Conditions: Long QT Syndrome Type 3
Keywords: Type 3 long QT syndrome (LQT3) Long QT syndrome Congenital long QT Sudden cardiac death
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 41
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the effect of oral eleclazine on mean daytime QTcF interval after 24 weeks of treatment with elecalzine in participants with long QT syndrome Type 3. 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 (OLE) phase.

Detailed description:

Arms:
arm 1: Eleclazine and/or eleclazine placebo up to Week 24 arm 2: Eligible participants will continue to receive open-label eleclazine until this drug is commercially available for the treatment of patients with LQT3, or until Gilead terminates development of eleclazine for the treatment of patients with LQT3, or the investigator deems it no longer in the participant's best interest.

Interventions: intervention 1: Eleclazine intervention 2: Eleclazine placebo
Intervention descriptions: intervention 1: Tablets administered orally intervention 2: Tablets administered orally

Protocol document: