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    Summary
    EudraCT Number:2015-002631-17
    Sponsor's Protocol Code Number:IIBSP-DUO-2015-46
    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:2015-11-03
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-002631-17
    A.3Full title of the trial
    An intra-subject, randomized, double blind, crossover study comparing immediate-release oral LD (IR-LD) and L-dopa/carbidopa intestinal gel (LCIG) over cognition and mood in non-demented advanced Parkinson?s disease (PD) patients
    Estudio randomizado, doble ciego y cruzado de comparación de levodopa de liberación inmediata (IR-LD) y gel intestinal de L-dopa/carbidopa (LCIG) en la cognición y humor en pacientes no dementes con enfermedad de Parkinson (EP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study comparing immediate-release oral Levodopa and L-dopa/carbidopa intestinal gel over cognition and mood in non-demented Parkinson?s disease (PD) patients
    Estudio de comparación de levodopa de liberación inmediata (IR-LD) y gel intestinal de L-dopa/carbidopa (LCIG) en la cognición y humor en pacientes no dementes con enfermedad de Parkinson (EP)
    A.4.1Sponsor's protocol code numberIIBSP-DUO-2015-46
    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 SponsorInstitut de Recerca del Hospital de la Santa Creu i Sant Pau
    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 supportAbbvie Inc
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recerca del Hospital de la Santa Creu i Sant Pau
    B.5.2Functional name of contact pointUnidad de Trastornos del Movimiento
    B.5.3 Address:
    B.5.3.1Street AddressSant Antoni Maria Claret 167
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08025
    B.5.3.4CountrySpain
    B.5.4Telephone number34935537613
    B.5.5Fax number34935537127
    B.5.6E-mailacampolongo@santpau.cat
    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 Duodopa
    D.2.1.1.2Name of the Marketing Authorisation holderAbbvie
    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 nameDuodopa
    D.3.4Pharmaceutical form Intestinal gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntestinal 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 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.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 Plus
    D.2.1.1.2Name of the Marketing Authorisation holderMSD
    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 nameSinemet Plus
    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 disease
    Enfermedad de Parkinson
    E.1.1.1Medical condition in easily understood language
    Parkinson disease
    Enfermedad de Parkinson
    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
    To compare the acute cognitive and affective effects of immediate-release oral LD (IR-LD) and continuous delivery of LCIG in patients with PD measured at baseline (-1 hour) and at time-points +1, +3 and +5 hour. Thus, as showed in the flow-chart section (pag. 15), cognitive and affective effects measures considered as main variables for statistical purposes will be collected at - 1hour (pre-dosing) and at +1 hour after initiating either IR-LD or LCIG and one hour after receiving either IR-LD or oral placebo (+3, +5 hour).
    Comparar los efectos cognitivos y afectivos agudos de IR-LD y de LCIG en pacientes con EP medidos basalmente (-1 hora) y en los puntos de tiempo +1, +3 y +5 horas. Así, como se muestra en el organigrama del estudio (pág.s 16-17), las variables cognitivas y afectivas -consideradas como las principales para propósitos estadísticos- serán recogidas a ? 1 hora (pre-dosis) y a +1 hora después de iniciar IR-LD o LCIG y una hora después de recibir IR-LD o placebo oral (+3, +5 horas).
    E.2.2Secondary objectives of the trial
    To compare at six consecutive time-points ( -1, +1, +2, +3, +4, +5 hour):
    - Changes in LD plasma levels.
    - Motor and dyskinesia scores.
    - Changes on mood and anxiety levels.
    Comparar en seis tiempos consecutivos ( -1, +1, +2, +3, +4, +5 horas):
    - Cambios en los niveles plasmáticos de LD.
    - Puntuaciones motoras y de discinesias.
    - Cambios de humor y niveles de ansiedad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients aged 40 to 80 years old with diagnosis of Idiopathic Parkinson?s Disease according to the London Brain Bank Criteria. [44]
    2. Patients must be able and willing to provide informed consent to participate in the study.
    3. Patients must be receiving optimized treatment with a stable dose of LCIG for at least four weeks before entering the study.
    4. Patients must be experiencing motor fluctuations with a minimum of two hours/of OFF time during the awake day
    5. Patients must have a Hoehn & Yahr stage between II and III in the ON condition [45].
    1. Pacientes varones o mujeres de edades comprendidas entre 40 y 80 años de edad con diagnóstico de enfermedad de Parkinson idiopática de acuerdo con los Criterios del Brian Bank de Londres.
    2. Los pacientes deben ser capaces de firmar el consentimiento informado para participar en el estudio.
    3. Los pacientes deben estar recibiendo tratamiento optimizado con una dosis estable de LCIG durante al menos cuatro semanas antes de entrar en el estudio.
