Parkinson's Disease
Conditions
Keywords
Parkinson's Disease, motor complications, dyskinesia, Motor complications associated with Parkinson's
Brief summary
The purpose of this study is to obtain preliminary information on the effect of piclozotan on motor complications associated with Parkinson's Disease.
Interventions
DRUGpiclozotan
piclozotan, intravenous (IV) infusion
0.9% sodium chloride (normal saline) intravenous (IV) infusion
Sponsors
Daiichi Sankyo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Idiopathic Parkinson's disease for at least 5 years * Presence of motor fluctuations and dyskinesia * Stable regimen of levodopa/carbidopa for 30 days * At least 25% response/improvement in Unified Parkinson's Disease Rating Scale (UPDRS) part III scores after dosing with regular Parkinson's disease (PD) medications * Mini-Mental State Examination (MMSE) score of 25 or higher Main
Exclusion criteria
* Atypical or secondary parkinsonism. * Prior use of neuroleptic agents. * History of intracranial procedures for PD. * Active psychosis. * History of drug or alcohol abuse in past 12 months. * Cardiac conduction system abnormality. * Predisposing medical condition that causes nausea or vomiting or routine use of an anti-emetic.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Percentage of On Time Without Dyskinesia Averaged Over Days 1 and 2 in Participants Treated With SUN N4057 and Those Treated With a Placebo | Baseline (Day-7) up to 2 days post-dose. | Improvement in motor complications associated with Parkinson's disease are measured as on (good medication response); OR on with dyskinesia (good medication response, but with superimposed involuntary movements that interfere with activities), OR off (poor medication response). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of on Time With Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Baseline (Day -7), Day 1, and Day 2 post-dose. | Improvement in motor complications associated with Parkinson's disease are measured as on (good medication response); OR on with dyskinesia (good medication response, but with superimposed involuntary movements that interfere with activities), OR off (poor medication response). Negative values indicate a decrease in on time from baseline to measured time point. |
| Percentage of on Time With Dyskinesia for the Average of Days 1 and 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Baseline (Day -7), Day 1, and Day 2 post-dose. | Improvement in motor complications associated with Parkinson's disease are measured as on (good medication response); OR on with dyskinesia (good medication response, but with superimposed involuntary movements that interfere with activities), OR off (poor medication response). Negative values indicate a decrease in on time from baseline to measured time point. |
| Percentage of on Time With or Without Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Baseline (Day -7), Day 1 and Day 2 post-dose. | Improvement in motor complications associated with Parkinson's disease are measured as on (good medication response); OR on with dyskinesia (good medication response, but with superimposed involuntary movements that interfere with activities), OR off (poor medication response). Negative values indicate a decrease in on time from baseline to measured time point. |
| Percentage of on Time With or Without Dyskinesia for the Average of Days 1 and 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Baseline (Day -7), Day 1 and Day 2 post-dose. | Improvement in motor complications associated with Parkinson's disease are measured as on (good medication response); OR on with dyskinesia (good medication response, but with superimposed involuntary movements that interfere with activities), OR off (poor medication response). Negative values indicate a decrease in on time from baseline to measured time point. |
| Percentage of Off Time at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Baseline (Day -7), Day 1, and Day 2 post-dose. | Improvement in motor complications associated with Parkinson's disease are measured as on (good medication response); OR on with dyskinesia (good medication response, but with superimposed involuntary movements that interfere with activities), OR off (poor medication response). Negative values indicate a decrease in off time from baseline to measured time point. |
| Percentage of Off Time for the Average of Days 1 and 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Baseline (Day -7), Day 1, and Day 2 post-dose. | Improvement in motor complications associated with Parkinson's disease are measured as on (good medication response); OR on with dyskinesia (good medication response, but with superimposed involuntary movements that interfere with activities), OR off (poor medication response). Negative values indicate a decrease in off time from baseline to measured time point. |
| Change From Baseline up to Day 2 in the Average Abnormal Involuntary Movement Scale (AIMS) Total Score in Participants Treated With SUN N4057 and Those Treated With a Placebo | Baseline (Day -7), Day 1, and Day 2 post-dose. | The Abnormal Involuntary Movement Scale (AIMS) is an assessment of dyskinesia in patients with movement disorders. The AIMS was originally developed to assess neuroleptic-induced extrapyramidal symptoms but has also been applied to the assessment of dyskinesia in patients with Parkinson's disease. AIMS questions 1 to 7 rate the degree of dyskinesia on a 0 to 4 scale in the extremities, trunk, and face, where 0 is no dyskinesia (better outcome) and 4 is severe dyskinesia (worse outcome). The total score range is 0 (better outcome) to 28 (worse outcome). Higher scores indicate a worse outcome. |
