EUCTR2015-003679-31-FR进行中（未招募）1 期
Conservative iron chelation as a disease-modifying strategy in Parkinson’s disease - FAIRPARK II
Centre Hospitalier Régional et Universitaire de Lille0 个研究点目标入组 338 人开始时间: 2016年2月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 338
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Adult Patients
- •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.
- •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
排除标准
- •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 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 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
- •oExclusion 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 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)
研究者
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