Phase 4 N=260 Randomized Treatment

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

Parkinsonian Syndromes

Bottom Line

View on ClinicalTrials.gov: NCT00382967 ↗

Enrolled (actual)

260

Serious AEs

0.0%

Results posted

Aug 2012

Primary outcome: Primary: Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product. — 33; 28; 19; 11 Number of changes in clinical management

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: DaTSCAN SPECT imaging (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: GE Healthcare
Primary completion: Jan 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.	35; 22; 16; 6; 7; 5	—
SECONDARY Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.	35; 22; 16; 6; 7; 5	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00382967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.