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    Summary
    EudraCT Number:2017-003254-17
    Sponsor's Protocol Code Number:IIBSP-SAF-2017-75
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-11-22
    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 number2017-003254-17
    A.3Full title of the trial
    A 24-Week, Multicenter, Randomized, Double-blind, Placebo-Controlled, Add-on, Parallel-Group Study to Assess the Effect of Safinamide on Apathy in Patients With Parkinson's Disease
    Estudio de 24 semanas, multicéntrico, aleatorizado, doble ciego, controlado con placebo en grupos paralelos para evaluar el efecto de la safinamida sobre la apatía en pacientes con enfermedad de Parkinson
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and efficacy of Safinamide (Xadago®) in apathy associated with Parkinson's disease
    Seguridad y eficacia de la Safinamida (Xadago®) en la apatía asociada a la enfermedad de Parkinson
    A.4.1Sponsor's protocol code numberIIBSP-SAF-2017-75
    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 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 supportInstitut de Recerca Hospital de la Santa Creu i Sant Pau
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recerca Hospital de la Santa Creu i Sant Pau
    B.5.2Functional name of contact pointUICEC Sant Pau
    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 number34935537636
    B.5.5Fax number34935537812
    B.5.6E-mailepenag@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 Xadago
    D.2.1.1.2Name of the Marketing Authorisation holderZambon S.p.A.
    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.3.4Pharmaceutical form Film-coated 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 INNSAFINAMIDE
    D.3.9.1CAS number 133865-89-1
    D.3.9.3Other descriptive nameSAFINAMIDE
    D.3.9.4EV Substance CodeSUB32946
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Parkinson's disease
    Enfermedad de Parkinson
    E.1.1.1Medical condition in easily understood language
    Parkinson's 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 determine the efficacy and tolerability of safinamide, a novel antiparkinsonian drug with dual mechanism of action (dopaminergic and anti-glutamatatergic), to improve symptoms of Apathy in patients with Parkinson’s disease (PD).
    Valorar la eficacia de la Safinamida en la mejoría clínica de la apatía asociada a la EP a través de la medición pre- y post- medicación de la puntuación en una escala neuropsicológica validada para el estudio de la apatía en EP (SAS: Starkstein Apathy Scale).
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female outpatients (aged 45 to 80 years inclusive)
    - Diagnosis of idiopathic Parkinson's Disease (PD) according to the Movement Disorder Society PD Criteria, suffering for fluctuations and a Hoehn and Yahr Stage of I to III (mild to moderate motor severity) at Screening. The diagnosis will be based on medical history and neurological examination
    - A total score > 20 on the Montreal Cognitive Assessment (MoCA)31
    - Scoring 1 or more on the Apathy Item of the Neuropsychiatric Inventory32
    - Clinical diagnosis of apathy as defined by Diagnostic Criteria for Apathy in Clinical Practice33
    - Be able to speak, read, and write in the language in which the tests are written and must be able to perform all the assessments in this language
    - Receiving treatment with dopaminergic therapy: levodopa (with or without entacapone) or levodopa plus dopamine agonists at a stable dose for at least four weeks prior to Screening and for the duration of the study.
    - Understand and sign the appropriate approved Informed Consent Form of the Study
    - Pacientes entre 45 y 80 años ambos inclusive
    - Diagnóstico de EP según los criterios de la Movement Disorders Society y un estadío entre I y III en la escala de Hoehn & Yahr.
    - Puntuación total > 20 en el Montreal Cognitive Assessment (MoCA)
    - Puntuación ≥ 1 en el ítem de apatía del Neuropsychiatric Inventory (NPI)
    - Diagnóstico clínico de apatía definido por los Diagnostic Criteria for Apathy in Clinical Practice
    - Capacidad para hablar, leer y entender el lenguaje de los tests administrados
    - En tratamiento actual con terapia dopaminérgica: levodopa (con o sin entacapona) y/o agonistas dopaminérgicos a dosis estables en las 4 semanas previas al screening y durante la duración del estudio.
    - Capacidad de comprender y firmar el consentimiento informado.
    E.4Principal exclusion criteria
    - Diagnosis of moderate to severe dementia associated with PD, according to the Clinical Diagnostic Criteria for Dementia Associated with PD34.
