CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 172 enrolled
Drug / intervention
DaTSCAN™ Ioflupane (123I) Injectiondrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04193527
NCT04193527Phase 3Completed
CompareCT.gov

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

GE Healthcare·interventional·Posted Dec 10, 2019·Updated Oct 16, 2023

In Brief

A Phase 3 clinical trial evaluating DaTSCAN™ Ioflupane (123I) Injection for Parkinsonian Syndrome and 4 related conditions. Completed, enrolled 172 participants across 10 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinsonian Syndrome, Parkinson Disease(PD), Multiple System Atrophy (MSA), Progressive Supranuclear Palsy (PSP), Essential Tremor
CountriesChina
CollaboratorsPPD Development, LP

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedDec 10, 2019
Enrollment StartJun 28, 2020
Primary CompletionDec 20, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 6.6 years ago

Interventions

DaTSCAN™ Ioflupane (123I) Injectiondrug

All 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.