Oncology Cardiology / Cardiovascular Respiratory / COPD / Asthma Infectious Disease Gastroenterology Diabetes / Metabolic Neurology Rheumatology Women's Health Mental Health / Psychiatry Dermatology Rare Diseases Men's Health
Clinical Trial ● Currently Recruiting Phase III NCT06953583

A Study to Learn More About the Effects and Long-Term Safety of Omaveloxolone (BIIB141) in Children and Teens With Friedreich’s Ataxia

A Study to Learn More About the Effects and Long-Term Safety of Omaveloxolone (BIIB141) in Children and Teens With Friedreich’s Ataxia — Recruiting • Phase III • NCT06953583.

📅 02 Jun 2026 ⏱ 3 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
Phase
Phase III
NCT ID
NCT06953583
Start
2025-06-09
Completion
2027-11-16
ClinicaliQ Trial Snapshot
  • A Study to Learn More About the Effects and Long-Term Safety of Omaveloxolone (BIIB141) in Children and Teens With Friedreich’s Ataxia — Recruiting • Phase III • NCT06953583.
  • Study testing omaveloxolone safety and effectiveness in children aged 2-15 with Friedreich's ataxia over three years.

Verify eligibility, endpoints and current status on the original ClinicalTrials.gov registry before acting on this summary.

Use This Page For
  • Quick orientation before opening the registry record.
  • Checking recruitment status, phase and sponsor at a glance.
  • Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying

In this study, researchers will learn more about omaveloxolone, also known as BIIB141 or SKYCLARYS®. Omaveloxolone is already approved for people with Friedreich's Ataxia (FA) who are 16 years of age or older. However, it is not yet available for younger teens and children. The main goal of this study is to learn how omaveloxolone affects symptoms of FA and its safety in younger participants between the ages of 2 and 15 years old. The main questions researchers want to answer in this study are: * How does omaveloxolone affect…

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
View Trial ↗
Share: Twitter/X LinkedIn