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Parkinson DiseasePhase 2FAIRPARKIINCT02655315

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

A Phase 2 study testing Deferiprone in people with Parkinson Disease, run by University Hospital, Lille at 25 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages Up to 80 years
Conditions the study is for
Parkinson Disease
What is being tested?
Deferiprone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
372 participants
Where
25 sitesin 8 countries
Study dates
9 Feb 2016to 22 Sep 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Adult patients
  • 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.
  • 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).
  • Patients covered by a Health Insurance System in countries where required by law
  • Written informed consent dated and signed prior to the beginning of any procedures related to the clinical trial

Who cannot join

  • Disease duration greater than 18 months.
  • Patients with high frequency of comorbidity or vital risks that may reasonably impair life expectancy
  • Subject with handicap required dopaminergic treatment at the inclusion and therefore likely not to bear 9 months without symptomatic treatment
  • Hoehn and Yahr stage 3 or more.
  • 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).
  • 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).
Show all 28Show fewer
  • 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.
  • Subjects undergoing brain stimulation.
  • Positive Human Immunodepression Virus serology.
  • Hypersensitivity to deferiprone.
  • Patients with agranulocytosis or with a history of agranulocytosis.
  • Patients taking a treatment at risk of agranulocytosis (clozapine, Closaril®/Leponex®).
  • Patients with anaemia (regardless of the latter's aetiology) or a history of another haematological disease. Haemochromatosis is not an exclusion criterion.
  • Pregnant or breastfeeding women or women of childbearing potential not taking highly effective contraception.
  • Kidney or liver failure.
  • Other serious diseases.
  • Inability to provide informed consent.
  • Participation in another clinical trial with investigational medicinal product within 3 months prior to inclusion in the study
  • Patient who has suffered mild or moderate depressive episode and isn't in remission and on a stable medication for at least 8 weeks
  • 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.
  • 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)

Trial locations and contacts

25 sites in 8 countries.

25 sites in 8 countries

France8 sites
  • CHU Pellegrin

    Bordeaux

  • Hôpital Wertheimer

    Bron

  • Hôpital Montpied

    Clermont-Ferrand

  • Hôpital Salengro, CHRU

    Lille

  • CHU la TIMONE

    Marseille

  • AP-HP, Hôpital Pitié-Salpêtrière

    Paris

  • CHU de Strasbourg, Hôpital de Hautepierre

    Strasbourg

  • Chu Purpan

    Toulouse

Other trials in France

Germany3 sites
  • University Hospital, Saarland University

    Homburg

  • Christian-albrechts universität zu kiel

    Kiel

  • Klinik und Poliklinik für Neurologie der Universitätsmedizin Rostock

    Rostock

Other trials in Germany

Portugal3 sites
  • Centro Hospitalar e universitario de Coimbra

    Coimbra

  • Centro Hospitalar do Alto Ave

    Guimarães

  • Centro Hospitalar Lisboa Norte

    Lisbon

Other trials in Portugal

Spain3 sites
  • Hospital Clinic Universitari de Barcelona

    Barcelona

  • Hospital de Bellvitge

    Barcelona

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

Other trials in Spain

United Kingdom3 sites
  • Cambridge University Hospital

    Cambridge

  • University of Glasgow

    Glasgow

  • Newcastle University

    Newcastle

Other trials in United Kingdom

Czechia2 sites
  • Charles University

    Prague

  • Univerzita Karlova V Praze

    Prague

Other trials in Czechia

Netherlands2 sites
  • Acadamic central center, Amsterdam

    Amsterdam

  • Radboud university medical center

    Nijmegen

Other trials in Netherlands

Austria1 site
  • Medizinische Universitat Innsbruck

    Innsbruck

Other trials in Austria

About this study

Official title: 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.

Read the 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.

Being tested
Deferiprone, Placebo
Keywords
Parkinson, Deferiprone, Chelation
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DeferiproneDrug

    Also called active drug

    15 mg / kg twice daily morning and evening (30mg / kg per day).The treatment lasts nine months.

