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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002216-25-ES

Enrollment

250

Registered

2006-05-11

Start date

2006-06-26

Completion date

Unknown

Last updated

2012-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The subjects included in this trial will have clinically uncertain parkinsonism in a general neurologist setting.

Interventions

Trade Name: DaTSCAN™ Product Name: DaTSCAN™ Pharmaceutical Form: Solution for injection Current Sponsor code: Ioflupane (123I) Concentration unit: MBq megabecquerel(s) Concentration type: range Concen

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

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

Measure

Time frame

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

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Countries

Denmark, Italy, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026