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    Summary
    EudraCT Number:2018-003289-15
    Sponsor's Protocol Code Number:0169
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-18
    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 ConcernedItaly - Italian Medicines Agency
    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
    Studio 0169: Studio di fase 3, della durata di 4 settimane, multicentrico, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli di TD 9855 nel trattamento dell’ipotensione ortostatica neurogena sintomatica in soggetti con insufficienza autonomica primaria
    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)
    Questo studio esaminerà se un farmaco sperimentale chiamato TD-9855 funziona e quanto è sicuro per il trattamento dell'ipotensione ortostatica neurogena sintomatica (snOH) in soggetti con Morbo di Parkinson, atrofia del sistema multiplo o insufficienza autonomica primaria.
    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
    Studio di fase 3 sull’effetto clinico di TD-9855 per il trattamento della snOH in soggetti con insuf
    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 ANTIBIOTICS, INC.
    B.1.3.4CountryIreland
    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.4.2CountryIreland
    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.5.3.4CountryIreland
    B.5.4Telephone number00353015394800
    B.5.5Fax number000000
    B.5.6E-mailbhaumann@theravance.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 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.3.1Product namena
    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.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Ipotensione ortostatica neurogena sintomatica in soggetti con insufficienza autonomica primaria
    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)
    Ipotensione ortostatica neurogena sintomatica in soggetti con malattia di Parkinson (MP), atrofia sistemica multipla (MSA) e insufficienza autonomica pura (PAF)
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10021102
    E.1.2Term Hypotension orthostatic symptomatic
    E.1.2System Organ Class 100000004866
    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.
    Valutare l’efficacia di TD-9855 in soggetti con atrofia sistemica multipla (MSA), malattia di Parkinson (MP) o insufficienza autonomica pura (PAF) che hanno manifestato ipotensione ortostatica neurogena sintomatica (snOH) rispetto al placebo, alla Settimana 4, misurata sulla base della variazione dal basale del punteggio del questionario di Valutazione dei sintomi di ipotensione ortostatica (OHSA) Domanda 1 (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.
    Valutare l’efficacia di TD-9855 in base alla valutazione dei sintomi e dell’attività utilizzando il punteggio OHSA e la Scala di attività quotidiana nell’ipotensione ortostatica (OHDAS).
    Valutare l’efficacia di TD-9855 usando il (PGI-C), strumenti specifici della malattia, la Scala unificata di valutazione della malattia di Parkinson (UMPRS), il Questionario (PQD-8), la Scala unificata di valutazione dell’atrofia sistemica multipla (UMSARS), la Scala composita dei sintomi autonomici a 31 voci (COMPASS-31) e l’incidenza delle cadute.
    Valutare l’efficacia di TD-9855 utilizzando la pressione sanguigna in posizione eretta durante il test ortostatico in posizione eretta.
    Valutare la sicurezza e tollerabilità di TD-9855, compresi eventi avversi (EA) e variazioni della pressione sanguigna (BP), battito cardiaco (HR), elettrocardiogramma (ECG), Scala per la valutazione della gravità del rischio suicidario formulata dalla Columbia University (C-SSRS) e test di laboratorio.
    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.
    1. Il soggetto è di sesso maschile o femminile e ha almeno 30 anni.
    Il soggetto è di sesso femminile non è in gravidanza né in allattamento. Le donne in età fertile devono essere negative al test di gravidanza, come dimostrato da apposita documentazione, alla Visita di screening.
    NOTA: Una donna è considerata in età fertile a meno che non sia in postmenopausa (amenorreica da almeno 2 anni) o chirurgicamente sterile, (legatura bilaterale delle tube o isterectomia totale) come dimostrato da apposita documentazione. Un soggetto di sesso femminile può essere ammesso allo studio sulla base di un test di gravidanza sulle urine negativo. Se il test della bHCG (gonadotropina corionica umana beta) nelle urine è positivo, deve essere eseguito un test della bHCG sierica. Il test di gravidanza deve essere confermato come negativo affinché un soggetto sia idoneo per questo studio.
