NCT01824602

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

Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) in Acute Manic Episodes Associated With Bipolar I Disorder in a Double-blind, Fixed Multiple Dose, Randomised, Placebo-controlled,Multicentre Clinical Trial.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary study objective was to evaluate the dose-dependent efficacy of eslicarbazepine acetate administered at doses of 600, 1200, and 1800 mg over a 3-week period, compared with placebo, as therapy in patients with acute mania. The secondary objectives of this study were to a) evaluate the safety and tolerability of eslicarbazepine acetate (BIA 2-093) administered at doses of 600, 1200, and 1800 mg compared with placebo, b) assess the duration to onset of action in the different dose groups, and c) monitor the appearance of depressive symptoms.

Detailed description

This was a phase II, double-blind, fixed multiple dose, randomised, placebo-controlled, multicentre clinical trial in patients with a diagnosis of bipolar I disorder who experienced an acute manic (including mixed) episode. Patients who met the selection criteria at randomisation visit (V) (V2, Day 1) were randomised to 1 of 4 treatment groups: 600, 1200, or 1800 mg eslicarbazepine acetate, or placebo. Patients started the assigned treatment on Day 1 and were followed for up to 3 weeks. On Day 10, patients who showed no improvement were switched to open-label escape therapy with an established antimanic therapy. Patients could have been hospitalized at screening or at any time during the study at the investigator's discretion. Following randomisation (V2, Day 1), patients were assessed on Days 3, 7, 10, 14, 21, 28, and 56, after which they could either enter a recurrence prevention study, or the study drug could be tapered off and they could undergo follow-up assessments.

Conditions

• BIPOLAR I DISORDER

Interventions

Type	Name	Description
DRUG	Eslicarbazepine acetate 1800 mg	Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets.
DRUG	Eslicarbazepine acetate 1200 mg	Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets.
DRUG	Eslicarbazepine acetate 600 mg	Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets.
DRUG	Placebo	Placebo sugar pills

Timeline

• Start date: 2006-02-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2013-04-05
• Last updated: 2014-03-27
• Results posted: 2013-09-18