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    EudraCT Number:2018-003289-15
    Sponsor's Protocol Code Number:0169
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-06-27
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2018-003289-15
    A.3Full title of the trial
    A Phase 3, 4-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure
    Estudio 0169: Estudio en fase III, de 4 semanas de duración, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupo paralelo de TD 9855 en el tratamiento de la hipotensión ortostática neurogénica sintomática en sujetos con fallo autonómico primario
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF)
    Este estudio comprobará como de eficaz y seguro es el producto en investigación TD-9855 en el tratamiento de la hipotensión ortostática neurogénica sintomática en sujetos con la enfermedad de Parkinson (EP), atrofia multisistémica (AMS) o con fallo anatómico puro (FAP)
    A.3.2Name or abbreviated title of the trial where available
    Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure
    A.4.1Sponsor's protocol code number0169
    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 SponsorTheravance Biopharma Ireland Limited
    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 supportTheravance Biopharma Ireland Limited
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTheravance Biopharma Ireland Limited
    B.5.2Functional name of contact pointDr. Brett Haumann
    B.5.3 Address:
    B.5.3.1Street AddressConnaught House, 1 Burlington Road
    B.5.3.2Town/ cityDublin 4
    B.5.3.3Post codeD04 C5Y6
    B.5.4Telephone number+353(0)1 539 4800
    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.3.2Product code TD-9855
    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 INNampreloxetine
    D.3.9.1CAS number 1227056-84-9
    D.3.9.2Current sponsor codeTD-9855
    D.3.9.3Other descriptive nameTD-9855
    D.3.9.4EV Substance CodeSUB194904
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 placeboTablet
    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
    Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure
    Hipotensión ortostática neurogénica sintomática en sujetos con fallo autonómico primario
    E.1.1.1Medical condition in easily understood language
    Symptomatic neurogenic Orthostatic Hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF)
    Hipotensión ortostática neurogénica sintomática en sujetos con la enfermedad de Parkinson (EP), atrofia multisistémica (AMS) o con fallo anatómico puro (FAP)
    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 evaluate the efficacy of TD-9855 in subjects with multiple system atrophy (MSA), Parkinson’s disease (PD), or pure autonomic failure (PAF) experiencing symptomatic neurogenic orthostatic hypotension (snOH) compared with placebo at Week 4, as measured by the change from baseline of the Orthostatic Hypotension Symptom Assessment (OHSA) Question 1 (OHSA#1) score.
    • Evaluar la eficacia de TD-9855 en sujetos con atrofia multisistémica (AMS), enfermedad Parkinson (EP) o fallo autonómico puro (FAP) que experimenten hipotensión ortostática neurogénica sintomática (snOH) comparada con un placebo en la semana 4, medida por el cambio desde el inicio de la puntuación de la pregunta 1 de la evaluación de los síntomas de la hipotensión ortostática (Orthostatic Hypotension Symptom Assessment, OHSA#1).
    E.2.2Secondary objectives of the trial
    − To evaluate the efficacy of TD-9855 by symptom and activity assessments using OHSA and the Orthostatic Hypotension Daily Activities Scale (OHDAS).
    − To evaluate the efficacy of TD-9855 using the Patient Global Impression of Change (PGI-C), disease-specific instruments, Unified Parkinson’s Disease Rating Scale (UPDRS), Parkinson’s Disease Questionnaire-8 (PDQ-8),
    Unified Multiple System Atrophy Rating Scale (UMSARS), Composite Autonomic Symptoms Score-31 (COMPASS-31), and incidence of falls.
    − To evaluate the efficacy of TD-9855 using standing blood pressure during orthostatic standing test.
    − To evaluate the safety and tolerability of TD-9855, including adverse events (AEs) and changes in blood pressure (BP), heart rate (HR), electrocardiogram (ECG), Columbia Suicide Severity Rating Scale (C-SSRS), and laboratory tests.
    Evaluar la eficacia de TD-9855 mediante las evaluaciones de los síntomas y de la actividad de OHSA y la escala de actividad diaria de la hipotensión ortostática (OHDAS).
    Evaluar la eficacia de TD-9855 utilizando la impresión global de cambio del paciente (PGI-C), los instrumentos específicos de la enfermedad, la escala unificada de evaluación de la enfermedad de Parkinson (UPDRS), el cuestionario 8 de la enfermedad de Parkinson (PDQ-8), la escala unificada de calificación de la atrofia multisistémica (UMSARS), la escala compuesta de síntomas autonómicos 31 (COMPASS-31) y la incidencia de caídas.
    Evaluar la eficacia de TD-9855 mediante la tensión arterial en bidipestación durante una prueba de posición ortostática.
