Conservative iron chelation as a disease-modifying strategy in Parkinson*s disease

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 33

Inclusion Criteria

1. Adult Patients
2. Parkinson*s disease diagnosed according The Movement Disorder Society
Clinical Diagnotic Criteria for Parkinson*s Disease (PD).
3. Treatment-naïve, i.e. the best population for assessing a disease-modifying
effect without the interaction of dopaminergic treatment (no dopaminergic
agonists, L-dopa, anticholinergics, monoamine oxidase B inhibitors (e.g.
rasagiline) or deep brain stimulation).
4. Patients covered by a Health Insurance System in countries where required by
law
5. Written informed consent dated and signed prior to the beginning of any
procedures related to the clinical trial

Exclusion Criteria

1. Disease duration greater than 18 months.
2. Patients with high frequency of comorbidity or vital risks that may
reasonably impair life expectancy
3. Subject with handicap required dopaminergic treatment at the inclusion and
therefore likely not to bear 9 months without symptomatic treatment
4. Hoehn and Yahr stage 3 or more.
5. Significant cognitive impairment (a Mini Mental State Examination score
<24 or an equivalent impairment on a similar scale) or dementia diagnosed in
accordance with the Movement Disorders Society criteria (Emre et al., 2007).
6. Atypical or secondary parkinsonism (supranuclear palsy, multisystem atrophy,
etc.)or significant cortical or subcortical atrophy (i.e. atypical for PD).
7. Progressing axis I psychiatric disorders (psychosis, hallucinations,
substance addiction, bipolar disorder, or severe depression), in accordance
with the Diagnostic and Statistical Manual of Mental Disorders.
8. Subjects undergoing brain stimulation.
9.Due to the high risk of agranulocytosis caused by the IMP and the unknown
mechanism by which this agranulocytosis is induced, it is not allowed to
combine Deferiprone with other medicinal products causing agranulocytosis (as
described in the IB). Such medicinal products are the already mentioned
clozapine and also some NSAIDs (e.g. Phenylbutazone or Metamizole), antithyroid
agents, sulfonamide antibiotics or metothrexate.
10. A history of relapsing neutropenia
11. Hypersensitivity to deferiprone.
12. Patients with agranulocytosis or with a history of agranulocytosis.
13. Patients taking a treatment at risk of agranulocytosis (clozapine,
Closaril®/Leponex®).
14. Patients with anaemia (regardless of the latter's aetiology) or a history
of another haematological disease. Haemochromatosis is not an exclusion
criterion.
15. Pregnant or breastfeeding women or women of childbearing potential not
taking highly effective contraception.
16. Kidney or liver failure.
17. Other serious diseases.
18. Inability to provide informed consent.
19. Participation in another clinical trial with investigational medicinal
product within 3 months prior to inclusion in the study
20. Patient who has suffered mild or moderate depressive episode and isn*t in
remission and on a stable medication for at least 8 weeks
21. Patient > 130kg

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method