Trial Outcomes & Findings for Nilotinib in Parkinson's Disease (NCT NCT03205488)
NCT ID: NCT03205488
Last Updated: 2020-07-22
Results Overview
The count of study participants who completed the 6-month study treatment period while active on their original assigned dose
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
76 participants
Primary outcome timeframe
6 months
Results posted on
2020-07-22
Participant Flow
From November 2017 to December 2018, 125 patients were assessed for eligibility. Of those screened, 76 participants were enrolled in the trial.
Of the patients assessed for eligibility, 49 (39%) were excluded. 42 patients did not meet inclusion criteria and 7 declined study participation.
Participant milestones
| Measure |
Placebo
Placebo enclosed in capsules to maintain the blind was administered orally once per day over the course of 6 months.
|
Nilotinib 150
Patients were administered 1 capsule of 150 mg Nilotinib and 1 capsule of matching placebo each day over the course of 6 months.
|
Nilotinib 300
Patients were administered 2 capsules of 150 mg Nilotinib each day over the course of 6 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
26
|
|
Overall Study
COMPLETED
|
24
|
23
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Placebo enclosed in capsules to maintain the blind was administered orally once per day over the course of 6 months.
|
Nilotinib 150
Patients were administered 1 capsule of 150 mg Nilotinib and 1 capsule of matching placebo each day over the course of 6 months.
|
Nilotinib 300
Patients were administered 2 capsules of 150 mg Nilotinib each day over the course of 6 months.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
4
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
Baseline Characteristics
Nilotinib in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=25 Participants
Placebo enclosed in capsules to maintain the blind was administered orally once per day over the course of 6 months.
|
Nilotinib 150
n=25 Participants
Patients were administered 1 capsule of 150 mg Nilotinib and 1 capsule of matching placebo each day over the course of 6 months.
|
Nilotinib 300
n=26 Participants
Patients were administered 2 capsules of 150 mg Nilotinib each day over the course of 6 months.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
61.2 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
66.9 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
64.6 years
STANDARD_DEVIATION 7.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
26 participants
n=5 Participants
|
76 participants
n=4 Participants
|
|
Parkinson's Disease History
Parkinson's Disease Duration
|
9.4 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
8.5 years
STANDARD_DEVIATION 3.2 • n=7 Participants
|
11.7 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
9.9 years
STANDARD_DEVIATION 4.7 • n=4 Participants
|
|
Parkinson's Disease History
Age at Diagnosis
|
56.2 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
52.7 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
55.2 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
54.7 years
STANDARD_DEVIATION 8.0 • n=4 Participants
|
|
MDS-UPDRS Total Score
MDS-UPDRS Total OFF Score
|
63.8 units on a scale
STANDARD_DEVIATION 21.3 • n=5 Participants
|
65.0 units on a scale
STANDARD_DEVIATION 16.0 • n=7 Participants
|
70.2 units on a scale
STANDARD_DEVIATION 20.2 • n=5 Participants
|
66.4 units on a scale
STANDARD_DEVIATION 19.3 • n=4 Participants
|
|
MDS-UPDRS Total Score
MDS-UPDRS Total ON Score
|
46.2 units on a scale
STANDARD_DEVIATION 17.8 • n=5 Participants
|
46.9 units on a scale
STANDARD_DEVIATION 15.1 • n=7 Participants
|
51.9 units on a scale
STANDARD_DEVIATION 15.7 • n=5 Participants
|
48.4 units on a scale
STANDARD_DEVIATION 16.2 • n=4 Participants
|
|
Parkinson's Disease Classifications
Hoehn and Yahr Stage 0-2
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Parkinson's Disease Classifications
Hoehn and Yahr Stage 3
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Parkinson's Disease Classifications
Class of Symptomatic Therapy, MAOB Inhibitors
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Levodopa Equivalent Daily Dose
|
1066.5 mg
STANDARD_DEVIATION 519.7 • n=5 Participants
|
971.8 mg
STANDARD_DEVIATION 251.4 • n=7 Participants
|
1012.5 mg
STANDARD_DEVIATION 390.5 • n=5 Participants
|
1016.9 mg
STANDARD_DEVIATION 398.7 • n=4 Participants
|
|
Education Adjusted MoCA Score
|
26.9 units on a scale
STANDARD_DEVIATION 2.4 • n=5 Participants
|
27.4 units on a scale
STANDARD_DEVIATION 1.9 • n=7 Participants
|
27.0 units on a scale
STANDARD_DEVIATION 2.4 • n=5 Participants
|
27.1 units on a scale
STANDARD_DEVIATION 2.2 • n=4 Participants
|
|
DRS-2
|
138.1 units on a scale
STANDARD_DEVIATION 5.7 • n=5 Participants
