Trial Outcomes & Findings for Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's Disease (NCT NCT00623363)
NCT ID: NCT00623363
Last Updated: 2021-03-11
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Baseline (Day-7) up to 2 days post-dose.
Results posted on
2021-03-11
Participant Flow
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.
Participant milestones
| Measure |
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.
|
SUN N4057
Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
20
|
|
Overall Study
COMPLETED
|
5
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
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.
|
SUN N4057
Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
Baseline Characteristics
Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=7 Participants
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.
|
SUN N4057
n=18 Participants
Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.4 years
STANDARD_DEVIATION 9.47 • n=5 Participants
|
59.3 years
STANDARD_DEVIATION 11.51 • n=7 Participants
|
59.9 years
STANDARD_DEVIATION 10.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Guatemala
|
3 participants
n=5 Participants
|
13 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Placebo
n=7 Participants
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.
|
SUN N4057
n=18 Participants
Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days.
|
|---|---|---|
|
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
|
17.36 percentage of on time
Standard Deviation 24.96
|
|
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
|
18.75 percentage of on time
Standard Deviation 22.38
|
|
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
|
36.11 percentage of on time
Standard Deviation 26.99
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Placebo
n=7 Participants
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.
|
SUN N4057
n=18 Participants
Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days.
|
|---|---|---|
|
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
|
18.75 percentage of on time
Standard Deviation 22.38
|
|
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
|
31.25 percentage of on time
Standard Deviation 30.39
|
|
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
|
12.50 percentage of on time
Standard Deviation 25.73
|
|
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
|
40.97 percentage of on time
Standard Deviation 35.04
|
|
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 12.50
|
22.22 percentage of on time
Standard Deviation 35.76
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=7 Participants
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.
|
SUN N4057
n=18 Participants
Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days.
|
|---|---|---|
|
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
|
60.42 percentage of on time
Standard Deviation 26.17
|
|
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
|
48.61 percentage of on time
Standard Deviation 27.75
|
|
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
|
-11.81 percentage of on time
Standard Deviation 31.64
|
|
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
|
49.31 percentage of on time
Standard Deviation 33.89
|
|
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
|
-11.11 percentage of on time
Standard Deviation 32.90
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=7 Participants
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.
|
SUN N4057
n=18 Participants
Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days.
|
|---|---|---|
|
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 34.40
|
48.96 percentage of on time
Standard Deviation 22.51
|
|
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
|
-11.46 percentage of on time
Standard Deviation 24.28
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=7 Participants
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.
|
SUN N4057
n=18 Participants
Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days.
|
|---|---|---|
|
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
|
79.17 percentage of on time
Standard Deviation 19.65
|
|
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
|
79.86 percentage of on time
Standard Deviation 25.05
|
|
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
|
0.69 percentage of on time
Standard Deviation 24.81
|
|
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
|
90.28 percentage of on time
Standard Deviation 18.47
|
|
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
|
11.11 percentage of on time
Standard Deviation 20.06
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=7 Participants
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.
|
SUN N4057
n=18 Participants
Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days.
|
|---|---|---|
|
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
|
85.07 percentage of on time
Standard Deviation 20.47
|
|
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
|
5.90 percentage of on time
Standard Deviation 21.06
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=7 Participants
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.
|
SUN N4057
n=18 Participants
Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days.
|
|---|---|---|
|
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
|
20.83 percentage of off time
Standard Deviation 19.65
|
|
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
|
20.14 percentage of off time
Standard Deviation 25.05
|
|
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
|
-0.69 percentage of off time
Standard Deviation 24.81
|
|
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
|
9.72 percentage of off time
Standard Deviation 18.47
|
|
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
|
-11.11 percentage of off time
Standard Deviation 20.06
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=7 Participants
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.
|
SUN N4057
n=18 Participants
Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days.
|
|---|---|---|
|
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
|
14.93 percentage of off time
Standard Deviation 20.47
|
|
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
|
-5.90 percentage of off time
Standard Deviation 21.06
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=7 Participants
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.
