86
Participants
Start Date
December 25, 2015
Primary Completion Date
March 21, 2017
Study Completion Date
March 21, 2017
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).
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