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    Summary
    EudraCT Number:2019-002425-30
    Sponsor's Protocol Code Number:0171
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-05-24
    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 number2019-002425-30
    A.3Full title of the trial
    A Phase 3, 182-week, Open-Label, Safety and Tolerability Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension (snOH) in Subjects with Primary Autonomic Failure
    Studio in aperto di fase 3, della durata di 182 settimane per valutare la sicurezza e la tollerabilità di TD 9855 nel trattamento dell’ipotensione ortostatica neurogena sintomatica (snOH) in soggetti con insufficienza autonomica primaria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 Extension Study of TD-9855 for Treating snOH in Subjects with Primary Autonomic Failure
    Studio di estensione di fase 3 di TD-9855 per il trattamento della snOH in soggetti con insufficienza autonomica primaria
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code number0171
    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.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 number353015394800
    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 hydrochloride
    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
    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 (snOH) 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 (snOH) in soggetti con malattia di Parkinson (MP), l’atrofia sistemica multipla (MSA) e l’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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to evaluate the long-term safety of TD-9855 over a 182-week period.
    valutare la sicurezza a lungo termine di TD-9855 nell’arco di un periodo di 182 settimane.
    E.2.2Secondary objectives of the trial
    Not applicable
    non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Completion of Study 0170 and, in the opinion of the Investigator, would benefit from long-term treatment with TD-9855.
    2. The subject must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study procedures (including any changes occurring in the subject’s current therapeutic regimen).
    3. The subject must be willing to continue on treatment and must continue to meet all the inclusion criteria for the preceding study (Study 0170) except, a score of =4 in OHSA#1.
    1. Il soggetto ha completato lo Studio 0170 e, a giudizio dello sperimentatore, potrebbe trarre beneficio dal trattamento a lungo termine con TD-9855.
    2. Il soggetto dovrà essere in grado di comprendere la natura dello studio e fornire il consenso informato scritto prima dell’esecuzione di una qualsiasi procedura dello studio (inclusi eventuali cambiamenti nell’attuale regime terapeutico del soggetto).
    3. Il soggetto deve essere disposto a continuare il trattamento e deve continuare a soddisfare tutti i criteri di inclusione per lo studio precedente (Studio 0170), ad eccezione di un punteggio >4 nella Domanda 1 del questionario per la valutazione dei sintomi dell’ipotensione ortostatica (OHSA#1).
    E.4Principal exclusion criteria
    1. Subjects may not be enrolled in another clinical trial, with the exception of purely observational studies, which are allowed.
    2. Psychiatric, neurological, or behavioral disorders that may interfere with the ability of subjects to give informed consent, or interfere with the conduct of the study.
    3. Medical, laboratory, or surgical issues deemed by the Investigator to be clinically significant.
    4. Hypersensitivity to TD-9855 or the formulation excipients.
    1. I soggetti non possono essere arruolati in un’altra sperimentazione clinica, con l’eccezione di studi puramente osservazionali, che sono consentiti.
    2. Disturbi psichiatrici, neurologici o comportamentali che potrebbero interferire con la capacità del soggetto di fornire il consenso informato o con la conduzione dello studio.
    3. Problemi medici, di laboratorio o chirurgici ritenuti dallo sperimentatore clinicamente significativi.
    4. Ipersensibilità a TD-9855 o agli eccipienti della formulazione
    E.5 End points
    E.5.1Primary end point(s)
    Primary safety and tolerability endpoints include:
    • Physical examination
    • Neurological examination
    • Vital signs
    • Resting ECGs
    • Clinical laboratory tests including biochemistry, hematology, and urinalysis.
    • Concomitant medication
    • AEs
    • Subject compliance to study treatment
    • Incidence of falls
    • Columbia Suicide Severity Rating Scale (C-SSRS)
    Gli endpoint primari di sicurezza e tollerabilità comprendono:
    • Esame obiettivo
    • Esame neurologico
    • Segni vitali
    • ECG a riposo
    • Esami clinici di laboratorio, comprese analisi biochimiche, ematologia e analisi delle urine
    • Farmaci concomitanti
    • EA
    • Conformità del soggetto al trattamento dello studio
    • Incidenza delle cadute
    • Scala per la valutazione della gravità del rischio suicidario formulata dalla Columbia University (C-SSRS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Physical examination evaluated at visits 1,4, 6
    • Neurological examination evaluated at visits 1,4, 6
    • Vital signs evaluated at visits 1, 2, 3, 4, 5, 6
    • Resting ECGs evaluated at visits 1, 4, 6
    • Clinical laboratory tests including biochemistry, hematology, and urinalysis evaluated at visits 1, 4 and 6
    • Concomitant medication evaluated at all visits and at telephone contacts
    • Subject compliance to study treatment evaluated at visits 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
    • Incidence of falls evaluated at visits 1, 2, 3, 4, 5 and 6
    • Columbia Suicide Severity Rating Scale (C-SSRS) evaluated at visits 1, 2, 3, 4, 5 and 6
    • Esame fisico valutato alle visite 1,4, 6
    • Esame neurologico valutato alle visite 1,4, 6
    • Segni vitali valutati alle visite 1, 2, 3, 4, 5, 6
    • ECG a riposo valutati alle visite 1, 4, 6
    • Test clinici di laboratorio tra cui biochimica, ematologia e analisi delle urine valutati alle visite 1, 4 e 6
    • Farmaci concomitanti valutati in tutte le visite e ai contatti telefonici
    • Conformità del soggetto al trattamento di studio valutato alle visite 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
    • Incidenza delle cadute valutata alle visite 1, 2, 3, 4, 5 e 6
    • Columbia Suicide Severity Rating Scale (C-SSRS) valutata alle visite 1, 2, 3, 4, 5 e 6
    E.5.2Secondary end point(s)
    Not applicable
    non applicabile
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    non applicabile
    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 No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    in aperto
    open
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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
    Australia
    Canada
    Israel
    New Zealand
    Russian Federation
    Ukraine
    United States
    Austria
    Bulgaria
    Denmark
    Estonia
    France
    Germany
    Hungary
    Ireland
    Italy
    Poland
    Portugal
    Spain
    United Kingdom
    Czechia
    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
    LVLS
    La fine dello studio è LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days13
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days13
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 52
    F.4.2.2In the whole clinical trial 84
    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)
    The expectation is that the subject would resume standard of care.
    L'aspettativa è che il soggetto riprenda gli standard di cura.
    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 Decision2020-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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