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

NCT ID: NCT01825837

Last Updated: 2014-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2007-06-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

BIA 2-093 1800 mg once daily [Group 1 (Part II)]

Intervention Type: DRUG

BIA 2-093 1800 mg taken orally in the evening, for 2 weeks

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.

Group Type: EXPERIMENTAL

BIA 2-093 900 mg once daily [Group 2 (Part II)]

Intervention Type: DRUG

BIA 2-093 900 mg taken orally in the evening, for 2 weeks

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.

Group Type: EXPERIMENTAL

BIA 2-093 300 mg once daily [Group 3 (Part II)]

Intervention Type: DRUG

BIA 2-093 300 mg taken orally in the evening, for 2 weeks.

ESL (Part I)

In Part I, all participants received open-label treatment with BIA 2-093 900 mg once daily for 2 weeks.

Group Type: EXPERIMENTAL

BIA 2-093 900 mg (Part I)

Intervention Type: DRUG

In Part I, patients received one 900 mg BIA 2-093 tablet once daily, taken orally in the evening, for 2 weeks.

Interventions

BIA 2-093 1800 mg once daily [Group 1 (Part II)]

BIA 2-093 1800 mg taken orally in the evening, for 2 weeks

Intervention Type: 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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Eslicarbazepine acetate; Eslicarbazepine acetate; Eslicarbazepine acetate; Eslicarbazepine acetate

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bial - Portela C S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrício Soares-da-Silva, MD, PhD

Role: STUDY_DIRECTOR

BIAL - Portela & Ca. SA

Other Identifiers

BIA-2093-205

Identifier Type: -

Identifier Source: org_study_id