    Evaluar la seguridad y la tolerabilidad de TD-9855, incluidos los (AA), los cambios en la tensión arterial (TA), la frecuencia cardíaca (FC), un electrocardiograma (ECG), la escala Columbia para evaluar el riesgo de suicidio y las pruebas analíticas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    *Subject is male or female and at least 30 years old.
    *Subject is female and must be nonpregnant and nonlactating. A woman of childbearing potential must have a documented negative pregnancy test at screening.
    *If sexually active, the subject must agree to use a highly effective method of birth control with partners of childbearing potential during the study and for 1 month after the last study medication dose. Male subjects should use condoms with spermicide, even after a vasectomy, during sexual intercourse with female partners while being treated with TD-9855 and for 1 month after the last dose to avoid exposing an embryo
    or fetus to TD-9855.
    *Subject must meet the diagnostic criteria of snOH, as demonstrated by a ≥20 mm Hg (systolic) or ≥10 mm Hg (diastolic) within 3 minutes of being tilted-up to ≥60 degrees from a supine position as determined by a tilt-table test.
    *Subject must score at least a 4 on the Orthostatic Hypotension Symptom Assessment Question #1 at randomization visit.
    *For subjects with PD only: Subject has a diagnosis of PD according to the United Kingdom Parkinson’s Disease Society (UKPDS) Brain Bank Criteria (1992).
    *For subjects with MSA only: Subject has a diagnosis of possible or probable MSA of the Parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C) according to The Gilman Criteria (2008).
    *For subjects with PAF only: Subject has impaired autonomic reflexes, as determined by absence of Phase IV BP overshoot after release of the Valsalva strain.
    *Subject has plasma NE levels >100 pg/mL after being in seated position for 30 minutes.
    *Subject is willing and able to provide signed and dated written informed consent to participate prior to initiation of any study related procedures.
    *Subject is able to communicate well with the investigator and clinic staff, understands the expectations of the study and is able to comply with the study procedures, requirements, and restrictions.
    *El sujeto es hombre o mujer y tiene al menos 30 años.
    *El sujeto es mujer y no está en periodo de embarazo o lactancia. Una mujer en edad fértil debe documentar una prueba de embarazo negativa en el momento de la selección.
    *Si es sexualmente activo, el sujeto debe aceptar utilizar un método anticonceptivo altamente eficaz con su pareja en edad fértil durante el estudio y 1 mes después de la última dosis de medicación del estudio. Los hombres deben utilizar preservativos con espermicida, incluso después de la vasectomía, durante las relaciones sexuales con sus parejas femeninas mientras están siendo tratados con TD-9855 y 1 mes después de la última dosis, para evitar así la exposición del feto o del embrión a TD-9855.
    *El sujeto debe cumplir los criterios diagnósticos de snOH, en base a una tensión ≥20 mm Hg (sistólica) o ≥10 mm Hg (diastólica) en un plazo de 3 minutos después de una inclinación de hasta ≥60° desde una posición supina, según lo determine la prueba de la mesa inclinada.
    *El sujeto debe obtener al menos una puntuación de 4 en la Pregunta 1 de la evaluación de los síntomas de la hipotensión ortostática de la visita de aleatorización.
    *Solo para los sujetos con EP: El sujeto presenta un diagnóstico de EP de acuerdo con los criterios del Banco de cerebros de la Sociedad de la Enfermedad de Parkinson del Reino Unido (United Kingdom Parkinson’s Disease Society Brain Bank) (1992).
    *Solo para los sujetos con AMS: El sujeto presenta un diagnóstico de AMS posible o probable del subtipo parkinsoniano (AMS-p) o del subtipo cerebral (AMS-c), de acuerdo con los criterios de Gilman (2008).
    *Solo para los sujetos con FAP: El sujeto presenta insuficiencia de los reflejos autonómicos, según lo determinado por la ausencia de exceso de TA en fase IV después de la maniobra de Valsalva.
    *El sujeto presenta niveles de NE plasmática >100 pg/ml después de estar sentado durante 30 minutos.
    *El sujeto está capacitado y dispuesto para otorgar un consentimiento informado por escrito firmado y fechado para participar antes del inicio de cualquier procedimiento relacionado con el estudio.
    *El sujeto es capaz de comunicarse correctamente con el investigador y el personal clínico, entiende las expectativas del estudio y puede cumplir todos los procedimientos, requisitos y todas las restricciones del mismo.
    E.4Principal exclusion criteria
    *Subject has a known systemic illness known to produce autonomic neuropathy, including but not limited to diabetes mellitus, diabetes insipidus, diabetic neuropathy, amyloidosis, and autoimmune neuropathies.
    *Subject has a known intolerance to other NRIs or SNRIs.
    *Subject currently uses concomitant antihypertensive medication for the treatment of essential hypertension unrelated to autonomic dysfunction.
    *Subject has used strong CYP1A2 inhibitors or inducers within 7 days or 5 half-lives, whichever is longer, prior to randomization or requires concomitant use until the follow-up visit.
