A single-center, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and tolerability of deferiprone (iron chelating agent) on cerebral iron overload related to motor and cognitive-behavioral disorders in Parkinson's disease.

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Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2009
INTERVENTION: Trade Name: Iron Chelating Agent Product Name: Deferiprone Pharmaceutical Form: Oral solution Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use CONDITION: Parkinson's disease PRIMARY OUTCOME: Main Objective: to show a decrease in excess iron in the substantia nigra of patients with Parkinson's disease treated with deferiprone compared to patients receiving a placebo Primary end point(s): The mean relaxation time on the T2* MRI sequence (R2*) over the entire main ROI the substantia nigra determined at baseline, at 3 months, then at 6 months. Secondary Objective: To determine if other structures also exhibit iron excess that may decrease under treatment, to analyze the therapeutic response clinically (motor and cognitive) and biologically on markers of oxidative stress and apoptosis in plasma and also in cerebrospinal fluid for patients who agree to participate in the ancillary study. INCLUSION CRITERIA: - Less than 3 years of disease progression - Patients undergoing treatment with a dopamine agonist (and/or) L-Dopa - Not exhibiting motor fluctuations. Are the trial subjects under 18? No. Number of subjects for this age range: F.1.2 Adults (18-64 years) Yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) Yes F.1.3.1 Number of subjects for this age range
Epistemonikos ID: 55cc8bfa406b9608af7b5fce8a4632497407d7a3
First added on: Aug 22, 2024
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