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Iron-Chelating Therapy and Friedreich Ataxia

Friedreich Ataxia Clinical Trial

Official title:
Effect of Iron-Chelating Therapy in Friedreich Ataxia. Study Phase I/II

Clinical Trial Summary

Friedreich ataxia, an autosomal recessive condition, ascribed to frataxin gene expansion, has been shown to result from an iron- induced injury to the mitochondrial respiratory chain. Buffering free radicals with short-chain quinones (Idebenone) protects the patients against cardiomyopathy but not CNS involvement. Removing CNS iron should limit the impact of the neurological symptoms of the disease.

Clinical Trial Description

The current clinical trial is a monocentric open phase1-2 trial in the context of rare diseases framework, aimed to the goal of defining the tolerance/efficacy of the treatment.

Inclusion criteria: minimum age: 13 years Follow up in the Dept of Genetics, Hospital Necker-Enfants Malades, Paris, France ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00224640
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact
Status Completed
Phase Phase 1/Phase 2
Start date March 2005
Completion date March 2008
View Details
See also
  Status Clinical Trial Phase
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Completed NCT00229632 - Idebenone to Treat Friedreich's Ataxia Phase 2
Completed NCT05579691 - A Double-Blind, Placebo-Controlled, Dose Exploration Study of CTI-1601 in Adult Subjects With Friedreich's Ataxia Phase 2
Completed NCT04273165 - Safety and Efficacy of Etravirine in Friedreich Ataxia Patients Phase 2
Not yet recruiting NCT05874388 - Characterisation of the Cognitive Profile of Patients Suffering From Friedreich's Ataxia N/A
Completed NCT02594917 - Genetic and Environmental Determinants That Control Metabolism in Pulmonary Hypertension
Completed NCT01716221 - An Objective Double-blind Evaluation of Bupropion and Citalopram in an Individual With Friedreich Ataxia Phase 4
Active, not recruiting NCT05485987 - A Study of Vatiquinone for the Treatment of Participants With Friedreich Ataxia Phase 2
Completed NCT03214588 - Efficacy, Tolerability, and Pharmacokinetics of Multiple Doses of Oral TAK-831 in Adults With Friedreich Ataxia Phase 2
Completed NCT03418740 - Neurology Measures in FA Children
Not yet recruiting NCT06054893 - A Study of Omaveloxolone in Children With Friedreich's Ataxia Phase 1
Recruiting NCT04921930 - Evaluation of the Effect of Artesunate in Friedreich Ataxia (FA) Phase 1/Phase 2
Completed NCT03933163 - Micronised Resveratrol as a Treatment for Friedreich Ataxia Phase 2
Completed NCT02705547 - Rosuvastatin (Crestor) in Friedreich Ataxia Early Phase 1
Completed NCT02035020 - A Phase IIa Trial to Test Safety and Efficacy Interferon Gamma Treatment in Elevating Frataxin Levels in FRDA Patients Phase 2
Completed NCT00015808 - Safety Study of Idebenone to Treat Friedreich's Ataxia Phase 1
Completed NCT04817111 - NAD+ Precursor Supplementation in Friedreich's Ataxia Phase 2
Active, not recruiting NCT05168774 - FRDA Investigator Initiated Study (IIS) With Elamipretide Phase 1/Phase 2
Completed NCT03917225 - A Clinical Study to Evaluate the Effect of MIN-102 on the Progression of Friedreich's Ataxia in Male and Female Patients Phase 2
Completed NCT00056186 - Transitional Life Events in Patients With Friedreich's Ataxia: Implications for Genetic Counseling N/A