Study to Evaluate the Effect of Eleclazine on QT, Safety, and Tolerability in Participants With Long QT2 Syndrome

Summary

The primary objective of the study is to evaluate the effect of oral eleclazine (formerly GS-6615) on corrected QT (QTc) interval in participants with long QT2 syndrome.

Timeline

Start

2015-07-20

Primary completion

2016-05-13

Completion

2016-06-13

Outcome

Missed primary endpoint

registry p = 0.358; Difference in LSM -7.7 (95% CI -26.0 to 10.5) NCT02365506 ↗

registry p = 0.338; Difference in LSM -6.0 (95% CI -19.8 to 7.8) NCT02365506 ↗

registry p = 0.174; Difference in LSM -6.5 (95% CI -16.5 to 3.5) NCT02365506 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Eleclazine	Small molecule	24 mg	Oral
Subject	Eleclazine	Small molecule	48 mg	Oral

Indications