    Se sessualmente attivo, il soggetto deve acconsentire a utilizzare un metodo contraccettivo altamente efficace con compagno in età fertile durante lo studio e per 1 mese dopo l’ultima dose di farmaco dello studio. I soggetti di sesso maschile devono utilizzare preservativi con spermicida, anche dopo una vasectomia, durante i rapporti sessuali con le proprie compagne nel corso del trattamento con TD-9855 e per 1 mese dopo l’ultima dose, per evitare di esporre l’embrione o il feto a TD-9855.
    NOTA: Si definiscono altamente efficaci i metodi di controllo delle nascite con un basso tasso di fallimento (ovvero, metodi che comportano un tasso di insuccesso inferiore all’1% all’anno) quando utilizzati in modo costante e corretto, quali impianti, iniezioni, contraccettivi orali combinati, alcuni dispositivi intrauterini (IUD), astinenza sessuale o un compagno vasectomizzato.
    Il soggetto deve soddisfare i criteri diagnostici di snOH, come dimostrato da =20 mm Hg (pressione sistolica) o =10 mm Hg (pressione diastolica) entro 3 minuti dal sollevamento =60o dalla posizione supina, come determinato dal tilt test.
    Il soggetto deve ottenere un punteggio non inferiore a 4 alla Domanda n. 1 del questionario per la valutazione dei sintomi dell’ipotensione ortostatica somministrato alla visita di randomizzazione.
    Solo per i soggetti con MP: il soggetto ha una diagnosi di MP in base ai Criteri della Banca cerebrale della Società per la malattia di Parkinson del Regno Unito (UKPDS) (1992).
    Solo per i soggetti con MSA: il soggetto ha una diagnosi di possibile o probabile MSA del sottotipo di Parkinson (MSA-P) o cerebellare (MSA-C) secondo i Criteri di Gilman (2008).
    Solo per i soggetti con PAF: il soggetto presenta una compromissione dei riflessi autonomici, determinata dal mancato incremento della pressione sanguigna nella Fase IV della manovra di Valsalva, successiva alla fase di rilasciamento.
    Il soggetto presenta livelli plasmatici di NE >100 pg/ml dopo essere stato in posizione seduta per 30 minuti.
    Il soggetto è disposto e in grado di fornire il consenso informato scritto alla partecipazione, firmato e datato, prima dell’inizio di qualsiasi procedura correlata allo studio.
    Il soggetto è in grado di comunicare bene con lo sperimentatore e il personale clinico, comprende le aspettative dello studio ed è in grado di rispettare le procedure, i requisiti e le restrizioni dello studio.
    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.
    Il soggetto:
    è affetto da malattia sistemica nota considerata possibile causa di neuropatia autonomica, inclusi, a titolo di esempio, diabete mellito, diabete insipido, neuropatia diabetica, amiloidosi e neuropatie autoimmuni.
    è affetto da intolleranza nota ad altri NRI o inibitori della ricaptazione della serotonina-norepinefrina (SNRI).
    attualmente fa uso di farmaci antipertensivi concomitanti per il trattamento dell’ipertensione essenziale non correlato a disfunzione autonomica.
    ha fatto uso di forti inibitori o induttori di CYP1A2 entro 7 giorni o 5 emivite, a seconda di quale periodo è più lungo, prima della randomizzazione o ne deve fare uso concomitante fino alla visita di follow-up.
    ha cambiato dose, frequenza o tipo di farmaco prescritto per l’ipotensione ortostatica (ad es., efedrina, diidroergotamina o fludrocortisone) entro 7 giorni prima della visita di randomizzazione. Questi farmaci devono essere gradualmente ridotti dopo la randomizzazione. La riduzione progressiva seguirà il foglio illustrativo statunitense del prodotto. Midodrina e droxidopa devono essere ridotte gradualmente almeno 7 giorni prima della randomizzazione.
    ha una nota o sospetta anamnesi di abuso di alcol o sostanze negli ultimi 12 mesi [definizione di abuso di alcol o sostanze (DSM-IV-TR®)].
    presenta coronaropatia clinicamente instabile, o evento cardiovascolare o neurologico maggiore negli ultimi 6 mesi.
    ha utilizzato un inibitore della monoamino ossidasi (I-MAO) nei 14 giorni prima della randomizzazione.
    ha un’anamnesi di glaucoma ad angolo chiuso non trattato o glaucoma ad angolo chiuso trattato che, secondo il parere di un oftalmologo, potrebbe aumentare i rischi per il soggetto.
    presenta un’aritmia cardiaca significativa non controllata.
    ha un punteggio =23 sulla scala di valutazione cognitiva di Montreal (MoCA).
    non è in grado o non è disposto a completare tutte le procedure specificate nel protocollo, inclusi i questionari.
    ha avuto un infarto del miocardio negli ultimi 6 mesi o presenta attualmente angina instabile.
    presenta insufficienza cardiaca congestizia nota (classe III o IV della New York Heart Association [NYHA]).
    presenta qualsiasi patologia maligna diversa da carcinoma in situ della cervice o carcinoma a cellule basali negli ultimi 2 anni precedenti allo screening.
    ha una condizione di tipo gastrointestinale nota, che, a giudizio dello sperimentatore, potrebbe compromettere l’assorbimento del farmaco dello studio (ad es., colite ulcerosa, bypass gastrico).
    presenta disturbi psichiatrici, neurologici o comportamentali che possono interferire con la sua capacità di fornire il consenso informato o con la conduzione dello studio.
    sta attualmente ricevendo un qualsiasi farmaco sperimentale o ha ricevuto un farmaco sperimentale entro 30 giorni dalla somministrazione. È definito sperimentale un farmaco non approvato da un’agenzia regolatoria (ad es., Food and Drug Administration).
    presenta risultati di laboratorio anomali clinicamente significativi (ad es., alanina aminotransferasi [ALT] o aspartato aminotransferasi [AST] >3,0 x limite superiore della norma [ULN]; bilirubina del sangue [totale] >1,5 x ULN; tasso di filtrazione glomerulare stimato (eGFR) <30 ml/min/1,73 m2 o qualsiasi valore di laboratorio anomalo che potrebbe interferire con la sicurezza del soggetto).
    ha dimostrato un’anamnesi di ideazione suicida e/o comportamento suicida nell’arco della vita, come descritto dalla C-SSRS (versione per basale/screening); in questo caso, deve essere valutato dal valutatore rispetto al rischio di suicidio e all’appropriatezza della sua inclusione nello studio.
    ha una malattia o condizione concomitante che, a giudizio dello sperimentatore, potrebbe interferire con la partecipazione allo studio o confondere la valutazione della sicurezza, tollerabilità o farmacocinetica del farmaco dello studio.
    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.
    L’endpoint primario dello studio è la variazione dal basale nella OHSA#1 (vertigini, sensazione di stordimento, sensazione di svenimento o di perdita di conoscenza) alla Settimana 4.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 4.
    Settimana 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
    ; Variazione dal basale nel punteggio composito OHSA nelle Settimane da 1 a 4
    Variazione dal basale nel punteggio composito OHDAS nelle Settimane da 1 a 4
    PGI-C alla Settimana 4
    Incidenza delle cadute
    Pressione arteriosa sistolica in posizione eretta nel test ortostatico in posizione eretta
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 4.
    Settimana 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.7.1.3.1Other 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 concerned13
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Canada
    Czechia
    Denmark
    Estonia
    France
    Germany
    Hungary
    Israel
    Italy
    Russian Federation
    Spain
    Ukraine
    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.
    La fine della speriemtnazione è LPLV per coloro che scelgono di non proseguire nello studio 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 state25
    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.
    I soggetti che completano il periodo di trattamento in doppio cieco di 4 settimane saranno idonei a iscriversi e continuare a ricevere i farmaci in studio nello Studio 0170.
    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 Decision2019-08-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-02
    P. End of Trial
    P.End of Trial StatusOngoing
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