| Change From Baseline up to Day 2 in the Percentage of on Time Without Dyskinesia, as Assessed Over Hours 1 to 8 for Each Time Point in Participants Treated With SUN N4057 and Those Treated With a Placebo | Baseline (Day -7), Day 1, and Day 2 post-dose. | Improvement in motor complications associated with Parkinson's disease are measured as on (good medication response); OR on with dyskinesia (good medication response, but with superimposed involuntary movements that interfere with activities), OR off (poor medication response). |
| Mean SUN N4057 Plasma Concentrations Over Time Following Treatment With SUN N4057 | Day 1 pre-dose (Hour 0), 1 hour, 6 hours, 12 hours; Day 2 pre-dose (Hour 24), 1 hour (Hour 25), 6 hours (Hour 30), 12 hours (Hour 36), and Day 3 Hour 0 (Hour 48) post-dose. | The mean concentration of study drug, SUN N4057, in participant blood plasma samples drawn during infusions. |
| Mean SUN N4057 Plasma Pharmacokinetic Parameter of Observed Maximum Concentration (Cmax) Following Treatment With SUN N4057 | Baseline (Day 1 pre-dose) up to Hour 24, and Hour 48 post-dose. | Cmax is the observed maximum concentration of SUN N4057 in the participant blood plasma sample after drug administration. |
| Mean SUN N4057 Plasma Pharmacokinetic Parameter of Observed Minimum Concentration (Cmin) Following Treatment With SUN N4057 | Day 1 pre-dose (Hour 0) up to Hour 24, and Hour 48 post-dose. | Cmin is the observed minimum concentration of SUN N4057 in the participant blood plasma sample after drug administration. Average of C24 and C48 \[ie, 24 hours after the initiation of infusion on Days 1 and 2. Cmin = average of (C24 and C48) |
| Mean SUN N4057 Plasma Pharmacokinetic Parameter of Observed Mean Concentration (Caverage) Following Treatment With SUN N4057 | Day 1 at 1 hour, 6 hours, and12 hours; Day 2 at 25 hours, 30 hours, and 36 hours post-dose. | Caverage is the mean concentration of SUN N4057 in the participant blood plasma sample obtained from the observed concentrations during the 2-day drug infusions (average of C1, C6, C12, C25, C30, and C36 \[ie, Hours 1, 6, 12, 25, 30, and 36 after the initiation of infusion on Day 1\]). Caverage = average of (C1, C6, C12, C25, C30, and C36) |
| Mean SUN N4057 Pharmacokinetic Parameter of Area Under the Drug Concentration vs Time Curve (AUCt) Following Treatment With SUN N4057 | Baseline (Day 1 pre-dose) up to Hour 0, Hour 1, Hour 6, Hour 12, Hour 24, Hour 25, Hour 30, Hour 36, and Hour 48 post-dose. | AUCt is defined as the area under the drug concentration vs time curve from zero up to the last sampling point with a quantifiable drug concentration which is above the lower limit of quantification. |
| Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Baseline up to Day 16 post-dose, up to approximately a total 12 months. | A treatment-emergent adverse event (TEAE) was defined as an Adverse Event (AE) that was new in onset or aggravated in severity or frequency following administration of the investigational agent. This included any change from the screening physical examination findings or results of diagnostic procedures (eg, laboratory test, ECG) that were clinically significant, eg, required diagnostic or therapeutic intervention beyond confirmation alone. |
| Average of Days 1 and 2 in the Average Abnormal Involuntary Movement Scale (AIMS) Total Score in Participants Treated With SUN N4057 and Those Treated With a Placebo | Day 1 and Day 2 post-dose. | The Abnormal Involuntary Movement Scale (AIMS) is an assessment of dyskinesia in patients with movement disorders. The AIMS was originally developed to assess neuroleptic-induced extrapyramidal symptoms but has also been applied to the assessment of dyskinesia in patients with Parkinson's disease. AIMS questions 1 to 7 rate the degree of dyskinesia on a 0 to 4 scale in the extremities, trunk, and face, where 0 is no dyskinesia (better outcome) and 4 is severe dyskinesia (worse outcome). The total score range is 0 (better outcome) to 28 (worse outcome). Higher scores indicate a worse outcome. |
Countries
Guatemala, Romania, United States
Participant flow
Recruitment details
A total of 27 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study at 4 clinic sites in the United States of America (USA), 1 in Guatemala, and 1 in Romania.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants with Parkinson's disease who were administered two 12-hour IV infusions of 0.9% sodium chloride (normal saline) placebo over 2 inpatient days. | 7 |
| SUN N4057 Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days. | 18 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
Baseline characteristics
| Characteristic | Placebo | Total | SUN N4057 |
|---|---|---|---|
| Age, Continuous | 61.4 years STANDARD_DEVIATION 9.47 | 59.9 years STANDARD_DEVIATION 10.83 | 59.3 years STANDARD_DEVIATION 11.51 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 17 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 8 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 15 Participants | 12 Participants |
| Race (NIH/OMB) White | 3 Participants | 9 Participants | 6 Participants |
| Region of Enrollment Guatemala | 3 participants | 16 participants | 13 participants |
| Region of Enrollment United States | 4 participants | 9 participants | 5 participants |
| Sex: Female, Male Female | 2 Participants | 6 Participants | 4 Participants |
| Sex: Female, Male Male | 5 Participants | 19 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 18 |
| other Total, other adverse events | 6 / 7 | 17 / 18 |
| serious Total, serious adverse events | 0 / 7 | 0 / 18 |
Outcome results
Primary
Change From Baseline in the Percentage of On Time Without Dyskinesia Averaged Over Days 1 and 2 in Participants Treated With SUN N4057 and Those Treated With a Placebo
Improvement in motor complications associated with Parkinson's disease are measured as on (good medication response); OR on with dyskinesia (good medication response, but with superimposed involuntary movements that interfere with activities), OR off (poor medication response).
