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    Summary
    EudraCT Number:2021-002126-24
    Sponsor's Protocol Code Number:SEP380-301
    National Competent Authority:Croatia - MIZ
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2023-06-28
    Trial 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 ConcernedCroatia - MIZ
    A.2EudraCT number2021-002126-24
    A.3Full title of the trial
    A Multi-region, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating SEP-4199 Controlled Release (CR) for the Treatment of Major Depressive Episode Associated with Bipolar I Disorder (Bipolar I Depression)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Research study to evaluate the effectiveness of SEP-4199 CR in patients with major depressive episodes associated with Bipolar I Disorder.
    A.4.1Sponsor's protocol code numberSEP380-301
    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 SponsorSunovion Pharmaceuticals 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 supportSunovion Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSUNOVION PHARMACEUTICALS INC.
    B.5.2Functional name of contact pointStacy Wu
    B.5.3 Address:
    B.5.3.1Street Address84 Waterford Drive
    B.5.3.2Town/ cityMarlborough, Massachusetts
    B.5.3.3Post code071752
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1508787-4227
    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 nameSEP-4199 CR 200mg
    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 INNAramisulpride
    D.3.9.1CAS number 71675-90-6
    D.3.9.2Current sponsor codeSEP-380262
    D.3.9.4EV Substance CodeSUB216374
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number170
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEsamisulpride
    D.3.9.1CAS number 71675-92-8
    D.3.9.2Current sponsor codeSEP-380255
    D.3.9.4EV Substance CodeSUB216375
    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.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
    Major Depressive Episode Associated with Bipolar I Disorder
    E.1.1.1Medical condition in easily understood language
    Depression in Bipolar Disorder
    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 PT
    E.1.2Classification code 10004939
    E.1.2Term Bipolar I disorder
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of Study SEP380-301 is to evaluate the efficacy, safety, and tolerability of SEP 4199 controlled release (CR) formulation given as monotherapy at fixed doses of 200 mg/day and 400 mg/day compared with placebo in the treatment of subjects with Major Depressive Episode associated with Bipolar I Disorder (Bipolar I Depression).

    Primary Efficacy:
    Evaluate the efficacy of SEP-4199 CR in the reduction of depression symptoms, as measured using the Montgomery-Asberg Depression Rating Scale (MADRS).
    E.2.2Secondary objectives of the trial
    Secondary Efficacy:
    Evaluate the efficacy of SEP-4199 CR in global improvement of bipolar depression severity, as measured using the Clinical Global Impression-Bipolar Version-Severity of Illness, Depression scale (CGI-BP-S depression).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.
    2.Subject or legally acceptable representative must possess an educational level and degree of understanding of English or the local language that enables them to communicate suitably with the Investigator and the study coordinator.
    3.Subject is 18 to 65 years of age, inclusive, at the time of informed consent.
    4.Subject meets DSM-5 criteria, based on the SCID-5-CT, for bipolar I disorder, current episode depressed with or without rapid cycling disease course (≥ 4 episodes of mood disturbance but < 8 episodes in the previous 12 months) with or without psychotic features.
    5.Subject has a lifetime history of at least 1 manic episode or manic episode with mixed features corroborated by medical records.
    6.Subject’s current major depressive episode is corroborated by medical records.
    7.Subject’s current major depressive episode is ≥ 4 weeks and less than 12 months in duration at Screening.
    8.Subject has a MADRS-S total score ≥ 22 at Screening.
    9.Subjecthas a MADRS total score ≥ 22 at both Screening and Baseline.
    10.Subject has a CGI-BP-S depression score ≥ 4 at both Screening and Baseline.
    11.Subject has a YMRS total score ≤ 12 at both Screening and Baseline.

