EUCTR2017-003763-35-FR进行中（未招募）1 期
Conservative Iron Chelation by Deferiprone as a disease-modifying Strategy for Amyotrophic Lateral Sclerosis using a Multicentre Parallel group, placebo controlled, Randomized clinical trial - FAIR ALS II
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
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
- •– Adults patients
- •– Categorized as; possible, laboratory supported probable, probable, or definite ALS (revised El Escorial criteria)
- •– Spinal and bulbar forms of ALS
- •– Duration of the disease since the first symptoms of motor deficit or amyotrophy = 7 months and = 18 months (isolated cramps or fasciculation will not be considered).
- •– A mild functional handicap score for ALSFRS-R =36
- •– An upright slow vital capacity = 75% of the predicted value for age, height, and sex and an inspiratory pressure > 60 cm of H2O at screening (In case of a limit abnormal value, it will be recommended that patient re-assessment occurs three months later).
- •– Able to swallow (required for oral treatment)
- •– Patients covered by a social insurance
- •– 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 240
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 240
排除标准
- •– Patients with high frequency of comorbidity or vital risks that may reasonably impair life expectancy
- •– Progressing axis I psychiatric disorders (psychosis, hallucinations, substance addiction, bipolar disorder, severe depression, suicidal ideation), in accordance with the Diagnostic and Statistical Manual of Mental Disorders. Before entry into the study, exclusion or stabilization of conditions must occur for patients suffering from mild or moderate depressive episodes (not in remission) or severe and uncontrolled anxiety.
- •– Dementia according to the Diagnostic and Statistical Manual of Mental Disorders
- •– If the patient is under riluzole, it has to be for at least 1 month (to rule out the principal risk of hepatitis)
- •– Due to the risk of agranulocytosis (estimated at 2%) caused by the Investigational Medicinal Products (IMPs) and the unknown mechanism by which this agranulocytosis is induced, combining deferiprone with other medicinal products known to cause agranulocytosis (as described in the IB) will not be allowed. Such medicinal products include clozapine as well as some NSAIDs (e.g. Phenylbutazone or Metamizole), antithyroid agents, sulfonamide antibiotics or metothrexate.
- •– Patients with agranulocytosis or with a history of agranulocytosis.
- •– A history of relapsing neutropenia
- •– Hypersensitivity to deferiprone
- •– Patients with anaemia (regardless of latter aetiology) or a history of another haematological disease. Haemochromatosis is not an exclusion criterion if controlled.
- •– Pregnant or breastfeeding women or women of childbearing potential not taking highly effective contraception.
- •– Kidney or liver failure.
- •– Inability to provide informed consent.
- •– Participation in another drug study (Investigational medical product) within 1 month prior to inclusion in the study
- •– Patients under trusteeship
- •Exclusion criteria for the biomarker study and the ancillary study
- •Subjects for whom MRI is contraindicated (e.g. metal objects in the body, severe claustrophobia, pacemaker, incompatible surgical material).
- •(ii) Lumbar puncture:
- •Blood coagulation disorders, antiplatelet drugs or anticoagulants.
- •Intracranial hypertension.
- •(iii) Contraindications to nitrous oxide (for painless lumbar puncture):
- •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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