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    Summary
    EudraCT Number:2016-000587-42
    Sponsor's Protocol Code Number:RVT-101-3002
    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:2018-02-27
    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 number2016-000587-42
    A.3Full title of the trial
    A Long-Term, Open-Label Extension Study of the Safety and Tolerability of RVT-101 in Subjects with Alzheimer’s Disease
    Studio di estensione a lungo termine, in aperto, sulla sicurezza e tollerabilità di RVT 101 in soggetti affetti da malattia di Alzheimer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Long-Term, Open-Label Extension Study of the Safety and Tolerability of RVT-101 in Subjects with Alzheimer’s Disease
    Studio di estensione a lungo termine, in aperto, sulla sicurezza e tollerabilità di RVT 101 in soggetti affetti da malattia di Alzheimer
    A.3.2Name or abbreviated title of the trial where available
    A Long-Term, Open-Label Extension Study of the Safety and Tolerability of RVT-101 in Subjects with A
    Studio di estensione a lungo termine, in aperto, sulla sicurezza e tollerabilità di RVT 101 in sogge
    A.4.1Sponsor's protocol code numberRVT-101-3002
    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 SponsorAXOVANT SCIENCES LTD.
    B.1.3.4CountryBermuda
    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 supportAxovant Sciences Limited
    B.4.2CountryBermuda
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWorldwide Clinical Trials
    B.5.2Functional name of contact pointProject Management
    B.5.3 Address:
    B.5.3.1Street Address2nd Floor, 172 Tottenham Court Road
    B.5.3.2Town/ cityLondra
    B.5.3.3Post codeW1T 7NS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00442071216161
    B.5.5Fax number00442071216160
    B.5.6E-mailangelico.carta@worldwide.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 nameRVT-101
    D.3.2Product code RVT-101
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 607742-69-8
    D.3.9.2Current sponsor codeRVT-101
    D.3.9.3Other descriptive name3-Phenylsulfonyl-8-(piperazin-1-yl)quinoline
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number35
    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 Yes
    D.3.11.13.1Other medicinal product typeRVT-101 is a nitrogen containing heterocycle
    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
    Alzheimer's Disease
    Malattia di Alzheimer
    E.1.1.1Medical condition in easily understood language
    Alzheimer's Disease (AD) is a brain disease that slowly destroys brain cells and has its worst effects on the areas of the brain that control memory, language, and thinking skills.
    Malattia di Alzheimer
    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 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 100000004852
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the long-term safety and tolerability of RVT-101
    Valutare la sicurezza a lungo termine e la tollerabilità di RVT-101
    E.2.2Secondary objectives of the trial
    To assess the effects of RVT-101 on subject dependency as measured by the Dependence Scale (DS).
    To assess the effects of RVT-101 on quality of life as measured by the EuroQOL 5 dimensions questionnaire (EQ-5D)
    Valutare gli effetti di RVT 101 sulla dipendenza dei soggetti misurata mediante la scala DS (Dependence Scale).
    Valutare gli effetti di RVT-101 sulla qualità della vita misurata mediante il questionario a 5 dimensioni EQ 5D (EuroQol).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects eligible for enrollment in the study must meet all of the following criteria:
    - Male or female subjects who have completed the last on-treatment visit (V8) of lead-in study RVT-101-3001.
    - Subject remains on donepezil at the current stable dose for at least the first 4 weeks of this study; changes in donepezil dose and/or use of alternate background therapy during the first 4 weeks may be made only after approval by the Medical Monitor
    - Female subjects must be:
    a.Of non-childbearing potential or surgically sterile
    b.If pre-menopausal or menopausal for 1 year or less, must have a negative pregnancy test and must not be lactating at the Screening and Baseline Visits. Female subjects of childbearing potential and who are sexually active are required to practice highly effective methods of birth control during the course of the study and until the completion of the follow-up visit.
    - Male subjects who are sexually active will be required to use an adequate form of birth control including at least 1 barrier method
    - Subject continues to be able to ingest pills (in tablet form) whole.
    - Subject has provided full written informed consent prior to the performance of any protocol-specified procedure; or if unable to provide informed consent due to cognitive status, subject has provided assent and a legally acceptable representative has provided full written informed consent on behalf of the subject.
    - Subject is able to comply with the study procedures in the opinion of the Investigator.
    - General health status is acceptable for participation in this study.
    - Subject lives with (or has substantial periods of contact with) a regular caregiver who is willing to attend Visits 1, 5 and 7 and report on subject's status, and who has substantial contact with the subject. If the caregiver does not cohabitate with the subject, he/she ideally should have a minimum of 10 hours total and at least 3 days contact with the subject per week. Every effort should be made to have the same caregiver throughout the study.
    - Caregiver has provided full written informed consent, on a separate informed consent form, on his/her own behalf prior to the performance of any protocol-specified procedure.
    I soggetti eleggibili all'arruolamento nello studio devono soddisfare tutti i criteri elencati di seguito.
    1.soggetti di entrambi i sessi che hanno completato l’ultima visita del periodo di trattamento (V8) dello studio iniziale RVT 101 3001.
