NCT02655315

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
372

participants targeted

Target at P75+ for phase_2 parkinson-disease

Timeline
Completed

Started Feb 2016

Longer than P75 for phase_2 parkinson-disease

Geographic Reach
8 countries

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 14, 2016

Completed
26 days until next milestone

Study Start

First participant enrolled

February 9, 2016

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2020

Completed
Last Updated

February 5, 2026

Status Verified

March 1, 2021

Enrollment Period

4.6 years

First QC Date

January 7, 2016

Last Update Submit

February 2, 2026

Conditions

Parkinson Disease

Keywords

ParkinsonDeferiproneChelation

Outcome Measures

Primary Outcomes (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)

    at 36 weeks

Secondary Outcomes (12)

  • Disease-modifying effect on motor and non motor handicap

    baseline, at 40 weeks

  • Effect of the motor symptoms

    baseline, at 12, 36 and 40 weeks

  • Quality of life and autonomy by PDQ-39 score

    baseline, at 36 and 40 weeks

  • Quality of life and autonomy by Clinical Global Impression score

    baseline, at 36 and 40 weeks

  • Health economics assessment

    baseline, at 36 and 40 weeks

  • +7 more secondary outcomes

Study Arms (2)

DEFERIPRONE

ACTIVE COMPARATOR

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

PLACEBO

PLACEBO COMPARATOR

Half of participants will receive the placebo twice daily morning and evening. The treatment lasts nine months.

Drug: Placebo

Interventions

DeferiproneDRUG

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

Also known as: active drug
DEFERIPRONE
PlaceboDRUG

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

Also known as: harmless pill, inactive drug
PLACEBO

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Disease duration greater than 18 months.
  • Patients with high frequency of comorbidity or vital risks that may reasonably impair life expectancy
  • 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).
  • 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®).
  • 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.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Medizinische Universitat Innsbruck

Innsbruck, Austria

Location

Charles University

Prague, Czechia

Location

Univerzita Karlova V Praze

Prague, Czechia

Location

CHU Pellegrin

Bordeaux, France

Location

Hôpital Wertheimer

Bron, France

Location

Hôpital Montpied

Clermont-Ferrand, France

Location

Hôpital Salengro, CHRU

Lille, France

Location

CHU la TIMONE

Marseille, France

Location

AP-HP, Hôpital Pitié-Salpêtrière

Paris, France

Location

CHU de Strasbourg, Hôpital de Hautepierre

Strasbourg, France

Location

Chu Purpan

Toulouse, France

Location

University Hospital, Saarland University

Homburg, Germany

Location

Christian-albrechts universität zu kiel

Kiel, Germany

Location

Klinik und Poliklinik für Neurologie der Universitätsmedizin Rostock

Rostock, Germany

Location

Acadamic central center, Amsterdam

Amsterdam, Netherlands

Location

Radboud university medical center

Nijmegen, Netherlands

Location

Centro Hospitalar e universitario de Coimbra

Coimbra, Portugal

Location

Centro Hospitalar do Alto Ave

Guimarães, Portugal

Location

Centro Hospitalar Lisboa Norte

Lisbon, Portugal

Location

Hospital Clinic Universitari de Barcelona

Barcelona, Spain

Location

Hospital de Bellvitge

Barcelona, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Cambridge University Hospital

Cambridge, United Kingdom

Location

University of Glasgow

Glasgow, United Kingdom

Location

Newcastle University

Newcastle, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 36449420RESULT

  • 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.

    PMID: 32726602DERIVED

  • 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.

    PMID: 29380903DERIVED

Related Links

MeSH Terms

Conditions

Parkinson Disease

Interventions

DeferiproneBulk Drugs

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

PyridonesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPharmaceutical Preparations

Study Officials

  • David Devos, MD, PhD

    University Hospital, Lille

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2016

First Posted

January 14, 2016

Study Start

February 9, 2016

Primary Completion

September 22, 2020

Study Completion

September 22, 2020

Last Updated

February 5, 2026

Record last verified: 2021-03

Locations

FR(8)DE(3)NL(2)ES(3)GB(3)CZ(2)AU(1)PT(3)