| 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). | The percentage of "on" time without dyskinesia was assessed using the modified intent-to-treat (MITT) population. | Posted | | Mean | Standard Deviation | percentage of on time | | Baseline (Day-7) up to 2 days post-dose. | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | SUN N4057 | Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days. |
| | | Title | Denominators | Categories |
|---|
| Baseline (Day -7) | | | Title | Measurements |
|---|
| - OG00012.50± 10.21
- OG00118.75± 22.38
|
| | Average of Days 1 and 2 | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Monte Carlo estimates | | 0.503 | | | | | | | | | | | | | | Superiority | | | | | | | |
|
| 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). | The percentage of "on" time without dyskinesia was assessed using the modified intent-to-treat (MITT) population. | Posted | | Mean | Standard Deviation | percentage of on time | | Baseline (Day -7), Day 1, and Day 2 post-dose. | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | SUN N4057 | Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days. |
| |
| 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. | The percentage of "on" time with dyskinesia was assessed using the modified intent-to-treat (MITT) population. | Posted | | Mean | Standard Deviation | percentage of on time | | Baseline (Day -7), Day 1, and Day 2 post-dose. | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | SUN N4057 | Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days. |
| |
| 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. | The percentage of "on" time with dyskinesia was assessed using the modified intent-to-treat (MITT) population. | Posted | | Mean | Standard Deviation | percentage of on time | | Baseline (Day -7), Day 1, and Day 2 post-dose. | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | SUN N4057 | Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days. |
| |
| 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. | The percentage of "on" time with or without dyskinesia was assessed using the modified intent-to-treat (MITT) population. | Posted | | Mean | Standard Deviation | percentage of on time | | Baseline (Day -7), Day 1 and Day 2 post-dose. | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | SUN N4057 | Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days. |
| |
| 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. | The percentage of "on" time with or without dyskinesia was assessed using the modified intent-to-treat (MITT) population. | Posted | | Mean | Standard Deviation | percentage of on time | | Baseline (Day -7), Day 1 and Day 2 post-dose. | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | SUN N4057 | Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days. |
| |
| 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. | The percentage of "off" time was assessed using the modified intent-to-treat (MITT) population. | Posted | | Mean | Standard Deviation | percentage of off time | | Baseline (Day -7), Day 1, and Day 2 post-dose. | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | SUN N4057 | Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days. |
| |
| 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. | The percentage of "off" time was assessed using the modified intent-to-treat (MITT) population. | Posted | | Mean | Standard Deviation | percentage of off time | | Baseline (Day -7), Day 1, and Day 2 post-dose. | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | SUN N4057 | Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days. |
| |
| 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. | The average abnormal involuntary movement scale was assessed using the modified intent-to-treat (MITT) population. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Day -7), Day 1, and Day 2 post-dose. | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | SUN N4057 | Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days. |
| |
| 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. | The average abnormal involuntary movement scale was assessed using the modified intent-to-treat (MITT) population. | Posted | | Mean | Standard Deviation | units on a scale | | Day 1 and Day 2 post-dose. | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | SUN N4057 | Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days. |
| |
| 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. | Mean plasma concentrations were assessed using the pharmacokinetic (PK) population. | Posted | | Mean | Standard Deviation | ng/mL | | 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. | | | | ID | Title | Description |
|---|
| OG000 | SUN N4057 | Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days. |
| |
| 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. | Cmax was assessed using the pharmacokinetic (PK) population. | Posted | | Mean | Standard Deviation | ng/mL | | Baseline (Day 1 pre-dose) up to Hour 24, and Hour 48 post-dose. | | | | ID | Title | Description |
|---|
| OG000 | SUN N4057 | Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days. |
| |
| 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)](streamdown:incomplete-link) | Cmin was assessed using the pharmacokinetic (PK) population. | Posted | | Mean | Standard Deviation | ng/mL | | Day 1 pre-dose (Hour 0) up to Hour 24, and Hour 48 post-dose. | | | | ID | Title | Description |
|---|
| OG000 | SUN N4057 | Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days. |
| |
| 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) | Caverage was assessed using the pharmacokinetic (PK) population. | Posted | | Mean | Standard Deviation | ng/mL | | Day 1 at 1 hour, 6 hours, and12 hours; Day 2 at 25 hours, 30 hours, and 36 hours post-dose. | | | | ID | Title | Description |
|---|
| OG000 | SUN N4057 | Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days. |
| |
| 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. | AUCt was assessed using the pharmacokinetic (PK) population. | Posted | | Mean | Standard Deviation | ng*hr/mL | | 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. | | | | ID | Title | Description |
|---|
| OG000 | SUN N4057 | Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days. |
| |
| 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. | Treatment-emergent adverse events (TEAEs) were assessed using the Safety population. | Posted | | Count of Participants | | Participants | | Baseline up to Day 16 post-dose, up to approximately a total 12 months. | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | SUN N4057 | Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days. |
| |