Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00224640
Status:
COMPLETED
Last Update Posted:
2009-03-04
First Post:
2005-09-16
Brief Title:
Iron-Chelating Therapy and Friedreich Ataxia
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Effect of Iron-Chelating Therapy in Friedreich Ataxia Study Phase III
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 toleranceefficacy of the treatment
Inclusion criteria minimum age 13 years Follow up in the Dept of Genetics Hospital Necker-Enfants Malades Paris France
Inclusion criteria minimum age 13 years Follow up in the Dept of Genetics Hospital Necker-Enfants Malades Paris France
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PCR 05001 | None | None | None |