Time frame: Baseline (Day-7) up to 2 days post-dose.
Population: The percentage of on time without dyskinesia was assessed using the modified intent-to-treat (MITT) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Percentage of On Time Without Dyskinesia Averaged Over Days 1 and 2 in Participants Treated With SUN N4057 and Those Treated With a Placebo | Baseline (Day -7) | 12.50 percentage of on time | Standard Deviation 10.21 |
| Placebo | Change From Baseline in the Percentage of On Time Without Dyskinesia Averaged Over Days 1 and 2 in Participants Treated With SUN N4057 and Those Treated With a Placebo | Average of Days 1 and 2 | 17.86 percentage of on time | Standard Deviation 25.37 |
| Placebo | Change From Baseline in the Percentage of On Time Without Dyskinesia Averaged Over Days 1 and 2 in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline | 5.36 percentage of on time | Standard Deviation 20.23 |
| SUN N4057 | Change From Baseline in the Percentage of On Time Without Dyskinesia Averaged Over Days 1 and 2 in Participants Treated With SUN N4057 and Those Treated With a Placebo | Baseline (Day -7) | 18.75 percentage of on time | Standard Deviation 22.38 |
| SUN N4057 | Change From Baseline in the Percentage of On Time Without Dyskinesia Averaged Over Days 1 and 2 in Participants Treated With SUN N4057 and Those Treated With a Placebo | Average of Days 1 and 2 | 36.11 percentage of on time | Standard Deviation 26.99 |
| SUN N4057 | Change From Baseline in the Percentage of On Time Without Dyskinesia Averaged Over Days 1 and 2 in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline | 17.36 percentage of on time | Standard Deviation 24.96 |
Comparison: Baseline (Day -7)p-value: 0.503Monte Carlo estimates
Comparison: Average of Days 1 and 295% CI: [1.82, 39.37]
Comparison: Change from Baseline95% CI: [-15.18, 22.37]
Comparison: Average of Days 1 and 295% CI: [24.04, 49.14]
Comparison: Change from Baselinep-value: 0.1695% CI: [7.04, 32.14]ANCOVA
Secondary
Average of Days 1 and 2 in the Average Abnormal Involuntary Movement Scale (AIMS) Total Score in Participants Treated With SUN N4057 and Those Treated With a Placebo
The Abnormal Involuntary Movement Scale (AIMS) is an assessment of dyskinesia in patients with movement disorders. The AIMS was originally developed to assess neuroleptic-induced extrapyramidal symptoms but has also been applied to the assessment of dyskinesia in patients with Parkinson's disease. AIMS questions 1 to 7 rate the degree of dyskinesia on a 0 to 4 scale in the extremities, trunk, and face, where 0 is no dyskinesia (better outcome) and 4 is severe dyskinesia (worse outcome). The total score range is 0 (better outcome) to 28 (worse outcome). Higher scores indicate a worse outcome.
Time frame: Day 1 and Day 2 post-dose.
Population: The average abnormal involuntary movement scale was assessed using the modified intent-to-treat (MITT) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Average of Days 1 and 2 in the Average Abnormal Involuntary Movement Scale (AIMS) Total Score in Participants Treated With SUN N4057 and Those Treated With a Placebo | Average of Days 1 and 2 | 3.04 units on a scale | Standard Deviation 3 |
| Placebo | Average of Days 1 and 2 in the Average Abnormal Involuntary Movement Scale (AIMS) Total Score in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline | -2.76 units on a scale | Standard Deviation 2.83 |
| SUN N4057 | Average of Days 1 and 2 in the Average Abnormal Involuntary Movement Scale (AIMS) Total Score in Participants Treated With SUN N4057 and Those Treated With a Placebo | Average of Days 1 and 2 | 2.63 units on a scale | Standard Deviation 1.49 |
| SUN N4057 | Average of Days 1 and 2 in the Average Abnormal Involuntary Movement Scale (AIMS) Total Score in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline | -1.67 units on a scale | Standard Deviation 2.44 |
Secondary
Change From Baseline up to Day 2 in the Average Abnormal Involuntary Movement Scale (AIMS) Total Score in Participants Treated With SUN N4057 and Those Treated With a Placebo
The Abnormal Involuntary Movement Scale (AIMS) is an assessment of dyskinesia in patients with movement disorders. The AIMS was originally developed to assess neuroleptic-induced extrapyramidal symptoms but has also been applied to the assessment of dyskinesia in patients with Parkinson's disease. AIMS questions 1 to 7 rate the degree of dyskinesia on a 0 to 4 scale in the extremities, trunk, and face, where 0 is no dyskinesia (better outcome) and 4 is severe dyskinesia (worse outcome). The total score range is 0 (better outcome) to 28 (worse outcome). Higher scores indicate a worse outcome.