    *Subject has changed dose, frequency, or type of prescribed medication for orthostatic hypotension (e.g., ephedrine, dihydroergotamine, or fludrocortisone), within 7 days prior to randomization visit. These medications must be tapered off postrandomization. Tapering will follow the product’s United States (US) package insert. Midodrine and droxidopa must be tapered off at least 7 days prior to randomization.
    *Subject has a known or suspected alcohol or substance abuse within the past 12 months (DSM-IV-TR® definition of alcohol or substance abuse).
    *Subject has a clinically unstable coronary artery disease, or major cardiovascular or neurological event in the past 6 months.
    *Subject has used any monoamine oxidase inhibitor (MAO-I) within 14 days prior to randomization.
    *Subject has a history of untreated closed angle glaucoma, or treated closed angle glaucoma that, in the opinion of an ophthalmologist, might result in an increased risk to the subject.
    *Subject has any significant uncontrolled cardiac arrhythmia.
    *Subject has a Montreal Cognitive Assessment (MoCA) ≤23.
    *Subject is unable or unwilling to complete all protocol specified procedures including questionnaires.
    *Subject had a myocardial infarction in the past 6 months or has current unstable angina.
    *Subject has known congestive heart failure (New York Heart Association [NYHA] Class 3 or 4).
    *Subject has any malignant disease other than carcinoma in situ of the cervix or basal cell carcinoma within the past 2 years prior to screening.
    *Subject has a known gastrointestinal (GI) condition, which in the investigator’s judgment, may affect the absorption of study medication (e.g., ulcerative colitis, gastric bypass).
    *Subject has psychiatric, neurological, or behavioral disorders that may interfere with the ability of the subject to give informed consent or interfere with the conduct of the study.
    *Subject is currently receiving any investigational drug or has received an investigational drug within 30 days of dosing. An investigational drug is defined as nonregulatory agency approved drug (e.g., Food and Drug Administration).
    *Subject has a clinically significant abnormal laboratory findings (e.g., alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >3.0 x upper limit of normal [ULN]; blood bilirubin [total] >1.5 x ULN; estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m², or any abnormal laboratory value that could interfere with safety of the subject).
    *Subject has demonstrated a history of lifetime suicidal ideation and/or suicidal behavior, as outlined by the C-SSRS (Baseline/Screening Version) subject should be assessed by the rater for risk of suicide and the subject’s appropriateness for inclusion in the study.
    *Subject has a concurrent disease or condition that, in the opinion of the investigator, would confound or interfere with study participation or evaluation of safety, tolerability, or pharmacokinetics of the study drug.
    *El sujeto padece una enfermedad sistémica que produzca una neuropatía autonómica, incluidas, entre otras, diabetes mellitus, diabetes insípida, neuropatía diabética, amiloidosis y neuropatías autoinmunes.
    *El sujeto tiene intolerancia conocida a otros IRN o a los inhibidores de la recaptación de serotonina-norepinefrina (IRSN).
    *El sujeto está tomando actualmente medicamentos antihipertensivos concomitantes para el tratamiento de la hipertensión esencial no relacionada con la disfunción autonómica.
    *El sujeto ha utilizado inductores o inhibidores de CYP1A2 potentes en un periodo de 7 días o 5 semividas, lo que sea mayor, antes de la aleatorización o requiere un uso concomitante hasta la visita de seguimiento.
    *El sujeto ha cambiado la dosis, la frecuencia o el tipo de medicación recetada para la hipotensión ortostática (p. ej., efedrina, dihidroergotamina o fludrocortisona) en un plazo de 7 días antes de la visita de aleatorización. Se debe reducir la ingesta de estos medicamentos después de la aleatorización. La reducción se realizará de acuerdo con el prospecto estadounidense del producto. La ingesta de midodrina y droxidopa se debe reducir al menos 7 días antes de la aleatorización.
    *Se sospecha o conoce que el sujeto ha consumido alcohol o drogas durante los últimos 12 meses (definición de consumo de drogas o alcohol de DSM IV TR®).
    *El sujeto ha padecido una arteriopatía coronaria clínicamente inestable o un acontecimiento neurológico o cardiovascular grave durante los últimos 6 meses.
    *El sujeto ha utilizado un inhibidor de la monoaminooxidasa (monoamine oxidase inhibitor, MAOI) en un plazo de 14 días anterior a la aleatorización.
    *El sujeto tiene antecedentes de glaucoma de ángulo cerrado tratado o sin tratar que según un oftalmólogo pueda provocar un riesgo elevado para el sujeto.
    *El sujeto padece arritmia cardíaca no controlada.
    *El sujeto presenta una evaluación cognitiva de Montreal (Montreal Cognitive Assessment, MoCA) ≤23.
