Phase 2 Completed N=25 Double-blind Treatment

Long-term Efficacy Study of Sodium Channel Blocker in LQT3 Patients

long QT syndrome

Source: ClinicalTrials.gov NCT01648205 ↗

Enrolled (actual)

Serious AEs

4.0%

Results posted

Apr 2022

Primary outcomePrimary: Change in QTc Duration at 2 Months — 503; 497 miliseconds — p=0.7958

Summary

The purpose of this study is to determine whether late sodium channel blockade might be effective in shortening the QTc interval in various LQT3 mutations and be considered as a safe therapeutic option for LQT3 patients.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in QTc Duration at 2 Months	503; 497	0.7958
SECONDARY Change in QTc at 6 Months	504; 501	0.3369

Eligibility Criteria

Inclusion Criteria

Genotyped positive for LQT3 (SCN5A) mutation
Age 21 years or older
Not currently taking an antiarrhythmic drug (beta blockers are allowed)
Enrolled in LQTS Registry

Exclusion Criteria

Age less than 21 years
Not confirmed to have an LQT3 mutation
Significant co-morbidity that would preclude subject's safe participation in this study
Females who are pregnant or nursing
Females of childbearing age who are not using acceptable method of birth control
Evidence of prior sensitivity to ranolazine
Hepatic or renal disease that might adversely affect ranolazine excretion
Currently taking strong CYP3A inhibitors
Currently taking P-gp inhibitors
Currently taking CYP3A inducers
In vitro studies of specific mutation show no effect of ranolazine on late sodium current kinetics or show repolarization prolongation

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01648205). 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. Informational only — not medical advice.