Time frame: Baseline (Day -7), Day 1, and Day 2 post-dose.
Population: The average abnormal involuntary movement scale was assessed using the modified intent-to-treat (MITT) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline up to Day 2 in the Average Abnormal Involuntary Movement Scale (AIMS) Total Score in Participants Treated With SUN N4057 and Those Treated With a Placebo | Day 1 | 3.11 units on a scale | Standard Deviation 3.74 |
| Placebo | Change From Baseline up to Day 2 in the Average Abnormal Involuntary Movement Scale (AIMS) Total Score in Participants Treated With SUN N4057 and Those Treated With a Placebo | Day 2 | 2.98 units on a scale | Standard Deviation 2.43 |
| Placebo | Change From Baseline up to Day 2 in the Average Abnormal Involuntary Movement Scale (AIMS) Total Score in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline to Day 1 | -2.70 units on a scale | Standard Deviation 3.16 |
| Placebo | Change From Baseline up to Day 2 in the Average Abnormal Involuntary Movement Scale (AIMS) Total Score in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline to Day 2 | -2.82 units on a scale | Standard Deviation 2.82 |
| Placebo | Change From Baseline up to Day 2 in the Average Abnormal Involuntary Movement Scale (AIMS) Total Score in Participants Treated With SUN N4057 and Those Treated With a Placebo | Baseline (Day -7) | 5.80 units on a scale | Standard Deviation 1.94 |
| SUN N4057 | Change From Baseline up to Day 2 in the Average Abnormal Involuntary Movement Scale (AIMS) Total Score in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline to Day 2 | -1.65 units on a scale | Standard Deviation 2.31 |
| SUN N4057 | Change From Baseline up to Day 2 in the Average Abnormal Involuntary Movement Scale (AIMS) Total Score in Participants Treated With SUN N4057 and Those Treated With a Placebo | Baseline (Day -7) | 4.31 units on a scale | Standard Deviation 2.28 |
| SUN N4057 | Change From Baseline up to Day 2 in the Average Abnormal Involuntary Movement Scale (AIMS) Total Score in Participants Treated With SUN N4057 and Those Treated With a Placebo | Day 1 | 2.60 units on a scale | Standard Deviation 2.04 |
| SUN N4057 | Change From Baseline up to Day 2 in the Average Abnormal Involuntary Movement Scale (AIMS) Total Score in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline to Day 1 | -1.70 units on a scale | Standard Deviation 3.16 |
| SUN N4057 | Change From Baseline up to Day 2 in the Average Abnormal Involuntary Movement Scale (AIMS) Total Score in Participants Treated With SUN N4057 and Those Treated With a Placebo | Day 2 | 2.66 units on a scale | Standard Deviation 1.91 |
Secondary
Change From Baseline up to Day 2 in the Percentage of on Time Without Dyskinesia, as Assessed Over Hours 1 to 8 for Each Time Point in Participants Treated With SUN N4057 and Those Treated With a Placebo
Improvement in motor complications associated with Parkinson's disease are measured as on (good medication response); OR on with dyskinesia (good medication response, but with superimposed involuntary movements that interfere with activities), OR off (poor medication response).
Time frame: Baseline (Day -7), Day 1, and Day 2 post-dose.
