Status:
UNKNOWN
Ferrochelating Treatment in Patients Affected by Neurodegeneration With Brain Iron Accumulation (NBIA)
Lead Sponsor:
Ente Ospedaliero Ospedali Galliera
Conditions:
Neurodegenerative Disease
Iron Overload
Eligibility:
All Genders
1-80 years
Phase:
PHASE2
Brief Summary
This trial is a multicenter, unblinded, single-arm pilot study, lasting one year (plus one year extension Amendment n.3 25 August 2009, plus two years follow-up Amendment n.7) , to evaluate the effica...
Detailed Description
The time interval between Study Start Date and Study First Received was related to bureaucratic problems. The treatment of systemic iron overload has in recent years improved notably since new drugs ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients over \> 1 years of age who have neurological symptoms that can be correlated with cerebral-level iron overload as documented with MRI.This inclusion criteria has been amended by Amendment 6, 24 march 2011)
- Patients who have given informed consent.
- Exclusion criteria:
- Inability to be subjected to MRI exam.
- Renal insufficiency (creatinine \> 1.5 mg/dl).
- Neoplasias.
- Patients with average levels of ALT \> 300 and patients with variations of ALT or AST of 300% during the year prior to enrolling. (At least 4 measurements in 12 months).
- Systemic cardiovascular, renal, hepatic etc., diseases that could counter-indicate the therapeutic options specified.
- Known hypersensitivity to deferiprone.
- Patient judged potentially unreliable and/or uncooperative with regard to study procedures.
- Pregnancy and breastfeeding.
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00907283
Start Date
November 1 2008
End Date
December 1 2024
Last Update
February 9 2023
Active Locations (3)
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1
Neurological Pathology Department, Brotzu Hospital
Cagliari, Italy, 09134
2
Centre of Microcitemia and Congenital Anemias, Galliera Hospital
Genoa, Italy, 16128
3
Clinic of Neurology, University of Genoa
Genoa, Italy, 16132