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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIA 2-093 1800 mg (Group 1) | Experimental | 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 (Group 2) | Experimental | 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 (Group 3) | Experimental | 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. |
|
| ESL (Part I) | Experimental | In Part I, all participants received open-label treatment with BIA 2-093 900 mg once daily for 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIA 2-093 1800 mg once daily [Group 1 (Part II)] | Drug | BIA 2-093 1800 mg taken orally in the evening, for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| PatrÃcio Soares-da-Silva, MD, PhD | BIAL - Portela & Ca. SA | Study Director |
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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
This was a multicenter study. Approximately 60 centers in Europe, South America, and South Africa enrolled patients in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 3 [(Part II) 300 mg] | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| PART I |
|
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| BIA 2-093 900 mg once daily [Group 2 (Part II)] | Drug | BIA 2-093 900 mg taken orally in the evening, for 2 weeks |
|
|
| BIA 2-093 300 mg once daily [Group 3 (Part II)] | Drug | BIA 2-093 300 mg taken orally in the evening, for 2 weeks. |
|
|
| BIA 2-093 900 mg (Part I) | Drug | In Part I, patients received one 900 mg BIA 2-093 tablet once daily, taken orally in the evening, for 2 weeks. |
|
|
| Group 2 [(Part II) 900 mg] |
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. |
| FG002 | Group 1 [(Part II) 1800 mg] | 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. |
| FG003 | ESL (Part I) | In Part I, all participants received open-label treatment with BIA 2-093 900 mg once daily for 2 weeks. The participants that completed part I were randomised in Part II. |
| Enrolled |
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| Safety Population (Open-Label) |
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| COMPLETED |
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| NOT COMPLETED |
|
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| PART II |
|
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The study was comprised of 2 sequential parts. Part I followed an open-label design in which 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 who completed part I. 17 patients did not complete part I.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 3 [(Part II) 300 mg] | 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. |
| BG001 | Group 2 [(Part II) 900 mg] | 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. |
| BG002 | Group 1 [(Part II) 1800 mg] | 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. |
| BG003 | ESL (Part I - Not Randomised Patients) | This group corresponds to the 17 patients who did not complete part I and therefore where not randomised to any traeatment group. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 6 months |
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Double-blind period (Part II first administration date until study termination) 6 months
Part II Double-Blind Period (Safety Population): safety population included all patients who received at least 1 dose of investigational product after randomization. Please note that adverse events that occurred in Parts I and II were summarized separately.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 3 [(Part II) 300 mg] | 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. | 2 | 35 | 7 | 35 | ||
| EG001 | Group 2 [(Part II) 900 mg] | 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. | 4 | 26 | 6 | 26 | ||
| EG002 | Group 1 [(Part II) 1800 mg] | 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. | 2 | 26 | 4 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (9.0) | Systematic Assessment |
| |
| Blood pressure systolic decreased | Investigations | MedDRA (9.0) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (9.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (9.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Research Section | BIAL - Portela & Ca, SA | 351 22 986 6100 | clinical.trials@bial.com |
| ID | Term |
|---|---|
| C416835 | eslicarbazepine acetate |
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| Patient non-compliance |
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| Adverse Event |
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| Treatment failure |
|
| reason unspecified |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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