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    Summary
    EudraCT Number:2019-002640-25
    Sponsor's Protocol Code Number:217-MDD-302
    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:2019-11-11
    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 number2019-002640-25
    A.3Full title of the trial
    A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF SAGE-217 WITH FIXED, REPEATED TREATMENT REGIMEN ON RELAPSE PREVENTION IN ADULTS WITH MAJOR DEPRESSIVE DISORDER
    Estudio en fase III, aleatorizado, doble ciego, controlado con placebo, de la eficacia y la seguridad de SAGE-217 con una pauta de tratamiento fija y repetida en la prevención de recidivas en adultos con trastorno depresivo mayor
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate SAGE-217 for Prevention of Relapse in Adult Subjects With Major Depressive Disorder
    Un estudio para evaluar SAGE-217 en la prevención de recaídas en sujetos adultos con trastorno depresivo mayor.
    A.4.1Sponsor's protocol code number217-MDD-302
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04007367
    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 SponsorSage Therapeutics, Inc.
    B.1.3.4CountryUnited States
    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 supportSage Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSage Therapeutics, Inc.
    B.5.2Functional name of contact pointTimothy Mariano
    B.5.3 Address:
    B.5.3.1Street Address215 First Street
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02142
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 617 949-5588
    B.5.6E-mailtimothy.mariano@sagerx.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 nameSage-217
    D.3.4Pharmaceutical form Capsule
    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 INNZuranolone
    D.3.9.1CAS number 1632051-40-1
    D.3.9.2Current sponsor codeSAGE-217
    D.3.9.3Other descriptive nameSGE-797; S-812217
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 No
    D.IMP: 2
    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 nameSage-217
    D.3.4Pharmaceutical form Capsule
    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 INNZuranolone
    D.3.9.1CAS number 1632051-40-1
    D.3.9.2Current sponsor codeSAGE-217
    D.3.9.3Other descriptive nameSGE-797; S-812217
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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 placeboCapsule
    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
    MAJOR DEPRESSIVE DISORDER
    Trastorno depresivo mayor
    E.1.1.1Medical condition in easily understood language
    MAJOR DEPRESSIVE DISORDER
    Trastorno depresivo mayor
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10025453
    E.1.2Term Major depressive disorder NOS
    E.1.2System Organ Class 100000004873
    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 SAGE-217 with a fixed, repeated treatment regimen in the prevention of relapse in subjects with major depressive disorder (MDD) who have responded to OL treatment with SAGE-217
    Evaluar la eficacia de SAGE-217 con una pauta de tratamiento fija y repetida en la prevención de recidivas en pacientes con trastorno depresivo mayor (TDM) que han respondido al tratamiento con A SAGE-217
    E.2.2Secondary objectives of the trial
    To evaluate the long-term safety and tolerability of a fixed, repeated treatment regimen of SAGE-217 up to 1 year
    Evaluar la seguridad y tolerabilidad a largo plazo de una pauta de tratamiento fija y repetida de SAGE-217 hasta 1 año
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Subject has a diagnosis of MDD as diagnosed by SCID-5-CT, with symptoms that have been present for at least a 4-week period.
    2.Subject has had at least 1 prior major depressive episode (MDE) in the 5 years prior to Screening (not including the current episode).
    3.Subject is willing to delay start of any antidepressant, anxiolytic, insomnia, psychostimulant, prescription opioid regimens, and new psychotherapy (including Cognitive Behavioral Therapy for Insomnia [CBT-I]) until after study completion.
    1. El paciente tiene un diagnóstico de TDM según lo diagnosticado por SCID-5-CT, con síntomas que han estado presentes durante al menos un periodo de 4 semanas.
    2. El paciente ha tenido al menos 1 episodio depresivo mayor (EDM) en los 5 años previos a la selección (sin incluir el episodio actual) según lo determinado por el SCID-5-CT.
    3. El paciente está dispuesto a retrasar el inicio de cualquier antidepresivo, ansiolítico, tratamiento para el insomnio, psicoestimulante, régimen de opioides de venta con receta y psicoterapia nueva (incluida la terapia cognitivo conductual para el insomnio [Cognitive Behavioral Therapy for Insomnio, CBT-I]) hasta después de la finalización del estudio.
