MedTrace Logo

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

NCT00897221 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2011-06-27

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Deferiprone oral solution 100mg/mL

Deferiprone oral solution (20 mg/kg/day)

DRUG

Deferiprone oral solution 100 mg/mL

Deferiprone oral solution(40mg/kg/day)

Sponsors & Collaborators

  • ApoPharma

    lead INDUSTRY

Principal Investigators

  • Massimo Pandolfo, M.D. · Hospital Erasme, Brussels, Belgium

  • Arnold Munnich, M.D. · Hospital Necker-Enfants Malades, Paris, France

  • Franco Taroni, M.D. · Fondazione IRCCS Istituto Neurologico "C. Besta", Milan, Italy

  • Javier Arpa, M.D. · La Fundaction Para la Investigacion Biomedica, Madrid, Spain

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • Belgium
  • France
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00897221 on ClinicalTrials.gov