Trial Outcomes & Findings for A Study of Lasmiditan on the Heart in Healthy Participants (NCT NCT03465436)
NCT ID: NCT03465436
Last Updated: 2020-01-31
Results Overview
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTcF = QT/RR\^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and R-R wave (RR), which is the interval between two R waves. PR is the interval between the P wave and the ventricular depolarization wave (QRS) complex.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
56 participants
Primary outcome timeframe
Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose
Results posted on
2020-01-31
Participant Flow
All randomized participants who received at least 1 dose of study drug.
Participant milestones
| Measure |
Sequence 1 ABDC
Day 1 of each treatment period with a washout period of 7-14 days.
A. 100 mg lasmiditan PO B. 400 mg lasmiditan PO D. 400 mg moxifloxacin PO (plus placebo) C. Placebo matched
|
Sequence 2 BCAD
Day 1 of each treatment period with a washout period of 7-14 days.
B. 400 mg lasmiditan PO C. Placebo matched A. 100 mg lasmiditan PO D. 400 mg moxifloxacin PO (plus placebo)
|
Sequence 3 CDBA
Day 1 of each treatment period with a washout period of 7-14 days.
C. Placebo matched D. 400 mg moxifloxacin PO (plus placebo) B. 400 mg lasmiditan PO A. 100 mg lasmiditan PO
|
Sequence 4 DACB
Day 1 of each treatment period with a washout period of 7-14 days.
D. 400 mg moxifloxacin PO (plus placebo) A. 100 mg lasmiditan PO C. Placebo matched B. 400 mg lasmiditan PO
|
|---|---|---|---|---|
|
Period 1
STARTED
|
14
|
14
|
14
|
14
|
|
Period 1
Received at Least 1 Dose of Study Drug
|
14
|
14
|
14
|
14
|
|
Period 1
COMPLETED
|
14
|
14
|
13
|
14
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
1
|
0
|
|
Period 2
STARTED
|
14
|
14
|
13
|
14
|
|
Period 2
Received at Least 1 Dose of Study Drug
|
14
|
13
|
13
|
14
|
|
Period 2
COMPLETED
|
14
|
13
|
13
|
14
|
|
Period 2
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Period 3
STARTED
|
14
|
13
|
13
|
14
|
|
Period 3
Received at Least One Dose of Study Drug
|
13
|
12
|
13
|
14
|
|
Period 3
COMPLETED
|
13
|
12
|
13
|
14
|
|
Period 3
NOT COMPLETED
|
1
|
1
|
0
|
0
|
|
Period 4
STARTED
|
13
|
12
|
13
|
14
|
|
Period 4
Received at Least 1 Dose of Study Drug
|
13
|
12
|
13
|
14
|
|
Period 4
COMPLETED
|
13
|
12
|
12
|
14
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1 ABDC
Day 1 of each treatment period with a washout period of 7-14 days.
A. 100 mg lasmiditan PO B. 400 mg lasmiditan PO D. 400 mg moxifloxacin PO (plus placebo) C. Placebo matched
|
Sequence 2 BCAD
Day 1 of each treatment period with a washout period of 7-14 days.
B. 400 mg lasmiditan PO C. Placebo matched A. 100 mg lasmiditan PO D. 400 mg moxifloxacin PO (plus placebo)
|
Sequence 3 CDBA
Day 1 of each treatment period with a washout period of 7-14 days.
C. Placebo matched D. 400 mg moxifloxacin PO (plus placebo) B. 400 mg lasmiditan PO A. 100 mg lasmiditan PO
|
Sequence 4 DACB
Day 1 of each treatment period with a washout period of 7-14 days.
D. 400 mg moxifloxacin PO (plus placebo) A. 100 mg lasmiditan PO C. Placebo matched B. 400 mg lasmiditan PO
|
|---|---|---|---|---|
|
Period 1
Protocol Violation
|
0
|
0
|
1
|
0
|
|
Period 2
Protocol Violation
|
0
|
1
|
0
|
0
|
|
Period 3
Protocol Violation
|
1
|
1
|
0
|
0
|
|
Period 4
Protocol Violation
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Lasmiditan on the Heart in Healthy Participants
Baseline characteristics by cohort
| Measure |
Sequence 1 ABDC
n=14 Participants
Day 1 of each treatment period with a washout period of 7-14 days.
