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.; MedDRA version: 8.0Level: LLTClassification code 10037142

• Registration Number: EUCTR2005-002216-25-DK
• Lead Sponsor: GE Healthcare Ltd and its affliates

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-04
• Last Update Posted: 28 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

•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

Exclusion Criteria

•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
Main Objective: •To assess the influence of DaTSCAN™ imaging on the clinical management of subjects with clinically uncertain parkinsonism.<br><br><br>;Secondary Objective: •To assess the influence of DaTSCAN™ imaging on the diagnosis of subjects with clinically uncertain parkinsonism.<br>•To assess changes in diagnostic confidence after DaTSCAN™ imaging.<br>•To describe healthcare resource use (HRU) from baseline to follow up.<br>•To explore the influence of DaTSCAN™ imaging on the Quality of Life (QoL) from baseline to follow up.<br>;Primary end point(s): •Proportion of subjects with one or more changes in clinical management from V1 to V3.