|
137.8 units on a scale
STANDARD_DEVIATION 7.8 • n=7 Participants
|
137.7 units on a scale
STANDARD_DEVIATION 6.3 • n=5 Participants
|
137.9 units on a scale
STANDARD_DEVIATION 6.6 • n=4 Participants
|
|
BDI-II
|
6.6 units on a scale
STANDARD_DEVIATION 4.9 • n=5 Participants
|
7.3 units on a scale
STANDARD_DEVIATION 5.4 • n=7 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 4.3 • n=5 Participants
|
6.8 units on a scale
STANDARD_DEVIATION 4.8 • n=4 Participants
|
|
PDSS
|
106.6 units on a scale
STANDARD_DEVIATION 21.8 • n=5 Participants
|
115.3 units on a scale
STANDARD_DEVIATION 11.6 • n=7 Participants
|
103.2 units on a scale
STANDARD_DEVIATION 18.6 • n=5 Participants
|
108.3 units on a scale
STANDARD_DEVIATION 18.3 • n=4 Participants
|
|
Modified S/E ADL
Modified S/E ADL OFF
|
73.2 units on a scale
STANDARD_DEVIATION 16.5 • n=5 Participants
|
77.3 units on a scale
STANDARD_DEVIATION 17.8 • n=7 Participants
|
77.0 units on a scale
STANDARD_DEVIATION 14.9 • n=5 Participants
|
75.8 units on a scale
STANDARD_DEVIATION 16.8 • n=4 Participants
|
|
Modified S/E ADL
Modified S/E ADL ON
|
86.8 units on a scale
STANDARD_DEVIATION 8.7 • n=5 Participants
|
92.2 units on a scale
STANDARD_DEVIATION 5.8 • n=7 Participants
|
87.0 units on a scale
STANDARD_DEVIATION 17.9 • n=5 Participants
|
88.6 units on a scale
STANDARD_DEVIATION 12.2 • n=4 Participants
|
|
PDQ-39
|
19.0 units on a scale
STANDARD_DEVIATION 12.7 • n=5 Participants
|
19.0 units on a scale
STANDARD_DEVIATION 9.4 • n=7 Participants
|
18.4 units on a scale
STANDARD_DEVIATION 10.3 • n=5 Participants
|
18.8 units on a scale
STANDARD_DEVIATION 10.8 • n=4 Participants
|
|
EQ-5D
EQ-5D Summary Index
|
0.79 units on a scale
STANDARD_DEVIATION 0.14 • n=5 Participants
|
0.83 units on a scale
STANDARD_DEVIATION 0.13 • n=7 Participants
|
0.78 units on a scale
STANDARD_DEVIATION 0.15 • n=5 Participants
|
0.80 units on a scale
STANDARD_DEVIATION 0.14 • n=4 Participants
|
|
EQ-5D
EQ-5D Health Score
|
70.6 units on a scale
STANDARD_DEVIATION 25.1 • n=5 Participants
|
71.5 units on a scale
STANDARD_DEVIATION 23.3 • n=7 Participants
|
76.0 units on a scale
STANDARD_DEVIATION 15.9 • n=5 Participants
|
72.8 units on a scale
STANDARD_DEVIATION 21.5 • n=4 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Intent-to-treat population, all randomized subjects per arm. The Count of participants below are the number of participants that met the criteria for analysis of tolerability.
The count of study participants who completed the 6-month study treatment period while active on their original assigned dose
Outcome measures
| Measure |
Placebo
n=25 Participants
Placebo enclosed in capsules to maintain the blind was administered orally once per day over the course of 6 months
|
Nilotinib 150 mg
n=25 Participants
Patients were administered 1 capsule of 150 mg Nilotinib and 1 capsule of matching placebo each day over the course of 6 months.
|
Nilotinib 300 mg
n=26 Participants
Patients were administered 2 capsules of 150 mg Nilotinib each day over the course of 6 months.
|
|---|---|---|---|
|
Tolerability of Nilotinib Over Placebo
|
21 Participants
|
19 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: We assessed adverse events that were collected from the first dose of study drug until 60 days after the participant's last dose.Population: Intent-to-treat population, all randomized subjects. The counts refer to the number of participants that experienced an SAE in each treatment arm.
The count of study participants who experienced any treatment-related SAE in each treatment group
Outcome measures
| Measure |
Placebo
n=25 Participants
Placebo enclosed in capsules to maintain the blind was administered orally once per day over the course of 6 months
|
Nilotinib 150 mg
n=25 Participants
Patients were administered 1 capsule of 150 mg Nilotinib and 1 capsule of matching placebo each day over the course of 6 months.
|
Nilotinib 300 mg
n=26 Participants
Patients were administered 2 capsules of 150 mg Nilotinib each day over the course of 6 months.
|
|---|---|---|---|
|
Safety of Nilotinib
|
2 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: The MDS-UPDRS Part III ON state was collected at baseline, day 14, day 30, month 3, month 6, 30 and 60 days post treatment. The OFF state was collected at baseline, month 3, month 6, 30 and 60 days post treatment.The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III is a motor examination in both practically defined medications OFF state (12 hrs post dose) and ON state (based on the participant/site investigator defined best ON and/or approximately 1 hour post dose). Measure Description: The part III subscale score ranges from 0-165. The Larger the value stands for more disability from PD.
