RecruitingPhase 2NCT06447025

An Open-Label Study of CTI-1601 in Subjects With Friedreich's Ataxia

An Open-Label Extension Study to Assess the Long-Term Safety, Efficacy, Pharmacodynamics, Pharmacokinetics, and Tolerability of Subcutaneous CTI-1601 in Subjects With Friedreich's Ataxia

Sponsor

Larimar Therapeutics, Inc.

Enrollment

85 participants

Start Date

Jan 25, 2024

Study Type

INTERVENTIONAL

Conditions

Friedreich Ataxia

Summary

An open label study designed to evaluate the safety, PK, PD, and clinical effects of long-term daily administration of CTI-1601 enrolling adolescent and adult patients with FRDA who have participated in a prior clinical study of CTI-1601 as well as children (age 2 years and older), adolescents and adults with FRDA who have not participated in a prior clinical study of CTI-1601.

Eligibility

Min Age: 2 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called CTI-1601 for people with friedreich ataxia. The study is currently recruiting participants at 8 locations. People eligible for this study include aged 2 Years to 60 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCTI-1601

CTI-1601 is a recombinant fusion protein and is intended to deliver human frataxin, the protein deficient in patients with Friedreich's ataxia

Locations(8)

University of California Los Angeles

Los Angeles, California, United States

Fixel Institute for Neurological Disease, University of Florida Health

Gainesville, Florida, United States

Morsani Center for Advanced Health Care, University of South Florida Health

Tampa, Florida, United States

University of Iowa

Iowa City, Iowa, United States

Uncommon Cures

Chevy Chase, Maryland, United States

Clinilabs Drug Development, Corp.

Eatontown, New Jersey, United States

Ohio State University United States

Columbus, Ohio, United States

Children's Hospital of the University of Pennsylvania (CHOP)

Philadelphia, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT06447025

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