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    EudraCT Number:2016-001403-23
    Sponsor's Protocol Code Number:M15-535
    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:2016-11-15
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2016-001403-23
    A.3Full title of the trial
    An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication)
    Estudio abierto y aleatorizado de 12 semanas de duración para comparar la eficacia del gel intestinal de levodopa y carbidopa/suspensión enteral de carbidopa y levodopa frente a tratamiento médico optimizado en la discinesia en sujetos con enfermedad de Parkinson avanzada - DYSCOVER (Ensayo intervencionista comparativo de Duodopa frente a medicación oral en la discinesia)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    12-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease
    Estudio de 12 semanas comparando el tratamiento gel intestinal de levodopa y carbidopa/ suspensión enteral de carbidopa y levodopa con el tratamiento médico optimizado para la discinesia en pacientes con enfermedad de Parkinson avanzada.
    A.3.2Name or abbreviated title of the trial where available
    DYSCOVER Study
    A.4.1Sponsor's protocol code numberM15-535
    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 SponsorAbbVie Deutschland GmbH & Co. KG
    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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd.
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+34901 20 01 03
    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. name Duodopa
    D. of the Marketing Authorisation holderAbbVie Deutschland GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Intestinal gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPGastroenteral 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/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCarbidopa
    D.3.9.1CAS number 38821-49-7
    D.3.9.3Other descriptive nameCARBIDOPA MONOHYDRATE
    D.3.9.4EV Substance CodeSUB21619
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Dyskinesia in advanced Parkinson's disease
    Discinesia en enfermedad de Parkinson avanzada.
    E.1.1.1Medical condition in easily understood language
    Advanced Parkinson's disease
    Enfermedad de Parkinson avanzada.
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10013113
    E.1.2Term Disease Parkinson's
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this interventional study is to examine the effect of LCIG treatment relative to that of Optimized Medical Treatment (OMT) on dyskinesia as measured by the Unified Dyskinesia Rating Scale (UDysRS) Total Score.
    El objetivo principal de este estudio intervencionista es examinar el efecto del tratamiento GILC en comparación con el tratamiento médico optimizado (TMO) en la discinesia, medida por la puntuación total de la Escala unificada de valoración de la discinesia (UDysRS).
    E.2.2Secondary objectives of the trial
    The Secondary objective is to assess the effect of LCIG treatment relative to that of OMT on dyskinesia as measured by PD Diaries, motor symptoms, motor complications, safety, tolerability and health-related outcome measures.
    El objetivo secundario es evaluar el efecto del tratamiento con GILC en comparación con el TMO en la discinesia medida utilizando diarios de la EP, síntomas motores, complicaciones motoras, seguridad, tolerabilidad y medidas de resultados relacionados con la salud.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects of at least 30 years old at the time of Visit 3.
    2. Subject must have a diagnosis of idiopathic Parkinson's disease according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria
    3. Patients with advanced levodopa-responsive Parkinson's disease and persistent motor fluctuations who have not been controlled with optimized medical treatment. "Optimized medical treatment" is defined as the maximum therapeutic effect obtained with pharmacological antiparkinsonian therapies when no further improvement is expected regardless of any additional manipulations of levodopa and/or other antiparkinsonian medication. This will be based on the Investigator's clinical judgment.
    4. UDysRS Total score ≥ 30 at Visit 3 based on Central Blinded Rater's score.
    5. Subject (or subject's proxy/caregiver) must be able to complete both the Subject Dosing Diary and the PD Diary and must be able to demonstrate the ability to operate, manipulate, and care for the pump and tubing.
    6. Subject must demonstrate at least 75% concordance with the Investigator's or qualified designee's assessment of symptoms on the Parkinson's Disease Diary following training at Screening Visit 1 with concordance on at least 1 time interval of "Off," concordance on at least 1 time interval of "ON regardless of dyskinesia" and at least 1 time interval of "ON with dyskinesia" irrespective of whether the dyskinesia are troublesome or not troublesome.
    7. Subject is eligible to transfer to commercial treatment of Duodopa after completing the study based on local country requirements.
    1. Varones o mujeres de 30 o más años de edad en el momento de la visita 3.
    2. El paciente tiene que tener diagnosticada la enfermedad idiopática de Parkinson, según los criterios del United Kingdom Parkinson’s Disease Society (UKPDS) Brain Bank.
