EUCTR2015-003679-31-PTActive, not recruitingPhase 1
Conservative iron chelation as a disease-modifying strategy in Parkinson’s disease - FAIRPARK II
Centre Hospitalier Régional et Universitaire de Lille0 sites338 target enrollmentStarted: January 28, 2016Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 338
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1.Adult Patients
- •2.Parkinson's disease diagnosed according The Movement Disorder Society Clinical Diagnotic 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 169
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 169
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 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, sulfonamide antibiotics or
- •metothrexate.
- •10. A history of relapsing neurotropenia
- •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 with investigational
- •medicinal product within 3 months prior to inclusion in the
- •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
- •21. Patient > 130 kg
- •Exclusion criteria for the biomarker study and the ancillary study
- •Subjects for whom MRI is contraindicated (metal objects in the
- •body, severe claustrophobia, pacemaker, incompatible surgical
- +9 more not shown
Investigators
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