|
SUN N4057
n=18 Participants
Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days.
|
|---|---|---|
|
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
|
4.31 units on a scale
Standard Deviation 2.28
|
|
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
|
2.60 units on a scale
Standard Deviation 2.04
|
|
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
|
-1.70 units on a scale
Standard Deviation 3.16
|
|
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
|
2.66 units on a scale
Standard Deviation 1.91
|
|
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
|
-1.65 units on a scale
Standard Deviation 2.31
|
SECONDARY outcome
Timeframe: Day 1 and Day 2 post-dose.Population: The average abnormal involuntary movement scale was assessed using the modified intent-to-treat (MITT) population.
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.
Outcome measures
| Measure |
Placebo
n=7 Participants
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.
|
SUN N4057
n=18 Participants
Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days.
|
|---|---|---|
|
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 3.00
|
2.63 units on a scale
Standard Deviation 1.49
|
|
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
|
-1.67 units on a scale
Standard Deviation 2.44
|
SECONDARY outcome
Timeframe: 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.
The mean concentration of study drug, SUN N4057, in participant blood plasma samples drawn during infusions.
Outcome measures
| Measure |
Placebo
n=17 Participants
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.
|
SUN N4057
Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days.
|
|---|---|---|
|
Mean SUN N4057 Plasma Concentrations Over Time Following Treatment With SUN N4057
Day 1: Hour 0
|
0.00 ng/mL
Standard Deviation 0.00
|
—
|
|
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
|
—
|
|
Mean SUN N4057 Plasma Concentrations Over Time Following Treatment With SUN N4057
Day 1: Hour 6
|
28.34 ng/mL
Standard Deviation 9.19
|
—
|
|
Mean SUN N4057 Plasma Concentrations Over Time Following Treatment With SUN N4057
Day 1: Hour 12
|
32.46 ng/mL
Standard Deviation 12.26
|
—
|
|
Mean SUN N4057 Plasma Concentrations Over Time Following Treatment With SUN N4057
Day 2: Hour 0
|
11.26 ng/mL
Standard Deviation 4.66
|
—
|
|
Mean SUN N4057 Plasma Concentrations Over Time Following Treatment With SUN N4057
Day 2: Hour 1
|
31.91 ng/mL
Standard Deviation 9.52
|
—
|
|
Mean SUN N4057 Plasma Concentrations Over Time Following Treatment With SUN N4057
Day 2: Hour 6
|
26.85 ng/mL
Standard Deviation 7.92
|
—
|
|
Mean SUN N4057 Plasma Concentrations Over Time Following Treatment With SUN N4057
Day 2: Hour 12
|
37.75 ng/mL
Standard Deviation 33.02
|
—
|
|
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 outcome
Timeframe: Baseline (Day 1 pre-dose) up to Hour 24, and Hour 48 post-dose.Population: Cmax was assessed using the pharmacokinetic (PK) population.
Cmax is the observed maximum concentration of SUN N4057 in the participant blood plasma sample after drug administration.
Outcome measures
| Measure |
Placebo
n=17 Participants
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.
|
SUN N4057
Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days.
|
|---|---|---|
|
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 outcome
Timeframe: Day 1 pre-dose (Hour 0) up to Hour 24, and Hour 48 post-dose.Population: Cmin was assessed using the pharmacokinetic (PK) population.
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)
Outcome measures
| Measure |
Placebo
n=17 Participants
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.
|
SUN N4057
Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days.
|
|---|---|---|
|
Mean SUN N4057 Plasma Pharmacokinetic Parameter of Observed Minimum Concentration (Cmin) Following Treatment With SUN N4057
|
11.95 ng/mL
Standard Deviation 5.30
|
—
|
SECONDARY outcome
Timeframe: 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.
