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Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) in Acute Manic Episodes Associated With Bipolar I Disorder

Primary Purpose

BIPOLAR I DISORDER

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Eslicarbazepine acetate 1800 mg
Eslicarbazepine acetate 1200 mg
Eslicarbazepine acetate 600 mg
Placebo
Sponsored by
Bial - Portela C S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for BIPOLAR I DISORDER focused on measuring BIPOLAR I DISORDER, Eslicarbazepine acetate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 18 years or more.
  • A documented diagnosis of bipolar I disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria (i.e., 296.0, 296.4 or 296.6).
  • Currently displaying an acute manic (including mixed) episode according to the DSM-IV criteria.
  • A Young Mania Rating Scale (YMRS) total score of 20 or greater.
  • Symptoms of the current manic episode starting within 2 weeks prior to Randomization (V2, Day 1).
  • Able to undergo a standard evaluation, including clinical interview, ratings and laboratory studies.
  • Signed informed consent form (ICF).
  • Post-menopausal or otherwise incapable of becoming pregnant by reason of surgery or tubal ligation. In case of woman of childbearing potential, patient presents a serum pregnancy test consistent with a non-gravid state and will use double-barrier contraception until at least the post-study visit (PSV).

Exclusion Criteria:

  • History of schizophrenia or schizoaffective disorder, psychotic features or rapid cycling.
  • Currently treated with carbamazepine or oxcarbazepine.
  • History of unresponsiveness, intolerance or hypersensitivity to related compounds (carbamazepine, oxcarbazepine or licarbazepine).
  • Use of any depot-neuroleptics for the current manic episode
  • Abuse of stimulating drugs or use of any systemic sympathicomimetic drug within the previous 2 weeks.
  • Electroconvulsive therapy (ECT) within the previous 3 months
  • History of dependence or chronic abuse from alcohol, drugs or medications within the last year.
  • Judged clinically to be at risk of harm to self or others.
  • Second or third-degree atrioventricular blockade not corrected with a pacemaker.
  • Relevant ECG or laboratory abnormalities.
  • Calculated creatinine clearance <30 ml/min [men: (140-age) x weight / serum creatinine x 72; women: (0.85) (140-age) x weight / serum creatinine x 72. Age in years, weight in kg, and serum creatinine in mg/dl].
  • Pregnancy or nursing.
  • Participation in other drug clinical trial within the last 2 months before Randomization visit
  • Not ensured capability to perform the trial or to comply with the study protocol (e.g. mental retardation or severe inability to communicate);
  • Any other uncontrolled clinically relevant disorder.
  • Previous treatment with Eslicarbazepine Acetate.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Group 1