    *El sujeto no está capacitado ni dispuesto a completar todos los procedimientos especificados en el protocolo, incluidos los cuestionarios.
    *El sujeto ha sufrido un infarto de miocardio en los últimos 6 meses o padece actualmente una angina inestable.
    *El sujeto padece una insuficiencia cardíaca congestiva conocida (de clase 3 o 4, según la Asociación de Cardiología de Nueva York [New York Heart Association, NYHA]).
    *El sujeto ha padecido cualquier enfermedad maligna que no sea un carcinoma localizado en el cuello uterino o un carcinoma basocelular en un periodo de 2 años antes de la selección.
    *El sujeto padece una enfermedad gastrointestinal (GI) que, a juicio del investigador, puede afectar a la absorción del medicamento del estudio (por ejemplo, colitis ulcerosa o derivación gástrica).
    *El sujeto padece trastornos del comportamiento, neurológicos o psiquiátricos que pueden interferir en la capacidad del sujeto para otorgar su consentimiento informado o en la realización del estudio.
    *El sujeto está recibiendo actualmente algún fármaco en investigación o lo ha recibido durante un plazo de 30 días. Un fármaco en investigación se define como un fármaco aprobado por una agencia no reguladora (por ejemplo, la Administración de Alimentos y Medicamentos estadounidense).
    *El sujeto presenta anomalías clínicamente significativas en los resultados analíticos, (por ejemplo, alanina aminotransferasa [ALT] o aspartato aminotransferasa [AST] >3 x límite superior de la normalidad [LSN], bilirrubina en sangre [total] >1,5 x LSN, tasa de filtración glomerular estimada [TFGe] <30 ml/min/1,73m2 o cualquier valor analítico anómalo que pudiera interferir en la seguridad del sujeto).
    *El sujeto ha presentado antecedentes de pensamientos suicidas y/o comportamientos suicidas duraderos, tal y como se describe en la C-SSRS (versión de inicio/selección), por lo tanto, el evaluador debería estudiar el riesgo de suicidio y la adecuación del sujeto para ser incluido en el estudio.
    *El sujeto tiene una afección o enfermedad concurrente que, en opinión del investigador, confundiría o interferiría con su participación en el estudio o la evaluación de la seguridad, la tolerabilidad o la farmacocinética del fármaco del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in OHSA#1 (dizziness, lightheadedness, feeling faint, or feeling like blacking out) at Week 4.
    Cambios desde la inclusión en OHSA#1 (mareos, aturdimiento, sensación de desmayo o sensación de desvanecimiento) hasta la semana 4.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 4.
    Semana 4
    E.5.2Secondary end point(s)
    • Change from baseline in OHSA composite score in Weeks 1 to 4
    • Change from baseline in OHDAS composite score in Weeks 1 to 4
    • PGI-C at Week 4
    • Incidence of falls
    • Standing systolic blood pressure during orthostatic standing test

    Additional key secondary endpoints by disease type include:
    For subjects with PD
    • Change from baseline in UPDRS at Week 4
    • Change from baseline in PDQ-8 at Week 4
    For subjects with MSA
    • Change from baseline in COMPASS-31 at Week 4
    • Change from baseline in UMSARS at Week 4
    • Cambio con respecto al inicio en la puntuación compuesta de la OHSA de la semana 1 a la 4
    • Cambio con respecto al inicio en la puntuación compuesta de la OHDAS de la semana 1 a la 4
    • PGI-C en la semana 4
    • Incidencia de caídas
    • Presión arterial sistólica en bidipestación durante la prueba de posición ortostática.

    Los criterios de valoración secundarios adicionales según el tipo de enfermedad incluyen:
    Para los sujetos con EP
    • Cambio desde el inicio en la UPDRS en la semana 4
    • Cambio desde el inicio en el PDQ-8 en la semana 4
    Para los sujetos con AMS
    • Cambio desde el inicio en COMPASS-31 en la semana 4
    • Cambio desde el inicio en UMSARS en la semana 4
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 4.
    Semana 4
    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 Yes
    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 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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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
    Czech Republic
    Russian Federation
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    End of trial is LPLV for those who choose not to continue in Study 170.
    Final del ensayo el la última visita del último paciente para aquellos que elijan no continuar en el estudio 170.
    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 months11
    E.8.9.1In the Member State concerned days22
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days22
    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: 95
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 95
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 86
    F.4.2.2In the whole clinical trial 188
    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 completing the 4-week double-blind treatment period will be eligible to enroll and continue receiving study medication in Study 0170.
    Los sujetos que completen el periodo de tratamiento doble ciego de 4 semanas serán elegibles para ser incluidos en el estudio 0170 y continuar recibiendo la medicación del estudio.
    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 Decision2019-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-06
    P. End of Trial
    P.End of Trial StatusOngoing
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