Population: The percentage of on time without dyskinesia was assessed using the modified intent-to-treat (MITT) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline up to Day 2 in the Percentage of on Time Without Dyskinesia, as Assessed Over Hours 1 to 8 for Each Time Point in Participants Treated With SUN N4057 and Those Treated With a Placebo | Day 1 | 23.21 percentage of on time | Standard Deviation 33.41 |
| Placebo | Change From Baseline up to Day 2 in the Percentage of on Time Without Dyskinesia, as Assessed Over Hours 1 to 8 for Each Time Point in Participants Treated With SUN N4057 and Those Treated With a Placebo | Day 2 | 12.50 percentage of on time | Standard Deviation 19.09 |
| Placebo | Change From Baseline up to Day 2 in the Percentage of on Time Without Dyskinesia, as Assessed Over Hours 1 to 8 for Each Time Point in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline to Day 1 | 10.71 percentage of on time | Standard Deviation 29.25 |
| Placebo | Change From Baseline up to Day 2 in the Percentage of on Time Without Dyskinesia, as Assessed Over Hours 1 to 8 for Each Time Point in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline to Day 2 | 0.00 percentage of on time | Standard Deviation 12.5 |
| Placebo | Change From Baseline up to Day 2 in the Percentage of on Time Without Dyskinesia, as Assessed Over Hours 1 to 8 for Each Time Point in Participants Treated With SUN N4057 and Those Treated With a Placebo | Baseline (Day -7) | 12.50 percentage of on time | Standard Deviation 10.21 |
| SUN N4057 | Change From Baseline up to Day 2 in the Percentage of on Time Without Dyskinesia, as Assessed Over Hours 1 to 8 for Each Time Point in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline to Day 2 | 22.22 percentage of on time | Standard Deviation 35.76 |
| SUN N4057 | Change From Baseline up to Day 2 in the Percentage of on Time Without Dyskinesia, as Assessed Over Hours 1 to 8 for Each Time Point in Participants Treated With SUN N4057 and Those Treated With a Placebo | Baseline (Day -7) | 18.75 percentage of on time | Standard Deviation 22.38 |
| SUN N4057 | Change From Baseline up to Day 2 in the Percentage of on Time Without Dyskinesia, as Assessed Over Hours 1 to 8 for Each Time Point in Participants Treated With SUN N4057 and Those Treated With a Placebo | Day 1 | 31.25 percentage of on time | Standard Deviation 30.39 |
| SUN N4057 | Change From Baseline up to Day 2 in the Percentage of on Time Without Dyskinesia, as Assessed Over Hours 1 to 8 for Each Time Point in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline to Day 1 | 12.50 percentage of on time | Standard Deviation 25.73 |
| SUN N4057 | Change From Baseline up to Day 2 in the Percentage of on Time Without Dyskinesia, as Assessed Over Hours 1 to 8 for Each Time Point in Participants Treated With SUN N4057 and Those Treated With a Placebo | Day 2 | 40.97 percentage of on time | Standard Deviation 35.04 |
Secondary
Mean SUN N4057 Pharmacokinetic Parameter of Area Under the Drug Concentration vs Time Curve (AUCt) Following Treatment With SUN N4057
AUCt is defined as the area under the drug concentration vs time curve from zero up to the last sampling point with a quantifiable drug concentration which is above the lower limit of quantification.
Time frame: Baseline (Day 1 pre-dose) up to Hour 0, Hour 1, Hour 6, Hour 12, Hour 24, Hour 25, Hour 30, Hour 36, and Hour 48 post-dose.
Population: AUCt was assessed using the pharmacokinetic (PK) population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean SUN N4057 Pharmacokinetic Parameter of Area Under the Drug Concentration vs Time Curve (AUCt) Following Treatment With SUN N4057 | 1271.20 ng*hr/mL | Standard Deviation 409.39 |
Secondary
Mean SUN N4057 Plasma Concentrations Over Time Following Treatment With SUN N4057
The mean concentration of study drug, SUN N4057, in participant blood plasma samples drawn during infusions.
Time frame: Day 1 pre-dose (Hour 0), 1 hour, 6 hours, 12 hours; Day 2 pre-dose (Hour 24), 1 hour (Hour 25), 6 hours (Hour 30), 12 hours (Hour 36), and Day 3 Hour 0 (Hour 48) post-dose.
Population: Mean plasma concentrations were assessed using the pharmacokinetic (PK) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean SUN N4057 Plasma Concentrations Over Time Following Treatment With SUN N4057 | Day 1: Hour 12 | 32.46 ng/mL | Standard Deviation 12.26 |
| Placebo | Mean SUN N4057 Plasma Concentrations Over Time Following Treatment With SUN N4057 | Day 2: Hour 0 | 11.26 ng/mL | Standard Deviation 4.66 |
| Placebo | Mean SUN N4057 Plasma Concentrations Over Time Following Treatment With SUN N4057 | Day 1: Hour 0 | 0.00 ng/mL | Standard Deviation 0 |
| Placebo | Mean SUN N4057 Plasma Concentrations Over Time Following Treatment With SUN N4057 | Day Day 1: Hour 1 | 33.40 ng/mL | Standard Deviation 9.71 |
| Placebo | Mean SUN N4057 Plasma Concentrations Over Time Following Treatment With SUN N4057 | Day 1: Hour 6 | 28.34 ng/mL | Standard Deviation 9.19 |
| Placebo | Mean SUN N4057 Plasma Concentrations Over Time Following Treatment With SUN N4057 | Day 2: Hour 1 | 31.91 ng/mL | Standard Deviation 9.52 |
| Placebo | Mean SUN N4057 Plasma Concentrations Over Time Following Treatment With SUN N4057 | Day 2: Hour 6 | 26.85 ng/mL | Standard Deviation 7.92 |
| Placebo | Mean SUN N4057 Plasma Concentrations Over Time Following Treatment With SUN N4057 | Day 2: Hour 12 | 37.75 ng/mL | Standard Deviation 33.02 |
| Placebo | Mean SUN N4057 Plasma Concentrations Over Time Following Treatment With SUN N4057 | Day 3: Hour 0 | 12.65 ng/mL | Standard Deviation 6.08 |
Secondary
Mean SUN N4057 Plasma Pharmacokinetic Parameter of Observed Maximum Concentration (Cmax) Following Treatment With SUN N4057
Cmax is the observed maximum concentration of SUN N4057 in the participant blood plasma sample after drug administration.
