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.
Sponsor study identifier
interventional
273
2 countries
2
Study Start
October 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2011
Actual (reported)Study Completion
January 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2011
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 29, 2006
Actual (reported)October 2006
Date type not reportedThis date has not been verified as actual or estimated.
October 2, 2006
Actual (reported)January 2011
Actual (reported)January 2011
Actual (reported)August 29, 2012
Actual (reported)Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.
The impact the Datscan image had on the Doctor's decisions on the clinical management of subjects. A record of the number of changes in the Doctor's clinical management. It is possible for a subject to have multiple changes in Clinical management and other subjects to have no change in their management.
Changes in clinical management made from Visit 1 (baseline) to Visit 3 (a 3 month period)
Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product.
From the first patient Visit 1 (1 month) to Visit 4 (12 months). This goes from the baseline (visit 1) up to 1 year post contrast administration.
A single intravenous injection of DaTSCAN with a total activity of 111-185 MBq (volume of 2.5 or 5.0 mL). SPECT scanning to be performed 3 to 6 hours after DaTSCAN injection.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
GE Healthcare
Princeton, New Jersey, 08540, United States
GE Healthcare
Vélizy-Villacoublay, 78457, France
Kupsch AR, Bajaj N, Weiland F, Tartaglione A, Klutmann S, Buitendyk M, Sherwin P, Tate A, Grachev ID. Impact of DaTscan SPECT imaging on clinical management, diagnosis, confidence of diagnosis, quality of life, health resource use and safety in patients with clinically uncertain parkinsonian syndromes: a prospective 1-year follow-up of an open-label controlled study. J Neurol Neurosurg Psychiatry. 2012 Jun;83(6):620-8. doi: 10.1136/jnnp-2011-301695. Epub 2012 Apr 6.
Prof. Dr. Andreas Kupsch
Virchov Klinikum, Berlin, Germany
Paul Sherwin, MD
GE Healthcare
273 participants (actual enrollment reported by the registry).
First Submitted
September 29, 2006
First Posted
October 2, 2006
Study Start
October 2006
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
January 2011
Actual (reported)Study Completion
January 2011
Actual (reported)Last Updated
September 3, 2012
Results First Posted
August 29, 2012
Record last verified: 2012-08
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Source: ClinicalTrials.gov.
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