Conservative iron chelation as a disease-modifying strategy in Parkinson’s disease (FAIR-PARK II)

Not Applicable

Completed

• Conditions: Parkinson's Disease; Parkinson's disease; Nervous System Diseases

• Registration Number: ISRCTN84188565
• Lead Sponsor: Centre Hospitalier Regional Universitaire de Lille

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36449420/ (added 03/10/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-03
• Study Completion: 2020-09-20
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 372

Inclusion Criteria

1. Adult patients aged 18 and older
2. Parkinson’s disease diagnosed according The Movement Disorder Society Clinical Diagnostic 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 anomalies on MRI suggestive of vascular involvement 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, sulphonamide antibiotics or methotrexate
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 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

Exclusion criteria for the biomarker study and the ancillary study:
1. Subjects for whom MRI is contraindicated (metal objects in the body, severe claustrophobia, pacemaker, incompatible surgical material)
2. Very severe rest tremor, which could induce MRI artefacts
3. Lumbar puncture
4. Blood coagulation disorders, antiplatelet drugs or anticoagulants
5. Intracranial hypertension
6. Contraindications to nitrous oxide
7. Ventilation with FiO2 >50%, emphysema or pneumothorax
8. Altered states of consciousness, non-cooperative patient (need to stop the nitrous oxide)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Motor symptoms, non-motor symptoms and daily life activities are assessed using the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), the change in the total score is measured between baseline and 36 weeks (i.e. the end of the placebo-controlled phase for analysis of both disease-modifying and symptomatic effects).