    3. Pacientes con Enfermedad de Parkinson avanzada que respondan a Levodopa, y con fluctuaciones motoras persistentes que no han sido controladas con un tratamiento médico optimizado. “Tratamiento Médico optimizado” se define como el efecto máximo terapéutico obtenido con terapias farmacológicas antiparkinsonianas cuando no se espera una mejoría mayor a pesar de cualquier manipulación adicional de levodopa y/u otra medicación antiparkinsoniana. Estará basado en el juicio del investigador clínico.
    4. Puntuación total de UDyRS ≥ 30 en la visita 3 basada en la puntuación de un evaluador central enmascarado.
    5. Paciente (o los cuidadores de los pacientes) tienen que ser capaces de completar tanto el diario de dosificación del paciente como el diario de EP, y tienen que ser también capaces de demostrar la habilidad de manejar, manipular y cuidar la bomba y la sonda.
    6. Los pacientes deberán demostrar una concordancia mínima del 75% con la evaluación de los síntomas realizada por el investigador o por otra persona cualificada en el diario de la enfermedad de Parkinson tras recibir instrucción en la visita 1 de selección, con concordancia en al menos 1 intervalo de tiempo "off", concordancia en al menos 1 intervalo de tiempo "on" con o sin discinesia y al menos un intervalo de tiempo "on" con discinesia, independientemente de que la discinesia sea o no problemática.
    7. El paciente cumple los requisitos locales de su país para pasar a recibir tratamiento comercial con Duodopa una vez completado el estudio.
    E.4Principal exclusion criteria
    1. Predominantly di-phasic dyskinesia, as per Investigator discretion.
    2. Patients who were treated with LCIG before
    3. Patients who have had previous surgery for PD including, but not limited to deep brain stimulation (DBS) or cell transplantation.
    4. A Mini-Mental State Examination (MMSE) score of < 24 at Visit 1 or significant cognitive impairment that, in the opinion of the Investigator, could impact the subject's ability to participate in the trial
    5. Current primary psychiatric diagnosis of uncontrolled acute psychotic disorder or primary psychiatric diagnoses of bipolar disorder, schizophrenia, obsessive compulsive disorder or currently experiencing a major depressive episode with psychotic features per Diagnostic and Statistical Manual of Mental Disorders Fifth Edition, Text Revision (DSM V-TR).
    6. Subject experiencing clinically significant sleep attacks or clinically significant impulsive behavior (e.g., pathological gambling, hypersexuality) at any point during the three months prior to the Screening evaluation as judged by the Investigator.
    7. Current diagnosis or history of drug or alcohol abuse (DSM-V-TR criteria) within 12 months prior to screening visit.
    8. Participation in a concurrent interventional or observational study.
    9. Lack of motivation or insufficient language skills to complete the study questionnaires.
    10. Subject's PD diagnosis is unclear or there is a suspicion that the subject has a parkinsonian syndrome such as secondary parkinsonism (e.g., caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), atypical Parkinson Syndrome (e.g., Multiple System Atrophy, Progressive supranuclear Palsy, Diffuse Lewy Body disease) or other neurodegenerative disease that might mimic the symptoms of PD.
    1. Discinesia predominantemente bifásica, a criterio del investigador.
    2. Pacientes tratados anteriormente con GILC.
    3. Pacientes que se hayan sometido previamente a un procedimiento quirúrgico para la EP, entre otros, estimulación cerebral profunda (ECP) o trasplante de células.
    4. Puntuación menor de 24 en el Miniexamen del estado mental (MMSE) en la visita 1 o deterioro cognitivo importante que, en opinión del investigador, pudiera afectar a la capacidad del sujeto para participar en el ensayo.
    5. Diagnóstico psiquiátrico primario de trastorno psicótico agudo y no controlado o de trastorno bipolar, esquizofrenia o trastorno obsesivo-compulsivo, o episodio actual de depresión mayor con manifestaciones psicóticas según el Manual diagnóstico y estadístico de los trastornos mentales, quinta edición, texto revisado (DSM-V-TR).
    6. Pacientes que experimenten ataques significantes durante el sueño, o impulsos de conducta clínicos significativos (ej.: hipersexualidad, problemas de juego) en cualquier momento durante los 3 meses antes a la evaluación de screening a juicio del investigador.
    7. Diagnóstico actual o antecedentes de alcoholismo o drogadicción (según los criterios del DSM-V-TR) en los 12 meses anteriores a la visita de selección.
