EUCTR2016-002454-20-FR进行中（未招募）1 期
Apomorphine Pump in Early Stage of Parkinson’s Disease - EARLY-PUMP
CHU de Rennes0 个研究点开始时间: 2017年3月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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 aged = 65 years,
- •- Idiopathic PD (According to British Brain Bank Criteria) without any other known or suspected cause of Parkinsonism,
- •- Hoehn and Yahr stage = 2.5 in the best ON,
- •- Disease duration = 4 years,
- •- Presence of fluctuations and/or dyskinesia for no more than 3 years,
- •- One of the two following forms of impairment:
- •* Impairment in activities of daily living (MDS-UPDRS II>6) due to PD-symptoms despite medical treatment in the worst condition or
- •* Impairment of social and occupational functioning (measured with SOFAS) due to PD-symptoms despite medical treatment (51-80%),
- •- PDQ39 completed,
- •- Able to understand and remember the components of the study,
- •- Written informed consent,
- •- Patients covered with social insurance.
- •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 192
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Dementia (MoCA score < 22),
- •- Major uncontrolled depression at the time of assessment (BDI > 25) or Bipolar disease
- •- Active Hallucinations or history of hallucinations in the past year
- •- Need for nursing care,
- •- Previous use of apomorphine pump treatment,
- •- History of respiratory depression
- •- History of deep brain stimulation or lesional surgery for PD or intrajejunal L-Dopa,
- •- Presence of severe freezing or clinically relevant postural instability leading to falls during the ON state,
- •-Symptomatic clinically relevant and medically uncontrolled orthostatic hypotension,
- •- Clinically relevant hepatic dysfunction (total bilirubin >2.0 mg/dL, ALT and AST >2 times the upper limit of normal)
- •- Clinically relevant renal dysfunction (serum creatinine >2.0 mg/dL),
- •- Pregnant and breastfeeding women,
- •- Hypersensitivity to apomorphine or any excipients of the medicinal product,
- •- Concomitant therapy or within 28 days prior to baseline with : alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (except Clozapine) , methylphenidate, or amphetamine, intrajejunal Ldopa
- •- History or current drug or alcohol abuse or dependencies,
- •- Patients with a borderline QT interval corrected for heart rate according to Bazett’s formula (QTc) of >450 ms for male and >470 ms for female at screening or history of long QTsyndrome; or >450 ms absolute duration,
- •- Adults legally protected (under judicial protection, guardianship or supervision), persons deprived of their liberty.
研究者
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