Status:
COMPLETED
Efficacy and Safety of the Iron Chelator Deferiprone in Parkinson's Disease
Lead Sponsor:
University Hospital, Lille
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30-80 years
Phase:
PHASE2
PHASE3
Brief Summary
Few available drugs can slow the progression of neurodegenerative pathologies such as Parkinson's disease (PD). One of the recent hypotheses concerning the reduction of oxidative stress and neuron dea...
Detailed Description
Primary objective: decrease the iron overload (as measured by the T2\* MRI sequence) in the substantia nigra in patients with Parkinson's disease (PD) after 6 months of deferiprone treatment, relative...
Eligibility Criteria
Inclusion
- Patients with typical Parkinson's disease according to the Gibb criteria and the Parkinson's Disease Society criteria (Daniel and Lees, 1993).
- Ideally less than 2 to 3 years since disease onset and never more than 4 years.
- Patients on dopaminergic drugs and/or L-Dopa.
- Non-fluctuating disease because otherwise the degenerative process would be well advanced, the clinical score would vary from one day to another and the imaging evaluation would be complicated by dyskinesia.
Exclusion
- Subjects over the age of 80
- Demented subjects: MMSE score ≤ 24, Mattis score of \< 130 and DSM IV criteria
- Subjects with radiological anomalies on MRI, whether incidental or suggestive of vascular involvement or significant cortical or subcortical atrophy
- Subjects for whom MRI is contra-indicated (metal objects in the body, severe claustrophobia, pacemaker, etc.)
- Subjects undergoing brain stimulation
- Very severe rest tremor, which could induce MRI artifacts
- Subjects that have not stabilized in terms of the therapeutic regimen and who are likely to require changes in their dopamine therapy in the coming 6 months
- Hoehn and Yahr stage ≥ 3 in the "Off" state, indicating the need for walking assistance in the absence of treatment.
- Hypersensitivity to iron chelator drugs
- Patients at risk of or having experienced agranulocytosis
- Patients on a drug that can potentially induce agranulocytosis (clozapine, Closaril®/Leponex®)
- Patients with anemia (regardless of the latter's etiology) or a history of other hematological diseases - even an iron deficiency
- Ferritin blood level \< 100 ng/ml (100 µg/l)
- A history of hemochromatosis or known iron metabolism disorders.
- Pregnant or breastfeeding women or women not taking effective contraception
- Kidney or liver failure
- Blood coagulation disorders, antiplatelet drugs or anticoagulants
- Concomitant treatment with aluminum-based antacids (interaction)
- Concomitant treatment with vitamin C (interaction)
- Presence of other serious diseases
- Inability to provide informed consent
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00943748
Start Date
October 1 2009
End Date
October 1 2011
Last Update
September 3 2012
Active Locations (1)
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1
Service de Neurologie, Clinique Neurologique, EA 2683, IFR 114
Lille, France, 59037