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 Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00382967
• Other study ID #: PDT409
• Status: Completed
• Phase: Phase 4
• First received: September 29, 2006
• Last updated: August 29, 2012
• Start date: October 2006
• Est. completion date: January 2011

Study information

• Verified date: August 2012
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesAustria: Agency for Health and Food SafetyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Italy: Ministry of HealthSpain: Spanish Agency of MedicinesSweden: Medical Products AgencyNorway: Norwegian Medicines AgencyDenmark: Danish Medicines AgencySwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinsonian Disorders
• Parkinsonian Syndromes

Intervention

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.

Locations

Country	Name	City	State
France	GE Healthcare	Velizy
United States	GE Healthcare	Princeton	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
GE Healthcare	i3 Statprobe

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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.	No