Conservative Iron Chelation as a Disease-modifying Strategy in Parkinson's Disease (FAIRPARKII)

February 2, 2026 updated by: University Hospital, Lille

Conservative Iron Chelation as a Disease-modifying Strategy in Parkinson's Disease. European Multicentre, Parallel-group, Placebo-controlled, Randomized Clinical Trial of Deferiprone"

This study evaluates the effect of iron chelation as a therapeutic strategy to slow the progression of Parkinson's disease. Half of participants will receive the deferiprone to 15 mg / kg twice daily morning and evening (30mg / kg per day), while the other half will receive a placebo. The treatment lasts nine months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is the new concept of "conservative iron chelation". We recently demonstrated (for the first time) the feasibility, efficacy and acceptability of the conservative iron chelation approach in pilot translational studies in Parkinson's disease with a prototype drug: deferiprone (1,2-dimethyl-3-hydroxypyridin-4-one) (in the FAIR-PARK-I project led by the applicant and funded by French Ministry of Health). The only available blood-brain-barrier-permeable iron chelator deferiprone is approved for treating systemic iron overload in transfused patients with thalassemia. Deferiprone has been on the European Union market since 1999, with a favourable risk/benefit balance at dose of 75 to 100 mg/kg/day. The investigators shall adopt a repositioning strategy by using deferiprone at a lower dose of 30 mg/kg/day in this new indication for local iron overload in Parkinson's disease. Deferiprone will be the first-in-class drug for this novel therapeutic strategy. On the basis of the preclinical and clinical data from (FAIR-PARK-I), the present (FAIR-PARK-II) project should constitute a model for future cytoprotection strategies in neurodegenerative diseases; if deferiprone treatment is associated with significant slower disease progression, it would be the first non-dopaminergic drug to have a proven disease-modifying effect in Parkinson's disease.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
372

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria
        • Medizinische Universität Innsbruck
  • Czechia
      • Prague, Czechia
        • Charles University
      • Prague, Czechia
        • Univerzita Karlova V Praze
  • France
      • Bordeaux, France
        • CHU Pellegrin
      • Bron, France
        • Hôpital Wertheimer
      • Clermont-Ferrand, France
        • Hôpital Montpied
      • Lille, France
        • Hôpital Salengro, CHRU
      • Marseille, France
        • CHU La Timone
      • Paris, France
        • AP-HP, Hôpital Pitié-Salpêtrière
      • Strasbourg, France
        • CHU de Strasbourg, Hôpital de Hautepierre
      • Toulouse, France
        • CHU Purpan
  • Germany
      • Homburg, Germany
        • University Hospital, Saarland University
      • Kiel, Germany
        • Christian-albrechts universität zu kiel
      • Rostock, Germany
        • Klinik und Poliklinik für Neurologie der Universitätsmedizin Rostock
  • Netherlands
      • Amsterdam, Netherlands
        • Acadamic central center, Amsterdam
      • Nijmegen, Netherlands
        • Radboud University Medical Center
  • Portugal
      • Coimbra, Portugal
        • Centro Hospitalar E Universitário De Coimbra
      • Guimarães, Portugal
        • Centro Hospitalar do Alto Ave
      • Lisbon, Portugal
        • Centro Hospitalar Lisboa Norte
  • Spain
      • Barcelona, Spain
        • Hospital de La Santa Creu i Sant Pau
      • Barcelona, Spain
        • Hospital de Bellvitge
      • Barcelona, Spain
        • Hospital Clinic Universitari de Barcelona
  • United Kingdom
      • Cambridge, United Kingdom
        • Cambridge University Hospital
      • Glasgow, United Kingdom
        • University of Glasgow
      • Newcastle, United Kingdom
        • Newcastle University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 76 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adult patients
  2. Parkinson's disease diagnosed according United Kingdom Parkinson's disease Society Brain Bank Clinical Diagnostic Criteria and based on the presence of at least two of the three cardinal features of the disease (rest tremor, bradykinesia and rigidity). If rest tremor is not present, subjects must have unilateral onset of symptoms.
  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 Parkinson's Disease).
  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. Positive Human Immunodepression Virus serology.
  10. Hypersensitivity to deferiprone.
  11. Patients with agranulocytosis or with a history of agranulocytosis.
  12. Patients taking a treatment at risk of agranulocytosis (clozapine, Closaril®/Leponex®).
  13. Patients with anaemia (regardless of the latter's aetiology) or a history of another haematological disease. Haemochromatosis is not an exclusion criterion.
  14. Pregnant or breastfeeding women or women of childbearing potential not taking highly effective contraception.
  15. Kidney or liver failure.
  16. Other serious diseases.
  17. Inability to provide informed consent.
  18. Participation in another clinical trial with investigational medicinal product within 3 months prior to inclusion in the study
  19. Patient who has suffered mild or moderate depressive episode and isn't in remission and on a stable medication for at least 8 weeks
  20. Patient > 130k

Exclusion criteria for the biomarker study and the ancillary study (i) Magnetic Resonance Imaging:

  • Subjects for whom Magnetic Resonance Imaging is contraindicated (metal objects in the body, severe claustrophobia, pacemaker, incompatible surgical material).
  • Very severe rest tremor, which could induce Magnetic Resonance Imaging artefacts.