  • PlaceboDrug

    Also called harmless pill, inactive drug

    the placebo twice daily morning and evening. The treatment lasts nine months

Study groups in NCT02655315
Study groupRoleWhat they receive
DEFERIPRONEActive comparatorHalf 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.
Receives: Drug: Deferiprone
PLACEBOPlacebo comparatorHalf of participants will receive the placebo twice daily morning and evening. The treatment lasts nine months.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Global effect (symptomatic and disease modifying effects) on motor and non motor handicap

    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)

    Measured: at 36 weeks

Secondary outcomes (12)
  1. Disease-modifying effect on motor and non motor handicap

    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

    Measured: baseline, at 40 weeks

  2. Effect of the motor symptoms

    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

    Measured: baseline, at 12, 36 and 40 weeks

  3. Quality of life and autonomy by PDQ-39 score

    It will be analyzed as the change in the Parkinson's Disease Quality of Life (PDQ-39, via a 39-item self-questionnaire)

    Measured: baseline, at 36 and 40 weeks

  4. Quality of life and autonomy by Clinical Global Impression score

    the Clinical Global Impression scored by the examiner and the patient

    Measured: baseline, at 36 and 40 weeks

  5. Health economics assessment

    will be performed via a specific questionnaire provides a simple descriptive profile and a single index value for health status

    Measured: baseline, at 36 and 40 weeks

  6. EQ-5D questionnaire

    the questionnaire provides a simple descriptive profile and a single index value for health status.

    Measured: baseline, at 36 and 40 weeks

  7. Safety criteria

    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)

    Measured: 40 weeks

  8. Effect on overall cognitive status

    Measured by the score in the Montreal Cognitive Assessment

    Measured: baseline, at 12, 36 and 40 weeks

  9. Effect on gait disorders

    Measured by the Stand Walk Sit test

    Measured: baseline, at 12, 36 and 40 weeks

  10. Effect on daily living

    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

    Measured: baseline, at 12, 36 and 40 weeks

  11. Effect on non-motor symptoms

    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

    Measured: baseline, at 12, 36 and 40 weeks

  12. Lack of occurrence of motor fluctuations

    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

    Measured: baseline, at 12, 36 and 40 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2016 (estimated)
  2. Study start9 Feb 2016
  3. Primary completion22 Sep 2020
  4. Study completion22 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
372 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02655315
Sponsor's protocol ID
2015_22
Other IDs
2015-003679-31, Grant agreement No 633190, HP751, 2015
Acronym
FAIRPARKII
Status last verified
Mar 2021
First submitted
7 Jan 2016
Last updated
5 Feb 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Devos D, Labreuche J, Rascol O, Corvol JC, Duhamel A, Guyon Delannoy P, Poewe W, Compta Y, Pavese N, Ruzicka E, Dusek P, Post B, Bloem BR, Berg D, Maetzler W, Otto M, Habert MO, Lehericy S, Ferreira J, Dodel R, Tranchant C, Eusebio A, Thobois S, Marques AR, Meissner WG, Ory-Magne F, Walter U, de Bie RMA, Gago M, Vilas D, Kulisevsky J, Januario C, Coelho MVS, Behnke S, Worth P, Seppi K, Ouk T, Potey C, Leclercq C, Viard R, Kuchcinski G, Lopes R, Pruvo JP, Pigny P, Garcon G, Simonin O, Carpentier J, Rolland AS, Nyholm D, Scherfler C, Mangin JF, Chupin M, Bordet R, Dexter DT, Fradette C, Spino M, Tricta F, Ayton S, Bush AI, Devedjian JC, Duce JA, Cabantchik I, Defebvre L, Deplanque D, Moreau C; FAIRPARK-II Study Group. Trial of Deferiprone in Parkinson's Disease. N Engl J Med. 2022 Dec 1;387(22):2045-2055. doi: 10.1056/NEJMoa2209254.

    PubMed 36449420
  • Streit WJ, Phan L, Bechmann I. Ferroptosis and pathogenesis of neuritic plaques in Alzheimer disease. Pharmacol Rev. 2025 Jan;77(1):100005. doi: 10.1124/pharmrev.123.000823. Epub 2024 Nov 22.

    PubMed 39952690
  • Mahoney-Sanchez L, Bouchaoui H, Ayton S, Devos D, Duce JA, Devedjian JC. Ferroptosis and its potential role in the physiopathology of Parkinson's Disease. Prog Neurobiol. 2021 Jan;196:101890. doi: 10.1016/j.pneurobio.2020.101890. Epub 2020 Jul 26.

    PubMed 32726602
  • Moreau C, Duce JA, Rascol O, Devedjian JC, Berg D, Dexter D, Cabantchik ZI, Bush AI, Devos D; FAIRPARK-II study group. Iron as a therapeutic target for Parkinson's disease. Mov Disord. 2018 Apr;33(4):568-574. doi: 10.1002/mds.27275. Epub 2018 Jan 30. No abstract available.

    PubMed 29380903

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Deferiprone in people with Parkinson Disease, run by University Hospital, Lille at 25 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in France, Germany, Portugal, Spain, United Kingdom and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global effect (symptomatic and disease modifying effects) on motor and non motor handicap (time frame: at 36 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02655315, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.

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