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

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.

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.

Study Overview

• Status: Completed
• Conditions: Parkinsonian Syndromes
• Intervention / Treatment: Procedure: DaTSCAN SPECT imaging

• Study Type: Interventional
• Enrollment (Actual): 273
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Velizy, France, 78457
    • GE Healthcare
• United States
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • GE Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Datscan Product	Procedure: DaTSCAN SPECT imaging; 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.; Other Names: I-123 Ioflupane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. From the first patient visit (baseline) to the fourth patient visit, which was 12 months. This was a 1 year time period being assessed.It is possible for a subject to have multiple changes in Clinical management and other subjects to have no change in their management.	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.

Collaborators and Investigators

• Sponsor: GE Healthcare
• Collaborators: i3 Statprobe
• Investigators: Principal Investigator: Prof. Dr. Andreas Kupsch, Virchov Klinikum, Berlin, Germany; Study Director: Paul Sherwin, MD, GE Healthcare

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: September 29, 2006
• First Submitted That Met QC Criteria: September 29, 2006
• First Posted (Estimate): October 2, 2006

Study Record Updates

• Last Update Posted (Estimate): September 3, 2012
• Last Update Submitted That Met QC Criteria: August 29, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Parkinsonian Syndromes, Parkinsonism, DaTSCAN, SPECT, clinical management, quality of life, movement disorder; Clinically uncertain Parkinsonian Syndromes
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease; Basal Ganglia Diseases; Movement Disorders; Syndrome; Parkinsonian Disorders
• Other Study ID Numbers: PDT409