Overview

This trial is active, not recruiting.

Condition long qt syndrome type 3
Treatments eleclazine, eleclazine placebo
Phase phase 3
Sponsor Gilead Sciences
Start date December 2014
End date February 2017
Trial size 41 participants
Trial identifier NCT02300558, 2014-000042-30, GS-US-372-1234

Summary

This study will evaluate the effect of eleclazine on shortening of the corrected QT interval (QTc), safety, and tolerability in adults with type 3 long QT syndrome (LQT3). During the single-blind treatment period (24 weeks), participants will receive eleclazine and/or eleclazine placebo. Following the single-blind treatment period, participants who have not permanently discontinued study drug will be eligible, at the discretion of the investigator, to continue receiving eleclazine during an open-label extension phase.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Single-blind treatment phase (24 weeks): eleclazine and/or eleclazine placebo
eleclazine GS-6615
Eleclazine tablet administered orally
eleclazine placebo
Eleclazine placebo tablet administered orally
(Experimental)
Open-label extension phase (if eligible): eleclazine
eleclazine GS-6615
Eleclazine tablet administered orally

Primary Outcomes

Measure
Difference between mean daytime QT interval corrected for heart rate using the Fridericia formula (QTcF) interval at baseline and at Week 24 (based on standard 12-lead ECG data)
time frame: Baseline; Week 24

Secondary Outcomes

Measure
Difference between the mean daytime QTcF interval at baseline and at Week 12 (based on standard 12-lead ECG data)
time frame: Baseline; Week 12
Difference between the mean daily QTcF interval at baseline and at Week 24 (based on Holter data)
time frame: Baseline; Week 24
Difference between the mean nocturnal QTcF interval at baseline and at Week 24 (based on Holter data)
time frame: Baseline; Week 24

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Individuals with an established diagnosis of LQT3 (by genotype testing) - Mean (of triplicate) QTc interval ≥ 480 msec (or ≥ 460 msec, for individuals who are currently taking ranolazine or Class I antiarrhythmic drugs such as mexiletine) at 3 or more time points, determined by standard 12-lead ECG, at screening Exclusion Criteria: - Known mutations associated with type 1 long QT syndrome (LQT1) or type 2 long QT syndrome (LQT2) - Known or suspected history of seizures or epilepsy - History of heart failure defined as New York Heart Association (NYHA) Class IV and/or known left ventricular ejection fraction (EF) ≤ 45% - Body mass index (BMI) ≥ 40 kg/m^2 at screening - Severe renal impairment at screening (defined as an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2, using the 4 Variable Modification of Diet in Renal Disease (MDRD) equation, as determined by the study center) - Abnormal liver function tests at screening, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN), or total bilirubin > 1.5 x ULN - An aborted cardiac arrest (ACA), implantable cardioverter-defibrillator (ICD) implantation, syncopal episode, or appropriate ICD therapy within 3 months prior to screening - Any other condition or circumstance that in the opinion of the investigator would preclude compliance with the study protocol

Additional Information

Official title A Phase 3, Single-Blind Study to Evaluate the Effect of Eleclazine (GS-6615) on Shortening of the QT Interval, Safety, and Tolerability in Subjects With Long QT Syndrome Type 3
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Gilead Sciences.