A Study to Learn More About the Effects and Long-Term Safety of BIIB141 (Omaveloxolone) in Participants With Friedreich's Ataxia Aged 2 to 15 Years Old

PHASE3RecruitingINTERVENTIONAL
Enrollment

255

Participants

Timeline

Start Date

June 9, 2025

Primary Completion Date

November 16, 2027

Study Completion Date

November 22, 2029

Conditions
Friedreich Ataxia
Interventions
DRUG

Omaveloxolone

Administered as specified in the treatment arm.

DRUG

Placebo

Administered as specified in the treatment arm.

Trial Locations (27)

165

NOT_YET_RECRUITING

Ospedale Pediatrico Bambino Gesù IRCCS, Rome

2100

NOT_YET_RECRUITING

Rigshospitalet - Juliane Marie Centret (JMC) Copenhagen, Copenhagen

3052

NOT_YET_RECRUITING

Murdoch Childrens Research Institute (MCRI), Parkville

6020

NOT_YET_RECRUITING

Universitätsklinikum Innsbruck, Innsbruck

8950

NOT_YET_RECRUITING

Hospital Sant Joan de Deu, Espluges de Llobregat

19104

RECRUITING

Children's Hospital of Philadelphia Buerger Center, Philadelphia

20133

NOT_YET_RECRUITING

Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan

20251

NOT_YET_RECRUITING

UKE Hamburg, Hamburg

28046

NOT_YET_RECRUITING

Hospital Universitario La Paz - PPDS, Madrid

31015

NOT_YET_RECRUITING

IRCCS Eugenio Medea - Polo. Scientifico Veneto, Conegliano

33612

NOT_YET_RECRUITING

USF Health Morsani College of Medicine Department of Neurology, Tampa

34090

NOT_YET_RECRUITING

CHU de Montpellier - Hôpital Arnaud de Villeneuve, Montpellier

35392

NOT_YET_RECRUITING

UKGM - Universitätsklinikum Giessen und Marburg GmbH - Standort Gießen, Giessen

52074

NOT_YET_RECRUITING

Universitätsklinikum Aachen, Aachen

75012

NOT_YET_RECRUITING

AP-HP - Hôpital Armand Trousseau, Paris

90095

NOT_YET_RECRUITING

UCLA Neurology Outpatient Clinic at Westwood, Los Angeles

32608-3928

NOT_YET_RECRUITING

Norman Fixel Institute for Neurological Diseases UF Health, Gainesville

38105-3678

NOT_YET_RECRUITING

St Jude Children's Research Hospital, Memphis

23507-1910

RECRUITING

Children's Hospital of the King's Daughters, Norfolk

70200-730

NOT_YET_RECRUITING

L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME, Brasília

13083-970

NOT_YET_RECRUITING

University of Campinas (UNICAMP) School of Medical Sciences, Campinas

04038-002

NOT_YET_RECRUITING

PSEG Centro de Pesquisa Clinica, São Paulo

H3H 2R9

NOT_YET_RECRUITING

McGill University, Montreal

D01 XD99

NOT_YET_RECRUITING

CHI at Temple Street, Dublin

6525 GA

NOT_YET_RECRUITING

Radboud Universitair Medisch Centrum, Nijmegen

S10 2TH

NOT_YET_RECRUITING

Sheffield Children's Hospital, Sheffield

WC1N 3BG

NOT_YET_RECRUITING

University College London, Institue of Neurology, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biogen

INDUSTRY