NL-OMON47754已完成2 期
Conservative iron chelation as a disease-modifying strategy in Parkinson*s disease - FAIRPARK II
Centre Hospitalier Régional Universitaire (CHRU) de Lille0 个研究点目标入组 33 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
- •5. Written informed consent dated and signed prior to the beginning of any
- •procedures related to the clinical trial
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 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
- •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
研究者
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