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    Summary
    EudraCT Number:2010-018671-20
    Sponsor's Protocol Code Number:P06384
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-06-14
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2010-018671-20
    A.3Full title of the trial
    A Double-Blind, Placebo-Controlled Trial of Asenapine in the Prevention of Recurrence of a Mood Episode After Stabilization of an Acute Manic/Mixed Episode in Subjects With Bipolar 1 Disorder (Phase 3B, Protocol P06384)

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Trial of Asenapine in the Prevention of Recurrence of a Mood Episode in Adults With Bipolar Disorder
    A.3.2Name or abbreviated title of the trial where available
    Asenapine bipolar 1 disorder recurrence prevention trial
    A.4.1Sponsor's protocol code numberP06384
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01396291
    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 SponsorForest Research Institute Inc., a wholly owned subsidiary of Forest Laboratories, LLC
    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 supportForest Research Institute Inc., a wholly owned subsidiary of Forest Laboratories, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationForest Research Institute Inc., a wholly owned subsidiary of Forest Laboratories, LLC
    B.5.2Functional name of contact pointMaia Mathews, MD
    B.5.3 Address:
    B.5.3.1Street AddressHarborside Financial Center, Plaza V
    B.5.3.2Town/ cityJersey City
    B.5.3.3Post codeNJ 07311
    B.5.3.4CountryUnited States
    B.5.4Telephone number0012014278769
    B.5.5Fax number0012014278200
    B.5.6E-mailmaja.mathews@frx.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 nameAsenapine
    D.3.2Product code Org 5222, SCH 900274
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAsenapine
    D.3.9.1CAS number 85650-56-2
    D.3.9.2Current sponsor codeOrg 5222, SCH 900274
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 nameAsenapine
    D.3.2Product code Org 5222, SCH 900274
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAsenapine
    D.3.9.1CAS number 85650-56-2
    D.3.9.2Current sponsor codeOrg 5222, SCH 900274
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboSublingual use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bipolar 1 Disorder
    E.1.1.1Medical condition in easily understood language
    Bipolar Disorder
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behaviours [F01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    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 determine the efficacy and safety of asenapine compared with placebo in preventing the recurrence of any mood episodes.
    E.2.2Secondary objectives of the trial
    To compare asenapine and placebo in the treatment of subjects with bipolar I disorder with respect to:
    1. Manic symptoms severity, as measured by the Young Mania Rating Scale (Y-MRS);
    2. Depressive symptoms severity, as measured by the Montgomery Asberg Depression Rating Scale(MADRS);
    3. Overall clinical impression of severity and improvement, as measured by the Clinical Global Impressions of improvement and Severity, Bipolar version (CGI-BP I and S);
    4. Psychotic symptoms severity (including positive and negative symptoms) and symptoms of general psychopathology, as measured by the Positive and Negative Symptoms Scale (PANSS);
    5. Suicidality, as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Open-Label Treatment Period
    1. Each subject must be at least 18 years of age and of legal minimum age for signing the consent form;
    2. Each subject must be a male or a female who is not of child-bearing potential (ie, surgically sterile, postmenopausal for at least 1 year) or who is non-pregnant, non-lactating and is using a medically accepted method of contraception.
    Acceptable methods of contraception include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device (IUD), and hormonal contraceptives. A female of child-bearing potential who is not currently sexually active must agree to use a medically accepted method of contraception should she become sexually active while participating in the trial;
    Note: Each sexually active female of child-bearing potential must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for 1 month after stopping the medication.
    3. Each subject must have a current diagnosis of bipolar I disorder, and a current manic (DSM-IV296.4x) or mixed (DSM-IV 296.6x) episode, as determined by a structured clinical interview (MINI version 6.0.0) at Screening;
    4. Each subject must have a Young Mania Rating Scale (Y-MRS) score ≥18 at Screening and at Baseline;
    5. Each subject must have a Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity score of moderately ill or greater (4 or greater) in both the Mania and Overall Bipolar Illness subscales at Screening and Baseline;
    6. Each subject must be confirmed (documented in the Psychiatric Intake Evaluation Form by the investigator and reviewed by the sponsor designated medical expert [SDME] prior to Enrollment into the Open-Label Treatment Period) to be experiencing an acute manic or mixed bipolar I episode, as evidenced by ALL of the following:
    a. The subject has not shown a response (50% improvement) since the start of the current episode;
    b. The subject’s current symptoms represent a marked and substantial change compared to the subject’s symptomatic state prior to the emergence of the current episode;
    c. The subject is in need of increased medical attention to treat his/her worsening current manic or mixed episode;
    d. The subject has a diagnosis of bipolar disorder for at least two years.
    7. Each subject must have documented history of at least two previous moderate-to-severe manic or mixed episodes with or without psychotic features (with at least one of these episode being adequately treated with psychotropic medication).
