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

NCT ID: NCT00382967

Last Updated: 2012-09-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

273 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinsonian Syndromes

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Datscan Product

Group Type EXPERIMENTAL

DaTSCAN SPECT imaging

Intervention Type PROCEDURE

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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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I-123 Ioflupane

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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i3 Statprobe

INDUSTRY

Sponsor Role collaborator

GE Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prof. Dr. Andreas Kupsch

Role: PRINCIPAL_INVESTIGATOR

Virchov Klinikum, Berlin, Germany

Paul Sherwin, MD

Role: STUDY_DIRECTOR

GE Healthcare

Locations

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GE Healthcare

Princeton, New Jersey, United States

Site Status

GE Healthcare

Vélizy-Villacoublay, , France

Site Status

Countries

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Germany United States France

References

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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.

Reference Type DERIVED
PMID: 22492213 (View on PubMed)

Other Identifiers

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PDT409

Identifier Type: -

Identifier Source: org_study_id