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

NCT01825837 | Completed Phase 2 Results

• 1 other identifier: BIA-2093-205
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/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.

Conditions

Bipolar I Disorder

Keywords

bipolar I disorder; Eslicarbazepine acetate; BIA 2-093

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

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.

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.

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.

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.

Drug: BIA 2-093 900 mg (Part I)

Interventions

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

Also known as: Eslicarbazepine acetate

BIA 2-093 1800 mg (Group 1)

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

Also known as: Eslicarbazepine acetate

BIA 2-093 900 mg (Group 2)

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.

Also known as: Eslicarbazepine acetate

BIA 2-093 300 mg (Group 3)

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.

Also known as: Eslicarbazepine acetate

ESL (Part I)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• relevant electrocardiogram (ECG) or laboratory abnormalities
• any uncontrolled clinically relevant disorder
• uninsured capability to comply with the study protocol

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

MeSH Terms

Interventions

eslicarbazepine acetate

Results Point of Contact

• Title: Head of Clinical Research Section
• Organization: BIAL - Portela & Ca, SA

clinical.trials@bial.com

351 22 986 6100

Study Officials

• Patrício Soares-da-Silva, MD, PhD

  BIAL - Portela & Ca. SA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2013
• First Posted: April 8, 2013
• Study Start: March 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: March 27, 2014
• Results First Posted: June 17, 2013

Record last verified: 2014-02