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

Who is this study for? Patients with Parkinson's disease
What treatments are being studied? Deferiprone
Status: Completed
Location: See all (23) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 80
Healthy Volunteers: No
View:

• 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

Locations
Other Locations
Austria
Medizinische Universitat Innsbruck
Innsbruck
France
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
Germany
University Hospital, Saarland University
Homburg
Christian-albrechts universität zu kiel
Kiel
Klinik und Poliklinik für Neurologie der Universitätsmedizin Rostock
Rostock
Netherlands
Acadamic central center, Amsterdam
Amsterdam
Radboud university medical center
Nijmegen
Portugal
Centro Hospitalar e universitario de Coimbra
Coimbra
Centro Hospitalar do Alto Ave
Guimarães
Centro Hospitalar Lisboa Norte
Lisbon
Spain
Hospital Clinic Universitari de Barcelona
Barcelona
Hospital de Bellvitge
Barcelona
Hospital de la Santa Creu i Sant Pau
Barcelona
United Kingdom
Cambridge University Hospital
Cambridge
University of Glasgow
Glasgow
Newcastle University
Newcastle
Time Frame
Start Date: February 9, 2016
Completion Date: September 22, 2020
Participants
Target number of participants: 372
Treatments
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.
Placebo Comparator: PLACEBO
Half of participants will receive the placebo twice daily morning and evening. The treatment lasts nine months.
Sponsors
Collaborators: ApoPharma, European Commission
Leads: University Hospital, Lille

This content was sourced from clinicaltrials.gov

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