EUCTR2019-000247-27-FR进行中（未招募）1 期
on-inferiority study of the molecular imaging of dopamine transporters using [123I]-FP/CIT-SPECT and [18F] LBT-999-PET to distinguish between Parkinson’s Disease and Essential Tremor. - DATTEP
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
- ZIONEXA
- 入组人数
- 112
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
- •Patient aged 35 to 80 (male or female)
- •- suffering from an essential tremor according to the 2000 criteria of Elble (excluding head's tremor)
- •- or with Parkinson's disease according to UKPDSBB criteria
- •Patient whose diagnosis is more than 18 months old
- •Patient affiliated with a health protection system or beneficiary of such a system
- •Patient who has received complete information on the organization of the research and signed his informed consent
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patient with atypical non-idiopathic parkinsonian syndrome (multisystematous atrophy, progressive supranuclear palsy, etc.)
- •Patient treated with deep brain stimulation
- •Patient suffering from abnormal functional psychogenic movements
- •Patient with severe and progressive psychiatric disorders
- •Patient with disabling dyskinesia or essential tremor, incompatible with performing imaging exams
- •Patient who had an ionizing examination at the cerebral level less than 3 months old
- •Person with a contraindication to performing PET or SPECT imaging:
- •o Patient with claustrophobia
- •o Patient refusing to be informed in case of abnormalities detected during imaging examinations
- •o Patients treated with amphetamines, benzatropine, amfebutamone, cocaine, mazindol, methylphenidate, phentermine or sertraline
- •o Person with a known allergy to the active substance or to any of the excipients of the evaluated product or reference product or to potassium iodide
- •A woman of childbearing potential who does not have effective contraception according to investigator judgment
- •Patient unable to sign the informed consent
- •Patient participating to a protocol or period of exclusion from a protocol
- •Patient who received benefits over € 4,500 in the last 12 months prior to inclusion in clinical studies
- •Patient in exclusion period in national volunteer file during which he can not participate in another clinical study
- •Patient not affiliated to a health protection system
- •Patient refusing to participate
- •Persons referred to in Articles L. 1121-5 to L. 1121-8 and L1122-2 of the French Public Health Code:
- •o Pregnant or lactating woman
- •o Person deprived of liberty by a judicial or administrative decision,
- •o Person under psychiatric care
- •o Person admitted to a health or social institution for purposes other than research
- •o Person who is the subject of a legal protection measure (tutelage, guardianship, safeguard of justice)
- •o Major person unable to express consent and who is not subject to a legal protection measure
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