    8. Participar en un estudio intervencionista u observacional concurrente.
    9. Falta de motivación o capacidades lingüísticas insuficientes para cumplimentar los cuestionarios del estudio.
    10. El diagnóstico de enfermedad de Parkinson es dudoso o se sospecha que el sujeto presenta un síndrome parkinsoniano, como parkinsonismo secundario (por ejemplo, por fármacos, toxinas, agentes infecciosos, enfermedad vascular, traumatismo, neoplasia cerebral), síndrome de Parkinson atípico (por ejemplo, atrofia multisistémica, parálisis supranuclear progresiva, enfermedad difusa con cuerpos de Lewy) u otra enfermedad neurodegenerativa que pueda imitar los síntomas de la enfermedad de Parkinson.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to week 12 in Unified Dyskinesia Rating Scale (UDysRS) Total Score.
    Cambio desde la visita basal a la semana 12 en el resultado total de la escala unificada para la discinesia (UDysRS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, Week 2, Week 4, Week 8, Week 12/Early termination visit
    Visita basal, visita semana 2, visita semana 4, visita semana 8, visita semana 12/visita de terminación temprana
    E.5.2Secondary end point(s)
    Secondary endpoints (with hierarchical analysis)

    • ON time without troublesome dyskinesia as measured by the PD Diary
    • PDQ-8 Summary Index
    • CGI-C
    • UPDRS Part II Score
    • OFF time as measured by PD Diary
    • UPDRS Part III Score

    Additional Efficacy Endpoints are:
    ● UDysRS Historical Score, Objective Score and Parts 1 through 4 Scores
    ● ON time with troublesome dyskinesia and ON time without dyskinesia as measured by PD Diary
    ● mAIMS

    Additional Health Outcome Endpoints:
    ● King's PD Pain Scale
    -Tiempo “on” con discinesia problemática medida por el Diario de EP
    -Puntuación global de PDQ-8
    -Puntuación de UPDRS, parte II
    - Tiempo “off” medido por el diario de EP
    Evaluaciones de eficacia adicional:
    - Puntuación histórica de UDysRS, puntuación objetiva y puntuaciones de las partes 1 a 4
    -Tiempo “on” con discinesia problemática a y tiempo “on” sin discinesia medida por el diario de EP
    Evaluaciones de resultados adicionales de salud:
    -Escala de dolor en la EP del King’s College Hospital
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Baseline, Week 2, Week 4, Week 8, Week 12/Early termination visit
    2. Baseline, Week 8, Week 12/Early termination visit
    3. Week 2, Week 4, Week 8, Week 12/Early termination visit
    4. Screening, Baseline, Week 2, Week 4, Week 8, Week 12/Early
    termination visit
    5. Baseline, Week 2, Week 4, Week 8, Week 12/Early termination visit
    6. Screening, Baseline, Week 2, Week 4, Week 8, Week 12/Early
    termination visit
    7. Baseline, Week 2, Week 4, Week 8, Week 12/Early termination visit
    8. Baseline, Week 2, Week 4, Week 8, Week 12/Early termination visit
    9. Baseline, Week 2, Week 4, Week 8, Week 12/Early termination visit
    10. Baseline, Week 4, Week 8, Week 12/Early termination visit
    1. Visita basal, visit sem 2, visit sem 4, visit sem 8, visit sem 12/visit de terminación temprana
    2. Visita basal, visit sem 8, visit sem 12/visit de terminación temprana
    3. visita semana 2, visit sem 4, visit sem 8, visit sem 12/ visit de terminación temprana
    4. visita de selección, visita basal, visit sem 2, visit sem 4, visit sem 8, visit sem 12/ visit de terminación temprana
    7. Visita basal, visit sem 2, visit sem 4 visit sem 8, visit sem 12/ visit de terminación temprana
    8. Visita basal, visit sem 2, visit sem 4, visit sem 8, visit sem 12/visit de terminación temprana.
    9. Visita basal, visit sem 2, visit sem 4, visit sem 8, visit sem 12/visit de terminación temprana.
    10. Visita basal, visit sem 4, visit sem 8, visit sem 12/visit de terminación temprana
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 Yes
    E. description
    Optimized medical treatment
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    European Union
    United States
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 60
    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)
    Subjects randomized to the LCIG treatment arm will be able to continue the treatment via commercial product. Subjects randomized in the OMT arm will be eligible for commercial LCIG/CLES. All commercial treatment will be provided through the local country's commercial program and local insurance reimbursement.
    Los sujetos aleatorizados con la rama del tratamiento GILC podrán continuar con el tratamiento mediante el producto comercial. Los sujetos aleatorizados en la rama TMO serán elegibles para el GILC/SECL comercial. Todos los tratamientos comercializados serán provisionados mediante el programa local del país y mediante un seguro de reembolso.
    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 Decision2016-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-09-19
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