Essential Tremor, Multiple System Atrophy (MSA), Parkinson Disease(PD), Parkinsonian Syndrome, Progressive Supranuclear Palsy (PSP)
Conditions
Brief 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.
Interventions
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.
Sponsors
PPD Development, LP
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
For all participants: 1. Chinese male or female, aged 40 to 80 years, has agreed to sign and date the written informed consent form. For Healthy Volunteers: 2. Non-patient volunteers with good age-appropriate health as established by clinical examination during screening and no evidence of movement disorder by complete neurological evaluation. For participants with Parkinson's disease: 3. A diagnosis of clinically established or clinically probable PD in accordance with the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease. For participants with MSA (SDD): 4. A diagnosis of probable or possible MSA in accordance with the Second Consensus Statement on the Diagnosis of MSA. For participants with PSP (SDD): 5. A diagnosis of probable or possible PSP in accordance with the Clinical Criteria for the Diagnosis of Progressive Supranuclear Palsy National Institute for Neurological Disorders and Society for PSP (NINDS-SPSP) For participants with ET (no SDD): 6. A diagnosis of definite or probable ET in accordance with the Washington Heights-Inwood Genetic Study of Essential Tremor (WHIGET) diagnostic criteria for ET (no SDD) .
Exclusion criteria
1. The participant is lactating. 2. The participant is pregnant as detected by a β-human chorionic gonadotropin (β-hCG) pregnancy test. 3. A cerebral structural vascular abnormality indicative of at least 1 infarction in the region of the basal ganglia (including the internal capsule) ≥5 mm has been confirmed, preferably by magnetic resonance imaging (MRI) performed within 6 months of screening. If an MRI is not clinically feasible, cerebral CT imaging within 6 months is also acceptable. 4. The participant is diagnosed with major neurocognitive disorder by the Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria, or Mini-Mental State Examination total score is \<24. 5. Participant is being investigated for or has been diagnosed and/or is being treated for repeated stroke with stepwise progression of Parkinson features. 6. History of repeated head injury (≥3 concussions, or history of professional sports with repeated head trauma \[e.g., boxing\]). 7. History of definite encephalitis (≥1 episode of confirmed encephalitis with objective residual neurologic deficit). 8. The participant is using or has insufficient washout from medication known or suspected to interact with striatal uptake through direct competition with binding of DaTSCAN™ to the dopamine transporters (i.e., amphetamine, benztropine, bupropion, cocaine, mazindol, methylphenidate, phentermine, sertraline, selective serotonin reuptake inhibitors) before the imaging visit. 9. The participant is using Chinese traditional medicine for PD treatment, which cannot be safely withdrawn for at least 1 week (7 days) before the imaging visit. 10. The participant has a moderate to severe renal impairment (e.g., serum creatinine \>1.5x upper limit of normal \[ULN\], blood urea nitrogen \[BUN\] \>30 mg/dL). 11. The participant has a moderate to severe hepatic impairment (bilirubin \>2x ULN and alanine aminotransferase (ALT) or aspartate aminotransferase (AST)\>3x ULN). 12. The participant has a history of current abuse of drugs and/or alcohol (for the previous 12 months before trial enrolment). 13. The participant has a history of occupational exposure to any radiation \>50 millisievert/year (mSv/year). 14. The participant has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening and/or any radiopharmaceutical within a minimum of 5 radioactive half-lives prior to screening. 15. The participant presents with symptoms suggestive of corticobasal degeneration or Huntington's disease. 16. The participant has known allergies to the investigational medicinal product (IMP). 17. The participant presents with any clinically active, serious, life-threatening disease with a life expectancy of less than 12 months. 18. Any laboratory value(s) exceeding the limits of normality if deemed to be clinically relevant by the investigator. 19. The participant complains of claustrophobia. 20. The participant has a moderate to severe thyroid disease (thyroid stimulating hormone \[TSH\] exceeding the limits of normality by more than 10%), if deemed to be clinically relevant by the investigator. For participants with ET: 21. The participant has at least 1 first-degree relative diagnosed with PD. For Healthy Volunteers: 22. History of psychiatric illness. For all participants: 23. It is the physician's best judgment not to include the participant in the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity Analysis of the Blinded Independent Read of DaTSCAN™ SPECT Images | At Day 1 | 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. |
| Specificity Analysis of the Blinded Independent Read of DaTSCAN™ SPECT Images | At Day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | At Day 1 | 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™. |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Serious TEAEs | From start of study drug administration up to Day 4 | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS) Participants with PS received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 mL intravenously on Day 1. | 75 |
| DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET) Participants with ET received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 mL intravenously on Day 1. | 75 |
| DaTSCAN™ Ioflupane: Healthy Volunteer (HV) Healthy Volunteers received a single dose of DaTSCAN™ ioflupane (123I) injection within the range of 111 to 185 MBq (3 to 5 mCi) per participant at a maximum volume of 5 mL intravenously on Day 1. | 22 |
| Total | 172 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Other | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS) | DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET) | DaTSCAN™ Ioflupane: Healthy Volunteer (HV) | Total |
|---|---|---|---|---|
| Age, Continuous | 63.0 years STANDARD_DEVIATION 8.07 | 65.8 years STANDARD_DEVIATION 7.24 | 61.3 years STANDARD_DEVIATION 5.38 | 64.0 years STANDARD_DEVIATION 7.57 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 75 Participants | 75 Participants | 22 Participants | 172 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 75 Participants | 75 Participants | 22 Participants | 172 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 34 Participants | 38 Participants | 14 Participants | 86 Participants |
| Sex: Female, Male Male | 41 Participants | 37 Participants | 8 Participants | 86 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 0 / 75 | 0 / 22 |
| other Total, other adverse events | 12 / 75 | 13 / 75 | 8 / 22 |
| serious Total, serious adverse events | 0 / 75 | 0 / 75 | 0 / 22 |
Outcome results
Primary
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
Population: Full-analysis set (FAS) consisted of all participants who had both a DaTSCAN™ image set and a clinical diagnosis made by the Investigator. Only the participants with a clinical diagnosis of PS were included in the sensitivity analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS) | Sensitivity Analysis of the Blinded Independent Read of DaTSCAN™ SPECT Images | Reader 1-Sensitivity | 0.851 ratio |
| DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS) | Sensitivity Analysis of the Blinded Independent Read of DaTSCAN™ SPECT Images | Reader 2-Sensitivity | 0.865 ratio |
| DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS) | Sensitivity Analysis of the Blinded Independent Read of DaTSCAN™ SPECT Images | Reader 3-Sensitivity | 0.919 ratio |
Primary
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
Population: Full-analysis set (FAS) consisted of all participants who had both a DaTSCAN™ image set and a clinical diagnosis made by the Investigator. Only participants with a clinical diagnosis of ET were included and the HVs were excluded from the specificity analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS) | Specificity Analysis of the Blinded Independent Read of DaTSCAN™ SPECT Images | Reader 1-Specificity | 0.933 ratio |
| DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS) | Specificity Analysis of the Blinded Independent Read of DaTSCAN™ SPECT Images | Reader 2-Specificity | 0.960 ratio |
| DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS) | Specificity Analysis of the Blinded Independent Read of DaTSCAN™ SPECT Images | Reader 3-Specificity | 0.813 ratio |
Secondary
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
Population: Full-analysis set (FAS) consisted of all participants who had both a DaTSCAN™ image set and a clinical diagnosis made by the Investigator.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Caudatus asymmetry ratio | 0.10454 ratio | Standard Deviation 0.083195 |
| DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Posterior putamen right ratio | 0.86673 ratio | Standard Deviation 0.51491 |
| DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Putamen asymmetry ratio | 0.08884 ratio | Standard Deviation 0.070714 |
| DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Caudatus left ratio | 1.70232 ratio | Standard Deviation 0.758242 |
| DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Striatum right ratio | 1.32485 ratio | Standard Deviation 0.560168 |
| DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Putamen to caudatus right ratio | 0.80208 ratio | Standard Deviation 0.094132 |
| DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Caudatus right ratio | 1.71398 ratio | Standard Deviation 0.660892 |
| DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Posterior putamen left ratio | 0.89624 ratio | Standard Deviation 0.506444 |
| DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Putamen to caudatus left ratio | 0.81527 ratio | Standard Deviation 0.11379 |
| DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Anterior putamen right ratio | 1.29315 ratio | Standard Deviation 0.577528 |
| DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Striatum left ratio | 1.34682 ratio | Standard Deviation 0.614929 |
| DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Striatum asymmetry ratio | 0.09290 ratio | Standard Deviation 0.069194 |
| DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Anterior putamen left ratio | 1.30474 ratio | Standard Deviation 0.635803 |
| DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Putamen right ratio | 1.15783 ratio | Standard Deviation 0.542656 |
| DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Putamen left ratio | 1.16697 ratio | Standard Deviation 0.578536 |
| DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Putamen left ratio | 2.53527 ratio | Standard Deviation 0.57706 |
| DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Striatum asymmetry ratio | 0.02879 ratio | Standard Deviation 0.02342 |
| DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Striatum right ratio | 2.65936 ratio | Standard Deviation 0.566834 |
| DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Striatum left ratio | 2.64850 ratio | Standard Deviation 0.584689 |
| DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Anterior putamen right ratio | 2.70530 ratio | Standard Deviation 0.577359 |
| DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Anterior putamen left ratio | 2.67536 ratio | Standard Deviation 0.585852 |
| DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Caudatus asymmetry ratio | 0.03906 ratio | Standard Deviation 0.029737 |
| DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Caudatus left ratio | 2.87229 ratio | Standard Deviation 0.648102 |
| DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Caudatus right ratio | 2.86571 ratio | Standard Deviation 0.616034 |
| DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Putamen to caudatus left ratio | 0.91598 ratio | Standard Deviation 0.071819 |
| DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Putamen to caudatus right ratio | 0.92631 ratio | Standard Deviation 0.076093 |
| DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Putamen asymmetry ratio | 0.03472 ratio | Standard Deviation 0.026388 |
| DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Posterior putamen left ratio | 2.26000 ratio | Standard Deviation 0.592376 |
| DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Posterior putamen right ratio | 2.28143 ratio | Standard Deviation 0.58323 |
| DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Putamen right ratio | 2.57079 ratio | Standard Deviation 0.567985 |
| DaTSCAN™ Ioflupane: Healthy Volunteers (HV) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Caudatus asymmetry ratio | 0.04212 ratio | Standard Deviation 0.023939 |
| DaTSCAN™ Ioflupane: Healthy Volunteers (HV) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Posterior putamen right ratio | 2.53907 ratio | Standard Deviation 0.861909 |
| DaTSCAN™ Ioflupane: Healthy Volunteers (HV) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Putamen asymmetry ratio | 0.03066 ratio | Standard Deviation 0.022587 |
| DaTSCAN™ Ioflupane: Healthy Volunteers (HV) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Anterior putamen left ratio | 2.92746 ratio | Standard Deviation 0.784174 |
| DaTSCAN™ Ioflupane: Healthy Volunteers (HV) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Anterior putamen right ratio | 2.94013 ratio | Standard Deviation 0.835608 |
| DaTSCAN™ Ioflupane: Healthy Volunteers (HV) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Putamen left ratio | 2.80555 ratio | Standard Deviation 0.78814 |
| DaTSCAN™ Ioflupane: Healthy Volunteers (HV) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Striatum right ratio | 2.86683 ratio | Standard Deviation 0.843327 |
| DaTSCAN™ Ioflupane: Healthy Volunteers (HV) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Striatum asymmetry ratio | 0.02774 ratio | Standard Deviation 0.019084 |
| DaTSCAN™ Ioflupane: Healthy Volunteers (HV) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Posterior putamen left ratio | 2.56593 ratio | Standard Deviation 0.817882 |
| DaTSCAN™ Ioflupane: Healthy Volunteers (HV) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Caudatus right ratio | 2.99258 ratio | Standard Deviation 0.885231 |
| DaTSCAN™ Ioflupane: Healthy Volunteers (HV) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Striatum left ratio | 2.89059 ratio | Standard Deviation 0.801328 |
| DaTSCAN™ Ioflupane: Healthy Volunteers (HV) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Putamen to caudatus left ratio | 0.94217 ratio | Standard Deviation 0.075958 |
| DaTSCAN™ Ioflupane: Healthy Volunteers (HV) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Caudatus left ratio | 3.05874 ratio | Standard Deviation 0.866446 |
| DaTSCAN™ Ioflupane: Healthy Volunteers (HV) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Putamen right ratio | 2.81286 ratio | Standard Deviation 0.834213 |
| DaTSCAN™ Ioflupane: Healthy Volunteers (HV) | Normalized DaTSCAN™ Uptake Based on Region Of Interest (ROI) With Central Read (by Semi-quantitative Assessment by Use of DaTQUANT™) of DaTSCAN™ SPECT Images | Putamen to caudatus right ratio | 0.95685 ratio | Standard Deviation 0.060599 |
Secondary
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
Population: Safety population included all participants who received an injection of Investigational Medicinal Product (IMP).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Serious TEAEs | Participants with TEAEs | 12 Participants |
| DaTSCAN™ Ioflupane: Participants With Parkinsonian Syndrome (PS) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Serious TEAEs | Participants with Serious TEAEs | 0 Participants |
| DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Serious TEAEs | Participants with TEAEs | 13 Participants |
| DaTSCAN™ Ioflupane: Participants With Essential Tremor (ET) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Serious TEAEs | Participants with Serious TEAEs | 0 Participants |
| DaTSCAN™ Ioflupane: Healthy Volunteers (HV) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Serious TEAEs | Participants with TEAEs | 8 Participants |
| DaTSCAN™ Ioflupane: Healthy Volunteers (HV) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), and Serious TEAEs | Participants with Serious TEAEs | 0 Participants |