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)
Outcome measures
| Measure |
Placebo
n=17 Participants
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.
|
SUN N4057
Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days.
|
|---|---|---|
|
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 outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=17 Participants
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.
|
SUN N4057
Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days.
|
|---|---|---|
|
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 outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=7 Participants
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.
|
SUN N4057
n=18 Participants
Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days.
|
|---|---|---|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Ear pain
|
0 Participants
|
1 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Patients with Any TEAE
|
6 Participants
|
17 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Nausea
|
2 Participants
|
12 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Dizziness
|
0 Participants
|
8 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Hypertension
|
0 Participants
|
7 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Vomiting
|
0 Participants
|
7 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Disorientation
|
1 Participants
|
3 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Headache
|
0 Participants
|
4 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Dyskinesia
|
1 Participants
|
2 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Hyperhidrosis
|
0 Participants
|
3 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Blood Pressure increased
|
2 Participants
|
0 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Cold sweat
|
0 Participants
|
2 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Abdominal pain
|
0 Participants
|
1 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Arrhythmia
|
1 Participants
|
0 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Asthenia
|
0 Participants
|
1 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Bundle branch block right
|
1 Participants
|
0 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Chills
|
0 Participants
|
1 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Confusional state
|
0 Participants
|
1 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Dizziness postural
|
0 Participants
|
1 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Electrocardiogram abnormal
|
0 Participants
|
1 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Electrocardiogram QT prolonged
|
1 Participants
|
0 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Fecal incontinence
|
0 Participants
|
1 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Flushing
|
0 Participants
|
1 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Heart rate increased
|
1 Participants
|
0 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Hypotension
|
0 Participants
|
1 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Muscle spasms
|
1 Participants
|
0 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Nightmare
|
0 Participants
|
1 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Paresthesia
|
0 Participants
|
1 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Peripheral coldness
|
0 Participants
|
1 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Somnolence
|
0 Participants
|
1 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Tachycardia
|
0 Participants
|
1 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Tremor
|
0 Participants
|
1 Participants
|
|
Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo
Vision blurred
|
0 Participants
|
1 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
SUN N4057
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=7 participants at risk
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.
|
SUN N4057
n=18 participants at risk
Participants with Parkinson's disease who were administered two 12-hour IV infusions of SUN N4057 (piclozotan) over 2 inpatient days.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
28.6%
2/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
66.7%
12/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
44.4%
8/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
38.9%
7/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
38.9%
7/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
Psychiatric disorders
Disorientation
|
14.3%
1/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
22.2%
4/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
27.8%
5/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
22.2%
4/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
Nervous system disorders
Dyskinesia
|
14.3%
1/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
11.1%
2/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
11.1%
2/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
Investigations
Blood pressure increased
|
28.6%
2/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
0.00%
0/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
General disorders
Cold sweat
|
0.00%
0/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
11.1%
2/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
5.6%
1/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
Cardiac disorders
Arrhythmia
|
14.3%
1/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
0.00%
0/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
5.6%
1/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
General disorders
Asthenia
|
0.00%
0/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
5.6%
1/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
5.6%
1/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
Cardiac disorders
Bundle branch block right
|
14.3%
1/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
0.00%
0/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
Musculoskeletal and connective tissue disorders
Chills
|
0.00%
0/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
5.6%
1/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
5.6%
1/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
5.6%
1/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
5.6%
1/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
5.6%
1/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
5.6%
1/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
5.6%
1/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
Investigations
Electrocardiogram QT prolonged
|
14.3%
1/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
0.00%
0/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
5.6%
1/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
Vascular disorders
Flushing
|
0.00%
0/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
5.6%
1/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
Investigations
Heart rate increased
|
14.3%
1/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
0.00%
0/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
5.6%
1/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
Injury, poisoning and procedural complications
Injection site extravasation
|
0.00%
0/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
5.6%
1/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
14.3%
1/7 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
0.00%
0/18 • Adverse event data were assessed from the date the informed consent was given to Day 16 post-dose, up to approximately a total of 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place