Time frame: Baseline (Day 1 pre-dose) up to Hour 24, and Hour 48 post-dose.
Population: Cmax was assessed using the pharmacokinetic (PK) population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean SUN N4057 Plasma Pharmacokinetic Parameter of Observed Maximum Concentration (Cmax) Following Treatment With SUN N4057 | 46.95 ng/mL | Standard Deviation 31.46 |
Secondary
Mean SUN N4057 Plasma Pharmacokinetic Parameter of Observed Mean Concentration (Caverage) Following Treatment With SUN N4057
Caverage is the mean concentration of SUN N4057 in the participant blood plasma sample obtained from the observed concentrations during the 2-day drug infusions (average of C1, C6, C12, C25, C30, and C36 \[ie, Hours 1, 6, 12, 25, 30, and 36 after the initiation of infusion on Day 1\]). Caverage = average of (C1, C6, C12, C25, C30, and C36)
Time frame: Day 1 at 1 hour, 6 hours, and12 hours; Day 2 at 25 hours, 30 hours, and 36 hours post-dose.
Population: Caverage was assessed using the pharmacokinetic (PK) population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean SUN N4057 Plasma Pharmacokinetic Parameter of Observed Mean Concentration (Caverage) Following Treatment With SUN N4057 | 31.91 ng/mL | Standard Deviation 8.96 |
Secondary
Mean SUN N4057 Plasma Pharmacokinetic Parameter of Observed Minimum Concentration (Cmin) Following Treatment With SUN N4057
Cmin is the observed minimum concentration of SUN N4057 in the participant blood plasma sample after drug administration. Average of C24 and C48 \[ie, 24 hours after the initiation of infusion on Days 1 and 2. Cmin = average of (C24 and C48)
Time frame: Day 1 pre-dose (Hour 0) up to Hour 24, and Hour 48 post-dose.
Population: Cmin was assessed using the pharmacokinetic (PK) population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean SUN N4057 Plasma Pharmacokinetic Parameter of Observed Minimum Concentration (Cmin) Following Treatment With SUN N4057 | 11.95 ng/mL | Standard Deviation 5.3 |
Secondary
Percentage of Off Time at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo
Improvement in motor complications associated with Parkinson's disease are measured as on (good medication response); OR on with dyskinesia (good medication response, but with superimposed involuntary movements that interfere with activities), OR off (poor medication response). Negative values indicate a decrease in off time from baseline to measured time point.
Time frame: Baseline (Day -7), Day 1, and Day 2 post-dose.
Population: The percentage of off time was assessed using the modified intent-to-treat (MITT) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percentage of Off Time at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Day 1 | 21.43 percentage of off time | Standard Deviation 26.73 |
| Placebo | Percentage of Off Time at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Day 2 | 23.21 percentage of off time | Standard Deviation 29.25 |
| Placebo | Percentage of Off Time at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline to Day 1 | 12.50 percentage of off time | Standard Deviation 10.09 |
| Placebo | Percentage of Off Time at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline to Day 2 | 14.29 percentage of off time | Standard Deviation 20.95 |
| Placebo | Percentage of Off Time at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Baseline (Day -7) | 8.93 percentage of off time | Standard Deviation 15.67 |
| SUN N4057 | Percentage of Off Time at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline to Day 2 | -11.11 percentage of off time | Standard Deviation 20.06 |
| SUN N4057 | Percentage of Off Time at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Baseline (Day -7) | 20.83 percentage of off time | Standard Deviation 19.65 |
| SUN N4057 | Percentage of Off Time at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Day 1 | 20.14 percentage of off time | Standard Deviation 25.05 |
| SUN N4057 | Percentage of Off Time at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline to Day 1 | -0.69 percentage of off time | Standard Deviation 24.81 |
| SUN N4057 | Percentage of Off Time at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Day 2 | 9.72 percentage of off time | Standard Deviation 18.47 |
Secondary
Percentage of Off Time for the Average of Days 1 and 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo
Improvement in motor complications associated with Parkinson's disease are measured as on (good medication response); OR on with dyskinesia (good medication response, but with superimposed involuntary movements that interfere with activities), OR off (poor medication response). Negative values indicate a decrease in off time from baseline to measured time point.