Outcome measures
| Measure |
Placebo
n=25 Participants
Placebo enclosed in capsules to maintain the blind was administered orally once per day over the course of 6 months
|
Nilotinib 150 mg
n=25 Participants
Patients were administered 1 capsule of 150 mg Nilotinib and 1 capsule of matching placebo each day over the course of 6 months.
|
Nilotinib 300 mg
n=26 Participants
Patients were administered 2 capsules of 150 mg Nilotinib each day over the course of 6 months.
|
|---|---|---|---|
|
Change in MDS-UPDRS Part III
Baseline MDS-UPDRS Part III (ON)
|
22.80 units on a scale
Standard Deviation 8.85
|
24.76 units on a scale
Standard Deviation 11.62
|
25.15 units on a scale
Standard Deviation 8.17
|
|
Change in MDS-UPDRS Part III
Day 14 MDS-UPDRS Part III (ON)
|
23.13 units on a scale
Standard Deviation 11.29
|
27.58 units on a scale
Standard Deviation 13.53
|
29.33 units on a scale
Standard Deviation 9.77
|
|
Change in MDS-UPDRS Part III
Day 30 MDS-UPDRS Part III (ON)
|
22.36 units on a scale
Standard Deviation 10.00
|
26.84 units on a scale
Standard Deviation 13.08
|
29.73 units on a scale
Standard Deviation 10.83
|
|
Change in MDS-UPDRS Part III
Month 3 MDS-UPDRS Part III (ON)
|
19.83 units on a scale
Standard Deviation 9.23
|
24.88 units on a scale
Standard Deviation 13.70
|
25.76 units on a scale
Standard Deviation 8.71
|
|
Change in MDS-UPDRS Part III
Month 6 MDS-UPDRS Part III (ON)
|
19.63 units on a scale
Standard Deviation 9.86
|
24.43 units on a scale
Standard Deviation 11.50
|
25.61 units on a scale
Standard Deviation 8.93
|
|
Change in MDS-UPDRS Part III
30 Day Post MDS-UPDRS Part III (ON)
|
20.52 units on a scale
Standard Deviation 8.82
|
25.13 units on a scale
Standard Deviation 12.26
|
26.79 units on a scale
Standard Deviation 9.10
|
|
Change in MDS-UPDRS Part III
60 Day Post MDS-UPDRS Part III (ON)
|
20.88 units on a scale
Standard Deviation 10.88
|
23.91 units on a scale
Standard Deviation 12.93
|
26.42 units on a scale
Standard Deviation 10.58
|
|
Change in MDS-UPDRS Part III
Baseline MDS-UPDRS Part III (OFF)
|
40.36 units on a scale
Standard Deviation 13.51
|
42.84 units on a scale
Standard Deviation 12.53
|
43.50 units on a scale
Standard Deviation 14.01
|
|
Change in MDS-UPDRS Part III
Month 3 MDS-UPDRS Part III (OFF)
|
37.92 units on a scale
Standard Deviation 14.46
|
39.92 units on a scale
Standard Deviation 12.41
|
41.04 units on a scale
Standard Deviation 13.38
|
|
Change in MDS-UPDRS Part III
Month 6 MDS-UPDRS Part III (OFF)
|
36.21 units on a scale
Standard Deviation 14.91
|
41.91 units on a scale
Standard Deviation 13.40
|
43.96 units on a scale
Standard Deviation 11.62
|
|
Change in MDS-UPDRS Part III
30 Day Post MDS-UPDRS Part III (OFF)
|
38.92 units on a scale
Standard Deviation 14.15
|
41.48 units on a scale
Standard Deviation 12.19
|
45.26 units on a scale
Standard Deviation 14.13
|
|
Change in MDS-UPDRS Part III
60 Day Post MDS-UPDRS Part III (OFF)
|
37.36 units on a scale
Standard Deviation 14.20
|
40.27 units on a scale
Standard Deviation 11.33
|
43.00 units on a scale
Standard Deviation 13.63
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Nilotinib 150
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Nilotinib 300
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=25 participants at risk
Placebo enclosed in capsules to maintain the blind was administered orally once per day over the course of 6 months.
|
Nilotinib 150
n=25 participants at risk
Patients were administered 1 capsule of 150 mg Nilotinib and 1 capsule of matching placebo once per day over the course of 6 months.
