the home visit.
    8. Subject has severe motor fluctuations, prominent ON dyskinesias.
    9. Subject has uncontrolled arterial hypertension. The subject has more than 140 / 90mmHg at the time prior to randomization.
    10. Subject has known moderate renal or moderate hepatic impairment.
    11. Subject has untreated glaucoma.
    12. The subject has uncontrolled malignancy.
    13. Concomitant treatment with monoamine oxidase inhibitors (MAOI)
    14. Pregnancy or lactation situation.
    15. Subjects who, for any reason, in the opinion of the IPs are not appropriate for participation in the study.
    1. El sujeto ha consumido metilfenidato en los 30 días previos a la inclusión.
    2. El sujeto se encuentra participando en otro ensayo clínico con un producto de investigación médico o ha participado en los 30 días previos a la aleatorización
    3. El sujeto tiene un síndrome parkinsoniano atípico o parkinsonismo secundario.
    4. El sujeto tiene deterioro cognitivo expresado a través de MoCA <26

    5. El sujeto ha presentado o presenta alucinaciones/ delirios/psicosis en los últimos 3 meses
    6. El sujeto ha presentado o presenta depresión mayor clínicamente significativa en los últimos 6 meses.
    7. El sujeto ha tenido algún intento de suicidio a lo largo de su vida ( incluye intento activo, interrumpido o abortado) o ha tenido ideación suicida en los últimos 6 meses, según ha indicado “Si” a las preguntas 4 o 5 de la CSSRS de la visita de inicio.
    8. El sujeto presenta fluctuaciones motoras graves, disquinesias ON prominentes.
    9. El sujeto presenta hipertensión arterial descontrolada. El sujeto presenta más de 140/90mmHg en el momento previo a aleatorización.
    10. El sujeto presenta conocida insuficiencia renal moderada o hepática moderada.
    11. El sujeto presenta glaucoma no tratado.
    12. El sujeto presenta malignidad no controlada.
    13. Tratamiento concomitante con inhibidores de la monoaminooxidasa (IMAO)
    14. Situación de embarazo o lactancia.
    15. Sujetos que, por cualquier motivo, a criterio de las IP no es apropiado para la participación en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Reduction of time reaction to predictive and random stimulus after methylphenidate
    Reducción del tiempo de reacción a estímulos predictivos y aleatorios tras toma de metilfenidato.
    E.5.1.1Timepoint(s) of evaluation of this end point
    90 min after the intake of Methylphenidate
    90 min tras la toma de Metilfenidato
    E.5.2Secondary end point(s)
    Reduction of MDS UPDRSIII puntuaction after Methylphenidate intake
    Reducción de la puntuación en la escala MDS UPDRS III tras la toma de metilfenidato.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From 60 to 120 minutes after study drug intake
    Desde 60 a 120 minutes de la toma del fármaco en estudio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Última visita del último paciente
    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 months6
    E.8.9.1In the Member State concerned days
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state40
    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)
    Expected normal treatment of the condition
    Tratamiento médico habitual
    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 Decision2021-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-02-01
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