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    Summary
    EudraCT Number:2021-002108-11
    Sponsor's Protocol Code Number:SEP380-303
    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 number2021-002108-11
    A.3Full title of the trial
    A 12-Month Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Effectiveness of 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
    An extension study to evaluate the long term safety, tolerability and
    effectiveness of SEP-4199 CR in patients with major depressive episodes associated with Bipolar I disorder.
    A.4.1Sponsor's protocol code numberSEP380-303
    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 supportSunovian 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Major Depressive Episodes 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
    To evaluate the long-term safety, tolerability, and effectiveness of SEP 4199 controlled release (CR) formulation at a flexible daily dose of 200 mg/day or 400 mg/day in subjects who previously completed a 6-week double-blind placebo-controlled lead-in study of SEP 4199 CR for the treatment of Major Depressive Episode associated with Bipolar I Disorder (Bipolar I Depression).
    Primary Objective:
    The primary objective of the current study is to evaluate long-term safety and tolerability of treatment with SEP-4199 CR 200-400 mg/day, as reflected in rates of adverse events (AE), discontinuations due to an AE, serious AEs (SAE), and adverse events of special interest (AESI).
    E.2.2Secondary objectives of the trial
    Additional Safety Objectives:
    Long-term safety and tolerability of flexible-dose SEP-4199 CR treatment will be evaluated as follows:
    •Measurements including 12-lead electrocardiogram (ECG), clinical laboratory values, vital signs, body weight, and metabolic parameters
    •Prolactin levels
    •Manic symptoms using the Young Mania Rating Scale (YMRS)
    •Suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
    •Movement disorders using the Barnes Akathisia Rating Scale (BARS), Abnormal Involuntary Movement Scale (AIMS), and modified Simpson Angus Scale (SAS)
    •Potential for withdrawal symptoms after discontinuation, using the Physician’s Withdrawal Checklist (PWC).
    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 has completed 6 weeks of double-blind treatment and all scheduled assessments from Visit 6/EOT (Day 42) of the lead-in study of SEP-4199 CR.
    3.Subject is medically appropriate for long-term open-label treatment with SEP 4199 CR in the opinion of the Investigator.
    4.Female subjects of childbearing potential must agree to use highly effective and reliablecontraception throughout the study and for at least 30 days after the last dose of study drug hasbeen taken. In the Investigator’s judgment, the subject will adhere to this requirement.Contraception requirements are detailed in Section 10.4.
    5.Male subjects agree to avoid fathering a child and to use highly effective methods of birth control throughout the study and until at least 90 days after the last study drug administration. Contraception requirements are detailed in Section 10.4.
    E.4Principal exclusion criteria
    1.Subject is at high risk of non-compliance in the opinion of the Investigator.
    2.Subject plans to initiate treatment with a prohibited psychotropic medication during the study.
    3.Subject plans to initiate treatment with transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), vagus nerve stimulation (VNS), or deep brain stimulation (DBS) during the study.
    4.Subject experienced a moderate or severe hyperprolactinemia-related AESI in lead-in study of SEP-4199 CR.
    5.Current symptoms of coronavirus disease 2019 (COVID-19), or the presence of long-term medical, neurologic, or psychiatric sequelae of prior COVID-19. (Note: A test may be administered when infection is suspected).
    6.Subject will require treatment with a drug that is associated with increases in QTc interval (see Section 23, Appendix IV for a list of medications, not all inclusive).
    7. Subject had any of the following at Visit 6/EOT (Day 42) of the lead-in study of SEP-4199 CR based on machine reading:
    •increase in QTcF interval of ≥ 30 msec AND a QTcF interval ≥ 480 msec
    •increase in QTcF interval ≥ 60 msec
    •QTcF interval ≥ 500 msec
    •treatment-emergent clinically significant ECG abnormality.
    8.Subject is considered by the Investigator to be at imminent risk of suicide or injury to self or others, has a MADRS item 10 (suicidal ideation) score ≥ 4, 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 Visit 6/EOT (Day 42) of the lead-in study of SEP-4199 CR.
    9.Female subject has a positive urine pregnancy test at Visit 6/EOT (Day 42) of the lead-in study of SEP-4199 CR or plans to become pregnant during the current study.
    10.Subject tests positive for any drug of abuse or cannabis at Visit 6/EOT (Day 42) of the lead-in study of SEP-4199 CR.
    E.5 End points
    E.5.1Primary end point(s)
    Safety Endpoints:
    •The incidence of overall AEs, discontinuation due to an AEs, and SAEs
    •The incidence of AESI including but not limited to hyperprolactinemia-related AEs
    •Clinical laboratory evaluations (chemistry, hematology, thyroid panel, urinalysis)
    •Clinical evaluation (vital signs including orthostatic effects, and 12-lead ECG measurements)
    •Changes in prolactin values
    •Changes in metabolic parameters (insulin, glucose, hemoglobin A1c (HbA1c), lipid panel)
    •Change and percent change in body weight
    •Change in BMI
    •Incidence of treatment-emergent mania, defined as a YMRS total score ≥ 16 at post-baseline visit (scheduled or unscheduled), or an adverse event of hypomania or mania
    •Changes from baseline in movement disorders scales: AIMS, BARS, and modified SAS
    •Frequency and severity of suicidal ideation and suicidal behavior using the C SSRS
    •Change from Week 52/EOT (end of treatment) visit to the safety follow-up visit on the PWC
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    E.5.2Secondary end point(s)
    Effectiveness Endpoints:
    •Changes in MADRS total score
    •Changes in CGI-BP-S depression score
    •The proportion of subjects with treatment response, defined as ≥ 50% reduction from Baseline in MADRS total score
    •The proportion of subjects meeting criteria for remission, defined as MADRS total score ≤ 12
    •Changes in HAM-A total score
    •Changes in QIDS-SR16 total score
    •Changes in SDS total and subscale scores (work/school, family, and social function)
    •The proportion of subjects meeting criteria for functional remission, defined as having a score ≤ 2 on each of the SDS subscale scores (work/school, family, and social function)
    •Changes in the EQ-5D-5L VAS and Index scores
    •Changes in the SHAPS total score
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 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 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 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 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
    LSLV
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months2
    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: 355
    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 38
    F.4.2.2In the whole clinical trial 355
    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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