ew therapeutic strategy in Parkinson?s disease

Phase 1

• Conditions: MedDRA version: 18.1Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disorders; De Novo Parkinson?s disease; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-13
• Last Update Posted: 17 May 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 338

Inclusion Criteria

1.Adult patients
1.2.Parkinson?s disease diagnosed according UK 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.
2.Aged under 80.
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 countires 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

1.1.Disease duration greater than 18 months.
2.Patients with high frequency of comorbidity or vital risks that may reasonably impair life expectancy
3.Subjects with a handicap likely to require symptomatic dopaminergic treatment in the coming nine months 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 anomalies on MRI suggestive of vascular involvement 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.Positive HIV serology.
10.Hypersensitivity to deferiprone.
11.Patients with agranulocytosis or with a history of agranulocytosis.
12.Patients taking a treatment at risk of agranulocytosis (clozapine, Closaril®/Leponex®).
13.Patients with anaemia (regardless of the latter's aetiology) or a history of another haematological disease. Haemochromatosis is not an exclusion criterion.
14.Pregnant or breastfeeding women or menopausal women of childbearing potential not taking highly effective contraception.
15.Kidney or liver failure.
16.Other serious diseases.
17.Inability to provide informed consent.
18.Participation in another clinical trial within 3 months prior to inclusion in the study
19.Patient who has suffered mild or moderate depressive episode and isn?t in remission and on a stable medication for at least 8 weeks.
Exclusion 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:
?Bloodcoagulationdisorders,antiplateletdrugsor 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

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the FAIR-PARK II trial is to demonstrate an effect of DFP on the course of PD (including both disease-modifying and symptomatic effects).;Secondary Objective: 1-The disease-modifying effect<br>2- The global effect on motor and non-motor symptoms<br>3-Effects on quality of life and autonomy <br>4-A health economics assessment will be performed via a specific questionnaire and EQ-5D questionnaire <br>5- biomarker analysis to assess the biomarkers' potential surrogate<br>value;Primary end point(s): the change in the total MDS-UPDRS;Timepoint(s) of evaluation of this end point: week 0, week12; week24; week36; week40