    Group 2

    Group 3

    Group 4

    Arm Description

    Eslicarbazepine acetate 1800 mg

    Eslicarbazepine acetate 1200 mg

    Eslicarbazepine acetate 600 mg

    Placebo pills

    Outcomes

    Primary Outcome Measures

    Change in Young Mania Rating Scale (YMRS) Total Score From Baseline Until the End of the 3-week Treatment Period
    The YMRS is used to assess disease severity in patients who have been previously diagnosed with mania and it has proven psychometric properties through 11 item multiple-choice diagnostic questionnaire and the total score is determined from the summation of each 11 individual scores (and can range from 0 - 60) based on the patient's subjective feedback of his clinical condition over the previous 48 hours. A higher score indicates a worse rating for symptoms related to mania. At every visit throughout the study, investigators administered the YMRS. The results of the primary analysis of efficacy were calculated using Analysis of covariance (ANCOVA) with Last Observation Carried Forward (LOCF). Primary variable is presented through ANCOVA results for absolute change in YMRS total score from baseline (V2) to end of treatment (V7). A responder has at least 50% improvement (reduction) in the YMRS total score or has a total score of less than 12 points at the end of treatment period.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 28, 2013
    Last Updated
    February 26, 2014
    Sponsor
    Bial - Portela C S.A.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01824602
    Brief Title
    Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) in Acute Manic Episodes Associated With Bipolar I Disorder
    Official Title
    Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) in Acute Manic Episodes Associated With Bipolar I Disorder in a Double-blind, Fixed Multiple Dose, Randomised, Placebo-controlled,Multicentre Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2013
    Overall Recruitment Status
    Terminated
    Why Stopped
    Due to a slow recruitment rate
    Study Start Date
    February 2006 (undefined)
    Primary Completion Date
    November 2006 (Actual)
    Study Completion Date
    November 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bial - Portela C S.A.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The primary study objective was to evaluate the dose-dependent efficacy of eslicarbazepine acetate administered at doses of 600, 1200, and 1800 mg over a 3-week period, compared with placebo, as therapy in patients with acute mania. The secondary objectives of this study were to a) evaluate the safety and tolerability of eslicarbazepine acetate (BIA 2-093) administered at doses of 600, 1200, and 1800 mg compared with placebo, b) assess the duration to onset of action in the different dose groups, and c) monitor the appearance of depressive symptoms.
    Detailed Description
    This was a phase II, double-blind, fixed multiple dose, randomised, placebo-controlled, multicentre clinical trial in patients with a diagnosis of bipolar I disorder who experienced an acute manic (including mixed) episode. Patients who met the selection criteria at randomisation visit (V) (V2, Day 1) were randomised to 1 of 4 treatment groups: 600, 1200, or 1800 mg eslicarbazepine acetate, or placebo. Patients started the assigned treatment on Day 1 and were followed for up to 3 weeks. On Day 10, patients who showed no improvement were switched to open-label escape therapy with an established antimanic therapy. Patients could have been hospitalized at screening or at any time during the study at the investigator's discretion. Following randomisation (V2, Day 1), patients were assessed on Days 3, 7, 10, 14, 21, 28, and 56, after which they could either enter a recurrence prevention study, or the study drug could be tapered off and they could undergo follow-up assessments.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    BIPOLAR I DISORDER
    Keywords
    BIPOLAR I DISORDER, Eslicarbazepine acetate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Experimental
    Arm Description
    Eslicarbazepine acetate 1800 mg
    Arm Title
    Group 2
    Arm Type
    Experimental
    Arm Description
    Eslicarbazepine acetate 1200 mg
    Arm Title
    Group 3
    Arm Type
    Experimental
    Arm Description
    Eslicarbazepine acetate 600 mg
    Arm Title
    Group 4
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo pills
    Intervention Type
    Drug
    Intervention Name(s)
    Eslicarbazepine acetate 1800 mg
    Other Intervention Name(s)
    Esl
    Intervention Description
    Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets.
    Intervention Type
    Drug
    Intervention Name(s)
    Eslicarbazepine acetate 1200 mg
    Other Intervention Name(s)
    Esl
    Intervention Description
    Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets.
    Intervention Type
    Drug
    Intervention Name(s)
    Eslicarbazepine acetate 600 mg
    Other Intervention Name(s)
    Esl
    Intervention Description
    Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Placebo sugar pills
    Intervention Description
    Placebo sugar pills
    Primary Outcome Measure Information:
    Title
    Change in Young Mania Rating Scale (YMRS) Total Score From Baseline Until the End of the 3-week Treatment Period
    Description
    The YMRS is used to assess disease severity in patients who have been previously diagnosed with mania and it has proven psychometric properties through 11 item multiple-choice diagnostic questionnaire and the total score is determined from the summation of each 11 individual scores (and can range from 0 - 60) based on the patient's subjective feedback of his clinical condition over the previous 48 hours. A higher score indicates a worse rating for symptoms related to mania. At every visit throughout the study, investigators administered the YMRS. The results of the primary analysis of efficacy were calculated using Analysis of covariance (ANCOVA) with Last Observation Carried Forward (LOCF). Primary variable is presented through ANCOVA results for absolute change in YMRS total score from baseline (V2) to end of treatment (V7). A responder has at least 50% improvement (reduction) in the YMRS total score or has a total score of less than 12 points at the end of treatment period.
    Time Frame
    baseline and 3-week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged 18 years or more. A documented diagnosis of bipolar I disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria (i.e., 296.0, 296.4 or 296.6). Currently displaying an acute manic (including mixed) episode according to the DSM-IV criteria. A Young Mania Rating Scale (YMRS) total score of 20 or greater. Symptoms of the current manic episode starting within 2 weeks prior to Randomization (V2, Day 1). Able to undergo a standard evaluation, including clinical interview, ratings and laboratory studies. Signed informed consent form (ICF). Post-menopausal or otherwise incapable of becoming pregnant by reason of surgery or tubal ligation. In case of woman of childbearing potential, patient presents a serum pregnancy test consistent with a non-gravid state and will use double-barrier contraception until at least the post-study visit (PSV). Exclusion Criteria: History of schizophrenia or schizoaffective disorder, psychotic features or rapid cycling. Currently treated with carbamazepine or oxcarbazepine. History of unresponsiveness, intolerance or hypersensitivity to related compounds (carbamazepine, oxcarbazepine or licarbazepine). Use of any depot-neuroleptics for the current manic episode Abuse of stimulating drugs or use of any systemic sympathicomimetic drug within the previous 2 weeks. Electroconvulsive therapy (ECT) within the previous 3 months History of dependence or chronic abuse from alcohol, drugs or medications within the last year. Judged clinically to be at risk of harm to self or others. Second or third-degree atrioventricular blockade not corrected with a pacemaker. Relevant ECG or laboratory abnormalities. Calculated creatinine clearance <30 ml/min [men: (140-age) x weight / serum creatinine x 72; women: (0.85) (140-age) x weight / serum creatinine x 72. Age in years, weight in kg, and serum creatinine in mg/dl]. Pregnancy or nursing. Participation in other drug clinical trial within the last 2 months before Randomization visit Not ensured capability to perform the trial or to comply with the study protocol (e.g. mental retardation or severe inability to communicate); Any other uncontrolled clinically relevant disorder. Previous treatment with Eslicarbazepine Acetate.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Patrício Soares-da-Silva, MD, PhD
    Organizational Affiliation
    BIAL - Portela & Ca. SA
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) in Acute Manic Episodes Associated With Bipolar I Disorder

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