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

BIAL

Status and phase: Completed; Phase 2

Conditions: Bipolar I Disorder

Treatments: Drug: BIA 2-093 300 mg once daily [Group 3 (Part II)]; 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 2-093 900 mg (Part I)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01825837

BIA-2093-205

Details and patient eligibility

About

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.

Full 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).

Enrollment: 104 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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104 participants in 4 patient groups

BIA 2-093 1800 mg (Group 1)

Experimental group

Description:

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.

Treatment:

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

BIA 2-093 900 mg (Group 2)

Experimental group

Description:

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.

Treatment:

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

BIA 2-093 300 mg (Group 3)

Experimental group

Description:

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.

Treatment:

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

ESL (Part I)

Experimental group

Description:

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

Treatment:

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