A. 100 mg lasmiditan PO B. 400 mg lasmiditan PO D. 400 mg moxifloxacin PO (plus placebo) C. Placebo matched
|
Sequence 2 BCAD
n=14 Participants
Day 1 of each treatment period with a washout period of 7-14 days.
B. 400 mg lasmiditan PO C. Placebo matched A. 100 mg lasmiditan PO D. 400 mg moxifloxacin PO (plus placebo)
|
Sequence 3 CDBA
n=14 Participants
Day 1 of each treatment period with a washout period of 7-14 days.
C. Placebo matched D. 400 mg moxifloxacin PO (plus placebo) B. 400 mg lasmiditan PO A. 100 mg lasmiditan PO
|
Sequence 4 DACB
n=14 Participants
Day 1 of each treatment period with a washout period of 7-14 days.
D. 400 mg moxifloxacin PO (plus placebo) A. 100 mg lasmiditan PO C. Placebo matched B. 400 mg lasmiditan PO
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.6 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
38.4 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
37.5 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
40.7 years
STANDARD_DEVIATION 9.1 • n=4 Participants
|
39.3 years
STANDARD_DEVIATION 10.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
56 Participants
n=21 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
|
0 Participants
n=21 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
|
0 Participants
n=21 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
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdosePopulation: All randomized participants who received at least 1 dose of study drug and have evaluable QTcF data.
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTcF = QT/RR\^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and R-R wave (RR), which is the interval between two R waves. PR is the interval between the P wave and the ventricular depolarization wave (QRS) complex.
Outcome measures
| Measure |
100 mg Lasmiditan
n=52 Participants
100 mg lasmiditan administered PO in 1 of 4 treatment periods
|
400 mg Lasmiditan
n=55 Participants
400 mg lasmiditan administered PO in 1 of 4 treatment periods
|
Placebo
n=54 Participants
Placebo administered PO in 1 of 4 treatment periods.
|
Moxifloxacin
n=52 Participants
Moxifloxacin administered PO in 1 of 4 treatment periods.
|
|---|---|---|---|---|
|
Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin
3.5 hours postdose
|
-2.39 milliseconds
Standard Deviation 7.63
|
3.58 milliseconds
Standard Deviation 6.88
|
-1.85 milliseconds
Standard Deviation 4.59
|
10.37 milliseconds
Standard Deviation 7.09
|
|
Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin
4 hours postdose
|
-2.12 milliseconds
Standard Deviation 6.89
|
4.77 milliseconds
Standard Deviation 7.49
|
-2.34 milliseconds
Standard Deviation 5.65
|
9.39 milliseconds
Standard Deviation 5.85
|
|
Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin
6 hours postdose
|
-4.33 milliseconds
Standard Deviation 7.32
|
-0.18 milliseconds
Standard Deviation 7.38
|
-3.39 milliseconds
Standard Deviation 6.59
|
4.91 milliseconds
Standard Deviation 7.05
|
|
Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin
8 hours postdose
|
-6.74 milliseconds
Standard Deviation 7.16
|
-1.84 milliseconds
Standard Deviation 7.82
|
-3.99 milliseconds
Standard Deviation 7.11
|
3.90 milliseconds
Standard Deviation 7.13
|
|
Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin
12 hours postdose
|
-3.73 milliseconds
Standard Deviation 5.72
|
-0.41 milliseconds
Standard Deviation 6.99
|
-1.79 milliseconds
Standard Deviation 5.91
|
4.63 milliseconds
Standard Deviation 7.12
|
|
Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin
24 hours postdose
|
0.74 milliseconds
Standard Deviation 7.51
|
0.38 milliseconds
Standard Deviation 7.06
|
0.45 milliseconds
Standard Deviation 6.18
|
6.61 milliseconds
Standard Deviation 7.91
|
|
Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin
30 minutes postdose
|