    2.Soggetto che continua a essere trattato con donepezil alla dose stabile attuale per almeno le prime 4 settimane di questo studio; modifiche della dose di donepezil e/o l’uso di un’altra terapia di fondo durante le prime 4 settimane potranno essere apportate solo con l’approvazione del responsabile del monitoraggio clinico.
    3.I soggetti femmine devono essere:
    a.non in età fertile (ossia, qualsiasi donna in postmenopausa [ciclo mestruale assente da più di 1 anno in assenza di terapia ormonale sostitutiva]) o chirurgicamente sterile; o,
    b.se in premenopausa o menopausa per un periodo pari o inferiore a 1 anno, devono risultare negative al test di gravidanza e non devono allattare nel periodo che coincide con alle visite di screening e basale. I soggetti femmine in età fertile, che sono sessualmente attivi, devono far uso di metodi contraccettivi altamente efficaci durante lo svolgimento dello studio e fino al momento di completamento della visita di follow up. I soggetti femmine il cui stato menopausale è incerto, a giudizio dello sperimentatore, dovranno far uso di un metodo contraccettivo altamente efficace. Per metodi contraccettivi altamente efficaci si intendono i metodi che dimostrano un tasso di fallimento inferiore all'1% all'anno, se utilizzati in modo costante e corretto e comprendono:
    •contraccettivo ormonale combinato (contenente estrogeni e progestinici) associato all’inibizione dell’ovulazione: orale, intravaginale o transdermico
    •contraccettivo contenente solo progestinici associato all’inibizione dell’ovulazione: orale, iniettabile o impiantabile
    •dispositivo intrauterino (IUD)
    •sistemi intrauterini a rilascio di ormoni (IUS)
    •occlusione tubarica bilaterale
    •partner vasectomizzato
    •astinenza dai rapporti sessuali
    4. Ai soggetti maschi sessualmente attivi sarà richiesto di far uso di un metodo contraccettivo adeguato che comprende almeno 1 metodo di barriera.
    5. Soggetto ancora in grado di ingerire le pillole (in forma di compresse) intere.
    6. Soggetto che ha espresso il pieno consenso informato per iscritto prima dell'effettuazione di qualsiasi procedura prevista dal protocollo; oppure, se incapace di accordare il consenso informato a causa dello stato cognitivo, il soggetto ha espresso l'assenso e un rappresentante legalmente riconosciuto ha accordato il pieno consenso informato per iscritto per conto del soggetto.
    7. Soggetto in grado, secondo il parere dello sperimentatore, di aderire alle procedure dello studio.
    8. Stato di salute generale accettabile per la partecipazione a questo studio.
    9. Soggetto che coabita (o che è in frequente contatto) con un regolare caregiver, disposto a presenziare alle Visite 1, 5 e 7, a segnalare le stato del soggetto e che abbia frequenti contatti con lo stesso. Se non coabita con il soggetto, il caregiver deve, nel caso ideale, essere in contatto con il soggetto per un minimo di 10 ore in totale e almeno 3 giorni alla settimana. Dovrà essere fatto quanto possibile per assicurare che il caregiver sia lo stesso per l’intera durata dello studio.
    10. Caregiver che ha espresso il pieno consenso informato per iscritto, in un modulo di consenso informato separato, per suo proprio conto prima dell'effettuazione di qualsiasi procedura prevista dal protocollo.
    E.4Principal exclusion criteria
    A subject will be excluded from participation in this study if any of the following criteria apply:
    - Subject experienced an uncontrolled AE in the lead-in study that would preclude continuation in a 12-month open label extension study, in the opinion of the Investigator. Subjects who experienced an SAE during the lead-in study may be considered for participation in this study only after discussion with the Medical Monitor.
    - Subject has a clinically significant vital signs or ECG abnormality at the end of the lead-in study, or at the Screening visit for this study, that would preclude continuation in a 12-month open label extension study, in the opinion of the Investigator.
    - Subject has a clinically significant laboratory abnormality at V7 or V8 of the lead-in study, or at the Screening visit for this study, that would preclude continuation in a 12-month open label extension study, in the opinion of the Investigator. Investigators need not wait for V8 results before enrolling the subject in this study. However, any clinically significant abnormality subsequently identified from V8 of the lead-in study and/or at the Screening visit for this study will be evaluated by the Investigator for continued involvement in this study.
    - Subject has developed any confounding medical or psychiatric condition that would preclude continuation in a 12-month open label extension study, in the opinion of the Investigator.
    - Significant suicide risk as defined by suicidal ideation as endorsed on items 4 or 5 on the C-SSRS at Screening of this study, or clinical assessment of significant suicidal risk.
    - Treatment with any concomitant medication detailed in Table 1.
    - Confirmed corrected QT interval (QTc) value ≥ to 450 msec for males or ≥ 470 msec for females. Subjects with a QRS value greater than 120 msec and QTc value less than 500 msec may be eligible following discussion with the Medical Monitor.
