A Study to Learn About the Effects and Safety of RTA 408 (Omaveloxolone) in People Aged 16 to 40 With Friedreich's Ataxia

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

172

Participants

Timeline

Start Date

January 31, 2015

Primary Completion Date

October 31, 2019

Study Completion Date

November 28, 2025

Conditions
Friedreich Ataxia
Interventions
DRUG

Omaveloxolone Capsules, 2.5 mg

DRUG

Omaveloxolone Capsules, 5 mg

DRUG

Omaveloxolone Capsules, 10 mg

DRUG

Placebo

DRUG

Omaveloxolone Capsules, 20 mg

DRUG

Omaveloxolone Capsules, 40 mg

DRUG

Omaveloxolone Capsules, 80 mg

DRUG

Omaveloxolone Capsules, 160 mg

DRUG

Omaveloxolone Capsules, 300 mg

DRUG

Omaveloxolone Capsules, 150 mg

Trial Locations (11)

3052

Murdoch Childrens Research Institute, Parkville

6020

Medical University Innsbruck, Innsbruck

19104

Children's Hospital of Philadelphia, Philadelphia

20133

Neurological Institute Carlo Besta, Milan

30329

Emory University Hospital - Neurology, Atlanta

32610

University of Florida - Neurology, Gainesville

33612

USF Ataxia Research Center, Tampa

43221

Ohio State University - Neurology, Columbus

52242

University of Iowa Stead Family Children's Hospital, Iowa City

90095

UCLA, Los Angeles

WC1E 6BT

University College of London, London

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

AbbVie

INDUSTRY

collaborator

Friedreich's Ataxia Research Alliance

OTHER

lead

Biogen

INDUSTRY