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NCT01284127 · ClinicalTrials.gov registry record
Observational Study of Deferiprone (Ferriprox®) in the Treatment of Superficial Siderosis
A clinical trial, sponsored by Johns Hopkins University.
- Completed
- Registry status
- 38
- Enrollment target
NCT01284127: Completed study, sponsored by Johns Hopkins University.
NCT01284127 is a clinical trial that has completed, run by Johns Hopkins University. The registered enrollment target is 38 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01284127 has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- 38 participants
- Enrollment target
Study Summary
Superficial siderosis is a progressive neurological disease caused by iron deposition in the central nervous system (CNS) from chronic subarachnoid bleeding. Until 2011, there has been no effective treatment for this progressive condition that leads to hearing loss, spasticity, weakness, loss of bowel/bladder function, incoordination, dementia and ultimately death. Last year, the investigators demonstrated that a lipid soluble iron chelator, deferiprone, can reduce hemosiderin deposition in patients with superficial siderosis by MRI in as little as 3 months. As the only therapy that can improve this condition, chelation with deferiprone is the standard of care for treatment of superficial siderosis. Now that the FDA has approved deferiprone in the United States for thalassemia, the investigators propose documenting the clinical effect of deferiprone over 2 years in superficial siderosis patients. The investigators' goal is to understand how the clinical course of this disease is altered using standard of care chelation therapy with deferiprone. Patients with superficial siderosis who are taking deferiprone for chelation therapy at doses consistent with the standard of care will be offered enrollment into this observational study. Patients will be treated and monitored locally by participating neurologists who have agreed to help the investigators collect information for this study. The investigators are interested in documenting the clinical effect of deferiprone on hearing, ataxia and myelopathy using standardized scales performed and documenting the effect of deferiprone on hemosiderin deposition in the CNS by MRI, all performed according to standard of care.
Primary Outcome
Number of participants who show stability, improvement or decline in self reported hearing.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2012-03 |
| Est. Completion | 2018-10-04 |
What the finished NCT01284127 record still lists
NCT01284127 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 38 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01284127 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01284127 about?
NCT01284127 is a clinical study titled "Observational Study of Deferiprone (Ferriprox®) in the Treatment of Superficial Siderosis". Superficial siderosis is a progressive neurological disease caused by iron deposition in the central nervous system (CNS) from chronic subarachnoid bleeding. Until 2011, there has been no effective treatment for this progressive condition that leads to hearing loss, spasticity, weakness, loss of bow...
What is the current status of trial NCT01284127?
This trial is currently completed. The enrollment target is 38 participants. The study started on 2012-03. Estimated completion is 2018-10-04.
Who is sponsoring clinical trial NCT01284127?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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