    Double-Blind Treatment Period
    8. Each subject must have completed a minimum of 12 weeks and up to 16 weeks of the Open-Label Treatment Period;
    9. Each subject must have met one of the following stabilization criteria:
    a. A Y-MRS and MADRS scores of <=12 at either the last 5 consecutive visits of the Open-Label Treatment Period (ie, visits at Weeks 4, 6, 8, 10, and 12 or visits at Weeks 6, 8, 10, 12, and 14 or Weeks 8, 10, 12, 14, and 16); or
    b. A Y-MRS and MADRS scores of <=12 at 5 out of 6 consecutive visits, with only one excursion event prior to the last visit in the series (the subject met the Y-MRS and MADRS scores at Weeks 6 and 16, and also 3 out of 4 times at Weeks 8, 10, 12, or 14;
    Note: Subjects must be on asenapine as a monotherapy (ie, previous psychotropic medications already discontinued) for 4 weeks before a stabilization period of 8 weeks can be evaluated. During the 8 week stabilization period an excursion event of Y-MRS and/or MADRS score of less than 16 at a single visit is permitted; excursions of >=16 require the subject to be discontinued from the trial.
    10. Each subject must not have taken or required disallowed medication during the Open-Label Treatment Period;
    11. Each subject must not have required or received hospitalization for his/her psychiatric symptoms during the Open-Label Treatment Period (excluding the discretionary in-patient stay up to Day 7 or extended hospitalization stay);
    12. Each subject must continue to meet all criteria in the Open-Label Treatment Period (except those pertaining to minimum Y-MRS and CGI-BP scores).
    E.4Principal exclusion criteria
    Key Open-Label Exclusion Criteria
    1. A subject must not have an uncontrolled, unstable, clinically significant medical condition (eg, renal, endocrine, hepatic, respiratory, cardiovascular, hematologic, immunologic or cerebrovascular disease, known serological evidence of human immunodeficiency virus [HIV] antibody, or malignancy) that may interfere with the interpretation of safety and efficacy evaluations in the opinion of the investigator;
    2. A subject must not have a body mass index (BMI) <18.5 or >40.0 kg/m2;
    3. A subject must not have clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram (ECG) findings at Screening that, in the investigator’s opinion, preclude the subject’s participation in the trial (potentially interferes with the ability to evaluate safety, tolerability, and efficacy of trial medication, or potentially impairs the subject’s ability to complete the trial);
    4. A subject must not be at imminent risk of self-harm or harm to others in the investigator’s opinion, based on clinical interview and responses provided on the Columbia-Suicide Severity Rating Scale (C-SSRS). Note that subjects must be excluded if they report suicidal ideation meeting the description of C-SSRS Type 4 or 5 (ie, suicidal ideation with intent, with or without a plan) in the past 2 months or suicidal behavior (as described by the C-SSRS) in the past 6 months at Screening. Subjects must be excluded at Baseline if they report suicidal ideation of Type 4 or 5 or suicidal behavior, as measured by the C-SSRS between Screening and Baseline.
    5. A subject must not have a history of imprisonment, parole, or assaultive behavior in the past 2 years prior to Screening;
    6. A subject must not have a history of rapid cycling according to DSM-IV-TRTM criteria.
    E.5 End points
    E.5.1Primary end point(s)
    The Primary Efficacy Endpoint for the current trial is time to recurrence of any mood event during the Double-Blind Treatment Period, defined as any of the following:
    • Requirement or initiation of any non-study medication to treat mixed, manic, or depressive symptoms, including an antipsychotic, antidepressant,or mood-stabilizing agent;
    • Requirement or initiation of psychiatric hospitalization;
    • Discontinuation from the study because of a mood event (as determined by the investigator); or
    • Y-MRS or MADRS score >= 16.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time to recurrence of any mood event during the Double-Blind Treatment Period
    E.5.2Secondary end point(s)
    The continuous efficacy variables will be summarized by visit for the Open-Label and Double Blind Treatment Periods separately for the ITT population.The change scores during the Double-Blind Treatment Period for the ITT population will be analyzed by using an analysis of covariance (ANCOVA) with baseline score included in the model for both the observed case (OC) data and last observation carried forward (LOCF) data. No adjustment will be made for the multiple testing. The change scores are listed as follows:
    For Open-Label Treatment Period:
    • Change from Baseline in Y-MRS total score by visit;
    • Change from Baseline on MADRS total scores by visit;
    • Change from Baseline on total PANSS scores and subscale (positive, negative, general psychopathology) scores by visit;
    • Change from Baseline on PANSS Marder factor (positive, negative, disorganized thought, hostility/excitement, and anxiety/depression symptom) scores by visit;
    • Change from Baseline on each CGI-BP severity score by visit.

    For Double-Blind Treatment Period:
    • Change from double-blind baseline in Y-MRS total score by visit;
    • Change from double-blind baseline in MADRS total score by visit;
    • Change from double-blind baseline on total PANSS scores and subscale (positive, negative, general psychopathology) scores by visit;
    • Change from double-blind baseline on PANSS Marder factor (positive, negative, disorganized thought, hostility/excitement, and anxiety/depression symptom) scores by visit;
    • Change from double-blind baseline on CGI-BP severity scores by visit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The continuous efficacy variables will be summarized by visit for the Open-Label and Double Blind Treatment Periods separately for the ITT population.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 Yes
    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 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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Bulgaria
    Canada
    Croatia
    India
    Philippines
    Portugal
    Romania
    Russian Federation
    Serbia
    Turkey
    Ukraine
    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
    Last contact with last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 520
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 550
    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)
    Treatment received by patient prior to study entry or alternative treatment as deemed medically appropriate after all assessments at the end of treatment visit are complete.
    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 Decision2012-08-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-30
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