    Please refer to Protocol for the complete list.
    E.4Principal exclusion criteria
    1.Subject currently has any DSM-5 defined psychiatric diagnosis other than bipolar I disorder that was the primary focus of treatment in the past 6 months prior to Screening.
    2.Subject has a lifetime history of, or symptoms consistent with, a major psychiatric diagnosis other than bipolar I disorder. These include (but are not limited to): schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, or post-traumatic stress disorder. (Note: Subjects with a previous diagnosis of major depressive disorder or bipolar II disorder that was subsequently changed to bipolar I disorder are allowed.)
    3.Subject has a history within the past 12 months prior to Screening of substance use disorder or moderate-to-severe tobacco (nicotine) use disorder. (Note: mild tobacco use disorder is acceptable.)
    4.Subject has confirmed or suspected borderline personality disorder.
    5.Subject demonstrates a decrease (improvement) of ≥ 25% in MADRS total score from Screening to Baseline.
    6.Subject is considered by the Investigator to be at imminent risk of suicide or injury to self or others, or has a score ≥ 4 on MADRS item 10 (suicidal ideation) or answers “yes” to “suicidal ideation” item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at the Screening Visit (in the past 3 months [90 days]) or at Baseline.
    7.Subject has received any psychotropic medication or herbal supplement within 3 days or 5 half-lives (whichever is longer) prior to Baseline or anticipates the need for psychotropic medications or herbal supplements during participation in this study, with the exception of the medications specified in Protocol Section 10.3. The following treatments have additional restrictions as specified below:
    a.Monoamine oxidase inhibitors (MAOIs) must be discontinued at least 28 days prior to Baseline.
    b.Fluoxetine, and olanzapine/fluoxetine combination must be discontinued at least 28 days prior to Baseline.
    c.Clozapine used at 200 mg/day or less for insomnia, agitation, or anxiety must be discontinued at least 28 days prior to Baseline. Subjects with a history of treatment with clozapine for any reason at doses greater than 200 mg/day or at doses less than or equal to 200 mg/day for a usage other than insomnia, agitation, or anxiety are excluded from study participation.
    d.Depot neuroleptics must have been discontinued at least one treatment cycle or at least 30 days (whichever is longer) prior to Baseline.
    e.Subject has received esketamine within 60 days prior to Baseline.
    f.Electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS) within 90 days prior to Baseline.
    g.Subjects with a history of treatment with vagus nerve stimulation (VNS) or deep brain stimulation (DBS) are excluded from study participation.
    8.Subject initiated a new psychotherapeutic intervention (eg, psychotherapy) focused on treatment of bipolar I depression within the past 12 weeks prior to Screening. (Note: Subjects who have participated in ongoing psychotherapy treatment for at least 12 weeks prior to Screening will be permitted to continue this treatment during the study.)
    9.Subject has a history of non-response to an adequate (6-week) trial of 3 or more antidepressants (with or without mood stabilizers) during the current major depressive episode.
    10.Subject was hospitalized during the Screening Period without explicit approval by the Medical Monitor. (Note: Hospitalization during the Screening Period will not be allowed, except where required by local regulations, or when determined to be clinically indicated based on the subject’s psychiatric history and current psychiatric symptoms. Medical justification must be provided to the Medical Monitor and the Medical Monitor must approve the request for hospitalization.)
    11.Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that would pose a risk to the subject or that might confound the results of the study. (Note: Active medical conditions that are minor or well-controlled are not exclusionary if they do not affect risk to subject or study results. In cases in which the impact of the condition upon risk to subject or study results is unclear, the Medical Monitor should be consulted.)
    a.Hematological (including deep vein thrombosis) or bleeding disorder, renal, metabolic, endocrine, pulmonary, gastrointestinal, urological, cardiovascular (including unstable hypertension), hepatic, neurologic, or allergic disease that is clinically significant or unstable (except for seasonal allergies at time of dosing). considered stable] must be discussed with the Medical Monitor before being randomized in the study.)

    Please refer to Protocol for the complete list.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint:
    •Change from Baseline to Week 6 in MADRS total score
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 6
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    •Change from Baseline to Week 6 in CGI-BP-S depression score
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 6
    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 Yes
    E.6.11Pharmacogenomic Yes
    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 trial3
    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 concerned4
    E.8.5The trial involves multiple Member States No
    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
    Ukraine
    Bulgaria
    Japan
    Russian Federation
    Serbia
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    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: 522
    F.1.3Elderly (>=65 years) No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 57
    F.4.2.2In the whole clinical trial 522
    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)
    None.
    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 Decision2023-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-10-10
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