- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01825837
Efficacy, Safety, and Tolerability of Eslicarbazepine Acetate in the Recurrence Prevention of Bipolar I Disorder
February 26, 2014 updated by: Bial - Portela C S.A.
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
104
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BIA 2-093 1800 mg (Group 1)
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 1800 mg taken orally in the evening, for 2 weeks
Other Names:
|
Experimental: BIA 2-093 900 mg (Group 2)
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 2-093 900 mg taken orally in the evening, for 2 weeks
Other Names:
|
Experimental: BIA 2-093 300 mg (Group 3)
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.
|
BIA 2-093 300 mg taken orally in the evening, for 2 weeks.
Other Names:
|
Experimental: ESL (Part I)
In Part I, all participants received open-label treatment with BIA 2-093 900 mg once daily for 2 weeks.
|
In Part I, patients received one 900 mg BIA 2-093 tablet once daily, taken orally in the evening, for 2 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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)
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.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Patrício Soares-da-Silva, MD, PhD, BIAL - Portela & Ca. SA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Primary Completion (Actual)
June 1, 2007
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
April 1, 2013
First Submitted That Met QC Criteria
April 5, 2013
First Posted (Estimate)
April 8, 2013
Study Record Updates
Last Update Posted (Estimate)
March 27, 2014
Last Update Submitted That Met QC Criteria
February 26, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIA-2093-205
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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