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

COMPLETEDPHASE2

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, Randomised, Dose Titration, Placebo Controlled, Multicentre Clinical Trial

NCT01822678•Bial - Portela C S.A.

View on ClinicalTrials.gov

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

Detailed 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•aged ≥18 years;
•a documented diagnosis of bipolar I disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria (i.e., 296.0, 296.4 or 296.6) \[8\];
•currently displaying an acute manic (including mixed) episode according to the DSM-IV criteria;
•a Young Mania Rating Scale (YMRS) total score of ≥20;
•symptoms of the current manic episode starting within 2 weeks prior to randomisation (V2, Day 1);
•able to undergo a standard evaluation, including clinical interview, ratings and laboratory studies;
•signed informed consent form;
•post-menopausal or otherwise incapable of becoming pregnant by reason of surgery or tubal ligation; women of childbearing potential had to present a serum pregnancy test consistent with a non-gravid state and had to use double-barrier contraception until the post-study visit (PSV).

Exclusion Criteria

•a history of schizophrenia or schizoaffective disorder, psychotic features or rapid cycling;
•currently treated with carbamazepine or oxcarbazepine;
•a history of unresponsiveness, intolerance or hypersensitivity to related compounds (carbamazepine, oxcarbazepine or licarbazepine);
•use of any depot-neuroleptics for the current manic episode;
•abuse of stimulating drugs or use of any systemic sympathicomimetic drug within the previous 2 weeks;
•electroconvulsive therapy within the previous 3 months;
•a history of dependence or chronic abuse from alcohol, drugs or medications within the last year;
•judged clinically to be at risk of harm to self or others;
•second or third-degree atrioventricular blockade not corrected with a pacemaker;
•relevant electrocardiogram (ECG) or laboratory abnormalities;
+10 more criteria

Key Dates

Start Date

December 1, 2005

Primary Completion Date

November 1, 2006

Completion Date

November 1, 2006

Last Updated

March 27, 2014

Enrollment

161

ACTUAL participants

Conditions

Bipolar I Disorder

Interventions

Eslicarbazepine Acetate

DRUG

Eslicarbazepine Acetate

DRUG

Placebo

DRUG

Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

NCT05303064

SchizophreniaBipolar I Disorder

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RECRUITINGPHASE3

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

NCT07172516

Bipolar DisorderBipolar Depression+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 27, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder

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