CLARITY-FA is a natural history study that is looking for individuals who have cardiomyopathy (heart muscle disease) associated with Friedreich ataxia (FA)
Dear Friedreich ataxia community members,
Below is a message from Lexeo Therapeutics:
We are reaching out to inform you about a research study sponsored by Lexeo Therapeutics Inc. (Lexeo) called CLARITY-FA. CLARITY-FA is a natural history study that is looking for individuals who have cardiomyopathy (heart muscle disease) associated with Friedreich ataxia (FA). About CLARITY-FA:
-The study includes two age groups:
-Individuals who are least 16 years of age
-Individuals who are between 6 and under 16 years of age
The study is open to individuals with genetically confirmed FA diagnosis and evidence of cardiomyopathy based on specific criteria.
Full eligibility criteria will be evaluated by the clinical trial doctor to determine if an individual is the right candidate for this trial.
The study has a location in Canada.
The goal of the Lexeo sponsored CLARITY-FA natural history study is to learn about how heart disease develops and worsens in individuals with FA. This is important because even though approximately 80% percent of people with FA develop heart muscle disease1, researchers currently do not know much about how the heart is impacted in FA.
Information gained from participation in this study will provide valuable data to learn more about heart disease in FA.
Unfortunately, there currently are no approved treatments for heart muscle disease in FA. Lexeo is researching an investigational gene therapy, called LX2006, to address this unmet need. The information from CLARITY-FA will also help advance our gene therapy research.
What is a natural history study and why is it important? In order to develop treatments for a disease, researchers must first learn more about it. A natural history study is a type of research that tracks how a disease develops and changes over time in people who have it.
Researchers observe symptoms, changes, and patterns to better learn what to expect from the disease, find ways to diagnose it earlier, and how to manage the disease better.
Information from natural history studies provide important knowledge that can help develop better or new treatments for a disease.
It is important to note that participants in natural history studies do not receive any investigational study drug as the goal is to learn about the natural course of the disease.
What can an individual expect from participating in the CLARITY-FA natural history study?
Before any study-related tests and procedures can be done, you will be asked to read and choose to sign and date an informed consent form. After you sign the informed consent form, your participation in the study will begin with a screening visit. The goal of the screening visit is to decide whether or not you meet the requirements to take part in this study.
If the study doctor decides that you meet all the requirements to be in this study, and you decide to participate, you will be asked to visit the study site three to four times over a 52-week period.
Please note: You will not receive any gene therapy in the CLARITY-FA natural history study. Your study doctor will learn about your heart disease through collecting medical information and performing routine study assessments. Other important information:
This study is sponsored by Lexeo Therapeutics, Inc.
All study-related assessments will be provided at no cost.
You will receive no direct payment for taking part in the study. Participants and their caregiver will be reimbursed for reasonable study-related expenses for travel (e.g., transportation, meals, and hotel, as appropriate)
As with any clinical study or trial, there may be risks involved with participation. We encourage any individual considering participation in a clinical study or trial to consult with your physician or medical team. You may withdraw from the study at any time for any reason. If you refuse to participate or decide to withdraw, you will not suffer any penalty, loss of rights, or loss of benefits to which you are entitled.
How to participate
If you are a patient or caregiver who would like to learn more about this study, please contact clinicaltrials@lexeotx.com.
Additional information on trial sites and locations can be found at: https://clinicaltrials.gov (NCT #06865482)
Information can also be found at https://lacaf.org/
Thank you to the FA families and community.
Sincerely, Ataxia Canada
Anyone considering participating in a clinical study or trial should discuss the matter with his or her physician. Ataxia Canada does not endorse or recommend any particular studies.
1. Lagedrost et al. 2011; Tsou et al. 2011; Regner et al. 2012
