Effect of Eleclazine on Shortening of the QT Interval, Safety, and Tolerability in Adults With Long QT Syndrome Type 3

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02300558
• Date of registration: 21/11/2014
• Prospective Registration: Yes
• Primary sponsor: Gilead Sciences
• Public title: Effect of Eleclazine on Shortening of the QT Interval, Safety, and Tolerability in Adults With Long QT Syndrome Type 3
• Scientific 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
• Date of first enrolment: December 17, 2014
• Target sample size: 41
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02300558
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: Phase 3

Countries of recruitment

Canada, Finland, France, Germany, Israel, Italy, Netherlands, Spain, United Kingdom, United States

Contacts

• Name: Gilead Study Director
• Affiliation: Gilead Sciences

Key inclusion & exclusion criteria

Key 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

Key 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Long QT Syndrome Type 3

Intervention(s)

Drug: Eleclazine placebo

Drug: Eleclazine

Primary Outcome(s)

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 Outcome(s)

Difference between the mean nocturnal QTcF interval at baseline and at Week 24 (based on Holter data) [Time Frame: Baseline; Week 24]

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]

Secondary ID(s)

2014-000042-30

GS-US-372-1234

Source(s) of Monetary Support

Please refer to primary and secondary sponsors