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A Phase IIa Trial to Test Safety and Efficacy Interferon Gamma Treatment in Elevating Frataxin Levels in FRDA Patients

Friedreich Ataxia Clinical Trial

Official title:
A Phase IIa Clinical Trial to Test the Safety and Efficacy of Interferon Gamma Treatment in Elevating Frataxin Levels in Friedreich's Ataxia (FRDA) Patients

Clinical Trial Summary

The primary objective of this study is to investigate whether the treatment with IFN gamma can induce significant accumulation of frataxin in FRDA patients, a possibility suggested by pre-clinical evidence in an animal model of the disease.

Clinical Trial Description

This is a Phase 2 clinical trial. A total of 10 FRDA patients will be recruited All subjects will be treated with a dose of 100-150-200-micrograms of IFN gamma 1b (Imukin®) subcutaneously, with an interval of 14 days, for a total of 3 injections. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02035020
Study type Interventional
Source Azienda Policlinico Umberto I
Contact
Status Completed
Phase Phase 2
Start date May 2013
Completion date July 30, 2014
View Details
See also
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