Ensayo en fase 4 multicéntrico, aleatorizado, abierto y comparativo para evaluar las modificaciones en el manejo clínico después de una tomografía con DaTSCAN en sujetos con parkinsonismo clínicamente incierto en una consulta de neurología general.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
- Conditions
- The subjects included in this trial will have clinically uncertain parkinsonism in a general neurologist setting.
- Registration Number
- EUCTR2005-002216-25-ES
- Lead Sponsor
- Amersham Health, S.A. (filial de GE Healthcare Ltd)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
•Subjects with clinically uncertain Parkinsonian Syndromes (PS) or monosymptomatic, atypical or incomplete presentation of tremor, rigidity, bradykinesia or postural instability.
•Onset of clinical manifestations within the last 5 years.
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
•Differential diagnosis between Parkinson’s Disease (PD) and Progressive Supranuclear Palsy (PSP) or between PD and Multiple System Atrophy (MSA).
•Subjects with an established/certain movement disorder clinical diagnosis.
•Presence of known causes of tremor (eg, hyperthyroidism).
•Subjects with a significant cognitive impairment as confirmed by a Mini-Mental State Examination score <24.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method