A Multicentre, Randomised, Open Label, Comparative Phase 4 Trial to Assess Changes in Clinical Management After DaTSCAN Imaging of Subjects With Clinically Uncertain Parkinsonism in a General Neurologist Setting.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 273
- 试验地点
- 3
- 主要终点
- Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.
研究概览
简要总结
Patients come to their doctor showing possible symptoms of a movement disorder. It is possible that these symptoms may get worse over time. There is more than one disease that can cause such symptoms. The most common movement disorder illnesses are Parkinson´s Disease and Essential Tremor. Sometimes it is difficult for doctors to make the right diagnosis because the symptoms caused by these illnesses are almost the same. On the other hand the correct treatment for Parkinson´s Disease is different from the correct treatment for Essential Tremor. This study aims to see whether having pictures of the brain taken with DaTSCAN can affect the way the doctor treats these patients and whether it can affect their quality of life directly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with clinically uncertain Parkinsonian Syndromes or monosymptomatic, atypical or incomplete presentation of tremor, rigidity, bradykinesia or postural instability.
- •Onset of clinical manifestations within the last 5 years
排除标准
- •Differential diagnosis between Parkinsons´s Disease and Progressive Supranuclear Palsy or between Parkinson´s Disease and Multiple System Atrophy
- •Subjects with an established/certain movement disorder clinical diagnosis
- •Presence of known causes of tremor
结局指标
主要结局
Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.
时间窗: Changes in clinical management made from Visit 1 (baseline) to Visit 3 (a 3 month period)
The impact the Datscan image had on the Doctor's decisions on the clinical management of subjects. A record of the number of changes in the Doctor's clinical management. It is possible for a subject to have multiple changes in Clinical management and other subjects to have no change in their management.
次要结局
- Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.(From the first patient Visit 1 (1 month) to Visit 4 (12 months). This goes from the baseline (visit 1) up to 1 year post contrast administration.)