Phase 2
N=25
Long-term Efficacy Study of Sodium Channel Blocker in LQT3 Patients
Long QT Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01648205 ↗Enrolled (actual)
25
Serious AEs
4.0%
Results posted
Apr 2022
Primary outcome: Primary: Change in QTc Duration at 2 Months — 503; 497 miliseconds — p=0.7958
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); Ranolazine (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Jul 2018
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 |
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.
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
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.