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A pilot clinical trial with the iron chelator Deferiprone in Parkinson's disease - Pilot clinical trial iron chelator Deferiprone in Parkinson's Vs1

Phase 1
Conditions
Parkinson's disease
Registration Number
EUCTR2011-001148-31-GB
Lead Sponsor
Imperial College London
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Not specified
Target Recruitment
48
Inclusion Criteria

All patients will have a diagnosis of clinical idiopathic Parkinson’s disease (UK PDS Brain Bank diagnostic criteria) disease duration < 5 yrs with a stable response to standard antiparkinson's drug e.g. L-DOPA or dopamine agonist. Aged 50-75 years.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

Patients with other neurological conditions, psychiatric disorders and history of depression will be excluded as will patients with a history of diabetes, renal or liver disease, blood disorders, immune compromised, history of agranulocytosis, or condition contraindicatory for MRI examination e.g pacemaker. Outside age bracket

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary end point(s): The primary outcome measure is the in vivo assessment of whether Deferiprone can remove excess brain iron in the substantia nigra of Parkinson's disease patients as assessed by MRI imaging without major side effects of drug treatment.;Main Objective: To assess whether 6 month treatment with Deferiprone is well tolerated by PD patients and assess whether such treatment removes excess iron in the brain area affected in PD, the substantia nigra, as assessed by MRI.;Secondary Objective: Assess whether Deferiprone therapy directly affects the symptoms of Parkinson's disease or other brain function e.g. psychological well being, during the course of the 6 months trial period.
Secondary Outcome Measures
NameTimeMethod
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