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 - ND
- Conditions
- clinically uncertain parkinsonismMedDRA version: 6.1Level: PTClassification code 10034010
- Registration Number
- EUCTR2005-002216-25-IT
- Lead Sponsor
- GE Healthcare Ltd e le sue filiali
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not 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