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    Summary
    EudraCT Number:2016-000587-42
    Sponsor's Protocol Code Number:RVT-101-3002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-08-10
    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 ConcernedSpain - AEMPS
    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
    Estudio de extension a largo termino, abierto de seguridad y tolerancia de RVT en pacientes con Enfermedad de 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
    Estudio de extension a largo termino, abierto de seguridad y tolerancia de RVT en pacientes con Enfermedad de Alzheimer.
    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 Limited
    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/ cityLondon
    B.5.3.3Post codeW1T 7NS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44207121 6161
    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 IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 Yes
    D.3.11.13.1Other medicinal product typeRVT-101 is a nitrogen containing heterocycle also possessing aliphatic amine, aromatic amine and aromatic sulfone functions.
    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
    Enfermedad de 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.
    La Enfemedad de Alzehimer es una enfermedad cerebral que destruye lentamente las celulas cerebrales. Los peores efectos estan en areas del cerebro de: memoria, lenguaje y habilidades de pensamiento.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 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
    Para evaluar la seguridad a largo plazo y la tolerabilidad de 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)
    Evaluar los efectos de RVT-101 en la dependencia de los sujetos medido con la Escala de Dependencia (DS)
    Evaluar los efectos de RVT-101 en la calidad de vida medido con el cuestionario EuroQOL 5 dimensiones (EQ-5D)
    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 iswilling 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.
    Para poder ser incluidos en el estudio los sujetos deben cumplir todos los criterios siguientes:
    1. Hombre o mujer que haya concluido la última visita durante el tratamiento (V8) del estudio precedente RVT 101-3001.
    2. El sujeto continúa con su dosis estable actual de donepezilo durante como mínimo las primeras 4 semanas de este estudio; solo se podrá modificar la dosis de donepezilo y/o emplear otro tratamiento de fondo durante las primeras 4 semanas con la aprobación previa del monitor médico.
    3. Si la participante es mujer, deberá:
    a. No ser potencialmente fértil (es decir, mujer posmenopáusica [más de un año sin menstruación en ausencia de tratamiento hormonal sustitutivo]) o haber sido sometida a esterilización quirúrgica; o,
    b. Si es premenopáusica o menopáusica desde hace un año o menos, deberá presentar una prueba de embarazo negativa y no estar en periodo de lactancia natural en las visitas de selección y basal. Las mujeres potencialmente fértiles con actividad sexual deberán emplear métodos anticonceptivos de gran eficacia a lo largo del estudio y hasta finalizar la visita de seguimiento. Si el investigador no tiene certeza del estado de menopausia de la sujeto, esta deberá emplear un método anticonceptivo de gran eficacia. Los métodos anticonceptivos de gran eficacia, que se definen como los que arrojan una tasa de fallos de menos del 1% al año en su uso correcto y constante, incluyen:
    • Anticonceptivos hormonales combinados (con estrógenos y gestágenos) para inhibición de la ovulación; orales, intravaginales o transdérmicos
    • Anticonceptivos hormonales gestagénicos para inhibición de la ovulación; orales, inyectables o implantables
    • Dispositivo intrauterino (DIU)
    • Sistema intrauterino liberador de hormonas (SIU)
    • Oclusión tubárica bilateral
    • Pareja vasectomizada
    • Abstinencia sexual
    4. Los varones sexualmente activos deberán emplear un método anticonceptivo adecuado que incluya como mínimo un método de barrera.
    5. El sujeto sigue pudiendo ingerir comprimidos enteros.
    6. El sujeto ha otorgado su pleno consentimiento informado por escrito antes de que se realice ningún procedimiento especificado en el protocolo; o, si no puede dar su consentimiento informado debido a su estado cognitivo, el sujeto ha dado su asentimiento y el representante legal ha otorgado su pleno consentimiento informado por escrito en nombre del sujeto.
    7. El sujeto puede realizar los procedimientos del estudio en opinión del investigador.
    8. Estado de salud general aceptable para participar en el estudio.
    9. El sujeto vive (o está en contacto durante periodos considerables) con un cuidador habitual que está dispuesto a acudir a las visitas 1, 5 y 7 y a informar sobre la situación del sujeto y que mantiene un contacto considerable con el sujeto. Si el cuidador no convive con el sujeto, lo ideal es que mantenga un contacto mínimo con el sujeto de 10 horas en total y al menos 3 días a la semana. Se procurará por todos los medios mantener al mismo cuidador durante todo el estudio.
