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

NCT01822678 | Completed Phase 2 Results

• 1 other identifier: BIA-2093-203
• Study Type: interventional
• Target: 161
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Bipolar I Disorder

Outcome Measures

Primary Outcomes (1)

• Change in the Young Mania Rating Scale (YMRS) Total Score at the End of the 3-week Treatment Period, in Relation to the Baseline.

  The YMRS is used to assess disease severity in patients who have been previously diagnosed with mania and it has proven psychometric properties through 11 item multiple-choice diagnostic questionnaire and the total score is determined from the summation of each 11 individual scores (and can range from 0 - 60) based on the patient's subjective feedback of his clinical condition over the previous 48 hours. A higher score indicates a worse rating for symptoms related to mania. At every visit throughout the study, investigators administered the YMRS. The results of the primary analysis of efficacy were calculated using Analysis of covariance (ANCOVA) with Last Observation Carried Forward (LOCF). Primary variable is presented through ANCOVA results for absolute change in YMRS total score from baseline (V2) to end of treatment (V7). A responder has at least 50% improvement (reduction) in the YMRS total score or has a total score of less than 12 points at the end of treatment period.

  baseline and 3-week

Study Arms (3)

Group 1

EXPERIMENTAL

Group 1: Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response.

Drug: Eslicarbazepine Acetate

Group 2

EXPERIMENTAL

Group 2: Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response.

Drug: Eslicarbazepine Acetate

Group 3

PLACEBO COMPARATOR

Group 3: Placebo (change in daily number of tablets administered, according to clinical response).

Drug: Placebo

Interventions

Eslicarbazepine Acetate DRUG

Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response.

Also known as: Eslicarbazepine Acetate tablets

Group 1

Placebo DRUG

Placebo

Also known as: sugar pill

Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;
• calculated creatinine clearance \<30 mL/min \[men: (140-age) x weight / serum creatinine x 72; women: (0.85) (140-age) x weight / serum creatinine x 72. Age in years, weight in kg, and serum creatinine in mg/dL\];
• pregnant or nursing;
• participating in another drug clinical trial within the last 2 months before the randomisation visit;
• not ensured capability to perform the trial or to comply with the study protocol (e.g., mental retardation or severe inability to communicate);
• any other uncontrolled clinically relevant disorder;

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

MeSH Terms

Interventions

eslicarbazepine acetate; Sugars

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

• Title: Head of Clinical Research Section
• Organization: BIAL - Portela & Ca, SA

clinical.trials@bial.com

351 22 986 6100

Study Officials

• Patrício Soares-da-Silva, MD, PhD

  BIAL - Portela & Ca. SA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2013
• First Posted: April 2, 2013
• Study Start: December 1, 2005
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: March 27, 2014
• Results First Posted: August 2, 2013

Record last verified: 2014-02