Clinical Trials Directory

Trials / Completed

CompletedNCT04193527

A Study to Evaluate the Diagnostic Efficacy of DaTSCAN™ Ioflupane (123I) Injection in Single Photon Emission Computed Tomography (SPECT) for the Diagnosis of Parkinsonian Syndrome (PS) in Chinese Patients

A Multicentre, Phase 3, Clinical Study to Compare the Striatal Uptake of a Dopamine Transporter Radioligand, DaTSCAN™ Ioflupane (123I) Injection, After Intravenous Administration to Chinese Patients With a Diagnosis of Parkinson's Disease, Multiple System Atrophy, Progressive Supranuclear Palsy, or Essential Tremor and to Healthy Controls

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
172 (actual)
Sponsor
GE Healthcare · Industry
Sex
All
Age
40 Years – 80 Years
Healthy volunteers
Accepted

Summary

This is a multicenter, open-label, non-controlled, non-randomized, phase 3 clinical study to compare the SPECT findings after a single IV administration of DaTSCAN™ ioflupane (123I) injection for patients with a clinical diagnosis of Parkinsonian syndrome (PS) involving striatal dopaminergic deficit (SDD; specifically, Parkinson's disease \[PD\] \[SDD\], multiple system atrophy \[MSA\] \[SDD\] or or progressive supranuclear palsy \[PSP\] \[SDD\]) as compared with patients with a clinical diagnosis of essential tremor (ET) (no SDD) and age-matched healthy controls.

Conditions

Interventions

TypeNameDescription
DRUGDaTSCAN™ Ioflupane (123I) InjectionAll participants (Participants with PS, ET, and HV) received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 megabecquerel (MBq) (3 to 5 millicurie \[mCi\]) per participant at a maximum volume of 5 milliliter \[mL\]) intravenously on Day 1.

Timeline

Start date
2020-06-28
Primary completion
2021-12-20
Completion
2021-12-20
First posted
2019-12-10
Last updated
2023-10-16
Results posted
2023-10-16

Locations

10 sites across 1 country: China

Source: ClinicalTrials.gov record NCT04193527. Inclusion in this directory is not an endorsement.