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Trial to Evaluate the Effect of Eslicarbazepine Acetate on Cardiac Repolarization | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Trial to Evaluate the Effect of Eslicarbazepine Acetate on Cardiac Repolarization

A Randomized, Double-blind, Placebo-controlled and Open Label Active-controlled, 4-period Crossover Trial to Evaluate the Effect of Eslicarbazepine Acetate on Cardiac Repolarization in Healthy Adult Men and Women

NCT02283788•Bial - Portela C S.A.

View on ClinicalTrials.gov

Summary

A randomized, double-blind, placebo-controlled and open label active-controlled, 4 period crossover trial to evaluate the effect of eslicarbazepine acetate on cardiac repolarization in healthy adult men and women

Detailed Description

The purpose of this randomized, double-blind, placebo-controlled and open label active-controlled, 4 period crossover study was to evaluate the effect of therapeutic and supra-therapeutic doses of eslicarbazepine acetate on the placebo corrected time-matched change from baseline using individually corrected QT (QTcI) interval durations in adult healthy volunteers.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Be a healthy male or female 18 to 45 years of age. Women were required to be postmenopausal (more than 12 months since last period); surgically sterile (hysterectomy or tubal ligation at least 6 months prior to enrollment); using an intrauterine device; or double barrier (i.e. diaphragm or spermicide plus male condom) non-hormonal contraceptive therapy for the duration of the trial and were required to have a negative pregnancy test at screening and upon each check-in to the study facility.
•Have a BMI within the range of 18-30 kg/m2.
•Be able to communicate effectively with the study personnel.
•Have no significant disease or abnormal laboratory values as determined by medical history, physical examination or laboratory evaluations, conducted at the screening visit and on each admission to the clinic.
•Have a normal 12-lead electrocardiogram, without any clinically significant abnormalities of rate, rhythm or conduction.
•Be nonsmokers defined as not having smoked in the past 6 months.
•Be adequately informed of the nature and risks of the study and give written informed consent prior to study entry.

Exclusion Criteria

•Known hypersensitivity or allergy to moxifloxacin, eslicarbazepine acetate or related compounds such as carbamazepine, oxcarbazepine, or licarbazepine.
•Women who were pregnant or breast feeding.
•Any disease or condition (medical or surgical) which, in the opinion of the investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or placed the subject at increased risk.
•A sustained supine systolic blood pressure \> 140 mmHg or \<100mm Hg or a diastolic blood pressure \> 95 mmHg at screening or baseline.
•A resting ECG heart rate of \<50 bpm or \>100 bpm.

Locations (1)

Comprehensive Phase OneTM

Miramar, Florida, United States

Key Dates

Start Date

March 1, 2007

Primary Completion Date

June 1, 2007

Completion Date

June 1, 2007

Last Updated

April 11, 2025

Enrollment

ACTUAL participants

Conditions

Epilepsy

Interventions

BIA 2-093

DRUG

Moxifloxacin

DRUG

Placebo

DRUG

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RECRUITINGPHASE1

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RECRUITINGNA

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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: April 11, 2025Data 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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Trial to Evaluate the Effect of Eslicarbazepine Acetate on Cardiac Repolarization

Inclusion Criteria

Exclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

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