    4. Los pacientes deben experimentar fluctuaciones motoras con un mínimo de dos horas de tiempo OFF durante el tiempo de vigilia
    5. Los pacientes deben tener un estadio de Hoehn & Yahr entre II y III en el estado ON
    E.4Principal exclusion criteria
    1. Any form of parkinsonism other than idiopathic Parkinson?s disease.
    2. Patients with deep brain stimulation or history of neurosurgical procedure.
    3. Untreated depressive disorder.
    4. Patients with functional illiteracy or impossibility to perform any of the tests (i.e. cognitive, blood test) of the study.
    5. Severe or ongoing unstable medical conditions (e.g. cardiac, hepatic, pulmonary, renal, metabolic or endocrine).
    6. Imminent risk of self-harm based on Investigator?s clinical judgment, with a ?yes? answer on item 4 or 5 on the Columbia Suicide Severity Rating Scale (CSSRS)[50] at screening.
    7. Parkinson?s Disease-Cognitive Rating Scale (PD-CRS) total score ? 64 and accomplishment of MDS criteria for dementia associated to PD at the time of screening [51, 52]. Patients with a PD-CRS total score ? 64, fulfilling diagnostic criteria for mild cognitive impairment in PD (PD-MCI) will be allowed to participate. [52, 53]
    8. Patients with clinically significant apathetic symptoms as judged by both caregiver and neurologist and scoring > 14 on the Starkstein?s Apathy Evaluation Scale.[49]
    9. Patients scoring ? 11 for anxiety and or depression on the Hospital Anxiety and Depression Scale (HADS). [37]
    10. Previous history of any psychiatric condition as defined by the DSM-IV criteria based on the MINI International Neuropsychiatric Interview. [47, 54]
    11. Patients with more than 30% of the day in off period and with dose failure episodes or unpredictable response to LD or severe dyskinesia that in opinion of the investigator could interfere with test performance or results.
    12. Patients included in other clinical trial during the study period or 6 weeks before the study
    13. Changes in psychotropic medication in the previous 4 weeks
    14. Patients currently treated with: (i) Anticholinergic drugs; (ii) Typical neuroleptics, or any other drug which, in the opinion of the investigator, would interfere with the cognitive tests. Concomitant treatments with atypical neuroleptics (such as quetiapine, ziprasidone, or aripiprazole can be administered provided they remain at the lowest effective dose)
    15. Permitted medications: anticholinesterase inhibitors and antidepressants initiated at least six weeks before study screening, or any other drug considered necessary for the safety and well-being of the patient are permitted during the study at the discretion of the investigator.
    1. Cualquier forma de parkinsonismo distinta de la enfermedad de Parkinson idiopática.
    2. Pacientes con estimulación cerebral profunda o antecedentes de procedimiento neuroquirúrgico.
    3. Trastorno depresivo significativo no tratado
    4. Pacientes con analfabetismo funcional o imposibilidad de realizar cualquiera de las pruebas del estudio (por ejemplo, tests cognitivos, análisis de sangre)
    5. Condiciones médicas severas o inestables (por ejemplo enfermedades cardíacas, hepáticas, pulmonares, renales, metabólicas o endocrinas).
    6. Riesgo inminente de autolesión basado en el juicio clínico del investigador, con una respuesta "sí" en el ítem 4 o 5 en la Columbia Suicidio Gravedad Rating Scale (CssRS) en el sreening.
    7. Puntuación total ? 64 en la Parkinson?s Disease -Cognitive Rating Scale (PD-CRS),y criterios de la MDS para la demencia asociada a la EP en el momento del screening. A los pacientes con una puntuación total PD-CRS ? 64 que cumplan criterios de diagnóstico para deterioro cognitivo leve en la EP (PD-MCI) se les permitirá participar.
    8. Pacientes con apatía clínicamente significativa juzgada tanto por el cuidador y el neurólogo y con puntuación > 14 en la Escala de Evaluación de la Apatía del Starkstein.
    9. Puntuación ? 11 en la Escala Hospitalaria de Depresión y Ansiedad (HADS).
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome measures will be the performance over time of different cognitive tasks: Wisconsin
    Card Sorting Test, Sternberg Test, phonetic and alternating verbal fluency and a
    reversal-learning task.
    Pruebas cognitivas: Wisconsin Card Sorting Test, Prueba de Sternberg, fluencias verbales fonética y alternante y un test de aprendizaje inverso.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Basal, +1 hour, +2 hours, +3 hours, +4 hours, +5 hours
    Basal, +1 hora, +2 horas, +3 horas, +4 horas, +5 horas
    E.5.2Secondary end point(s)
    Motor function, mood and anxiety
    Función motora, y estado de ánimo y ansiedad
    E.5.2.1Timepoint(s) of evaluation of this end point
    Basal, +1 hour, +2 hours, +3 hours, +4 hours, +5 hours
    Basal, +1 hora, +2 horas, +3 horas, +4 horas, +5 horas
    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 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) 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) Yes
    E.8.2.2Placebo No
    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 sujeto
    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 months8
    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: 9
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 state18
    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 that condition
    Tratamiento 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 Decision2015-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-30
    P. End of Trial
    P.End of Trial StatusCompleted
    The status of studies in GB is no longer updated from 1.1.2021
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