Back to resultsEfficacy 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
About this trial
This is an interventional treatment trial for BIPOLAR I DISORDER focused on measuring BIPOLAR I DISORDER, Eslicarbazepine acetate
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.
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
NCT ID
NCT01824602
First Posted
March 28, 2013
Last Updated
February 26, 2014
Sponsor
Bial - Portela C S.A.
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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