(ii) Lumbar puncture:

  • Blood coagulation disorders, antiplatelet drugs or anticoagulants.
  • Intracranial hypertension. (iii) Contraindications to nitrous oxide:
  • Ventilation with Fraction of inspired Oxygen >50%, emphysema or pneumothorax
  • Altered states of consciousness, non-cooperative patient (need to stop the nitrous oxide)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: DEFERIPRONE
Half of participants will receive the deferiprone (DFP) to 15 mg / kg twice daily morning and evening (30mg / kg per day).The treatment lasts nine months.
Drug: Deferiprone
15 mg / kg twice daily morning and evening (30mg / kg per day).The treatment lasts nine months.
Other Names:
  • active drug
Placebo Comparator: PLACEBO
Half of participants will receive the placebo twice daily morning and evening. The treatment lasts nine months.
Drug: Placebo
the placebo twice daily morning and evening. The treatment lasts nine months
Other Names:
  • inactive drug
  • harmless pill

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Global effect (symptomatic and disease modifying effects) on motor and non motor handicap
Time Frame: at 36 weeks
the change in the total Movement Disorders Society-Unified Parkinson Disease Rating Scale score between baseline and 36 weeks (i.e. the end of the placebo-controlled phase for analysis of both disease-modifying and symptomatic effects)
at 36 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease-modifying effect on motor and non motor handicap
Time Frame: baseline, at 40 weeks
It will be measured as the changes in the overall Movement Disorders Society-Unified Parkinson Disease Rating Scale score between baseline and week 40 (i.e. the end of the one-month post-treatment monitoring period), to analyse the disease-modifying effect without bias from the symptomatic effect of ongoing deferiprone treatment) on the study population
baseline, at 40 weeks
Effect of the motor symptoms
Time Frame: baseline, at 12, 36 and 40 weeks
The effect of the motor symptoms will be analysed as the change in the subscale part III of the Movement Disorders Society-Unified Parkinson Disease Rating Scale score
baseline, at 12, 36 and 40 weeks
Quality of life and autonomy by PDQ-39 score
Time Frame: baseline, at 36 and 40 weeks
It will be analyzed as the change in the Parkinson's Disease Quality of Life (PDQ-39, via a 39-item self-questionnaire)
baseline, at 36 and 40 weeks
Quality of life and autonomy by Clinical Global Impression score
Time Frame: baseline, at 36 and 40 weeks
the Clinical Global Impression scored by the examiner and the patient
baseline, at 36 and 40 weeks
Health economics assessment
Time Frame: baseline, at 36 and 40 weeks
will be performed via a specific questionnaire provides a simple descriptive profile and a single index value for health status
baseline, at 36 and 40 weeks
EQ-5D questionnaire
Time Frame: baseline, at 36 and 40 weeks
the questionnaire provides a simple descriptive profile and a single index value for health status.
baseline, at 36 and 40 weeks
Safety criteria
Time Frame: 40 weeks

All the safety concerns will be listed in a table with the number of patients, the type the severity and the time of occurrence for

  • adverse events
  • neutropenia (weekly complete blood count)
  • agranulocytosis (weekly complete blood count)
  • anemia (weekly complete blood count)
  • iron metabolism abnormalities (haemoglobin, serum iron, ferritinemia, transferrin, total binding capacity, transferrin saturation coefficient, 24-hour urine iron).
  • Standard biological abnormalities (fasting glucose, urea, creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and (for all sexually active, fertile females) urine pregnancy tests.
  • Abnormal physical examination (including vital signs, bodyweight, electrocardiogram and blood pressure)
40 weeks
Effect on overall cognitive status
Time Frame: baseline, at 12, 36 and 40 weeks
Measured by the score in the Montreal Cognitive Assessment
baseline, at 12, 36 and 40 weeks
Effect on gait disorders
Time Frame: baseline, at 12, 36 and 40 weeks
Measured by the Stand Walk Sit test
baseline, at 12, 36 and 40 weeks
Effect on daily living
Time Frame: baseline, at 12, 36 and 40 weeks
The effect on daily living will be analysed as the change in the subscale part II (activities of daily living) of the Movement Disorders Society-Unified Parkinson Disease Rating Scale score
baseline, at 12, 36 and 40 weeks
Effect on non-motor symptoms
Time Frame: baseline, at 12, 36 and 40 weeks
The effect on non motor symptoms will be analysed as the change in the subscale part I (cognition and behavior) of the Movement Disorders Society-Unified Parkinson Disease Rating Scale score
baseline, at 12, 36 and 40 weeks
Lack of occurrence of motor fluctuations
Time Frame: baseline, at 12, 36 and 40 weeks
The lack of occurrence of motor fluctuations will be analysed on the subscale part IV of the Movement Disorders Society-Unified Parkinson Disease Rating Scale score
baseline, at 12, 36 and 40 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Lille

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
European Commission
ApoPharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: David DEVOS, MD, PhD, University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 9, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 22, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 22, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015_22
  • 2015-003679-31 (EudraCT Number)
  • Grant agreement No 633190 (Other Grant/Funding Number: European Union's Horizon 2020)
  • HP751 (Other Identifier: CTFG VHP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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