Time frame: Baseline (Day -7), Day 1, and Day 2 post-dose.
Population: The percentage of off time was assessed using the modified intent-to-treat (MITT) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percentage of Off Time for the Average of Days 1 and 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Average of Days 1 and 2 | 22.32 percentage of off time | Standard Deviation 27.92 |
| Placebo | Percentage of Off Time for the Average of Days 1 and 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline | 13.39 percentage of off time | Standard Deviation 19.91 |
| SUN N4057 | Percentage of Off Time for the Average of Days 1 and 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline | -5.90 percentage of off time | Standard Deviation 21.06 |
| SUN N4057 | Percentage of Off Time for the Average of Days 1 and 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Average of Days 1 and 2 | 14.93 percentage of off time | Standard Deviation 20.47 |
Secondary
Percentage of on Time With Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo
Improvement in motor complications associated with Parkinson's disease are measured as on (good medication response); OR on with dyskinesia (good medication response, but with superimposed involuntary movements that interfere with activities), OR off (poor medication response). Negative values indicate a decrease in on time from baseline to measured time point.
Time frame: Baseline (Day -7), Day 1, and Day 2 post-dose.
Population: The percentage of on time with dyskinesia was assessed using the modified intent-to-treat (MITT) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percentage of on Time With Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Day 1 | 55.36 percentage of on time | Standard Deviation 41.37 |
| Placebo | Percentage of on Time With Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Day 2 | 64.29 percentage of on time | Standard Deviation 28.35 |
| Placebo | Percentage of on Time With Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline to Day 1 | -23.21 percentage of on time | Standard Deviation 32.62 |
| Placebo | Percentage of on Time With Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline to Day 2 | -14.29 percentage of on time | Standard Deviation 19.67 |
| Placebo | Percentage of on Time With Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Baseline (Day -7) | 78.57 percentage of on time | Standard Deviation 13.91 |
| SUN N4057 | Percentage of on Time With Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline to Day 2 | -11.11 percentage of on time | Standard Deviation 32.9 |
| SUN N4057 | Percentage of on Time With Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Baseline (Day -7) | 60.42 percentage of on time | Standard Deviation 26.17 |
| SUN N4057 | Percentage of on Time With Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Day 1 | 48.61 percentage of on time | Standard Deviation 27.75 |
| SUN N4057 | Percentage of on Time With Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline to Day 1 | -11.81 percentage of on time | Standard Deviation 31.64 |
| SUN N4057 | Percentage of on Time With Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Day 2 | 49.31 percentage of on time | Standard Deviation 33.89 |
Secondary
Percentage of on Time With Dyskinesia for the Average of Days 1 and 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo
Improvement in motor complications associated with Parkinson's disease are measured as on (good medication response); OR on with dyskinesia (good medication response, but with superimposed involuntary movements that interfere with activities), OR off (poor medication response). Negative values indicate a decrease in on time from baseline to measured time point.
Time frame: Baseline (Day -7), Day 1, and Day 2 post-dose.
Population: The percentage of on time with dyskinesia was assessed using the modified intent-to-treat (MITT) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percentage of on Time With Dyskinesia for the Average of Days 1 and 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Average of Days 1 and 2 | 59.82 percentage of on time | Standard Deviation 34.4 |
| Placebo | Percentage of on Time With Dyskinesia for the Average of Days 1 and 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline | -18.75 percentage of on time | Standard Deviation 25.52 |
| SUN N4057 | Percentage of on Time With Dyskinesia for the Average of Days 1 and 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Average of Days 1 and 2 | 48.96 percentage of on time | Standard Deviation 22.51 |
| SUN N4057 | Percentage of on Time With Dyskinesia for the Average of Days 1 and 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline | -11.46 percentage of on time | Standard Deviation 24.28 |
Secondary
Percentage of on Time With or Without Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo
Improvement in motor complications associated with Parkinson's disease are measured as on (good medication response); OR on with dyskinesia (good medication response, but with superimposed involuntary movements that interfere with activities), OR off (poor medication response). Negative values indicate a decrease in on time from baseline to measured time point.
Time frame: Baseline (Day -7), Day 1 and Day 2 post-dose.
