Safety, Tolerability and Efficacy of ACTIMMUNE® Dose Escalation in Friedreich's Ataxia Study

PHASE3CompletedINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

December 25, 2015

Primary Completion Date

March 21, 2017

Study Completion Date

March 21, 2017

Conditions
Friedreich's Ataxia
Interventions
DRUG

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).

Trial Locations (4)

19104

Children's Hospital of Philadelphia, Philadelphia

32603

University of Florida - Clinical Research Center, Gainesville

52242

University of Iowa Children's Hospital, Iowa City

90038

University of California, Los Angeles Neurology Clinic, Los Angeles

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Friedreich's Ataxia Research Alliance

OTHER

lead

Amgen

INDUSTRY

NCT02593773 - Safety, Tolerability and Efficacy of ACTIMMUNE® Dose Escalation in Friedreich's Ataxia Study | Biotech Hunter | Biotech Hunter