    - Subject is unable to take the investigational product as prescribed throughout the study (with assistance is acceptable).
    - Subject or caregiver is an immediate family member or employee of the participating investigator, any of the participating site staff, or of the sponsor study staff.
    Un soggetto non sarà eleggibile all’inclusione nello studio se soddisfa uno qualsiasi dei criteri riportati di seguito.
    -Soggetto che ha manifestato un AE non controllato nello studio preliminare che, secondo l’opinione dello sperimentatore, precluderebbe la continuazione della partecipazione a uno studio di estensione in aperto della durata di 12 mesi. I soggetti che hanno manifestato un evento avverso grave (SAE) durante lo studio preliminare possono essere considerati per la partecipazione a questo studio solo dopo averne discusso con il responsabile del monitoraggio clinico.
    -Soggetto che presenta un’anomalia clinicamente significativa dei parametri vitali o dell’elettrocardiogramma alla fine dello studio iniziale o alla visita di screening del presente studio che, secondo l’opinione dello sperimentatore, precluderebbe la continuazione della partecipazione a uno studio di estensione in aperto della durata di 12 mesi.
    -Soggetto che presenta un’anomalia clinicamente significativa nelle analisi di laboratorio alla V7 e V8 dello studio iniziale o alla visita di screening del presente studio che, secondo l’opinione dello sperimentatore, precluderebbe la continuazione della partecipazione a uno studio di estensione in aperto della durata di 12 mesi. Non è necessario che gli sperimentatori attendano i risultati della V8 prima di arruolare il soggetto nello studio. Tuttavia, lo sperimentatore valuterà l’opportunità di continuare la partecipazione a questo studio qualora venissero identificate, in un momento successivo, eventuali anomalie clinicamente significative nei risultati della V8 dello studio iniziale e/o della visita di screening.
    -Soggetto che ha manifestato una patologia medica o psichiatrica confondente che, secondo l’opinione dello sperimentatore, precluderebbe la continuazione della partecipazione a uno studio di estensione in aperto della durata di 12 mesi.
    -Rischio significativo di suicidio definito da ideazione suicidaria confermata dagli item 4 o 5 della scala C-SSRS allo screening di questo studio o valutazione clinica di notevole rischio suicidario.
    -Terapia con qualsiasi medicinale concomitante, riportato nella Tabella 1 del protocollo.
    -Valore confermato dell'intervallo QT corretto (QTc) pari o superiore a 450 msec per i maschi o pari o superiore a 470 msec per le donne. I soggetti con un valore QRS superiore a 120 msec e QTc inferiore a 500 msec potranno essere considerati eleggibili previa discussione con il responsabile del monitoraggio medico.
    -Soggetto incapace di assumere il prodotto sperimentale come prescritto per l'intera durata dello studio (è accettabile se riceve assistenza).
    -Soggetto o caregiver che appartiene al nucleo familiare o che è un dipendente dello sperimentatore principale, o di qualsiasi altra persona facente parte dello staff del centro partecipante o del personale del promotore.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of AEs and changes in physical examinations, vital signs
    measurements, ECGs, clinical laboratory assessments, and C-SSRS
    results
    Incidenza di eventi avversi e di cambiamenti in esami fisici, misurazione segni vitali, ECG, esami di laboratorio, clinici e risultati in C-SSRS
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    Setimana 52
    E.5.2Secondary end point(s)
    DS score change from baseline at Weeks 28 and 52
    EQ-5D score change from baseline at Weeks 28 and 52
    Cambiamento del punteggio DS dal basale alle settimane 28 e 52.
    Cambiamento del punteggio EQ-5D dal basale alle settimane 28 e 52.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 28 & Week 52
    Settimana 28 e settimana 52
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) 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 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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA74
    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
    Argentina
    Australia
    Brazil
    Bulgaria
    Canada
    Chile
    Croatia
    Czech Republic
    France
    Germany
    Italy
    Korea, Democratic People's Republic of
    Korea, Republic of
    Poland
    Serbia
    Singapore
    Slovakia
    Spain
    Taiwan
    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
    LVLS
    LVLS
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    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.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 550
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 600
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects diagnosed with Alzheimer's Disease who may or may not be able to consent personally. Full, written consent will be obtained from each subject or his/her legal representative/caregiver where applicable, prior to recruitment.
    Soggetti con malattia di Alzheimer che possono o meno essere in grado di dare il consenso personalmente. Consenso sarà ottenuto per ogni soggetto dal proprio rapresentante legale, se applicabile, prima dell'arruolamento.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state44
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 440
    F.4.2.2In the whole clinical trial 1150
    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)
    Subsequent treatments of the study subject will be at the discretion of the investigator in accordance to standard care. The investigator is responsible for ensuring that consideration has been given to the poststudy care of the subject's medical condition.
    I trattamenti successivi del paziente saranno a discrezione dello sperimentatore in conformità con lo standard terapeutico. Lo sperimentatore è responsabile di accertarsi che il trattamento del paziente dopo lo studio sia soggetto a controlli.
    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 Decision2016-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-05
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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