ew therapeutic strategy in Parkinson’s disease

Phase 1

• Conditions: De Novo Parkinson’s disease; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-003679-31-AT
• Lead Sponsor: Centre Hospitalier Régional et Universitaire de Lille

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-11
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 372

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 neutropenia
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 study
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 >130kg

oExclusion criteria for the biomarker study and the ancillary study
(i) MRI:
• Subjects for whom MRI is contraindicated (metal objects in the body, severe claustrophobia, pacemaker, incompatible surgical material).
• Very severe rest tremor, which could induce MRI artefacts.
(ii) Lumbar puncture:
• Blood coagulation disorders, antiplatelet drugs or anticoagulants.
• Intracranial hypertension.
(iii) Contraindications to nitrous oxide:
• Ventilation with FiO2 >50%, emphysema or pneumothorax
• Altered states of consciousness, non-cooperative patient (need to stop the nitrous oxide)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified