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Efficacy, Safety, and Tolerability of Eslicarbazepine Acetate in the Recurrence Prevention of Bipolar I Disorder

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ClinicalTrials.gov Identifier: NCT01825837
Recruitment Status : Completed
First Posted : April 8, 2013
Results First Posted : June 17, 2013
Last Update Posted : March 27, 2014
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

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.

Condition or disease Intervention/treatment Phase
Bipolar I Disorder Drug: BIA 2-093 1800 mg once daily [Group 1 (Part II)] Drug: BIA 2-093 900 mg once daily [Group 2 (Part II)] Drug: BIA 2-093 300 mg once daily [Group 3 (Part II)] Drug: BIA 2-093 900 mg (Part I) Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : March 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine


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.
Drug: BIA 2-093 1800 mg once daily [Group 1 (Part II)]
BIA 2-093 1800 mg taken orally in the evening, for 2 weeks
Other Name: Eslicarbazepine acetate

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.
Drug: BIA 2-093 900 mg once daily [Group 2 (Part II)]
BIA 2-093 900 mg taken orally in the evening, for 2 weeks
Other Name: Eslicarbazepine acetate

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.
Drug: BIA 2-093 300 mg once daily [Group 3 (Part II)]
BIA 2-093 300 mg taken orally in the evening, for 2 weeks.
Other Name: Eslicarbazepine acetate

Experimental: ESL (Part I)
In Part I, all participants received open-label treatment with BIA 2-093 900 mg once daily for 2 weeks.
Drug: BIA 2-093 900 mg (Part I)
In Part I, patients received one 900 mg BIA 2-093 tablet once daily, taken orally in the evening, for 2 weeks.
Other Name: Eslicarbazepine acetate




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01825837


Sponsors and Collaborators
Bial - Portela C S.A.
Investigators
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Study Director: Patrício Soares-da-Silva, MD, PhD BIAL - Portela & Ca. SA

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Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT01825837    
Other Study ID Numbers: BIA-2093-205
First Posted: April 8, 2013    Key Record Dates
Results First Posted: June 17, 2013
Last Update Posted: March 27, 2014
Last Verified: February 2014
Keywords provided by Bial - Portela C S.A.:
bipolar I disorder
Eslicarbazepine acetate
BIA 2-093
Additional relevant MeSH terms:
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Disease
Recurrence
Pathologic Processes
Disease Attributes
Eslicarbazepine acetate
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action