Bipolar I DisorderPhase 2NCT01825837
Efficacy, Safety, and Tolerability of Eslicarbazepine Acetate in the Recurrence Prevention of Bipolar I Disorder
A Phase 2 study testing BIA 2-093 1800 mg once daily [Group 1 (Part II)], BIA 2-093 900 mg once daily [Group 2 (Part II)] and BIA 2-093 300 mg once daily [Group 3 (Part II)] in people with Bipolar I Disorder, run by Bial - Portela C S.A..
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bipolar I Disorder
- What is being tested?
- BIA 2-093 1800 mg once daily [Group 1 (Part II)], BIA 2-093 900 mg once daily [Group 2 (Part II)] and BIA 2-093 300 mg once daily [Group 3 (Part II)]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to Jun 2007
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- relevant electrocardiogram (ECG) or laboratory abnormalities
- any uncontrolled clinically relevant disorder
- uninsured capability to comply with the study protocol
About this study
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
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.
Read the 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).
- Conditions
- Bipolar I Disorder
- Being tested
- 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)
- Keywords
- bipolar I disorder, Eslicarbazepine acetate, BIA 2-093
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIA 2-093 1800 mg once daily [Group 1 (Part II)]Drug
Also called Eslicarbazepine acetate
BIA 2-093 1800 mg taken orally in the evening, for 2 weeks
BIA 2-093 900 mg once daily [Group 2 (Part II)]Drug
Also called Eslicarbazepine acetate
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
Also called Eslicarbazepine acetate
BIA 2-093 300 mg taken orally in the evening, for 2 weeks.
BIA 2-093 900 mg (Part I)Drug
Also called Eslicarbazepine acetate
In Part I, patients received one 900 mg BIA 2-093 tablet once daily, taken orally in the evening, for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: BIA 2-093 1800 mg once daily [Group 1 (Part II)] |
| 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. Receives: Drug: BIA 2-093 900 mg once daily [Group 2 (Part II)] |
| 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. Receives: Drug: BIA 2-093 300 mg once daily [Group 3 (Part II)] |
| ESL (Part I) | Experimental | In Part I, all participants received open-label treatment with BIA 2-093 900 mg once daily for 2 weeks. Receives: Drug: BIA 2-093 900 mg (Part I) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startMar 2006
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bipolar I DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bial - Portela C S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrício Soares-da-Silva, MD, PhD, Study director, BIAL - Portela & Ca. SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825837
- Sponsor's protocol ID
- BIA-2093-205
- Status last verified
- Feb 2014
- First submitted
- 1 Apr 2013
- Last updated
- 27 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01825837
- Acronym / sponsor ID
- BIA-2093-205
- Conditions
- Bipolar I Disorder
- Keywords
- bipolar I disorder, Eslicarbazepine acetate, BIA 2-093
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 8 Apr 2013 (estimated)
- Results
- Posted 17 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BIA 2-093 1800 mg (Group 1) | Experimental | Drug: BIA 2-093 1800 mg once daily [Group 1 (Part II)]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 | Drug: BIA 2-093 900 mg once daily [Group 2 (Part II)]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 | Drug: BIA 2-093 300 mg once daily [Group 3 (Part II)]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 | Drug: BIA 2-093 900 mg (Part I)In Part I, all participants received open-label treatment with BIA 2-093 900 mg once daily for 2 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- relevant electrocardiogram (ECG) or laboratory abnormalities
- any uncontrolled clinically relevant disorder
- uninsured capability to comply with the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIA 2-093 1800 mg once daily [Group 1 (Part II)]Also: Eslicarbazepine acetateBIA 2-093 1800 mg taken orally in the evening, for 2 weeks | Drug | BIA 2-093 1800 mg (Group 1) |
| BIA 2-093 900 mg once daily [Group 2 (Part II)]Also: Eslicarbazepine acetateBIA 2-093 900 mg taken orally in the evening, for 2 weeks | Drug | BIA 2-093 900 mg (Group 2) |
| BIA 2-093 300 mg once daily [Group 3 (Part II)]Also: Eslicarbazepine acetateBIA 2-093 300 mg taken orally in the evening, for 2 weeks. | Drug | BIA 2-093 300 mg (Group 3) |
| BIA 2-093 900 mg (Part I)Also: Eslicarbazepine acetateIn Part I, patients received one 900 mg BIA 2-093 tablet once daily, taken orally in the evening, for 2 weeks. | Drug | ESL (Part I) |
Primary outcome
Proportion of Patients Who Showed no Worsening According to the Clinical Global Impression - Bipolar Version (CGI-BP) Scale (Intent-to-Treat Population)
Time frame: 6 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrício Soares-da-Silva, MD, PhD study director
BIAL - Portela & Ca. SA
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIA 2-093 1800 mg once daily [Group 1 (Part II)], BIA 2-093 900 mg once daily [Group 2 (Part II)] and BIA 2-093 300 mg once daily [Group 3 (Part II)] in people with Bipolar I Disorder, run by Bial - Portela C S.A..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Who Showed no Worsening According to the Clinical Global Impression - Bipolar Version (CGI-BP) Scale (Intent-to-Treat Population) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2014.