Phase 4
Completed N=260
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
Source: ClinicalTrials.gov NCT00382967 ↗
Enrolled (actual)
260
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcomePrimary: 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
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.
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 | — |
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
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. Informational only — not medical advice.