Back to resultsEfficacy, Safety, and Tolerability of Eslicarbazepine Acetate in the Recurrence Prevention of Bipolar I Disorder
Primary Purpose
Bipolar I Disorder
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
BIA 2-093 1800 mg once daily [Group 1 (Part II)]
BIA 2-093 900 mg once daily [Group 2 (Part II)]
BIA 2-093 300 mg once daily [Group 3 (Part II)]
BIA 2-093 900 mg (Part I)
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar I Disorder focused on measuring bipolar I disorder, Eslicarbazepine acetate, BIA 2-093
Eligibility Criteria
Inclusion Criteria:
- signed the Informed consent form (ICF)
- completed the 3-week treatment period in Protocol with identification number SCO/BIA-2093-203 or Protocol with identification number PRA/BIA-2093-204 and shown response to treatment, defined as ≥ 50% improvement in the Young Mania Rating Scale (YMRS) total score or a YMRS total score < 12
- presented a serum pregnancy test (in cases of women of childbearing potential) consistent with a non-gravid state and used double-barrier contraception throughout the study
Exclusion Criteria:
- relevant electrocardiogram (ECG) or laboratory abnormalities
- any uncontrolled clinically relevant disorder
- uninsured capability to comply with the study protocol
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
BIA 2-093 1800 mg (Group 1)
BIA 2-093 900 mg (Group 2)
BIA 2-093 300 mg (Group 3)
ESL (Part I)
Arm Description
BIA 2-093 1800 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
BIA 2-093 900 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
BIA 2-093 300 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
In Part I, all participants received open-label treatment with BIA 2-093 900 mg once daily for 2 weeks.
Outcomes
Primary Outcome Measures
Proportion of Patients Who Showed no Worsening According to the Clinical Global Impression - Bipolar Version (CGI-BP) Scale (Intent-to-Treat Population)
The CGI-BP scale is a modification of the CGI scale, which provides a means of assessing severity and treatment-related improvement in manic and depressive domains reflecting clinically relevant degrees of change. The concept of improvement refers to the clinical distance between the individual's current condition and that prior to the start of treatment. The scale for 'severity of illness' measures mania, depression and overall illness on a 7 point scale from 1 ('normal, not ill') to 7 ('very severely ill'). The scale for 'change from preceding phase' and 'change from worst phase' measures mania, depression, and overall illness on an 8-point scale from 1 (very much improved) to 8 ('not applicable'). If the patient, in 'change from preceding phase', at any visit during the double-blind, has a score of 5, 6, or 7 in any of 3 categories (mania, depression, or overall bipolar illness), then the illness will be considered to have worsened.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01825837
Brief Title
Efficacy, Safety, and Tolerability of Eslicarbazepine Acetate in the Recurrence Prevention of Bipolar I Disorder
Official Title
Extension Study to Investigate the Efficacy, Safety, and Tolerability of Eslicarbazepine Acetate (BIA 2-093) in the Recurrence Prevention of Bipolar I Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (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
This was an extension study consisting of 2 parts. In Part I, all participants received open-label treatment with BIA 2-093 900 mg once daily for 2 weeks. Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily. Patients stable in remission continued double-blind therapy until approximately 6 months after the last patient entered Part II.
Detailed Description
The occurrence of a new manic/depressive episode was considered a treatment failure, and the patient was discontinued from the study. At the end of Part II, 6 months after last patient enrolled and after no longer than approximately 15 months, if patients were still in remission and the investigational product was well-tolerated, patients had the option to enter long-term open-label treatment at the same dosage as used in Part II until a new episode occurred, until marketing was authorized, or until clinical development of BIA 2-093 in the recurrence prevention indication was discontinued. If patients did not enter long-term treatment, an established recurrence prevention medication was prescribed, and BIA 2-093 was tapered off (patients assigned to 1800 mg had the daily dose decreased to 900 mg for 6 days; those assigned to 900 mg or 300 mg received placebo for 6 days).
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, BIA 2-093
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BIA 2-093 1800 mg (Group 1)
Arm Type
Experimental
Arm Description
BIA 2-093 1800 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
Arm Title
BIA 2-093 900 mg (Group 2)
Arm Type
Experimental
Arm Description
BIA 2-093 900 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
Arm Title
BIA 2-093 300 mg (Group 3)
Arm Type
Experimental
Arm Description
BIA 2-093 300 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
Arm Title
ESL (Part I)
Arm Type
Experimental
Arm Description
In Part I, all participants received open-label treatment with BIA 2-093 900 mg once daily for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
BIA 2-093 1800 mg once daily [Group 1 (Part II)]
Other Intervention Name(s)
Eslicarbazepine acetate
Intervention Description
BIA 2-093 1800 mg taken orally in the evening, for 2 weeks
Intervention Type
Drug
Intervention Name(s)
BIA 2-093 900 mg once daily [Group 2 (Part II)]
Other Intervention Name(s)
Eslicarbazepine acetate
Intervention Description
BIA 2-093 900 mg taken orally in the evening, for 2 weeks
Intervention Type
Drug
Intervention Name(s)
BIA 2-093 300 mg once daily [Group 3 (Part II)]
Other Intervention Name(s)
Eslicarbazepine acetate
Intervention Description
BIA 2-093 300 mg taken orally in the evening, for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
BIA 2-093 900 mg (Part I)
Other Intervention Name(s)
Eslicarbazepine acetate
Intervention Description
In Part I, patients received one 900 mg BIA 2-093 tablet once daily, taken orally in the evening, for 2 weeks.
Primary Outcome Measure Information:
Title
Proportion of Patients Who Showed no Worsening According to the Clinical Global Impression - Bipolar Version (CGI-BP) Scale (Intent-to-Treat Population)
Description
The CGI-BP scale is a modification of the CGI scale, which provides a means of assessing severity and treatment-related improvement in manic and depressive domains reflecting clinically relevant degrees of change. The concept of improvement refers to the clinical distance between the individual's current condition and that prior to the start of treatment. The scale for 'severity of illness' measures mania, depression and overall illness on a 7 point scale from 1 ('normal, not ill') to 7 ('very severely ill'). The scale for 'change from preceding phase' and 'change from worst phase' measures mania, depression, and overall illness on an 8-point scale from 1 (very much improved) to 8 ('not applicable'). If the patient, in 'change from preceding phase', at any visit during the double-blind, has a score of 5, 6, or 7 in any of 3 categories (mania, depression, or overall bipolar illness), then the illness will be considered to have worsened.
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
signed the Informed consent form (ICF)
completed the 3-week treatment period in Protocol with identification number SCO/BIA-2093-203 or Protocol with identification number PRA/BIA-2093-204 and shown response to treatment, defined as ≥ 50% improvement in the Young Mania Rating Scale (YMRS) total score or a YMRS total score < 12
presented a serum pregnancy test (in cases of women of childbearing potential) consistent with a non-gravid state and used double-barrier contraception throughout the study
Exclusion Criteria:
relevant electrocardiogram (ECG) or laboratory abnormalities
any uncontrolled clinically relevant disorder
uninsured capability to comply with the study protocol
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, Safety, and Tolerability of Eslicarbazepine Acetate in the Recurrence Prevention of Bipolar I Disorder
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