|
Nilotinib 300
n=26 participants at risk
Patients were administered 2 capsules of 150 mg Nilotinib once per day over the course of 6 months.
|
|---|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/25 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
0.00%
0/25 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
3.8%
1/26 • Number of events 1 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.0%
1/25 • Number of events 1 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
0.00%
0/25 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
0.00%
0/26 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.0%
1/25 • Number of events 1 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
0.00%
0/25 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
0.00%
0/26 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/25 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
4.0%
1/25 • Number of events 1 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
0.00%
0/26 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
Other adverse events
| Measure |
Placebo
n=25 participants at risk
Placebo enclosed in capsules to maintain the blind was administered orally once per day over the course of 6 months.
|
Nilotinib 150
n=25 participants at risk
Patients were administered 1 capsule of 150 mg Nilotinib and 1 capsule of matching placebo once per day over the course of 6 months.
|
Nilotinib 300
n=26 participants at risk
Patients were administered 2 capsules of 150 mg Nilotinib once per day over the course of 6 months.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.0%
2/25 • Number of events 2 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
0.00%
0/25 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
0.00%
0/26 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
4.0%
1/25 • Number of events 1 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
8.0%
2/25 • Number of events 2 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
3.8%
1/26 • Number of events 1 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/25 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
8.0%
2/25 • Number of events 2 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
7.7%
2/26 • Number of events 2 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
12.0%
3/25 • Number of events 4 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
0.00%
0/25 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
0.00%
0/26 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
8.0%
2/25 • Number of events 2 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
15.4%
4/26 • Number of events 5 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
|
General disorders
Fatigue
|
16.0%
4/25 • Number of events 5 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
16.0%
4/25 • Number of events 4 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
0.00%
0/26 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
5/25 • Number of events 5 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
8.0%
2/25 • Number of events 2 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
7.7%
2/26 • Number of events 3 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
8.0%
2/25 • Number of events 3 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
4.0%
1/25 • Number of events 1 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
0.00%
0/26 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
8.0%
2/25 • Number of events 2 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
4.0%
1/25 • Number of events 1 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
0.00%
0/26 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
|
Investigations
Amylase Increased
|
8.0%
2/25 • Number of events 2 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
16.0%
4/25 • Number of events 4 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
15.4%
4/26 • Number of events 6 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/25 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
0.00%
0/25 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
7.7%
2/26 • Number of events 2 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
|
Investigations
CSF protein increased
|
0.00%
0/25 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
0.00%
0/25 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
7.7%
2/26 • Number of events 2 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
|
Investigations
Lipase increased
|
16.0%
4/25 • Number of events 5 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
28.0%
7/25 • Number of events 11 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
23.1%
6/26 • Number of events 9 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.0%
2/25 • Number of events 2 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
8.0%
2/25 • Number of events 2 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
7.7%
2/26 • Number of events 2 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/25 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
8.0%
2/25 • Number of events 2 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
0.00%
0/26 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.0%
3/25 • Number of events 3 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
0.00%
0/25 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
0.00%
0/26 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.0%
1/25 • Number of events 1 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
8.0%
2/25 • Number of events 2 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
0.00%
0/26 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
|
Nervous system disorders
Dizziness
|
4.0%
1/25 • Number of events 1 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
16.0%
4/25 • Number of events 4 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
0.00%
0/26 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
|
Nervous system disorders
Dyskinesia
|
4.0%
1/25 • Number of events 1 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
8.0%
2/25 • Number of events 2 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
0.00%
0/26 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
|
Nervous system disorders
Headache
|
8.0%
2/25 • Number of events 2 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
4.0%
1/25 • Number of events 1 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
11.5%
3/26 • Number of events 3 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
|
Nervous system disorders
Tremor
|
4.0%
1/25 • Number of events 2 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
8.0%
2/25 • Number of events 2 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
3.8%
1/26 • Number of events 1 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
20.0%
5/25 • Number of events 11 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
16.0%
4/25 • Number of events 4 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
0.00%
0/26 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
12.0%
3/25 • Number of events 4 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
0.00%
0/25 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
0.00%
0/26 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/25 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
12.0%
3/25 • Number of events 3 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
3.8%
1/26 • Number of events 1 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.0%
1/25 • Number of events 1 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
8.0%
2/25 • Number of events 2 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
0.00%
0/26 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
|
Vascular disorders
Hypertension
|
4.0%
1/25 • Number of events 1 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
8.0%
2/25 • Number of events 2 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
3.8%
1/26 • Number of events 1 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/25 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
4.0%
1/25 • Number of events 1 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
7.7%
2/26 • Number of events 2 • Treatment emergent adverse events were collected following the first dose of study drug until 30 days after the participant's last dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place