    - Subjects with active psychosis or major hallucinations, severe depression or delirium; current diagnosis of substance abuse or history of alcohol or drug abuse for 3 months prior to Visit 1 (Screening)
    - Mental/physical/social condition which could preclude performing efficacy or safety assessments
    - Severe white matter disease, multiple lacunar infarcts, or signs of significant vascular changes on Magnetic Resonance Imaging (MRI)
    - Clinically significant or unstable medical or surgical condition and history of vascular disease (stroke) or melanoma, gastrointestinal, renal, hepatic, endocrine, pulmonary, or cardiovascular disease, including not well controlled hypertension, asthma, chronic obstructive pulmonary disease, and Type 1 diabetes that would, in the opinion of the Investigator, preclude participation to the study
    - Any clinically relevant abnormality, either on medical history, physical and neurological examination, ECG, or by diagnostic laboratory tests that, in the opinion of then Investigator, could hinder participation to the study
    - Currently experiencing significant motor complications (moderate or severe wearing off defined as score > 2 on Item 4.4 of MDS-UPDRS Part IV) or disabling dyskinesia (defined as score > 2 on Item 4.2 of MDS-UPDRS Part IV)35
    - Currently participating to another clinical trial or who participated in a previous clinical trial within 30 days prior to Visit 1 (Screening) or who received any investigational product within 30 days or five half-lives, whichever was longer, prior to Visit 1 (Screening)
    - Previously treated with safinamide
    - Patients recently started with anticholinergic medication or acetylcholinesterase inhibitors or changes in drug doses within 4 weeks prior to the Screening visit.
    - Use of MAO-B inhibitors (e.g., selegiline, rasagiline) within 4 weeks prior to Visit 1 (Screening).
    - Active psychosis or currently receiving antipsychotic treatment
    - Patients taking memantine or antagonists of dopamine receptors (except domperidone) within 4 weeks prior to Visit 1 (Screening)
    - Subjects who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study
    - Women who are pregnant, lactating, or who are attempting to conceive
    - Women of childbearing potential not willing to use an adequate contraceptive method (unless surgically sterilized) for 4 weeks prior to, during, and 4 weeks after the last dose of trial medication
    - Known hypersensitivity to the trial treatment(s), including placebo
    - Legal incapacity or limited legal capacity
    - Diagnóstico de demencia moderada o severa asociada a EP, según los Clinical Diagnostic Criteria for Dementia Associated with PD.
    - Sujetos con psicosis active o alucinaciones estructuradas, depresión severa o delirio; diagnóstico actual de abuso de sustancias o historia de alcoholismo o abuso de drogas en los 3 meses previos a la visita de screening.
    - Condición mental/física/social que pueda afectar a la eficacia o seguridad de las evaluaciones
    - Leucoencefalopatía marcada, infartos lacunares múltiples, o signos de lesiones vasculares significativas en la resonancia magnética.
    - Condición médica o quirúrgica clínicamente significativa o inestable, o historia de melanoma, enfermedad gastrointestinal, renal, hepática, endocrinológica, pulmonar o cardiovascular, incluyendo hipertensión mal controlada, asma, enfermedad pulmonar obstructiva crónica, y diabetes mellitus tipo 1, que podrían afectar al estudio bajo criterio del investigador.
    - Cualquier alteración clínicamente relevante, ya sea por historial medico, exploración física o neurológica, ECG, o por pruebas complementarias que, en opinión del investigador, puedan afectar a la participación del estudio.
    - Paciente con fluctuaciones motoras complejas (wearing off moderado o severo, definido como una puntuación > 2 en el ítem 4.4 de la MDS-UPDRS parte IV) o discinesia incapacitante (definida como una puntuación >2 en el ítem 4.2 de la MDS-UPDRS parte IV).
    - Participación activa en otro ensayo clínico, o participación en otro ensayo clínico en los 30 días previos a la visita de screening, o paciente que haya recibido cualquier producto en investigación en los últimos 30 días o el tiempo correspondiente a 5 vidas medias, lo que fuera más prolongado.
    - Pacientes previamente tratados con safinamida.
