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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
172
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.
Beijing Anzhen Hospital, Capital Medical University
Beijing, Chaoyang District, China
Peking Union Medical College Hospital
Beijing, Dongcheng District, China
Nanfang Hospital, Nanfang Medical Univeristy
Guangdong, Guangzhou, China
Nanjing First Hospital
Nanjing, Jiangsu, China
The Second Affilicated Hospital of Soochow University
Suzhou, Jiangsu, China
Shanghai General Hospital
Hongkou, Shanghai Municipality, China
Peking University First Hospital
Beijing, China
Beijing Friendship Hospital Afflication to Capital Medical University
Beijing, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Tianjin Medical University General Hospital
Tianjin, China
Sensitivity Analysis of the Blinded Independent Read of DaTSCAN™ SPECT Images
Sensitivity was defined as positive percentage agreement and calculated as the number of true positives (TP) / (number of TP + number of false negatives \[FN\]): TP/(TP + FN), and a 2-sided 95% binomial confidence interval constructed around it. Only the participants with a clinical diagnosis of PS were included in the sensitivity analysis. The sensitivity of the blinded independent read of DaTSCAN™ SPECT images in detecting or excluding striatal dopaminergic deficit (SDD), when the clinical diagnosis as established by the investigator was used as the standard of truth, were summarized with by reader. Each participant's SPECT image was read by 3 blinded readers.
Time frame: At Day 1
Specificity Analysis of the Blinded Independent Read of DaTSCAN™ SPECT Images
Specificity was defined as negative percentage agreement and calculated as the number of true negatives (TN) / (number of TN + number of false positives \[FP\]): TN/(TN + FP), and a 2-sided 95% binomial confidence interval constructed around it. For the specificity analysis, only participants with a clinical diagnosis of ET were included; the HVs were excluded from this analysis. The specificity of the blinded independent read of DaTSCAN™ SPECT images in detecting or excluding striatal dopaminergic deficit (SDD), when the clinical diagnosis as established by the investigator was used as the standard of truth, were summarized with by reader. Each participant's SPECT image was read by 3 blinded readers.
Time frame: At Day 1
Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images
A semi-quantitative analysis of the striatal uptake ratios in specific regions of interest (ROIs, i.e., left and right striatum, caudate, and putamen) of DaTSCAN™ SPECT images was performed with DaTQUANT™.
Time frame: At Day 1
Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Serious TEAEs
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this investigational product (IP) or medicinal product. A Serious Adverse Event(SAE) was any untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. A TEAE was any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the IP or medicinal product. Number of participants with TEAEs and serious TEAEs were reported.
Time frame: From start of study drug administration up to Day 4
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