MedTrace Logo

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

NCT01824602 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2014-03-27

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Principal Investigators

  • Patrício Soares-da-Silva, MD, PhD · BIAL - Portela & Ca. SA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2006-11-30
Completion
2006-11-30

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01824602 on ClinicalTrials.gov