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Phase 1 N=67 Randomized Treatment

Trial to Evaluate the Effect of Eslicarbazepine Acetate on Cardiac Repolarization

Epilepsy

Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: QTcI - QT Interval Individually Corrected for Heart Rate - Day 5 — -8.05; -6.15; -2.77; -4.39 msec

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
BIA 2-093 (Drug); Moxifloxacin (Drug); Placebo (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Bial - Portela C S.A.
Primary completion
Jun 2007

Outcome Measures

OutcomeResultp-value
PRIMARY
QTcI - QT Interval Individually Corrected for Heart Rate - Day 5
-8.05; -6.15; -2.77; -4.39; -9.34; -7.34
SECONDARY
QTcB - QT Interval Corrected for Heart Rate Using Bazett's Formula
SECONDARY
QTcF - QT Interval Corrected Using Fridericia's Formula

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

Eligibility Criteria

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 95 mmHg at screening or baseline.
  • A resting ECG heart rate of 100 bpm.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02283788). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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