NCT00382967

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
273

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2006

Longer than P75 for phase_4

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2006

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2006

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

August 29, 2012

Completed
Last Updated

September 3, 2012

Status Verified

August 1, 2012

Enrollment Period

4.3 years

First QC Date

September 29, 2006

Results QC Date

May 14, 2012

Last Update Submit

August 29, 2012

Conditions

Parkinsonian Syndromes

Keywords

Parkinsonian Syndromes, Parkinsonism, DaTSCAN, SPECT, clinical management, quality of life, movement disorderClinically uncertain Parkinsonian Syndromes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Study Arms (2)

Datscan Product

EXPERIMENTAL
Procedure: DaTSCAN SPECT imaging

Control

NO INTERVENTION

Interventions

DaTSCAN SPECT imagingPROCEDURE

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.

Also known as: I-123 Ioflupane
Datscan Product

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

GE Healthcare

Princeton, New Jersey, 08540, United States

Location

GE Healthcare

Vélizy-Villacoublay, 78457, France

Location

Related Publications (1)

  • 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.

    PMID: 22492213DERIVED

MeSH Terms

Conditions

Parkinsonian DisordersMovement Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

Title
Igor Grachev, MD
Organization
GE Healthcare
igor.grachev@ge.com
1-609-514-6857

Study Officials

  • Prof. Dr. Andreas Kupsch

    Virchov Klinikum, Berlin, Germany

    PRINCIPAL INVESTIGATOR

  • Paul Sherwin, MD

    GE Healthcare

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2006

First Posted

October 2, 2006

Study Start

October 1, 2006

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

September 3, 2012

Results First Posted

August 29, 2012

Record last verified: 2012-08

Locations

FR(1)US(1)