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A Study to Assess Changes in Clinical Management After DaTSCAN Imaging of Subjects With Clinically Uncertain Parkinsonism or an Illness With Similar Symptoms

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General Electric (GE)

Status and phase

Completed
Phase 4

Conditions

Parkinsonian Syndromes

Treatments

Procedure: DaTSCAN SPECT imaging

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

273 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

273 participants in 2 patient groups

Datscan Product
Experimental group
Treatment:
Procedure: DaTSCAN SPECT imaging
Control
No Intervention group

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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