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Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) in Acute Manic Episodes Associated With Bipolar I Disorder

Bipolar I Disorder Clinical Trial

Official title:
Efficacy and Safety of Eslicarbazepine Acetate (BIA 2 093) in Acute Manic Episodes Associated With Bipolar I Disorder in a Double Blind, Randomised, Dose Titration, Placebo Controlled, Multicentre Clinical Trial

Clinical Trial Summary

Multicentre, double-blind, randomised, parallel-group, placebo-controlled dose-titration study; depending on clinical efficacy, up-titration of dosage 3 and 6 days after start of treatment; maintenance of individual maximum dose for the rest of the total 3-week treatment period; subsequently, down-titration (according to the dose steps and the time intervals of up-titration) and administration of an established anti-manic therapy during the tapering-off period (in patients who discontinued treatment) or entry into a recurrence prevention study (Protocol PRA+SCO/BIA-2093-205; reported under separate cover) as an option for patients who responded to the study treatment

Clinical Trial Description

Objectives:

The primary objective was to evaluate the dose-dependent efficacy of 2 dose-titration regimens of Eslicarbazepine Acetate (ESL) compared with placebo as therapy in patients with acute mania.

The secondary objective was to evaluate the safety and tolerability of 2 dose-titration regimens of Eslicarbazepine Acetate in comparison to placebo. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01822678
Study type Interventional
Source Bial - Portela C S.A.
Contact
Status Completed
Phase Phase 2
Start date December 2005
Completion date November 2006
View Details
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