drugset / Trial / NCT00897221

A Study Investigating the Long-term Safety and Efficacy of Deferiprone in Patients With Friedreich's Ataxia

NCT00897221

Phase 2 Completed 36 enrolled ApoPharma
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study is to evaluate the long-term safety and tolerability of deferiprone in subjects with Friedreich's ataxia (FRDA). The secondary objective is to evaluate the long-term efficacy of deferiprone for the treatment of FRDA. The tertiary objectives are to evaluate the effect of deferiprone on: 1. cardiac function, 2. quality of life, and 3. functional status.

Timeline

Start
2009-06
Primary completion
2011-03
Completion
2011-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Deferiprone Small molecule 20 mg/kg Oral
Subject Deferiprone Small molecule 40 mg/kg Oral

Indications