92
Participants
Start Date
June 30, 2015
Primary Completion Date
November 30, 2016
Study Completion Date
November 30, 2016
Interferon γ-1b
The study drug dose is planned to be escalated on a weekly basis over the first 4 weeks of treatment (from 10 µg/m² to 25, 50, and 100 µg/m²). The dose may be reduced, interrupted, or held based on tolerability. By Week 13, all participants are to be on a stable tolerated dose of study drug in order to continue study participation; the dose may not be further increased after week 13, however, it may be reduced on a case-by-case basis to manage drug-related adverse events (AEs).
Placebo
The volume of placebo is planned to correspond with volume of study drug that would be given to the participant if the participant was randomized to the study drug arm.
Children's Hospital of Philadelphia, Philadelphia
University of Florida - Clinical Research Center, Gainesville
University of Iowa Children's Hospital, Iowa City
University of California, Los Angeles Neurology Clinic, Los Angeles
Lead Sponsor
Friedreich's Ataxia Research Alliance
OTHER
Amgen
INDUSTRY