Hope for kids with Friedreich's ataxia: drug already approved for teens now tested in younger children

NCT ID NCT06953583

Recruiting now Disease control Sponsor: Biogen Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether omaveloxolone, a drug already approved for people 16 and older with Friedreich's ataxia, can safely help children aged 2 to 15. About 255 participants will first receive either the drug or a placebo for a year, then all will receive the drug for two more years. Researchers will measure changes in movement, balance, and daily function, and monitor side effects and overall health.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Get updates

Get notified about this study

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

Friedreich ataxia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

FRIEDREICH ATAXIA

Contacts and locations

Locations

AP-HP - Hôpital Armand Trousseau
RECRUITING

Paris, 75012, France
All India Institute of Medical Sciences (AIIMS) - New Delhi
WITHDRAWN

New Delhi, National Capital Territory of Delhi, 110029, India
CHI at Temple Street
RECRUITING

Dublin, D01 XD99, Ireland
CHKD's Health Center - South Campus - PIN
RECRUITING

Norfolk, Virginia, 23507-1910, United States
CHU de Montpellier- Hôpital Gui De Chauliac
RECRUITING

Montpellier, Hérault, 34090, France
CHU de Quebec -Universite Laval
RECRUITING

Québec, Quebec, G1V 4G2, Canada
Children's Hospital of Philadelphia - Buerger Center for Advanced Pediatric Care - PIN
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
Fondazione IRCCS Istituto Neurologico Carlo Besta
RECRUITING

Milan, 20133, Italy
Hospital Sant Joan de Deu - PIN
RECRUITING

Espluges de Llobregat, Barcelona, 8950, Spain
Hospital Universitario La Paz - PPDS
RECRUITING

Madrid, 28046, Spain
IRCCS Eugenio Medea - Polo. Scientifico Veneto
NOT_YET_RECRUITING

Conegliano, Veneto, 31015, Italy
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
WITHDRAWN

Istanbul, 34093, Turkey (Türkiye)
John Radcliffe Hospital
RECRUITING

Oxford, Oxfordshire, OX3 9DU, United Kingdom
King Faisal Specialist Hospital & Research Centre
WITHDRAWN

Riyadh, Ar Riya, 12875, Saudi Arabia
L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME
RECRUITING

Brasília, Federal District, 70200-730, Brazil
McGill University
RECRUITING

Montreal, Quebec, H3H 2R9, Canada
Murdoch Childrens Research Institute (MCRI)
RECRUITING

Parkville, Victoria, 3052, Australia
Norman Fixel Institute for Neurological Diseases UF Health
RECRUITING

Gainesville, Florida, 32610-3010, United States
Ospedale Pediatrico Bambino Gesù IRCCS
NOT_YET_RECRUITING

Rome, Lazio, 165, Italy
PSEG Centro de Pesquisa Clinica
RECRUITING

São Paulo, São Paulo, 04024-002, Brazil
Radboud Universitair Medisch Centrum
RECRUITING

Nijmegen, 6525 GA, Netherlands
Rigshospitalet - Juliane Marie Centret (JMC) Copenhagen
NOT_YET_RECRUITING

Copenhagen, 2100, Denmark
Seattle Children's Hospital
RECRUITING

Seattle, Washington, 98105-3901, United States
Sheffield Children's Hospital - PPDS
RECRUITING

Sheffield, South Yorkshire, S10 5DD, United Kingdom
St. Jude Children's Research Hospital - PIN
RECRUITING

Memphis, Tennessee, 38105-3678, United States
Sydney Children's Hospital
NOT_YET_RECRUITING

Randwick, New South Wales, 2031, Australia
UCLA Neurology Outpatient Clinic at Westwood
NOT_YET_RECRUITING

Los Angeles, California, 90095, United States
UKGM - Universitätsklinikum Giessen und Marburg GmbH - Standort Gießen
RECRUITING

Giessen, 35392, Germany
USF Health Morsani College of Medicine Department of Neurology
RECRUITING

Tampa, Florida, 33612, United States
University College Hospital - PPDS
RECRUITING

London, Lincolnshire, NW1 2BU, United Kingdom
University of Campinas (UNICAMP) School of Medical Sciences
NOT_YET_RECRUITING

Campinas, São Paulo, 13083-970, Brazil
Universitätsklinikum Aachen
RECRUITING

Aachen, North Rhine-Westphalia, 52074, Germany
Universitätsklinikum Hamburg Eppendorf
RECRUITING

Hamburg, 20246, Germany
Universitätsklinikum Innsbruck
RECRUITING

Innsbruck, 6020, Austria

More trials for these conditions

Other studies related to the condition(s) this trial covers.