LQT-1213 for Long QT Syndrome
Trial Summary
What is the purpose of this trial?
This trial tests a new medication, LQT-1213, to help with heart rhythm problems. It involves healthy adults and patients with specific heart rhythm disorders (LQT2 or LQT3). The medication aims to keep the heart's electrical signals normal, preventing irregular heartbeats.
Do I have to stop taking my current medications for the trial?
Yes, participants must stop taking certain medications. For Part 1, you must refrain from using any drugs, including prescription and nonprescription medications, herbal remedies, or vitamin supplements, starting 14 days before the first dose and until the end of the study. For Part 2, you cannot take antiarrhythmic medications or drugs known to affect the QT interval within 7 days before admission or 5 half-lives (whichever is longer), unless approved by the sponsor and principal investigator.
Will I have to stop taking my current medications?
The trial requires participants to refrain from using any prescription or nonprescription medications, herbal remedies, or vitamin supplements starting 14 days before the first dose and until the end of the study, unless approved by the sponsor and principal investigator. This means you may need to stop taking your current medications, but you should discuss this with the study team.
What data supports the idea that LQT-1213 for Long QT Syndrome is an effective drug?
The available research does not provide specific data on the effectiveness of LQT-1213 for Long QT Syndrome. Instead, it discusses other treatments and approaches for managing the condition. For example, one study focuses on the drug flecainide for a specific type of Long QT Syndrome, while another explores a different compound, NS1643, in rabbit models. Additionally, there is mention of personalized care and the use of automated external defibrillators as part of a comprehensive treatment program. However, none of these studies directly address LQT-1213.12345
What safety data is available for the treatment LQT-1213 for Long QT Syndrome?
The provided research does not contain specific safety data for LQT-1213 or its other names like Dofetilide or Tikosyn. The studies focus on other treatments and aspects of Long QT Syndrome, such as flecainide, sevoflurane, and 4-phenylbutyric acid, but do not mention LQT-1213. Therefore, no safety data for LQT-1213 is available in the provided research.14678
Is the drug LQT-1213 a promising treatment for Long QT Syndrome?
How is the drug LQT-1213 different from other treatments for Long QT Syndrome?
LQT-1213 is unique because it may target specific ion channels involved in Long QT Syndrome, potentially offering a more tailored approach compared to existing treatments that often use a 'one-size-fits-all' strategy. This drug could provide a novel mechanism of action by modulating specific pathways related to the condition, unlike traditional treatments that may not address the underlying genetic factors.124910
Research Team
Jan Matousek, DO
Principal Investigator
Spaulding Clinical Research LLC
Eligibility Criteria
Healthy adults and patients with Type 2 or 3 Long QT Syndrome (LQT2 or LQT3) can join this trial. Healthy participants must be 19-60 years old, have a BMI of 18-35 kg/m^2, not have used tobacco recently, and agree to use effective contraception. Patients with LQT need an ICD implanted and a specific QTcF interval. People with certain health conditions, recent blood donations, drug abuse history, or those on conflicting medications cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Randomized, double-blind, crossover, dose-escalation study with dofetilide and LQT-1213 in healthy subjects
Treatment Part 2
Single-blind, multiple-dose safety study of LQT-1213 in patients with Long QT Syndrome
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Dofetilide
- LQT-1213
- Placebo
LQT-1213 is already approved in United States for the following indications:
- Congenital Long QT Syndrome (Type 1, 2, and 3)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Thryv Therapeutics, Inc.
Lead Sponsor