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

NCT01824602 | Terminated Phase 2 Results

• 1 other identifier: BIA-2093-204
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief 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

BIPOLAR I DISORDER

Keywords

BIPOLAR I DISORDER, Eslicarbazepine acetate

Outcome Measures

Primary Outcomes (1)

• Change in Young Mania Rating Scale (YMRS) Total Score From Baseline Until the End of the 3-week Treatment Period

  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 (4)

Group 1

EXPERIMENTAL

Eslicarbazepine acetate 1800 mg

Drug: Eslicarbazepine acetate 1800 mg

Group 2

EXPERIMENTAL

Eslicarbazepine acetate 1200 mg

Drug: Eslicarbazepine acetate 1200 mg

Group 3

EXPERIMENTAL

Eslicarbazepine acetate 600 mg

Drug: Eslicarbazepine acetate 600 mg

Group 4

PLACEBO COMPARATOR

Placebo pills

Drug: Placebo

Interventions

Eslicarbazepine acetate 1800 mg DRUG

Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets.

Also known as: Esl

Group 1

Eslicarbazepine acetate 1200 mg DRUG

Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets.

Also known as: Esl

Group 2

Eslicarbazepine acetate 600 mg DRUG

Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets.

Also known as: Esl

Group 3

Placebo DRUG

Placebo sugar pills

Also known as: Placebo sugar pills

Group 4

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 or more.
• 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).
• Currently displaying an acute manic (including mixed) episode according to the DSM-IV criteria.
• A Young Mania Rating Scale (YMRS) total score of 20 or greater.
• Symptoms of the current manic episode starting within 2 weeks prior to Randomization (V2, Day 1).
• Able to undergo a standard evaluation, including clinical interview, ratings and laboratory studies.
• Signed informed consent form (ICF).
• Post-menopausal or otherwise incapable of becoming pregnant by reason of surgery or tubal ligation. In case of woman of childbearing potential, patient presents a serum pregnancy test consistent with a non-gravid state and will use double-barrier contraception until at least the post-study visit (PSV).

You may not qualify if:

• History of schizophrenia or schizoaffective disorder, psychotic features or rapid cycling.
• Currently treated with carbamazepine or oxcarbazepine.
• 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 (ECT) within the previous 3 months
• 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 ECG or laboratory abnormalities.
• Calculated creatinine clearance \<30 ml/min \[men: (140-age) x weight / serum creatinine x 72; women: (0.85) (140-age) x weight / serum creatinine x 72. Age in years, weight in kg, and serum creatinine in mg/dl\].
• Pregnancy or nursing.
• Participation in other drug clinical trial within the last 2 months before Randomization 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

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: TRIPLE
• Who Masked: PARTICIPANT, 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 5, 2013
• Study Start: February 1, 2006
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: March 27, 2014
• Results First Posted: September 18, 2013

Record last verified: 2013-08