At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Eslicarbazepine Acetate and Placebo for Bipolar I Disorder. Completed, enrolled 161 participants.
Detailed 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
Study Details
Timeline
Interventions
Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response.
Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response.
Placebo