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Horizon Pharma plc Completes Target Enrollment of 90 Patients for Phase 3 Trial of ACTIMMUNE(R) (interferon gamma-1b) for the Treatment of People With Friedreich's Ataxia

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Additional Information

Additional Relevant Details he Safety, Tolerability and Efficacy of ACTIMMUNE Dose Escalation in Friedreich's Ataxia study ("STEADFAST") is a randomized, multi-center, double-blind, placebo-controlled study with patients randomized 1:1 to receive subcutaneous doses of either ACTIMMUNE or placebo three times a week for a total of 26 weeks. The primary endpoint will evaluate the effect of ACTIMMUNE versus placebo on the change from baseline to Week 26 in neurological outcome as measured by a modified version of the Friedreich's Ataxia Rating Scale (FARS). The FARS is used to measure neurological signs associated with FA, with higher scores reflecting a greater level of disability. In addition to safety and efficacy, the STEADFAST trial will evaluate the pharmacokinetic characteristics of ACTIMMUNE in people with FA. After completion of the study, patients who participated in STEADFAST will have the opportunity to transition to an open-label extension study (NCT02593773).
http://ir.horizon-ph...
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Catalyst Date
Occurred on:
May 05, 2016
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Related Keywords Actimmune, Interferon Gamma-1b, Friedreich's Ataxia