Text Size

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

This study has been completed.
Sponsor:
Collaborator:
i3 Statprobe
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00382967
First received: September 29, 2006
Last updated: August 29, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Parkinsonian Syndromes
 Procedure: DaTSCAN SPECT imaging
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product. [ Time Frame: Changes in clinical management made from Visit 1 (baseline) to Visit 3 (a 3 month period) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Changes That the Doctor Made in the Clinical Management of Subjects Based Upon the Impact of the Imaging Product. [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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.


Enrollment: 273
Study Start Date: October 2006
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: I-123 Ioflupane
No Intervention: Control

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00382967

Locations
United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
France
GE Healthcare
Velizy, France, 78457
Sponsors and Collaborators
GE Healthcare
i3 Statprobe
Investigators
Principal Investigator: Prof. Dr. Andreas Kupsch Virchov Klinikum, Berlin, Germany
Study Director: Paul Sherwin, MD GE Healthcare
  More Information

No publications provided by GE Healthcare

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT00382967     History of Changes
Other Study ID Numbers: PDT409
Study First Received: September 29, 2006
Results First Received: May 14, 2012
Last Updated: August 29, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Agency for Health and Food Safety
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: Ministry of Health
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Norway: Norwegian Medicines Agency
Denmark: Danish Medicines Agency
Switzerland: Swissmedic

Keywords provided by GE Healthcare:
Parkinsonian Syndromes, Parkinsonism, DaTSCAN, SPECT, clinical management, quality of life, movement disorder
Clinically uncertain Parkinsonian Syndromes

Additional relevant MeSH terms:
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders

ClinicalTrials.gov processed this record on May 22, 2013