    10. El cuidador ha otorgado su pleno consentimiento informado por escrito, en un document de consentimiento informado aparte, en su propio nombre, antes de que se realice ningún procedimiento especificado en el protocolo.
    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 sujeto quedará excluido de participar en este estudio si cumple cualquiera de los siguientes criterios:

    1. El sujeto ha presentado un AA no controlado en el estudio precedente que le impediría continuar en un estudio de extensión abierta de 12 meses, en opinión del investigador. Solo se podrá considerar la participación en este estudio de los sujetos que hayan presentado un AAG en el estudio precedente tras comentarse el caso con el monitor médico.
    2. El sujeto presenta una alteración clínicamente importante de las constantes vitales o del ECG al final del estudio precedente, o en la visita de selección de este estudio, que le impediría continuar en un estudio de extensión abierta de 12 meses, en opinión del investigador.
    3. El sujeto presenta una alteración clínicamente importante de los análisis de laboratorio en la V7 o V8 del estudio precedente, o en la visita de selección de este estudio, que le impediría continuar en un estudio de extensión abierta de 12 meses, en opinión del investigador. No es preciso que los investigadores esperen a tener los resultados de la V8 para poder incluir al sujeto en este estudio. Sin embargo, el investigador evaluará toda alteración clínicamente importante que se detecte después en la V8 del estudio precedente y/o en la visita de selección de este estudio para comprobar si puede continuar la participación del sujeto en el presente estudio.
    4. El sujeto ha presentado un proceso médico o psiquiátrico que supone un factor de confusión y que le impediría continuar en un estudio de extensión abierta de 12 meses, en opinión del investigador.
    5. Riesgo de suicidio importante, definido como ideación suicida según los elementos 4 o 5 de la C-SSRS en la selección de este estudio, o riesgo de suicidio importante a juzgar por el cuadro clínico.
    6. Tratamiento concomitante con cualquiera de los medicamentos que se señalan en la Tabla 1.
    7. Valor confirmado del intervalo QT corregido (QTc) ≥450 ms en los hombres o ≥470 ms en las mujeres. Tras comentarse el caso con el monitor médico, los sujetos con un valor de QRS mayor de 120 ms y un valor de QTc menor de 500 ms podrán ser elegibles.
    8. El sujeto es incapaz de tomar el producto en investigación del modo prescrito a lo largo del estudio (se admite que lo haga con ayuda).
    9. El sujeto o el cuidador es un familiar directo o empleado del investigador participante, de algún miembro del personal del centro participante o del personal del estudio del promotor.
    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
    Incidencia de AEs y cambios en los examenes fisicos, signos vitales, ECGs, pruebas de laboratorio y resultados del C-SSRS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    Semana 52
    E.5.2Secondary end point(s)
    DS score change from baseline at Week 28 and 52
    EQ-5D from baseline at Week 28 and 52
    Cambio en la puntuacion de DS en la visita basal en las semanas 28 y 52.
    Cambio en la puntuacion de EQ-5D en la visita basal en las semanas 28 y 52.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable
    No aplicable.
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned11
    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 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
    Argentina
    Australia
    Brazil
    Bulgaria
    Canada
    Chile
    Croatia
    Czech Republic
    France
    Germany
    Italy
    Korea, Republic of
    Malaysia
    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 days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    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: 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 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 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.
    Pacientes diagnosticados de Enf. de Alzheimer que puedan o no de dar consentimiento informado personalmente. El consentimiento informado completo por escrito se obtendra de cada paciente o de su representante legal/cuidador antes del reclutamiento.
    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 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.
    Los tratamientos posteriores del sujeto de estudio serán a discreción del investigador, de acuerdo con el tratamiento convencional. El investigador es responsable de asegurar que se presta, despues del estudio la atención de la condición médica del sujeto.
    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 Decision2016-10-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-01-08
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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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