    E.4Principal exclusion criteria
    1.Subject has attempted suicide associated with the current episode of MDD
    2.Subject has treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants within the current major depressive episode (excluding antipsychotics) from two different classes for at least 4 weeks of treatment. Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH ATRQ) will be used for this purpose.
    3.Subject has a positive pregnancy test at screening or on Day 1 prior to dosing.
    1. El paciente ha tenido algún intento de suicidio asociado con el episodio actual de TDM.
    2. El paciente tiene depresión resistente al tratamiento, definida como síntomas de depresión persistentes a pesar del tratamiento con dosis adecuadas de antidepresivos en el episodio actual de depresión mayor (excepto antipsicóticos) de dos clases diferentes durante al menos 4 semanas de tratamiento. Para este fin se utilizará el cuestionario de respuesta al tratamiento antidepresivo del Hospital General de Massachusetts (Massachusetts General Hospital Antidepressant Treatment Response Questionnaire, MG ATRQ).
    3. La paciente tiene una prueba de embarazo positiva en la selección o en el día 1 antes de la administración de la dosis.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is time to relapse during the double-blind (DB) Phase (days; from first dose of study drug in the DB Phase to relapse [date] during the DB Phase).
    El principal punto final de este estudio es tiempo hasta la recidiva durante la fase de DC (días; desde la primera dosis del fármaco del estudio en la fase de DC hasta la recidiva [fecha] durante la fase de DC)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Symptom driven, up to 275 Days
    Manejo de indicadores, hasta 275 dias
    E.5.2Secondary end point(s)
    • Percentage of subjects who relapse during the DB Phase
    • Change from baseline in the 17-item HAM-D total score at the end of each 14-day treatment period in the DB Phase.
    • HAM-D response at the end of each 14-day treatment period in the DB Phase, defined as a ≥50% reduction in HAM-D score from baseline
    • HAM-D remission at the end of each 14-day treatment period in the DB Phase, defined as HAM-D total score ≤7
    • CGI-I response, defined as “much improved” or “very much improved”, at the end of each 14-day treatment period in the DB Phase
    • Change from baseline in Clinical Global Impression - Severity (CGI-S) score at the end of each 14-day treatment period in the DB Phase
    • Change from baseline in 9-item Patient Health Questionnaire (PHQ-9) score at the end of each 14-day treatment period in the DB Phase
    • Time to relapse during the DB phase (days; from first dose of study drug in DB Phase to relapse [date] during the DB Phase) for subjects who achieved HAM-D remission in the OL Phase
    • Incidence of TEAEs
    • Porcentaje de pacientes que sufran una recidiva durante la fase de DC.
    • Cambio desde el inicio en la puntuación total en la Escala de valoración de Hamilton de 17 ítems para la depresión al final de cada periodo de tratamiento de 14 días en la fase de DC.
    •Respuesta según la HAM-D al final de cada periodo de tratamiento de 14 días en la fase de DC, definida como una reducción ≥50 % en la puntuación de HAM-D desde el inicio
    •La remisión en HAM-D al final de cada periodo de tratamiento de 14 días en la fase de DC, que se define como una puntuación total de HAM D ≤7
    •Respuesta a la Impresión Clínica Global: mejoría, definida como “mucho mejor” o “muy mejorado”, al final de cada periodo de tratamiento de 14 días en la fase de DC.
    •Cambio desde el inicio en la puntuación de la Impresión clínica global-gravedad (CGI-S) al final de cada periodo de tratamiento de 14 días en la fase de DC.
    •Cambio desde el inicio en la puntuación del Cuestionario de salud del paciente de 9 ítems (PHQ-9) al final de cada periodo de tratamiento de 14 días en la fase de DC.
    •Tiempo hasta la recidiva durante la fase de DC (días; desde la primera dosis del fármaco del estudio en la fase de DC hasta la recidiva [fecha] durante la fase de DC) para los pacientes que lograron remisión en la HAM D en la fase A
    •Incidencia de AAST
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of each 14-day treatment period in the double blind phase, up to 233 Days; TEAE assessment is ongoing
    Al final de cada período de tratamiento de 14 días en la fase doble ciego, hasta 233 días;
    La evaluación de AAST continua
    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 Yes
    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 Yes
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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
    This is a study with an OL phase followed by a randomized, DB, placebo-controlled phase
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Canada
    Denmark
    France
    Germany
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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
    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.1.1.1In 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: 541
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 546
    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)
    Patients will return to standard treatment
    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 Decision2020-02-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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