Population: The percentage of on time with or without dyskinesia was assessed using the modified intent-to-treat (MITT) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percentage of on Time With or Without Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Baseline (Day -7) | 91.07 percentage of on time | Standard Deviation 15.67 |
| Placebo | Percentage of on Time With or Without Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Day 2 | 76.79 percentage of on time | Standard Deviation 29.25 |
| Placebo | Percentage of on Time With or Without Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline to Day 1 | -12.50 percentage of on time | Standard Deviation 19.09 |
| Placebo | Percentage of on Time With or Without Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline to Day 2 | -14.29 percentage of on time | Standard Deviation 20.95 |
| Placebo | Percentage of on Time With or Without Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Day 1 | 78.57 percentage of on time | Standard Deviation 26.73 |
| SUN N4057 | Percentage of on Time With or Without Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline to Day 2 | 11.11 percentage of on time | Standard Deviation 20.06 |
| SUN N4057 | Percentage of on Time With or Without Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Baseline (Day -7) | 79.17 percentage of on time | Standard Deviation 19.65 |
| SUN N4057 | Percentage of on Time With or Without Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Day 1 | 79.86 percentage of on time | Standard Deviation 25.05 |
| SUN N4057 | Percentage of on Time With or Without Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline to Day 1 | 0.69 percentage of on time | Standard Deviation 24.81 |
| SUN N4057 | Percentage of on Time With or Without Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Day 2 | 90.28 percentage of on time | Standard Deviation 18.47 |
Secondary
Percentage of on Time With or Without Dyskinesia for the Average of Days 1 and 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo
Improvement in motor complications associated with Parkinson's disease are measured as on (good medication response); OR on with dyskinesia (good medication response, but with superimposed involuntary movements that interfere with activities), OR off (poor medication response). Negative values indicate a decrease in on time from baseline to measured time point.
Time frame: Baseline (Day -7), Day 1 and Day 2 post-dose.
Population: The percentage of on time with or without dyskinesia was assessed using the modified intent-to-treat (MITT) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percentage of on Time With or Without Dyskinesia for the Average of Days 1 and 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Average of Days 1 and 2 | 77.68 percentage of on time | Standard Deviation 27.92 |
| Placebo | Percentage of on Time With or Without Dyskinesia for the Average of Days 1 and 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline | -13.39 percentage of on time | Standard Deviation 19.91 |
| SUN N4057 | Percentage of on Time With or Without Dyskinesia for the Average of Days 1 and 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Average of Days 1 and 2 | 85.07 percentage of on time | Standard Deviation 20.47 |
| SUN N4057 | Percentage of on Time With or Without Dyskinesia for the Average of Days 1 and 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo | Change from Baseline | 5.90 percentage of on time | Standard Deviation 21.06 |
Secondary
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
A treatment-emergent adverse event (TEAE) was defined as an Adverse Event (AE) that was new in onset or aggravated in severity or frequency following administration of the investigational agent. This included any change from the screening physical examination findings or results of diagnostic procedures (eg, laboratory test, ECG) that were clinically significant, eg, required diagnostic or therapeutic intervention beyond confirmation alone.
Time frame: Baseline up to Day 16 post-dose, up to approximately a total 12 months.
Population: Treatment-emergent adverse events (TEAEs) were assessed using the Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Nausea | 2 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Dizziness postural | 0 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Blood Pressure increased | 2 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Ear pain | 0 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Disorientation | 1 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Electrocardiogram abnormal | 0 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Cold sweat | 0 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Electrocardiogram QT prolonged | 1 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Hypertension | 0 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Fecal incontinence | 0 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Abdominal pain | 0 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Flushing | 0 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Headache | 0 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Heart rate increased | 1 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Arrhythmia | 1 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Hypotension | 0 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Dizziness | 0 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Muscle spasms | 1 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Asthenia | 0 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Nightmare | 0 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Dyskinesia | 1 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Paresthesia | 0 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Bundle branch block right | 1 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Peripheral coldness | 0 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Vomiting | 0 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Somnolence | 0 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Chills | 0 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Tachycardia | 0 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Hyperhidrosis | 0 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Tremor | 0 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Confusional state | 0 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Vision blurred | 0 Participants |
| Placebo | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Patients with Any TEAE | 6 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Vision blurred | 1 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Patients with Any TEAE | 17 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Nausea | 12 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Dizziness | 8 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Hypertension | 7 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Vomiting | 7 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Disorientation | 3 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Headache | 4 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Dyskinesia | 2 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Hyperhidrosis | 3 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Blood Pressure increased | 0 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Cold sweat | 2 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Abdominal pain | 1 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Arrhythmia | 0 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Asthenia | 1 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Bundle branch block right | 0 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Chills | 1 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Confusional state | 1 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Dizziness postural | 1 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Ear pain | 1 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Electrocardiogram abnormal | 1 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Electrocardiogram QT prolonged | 0 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Fecal incontinence | 1 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Flushing | 1 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Heart rate increased | 0 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Hypotension | 1 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Muscle spasms | 0 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Nightmare | 1 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Paresthesia | 1 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Peripheral coldness | 1 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Somnolence | 1 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Tachycardia | 1 Participants |
| SUN N4057 | Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo | Tremor | 1 Participants |