    - Pacientes que hayan comenzado recientemente (en las 4 semanas previas a la visita de screening) con medicación antidopaminérgica, anticolinérgica o inhibidores de la acetilcolinesterasa, o cambios en la dosis de dichos fármacos en las 4 semanas previas a la visita de screening.
    - Uso de inhibidores de la MAO-B (selegilina, rasagilina) en las 4 semanas previas a la visita de screening.
    - Sujetos que, a juicio del investigador, sea esperable que no cumplan correctamente con la medicación y/o las visitas del estudio.
    - Mujeres embarazadas, en período de lactancia, o que pretendan un embarazo durante el período del estudio.
    - Mujeres en edad reproductiva que no puedan asegurar una contracepción adecuada 4 semanas antes, durante el estudio, y 4 semanas después de la última dosis recibida.
    - Hipersensibilidad conocida al fármaco en estudio, incluido el placebo.
    - Incapacidad legal o capacidad legal limitada.
    E.5 End points
    E.5.1Primary end point(s)
    Mean change from baseline to Week 24 in the AS total score (Time Frame: baseline to Week 24 (or early discontinuation).
    Media del cambio en la puntuación de la Starkstein Apathy Scale (SAS) desde la visita basal a la semana 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    24 semanas
    E.5.2Secondary end point(s)
    - Mean change from baseline to Week 24 in the Parkinson’s Disease – Cognitive Rating Scale (PD-CRS) total score (Time Frame: baseline to Week 24 (or early discontinuation).
    - Mean change from baseline to Week 24 in the Parkinson's disease - Cognitive Functional Rating Scale (PD-CFRS) total score (Time Frame: baseline to Week 24 (or arly discontinuation).
    - Mean change from baseline to Week 24 in the Neuropsychiatric Inventory (NPI) scores (Time Frame: baseline to Week 4, Week 12, and Week 24 (or early discontinuation) Visits.
    - Mean change from baseline to Week 24 in the Hamilton Depression Rating Scale (HAM-D) total score (Time Frame: baseline to Week 24 (or early discontinuation).
    - Mean change from baseline to Week 24 in the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) motor subscale (Part III) total score (Time Frame: baseline to Week 24 (or early discontinuation).
    - Mean change from baseline to Week 24 in the Schwab & England Activities of Daily Living Scale (S&E-ADL) total score (Time Frame: baseline to week 24 or early discontinuation)
    - Mean change from baseline to Week 24 in the 39-item Parkinson's Disease Questionnaire (PDQ-39) total score (Time Frame: baseline to week 24 or early discontinuation)
    - Mean change on the Patient's Clinical Global Impression of Change (P-CGI) of Apathy (Time Frame: baseline to week 24 or early discontinuation)
    - Mean change on the Clinical Global Impression of Change (CGI) of apathy (Time Frame: baseline to week 24 or early discontinuation).
    - Media del cambio en la puntuación de la Parkinson’s Disease – Cognitive Rating Scale (PD-CRS) total desde la visita basal a la semana 24.
    - Media del cambio en la puntuación de la Parkinson's disease - Cognitive Functional Rating Scale (PD-CFRS) total desde la visita basal a la semana 24.
    - Media del cambio en la puntuación del Neuropsychiatric Inventory (NPI) desde la visita basal a la semana 24.
    - Media del cambio en la puntuación de la Hamilton Depression Rating Scale (HAM-D) total desde la visita basal a la semana 24.
    - Media del cambio en la puntuación de la Unified Parkinson's Disease Rating Scale (MDS-UPDRS) subescala motora (Parte III) desde la visita basal a la semana 24.
    - Media del cambio en la puntuación de la Schwab & England Activities of Daily Living Scale (S&E-ADL) desde la visita basal a la semana 24.
    - Media del cambio en la puntuación de la escala 39-item Parkinson's Disease Questionnaire (PDQ-39) desde la visita basal a la semana 24.
    - Media del cambio en la puntuación de la escala Patient's Clinical Global Impression of Change (P-CGI) of Apathy desde la visita basal a la semana 24.
    - Media del cambio en la puntuación de la escala Clinical Global Impression of Change (CGI) of apathy desde la visita basal a la semana 24.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks
    24 semanas
    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) 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 Yes
    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 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 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 concerned2
    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
    UVUS
    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 months20
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state36
    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 Decision2017-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-09-15
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