-8.90 milliseconds
Standard Deviation 7.20
|
-9.27 milliseconds
Standard Deviation 6.29
|
-5.49 milliseconds
Standard Deviation 5.52
|
1.90 milliseconds
Standard Deviation 8.69
|
|
Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin
1 hour postdose
|
-7.42 milliseconds
Standard Deviation 5.83
|
-4.58 milliseconds
Standard Deviation 8.13
|
-3.94 milliseconds
Standard Deviation 5.15
|
8.36 milliseconds
Standard Deviation 6.51
|
|
Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin
1.5 hours postdose
|
-7.63 milliseconds
Standard Deviation 5.98
|
-3.07 milliseconds
Standard Deviation 7.91
|
-3.68 milliseconds
Standard Deviation 4.66
|
7.63 milliseconds
Standard Deviation 6.32
|
|
Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin
2 hours postdose
|
-6.96 milliseconds
Standard Deviation 7.08
|
-1.12 milliseconds
Standard Deviation 8.10
|
-3.83 milliseconds
Standard Deviation 5.28
|
8.16 milliseconds
Standard Deviation 7.21
|
|
Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin
2.5 hours postdose
|
-5.26 milliseconds
Standard Deviation 7.36
|
0.15 milliseconds
Standard Deviation 8.67
|
-2.89 milliseconds
Standard Deviation 4.99
|
8.12 milliseconds
Standard Deviation 7.15
|
|
Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin
3 hours postdose
|
-2.81 milliseconds
Standard Deviation 6.95
|
2.06 milliseconds
Standard Deviation 8.18
|
-2.04 milliseconds
Standard Deviation 5.71
|
10.01 milliseconds
Standard Deviation 6.42
|
SECONDARY outcome
Timeframe: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdosePopulation: All randomized participants who received at least 1 dose of study drug and have evaluable QTcI data.
The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for participant pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.
Outcome measures
| Measure |
100 mg Lasmiditan
n=52 Participants
100 mg lasmiditan administered PO in 1 of 4 treatment periods
|
400 mg Lasmiditan
n=55 Participants
400 mg lasmiditan administered PO in 1 of 4 treatment periods
|
Placebo
n=54 Participants
Placebo administered PO in 1 of 4 treatment periods.
|
Moxifloxacin
n=52 Participants
Moxifloxacin administered PO in 1 of 4 treatment periods.
|
|---|---|---|---|---|
|
Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin
30 minutes postdose
|
-9.92 milliseconds
Standard Deviation 7.62
|
-10.56 milliseconds
Standard Deviation 8.00
|
-5.27 milliseconds
Standard Deviation 6.04
|
2.24 milliseconds
Standard Deviation 8.88
|
|
Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin
1 hour postdose
|
-9.50 milliseconds
Standard Deviation 7.74
|
-6.90 milliseconds
Standard Deviation 8.98
|
-3.35 milliseconds
Standard Deviation 5.52
|
8.96 milliseconds
Standard Deviation 7.14
|
|
Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin
1.5 hours postdose
|
-9.39 milliseconds
Standard Deviation 6.93
|
-4.73 milliseconds
Standard Deviation 8.29
|
-2.81 milliseconds
Standard Deviation 5.58
|
8.61 milliseconds
Standard Deviation 6.42
|
|
Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin
2 hours postdose
|
-8.74 milliseconds
Standard Deviation 8.34
|
-2.65 milliseconds
Standard Deviation 8.56
|
-3.49 milliseconds
Standard Deviation 5.82
|
8.29 milliseconds
Standard Deviation 7.03
|
|
Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin
2.5 hours postdose
|
-7.90 milliseconds
Standard Deviation 9.42
|
-1.80 milliseconds
Standard Deviation 8.84
|
-2.44 milliseconds
Standard Deviation 5.61
|
8.40 milliseconds
Standard Deviation 7.53
|
|
Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin
3.5 hours postdose
|
-3.86 milliseconds
Standard Deviation 8.72
|
1.90 milliseconds
Standard Deviation 7.48
|
-1.67 milliseconds
Standard Deviation 5.01
|
11.43 milliseconds
Standard Deviation 7.38
|
|
Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin
4 hours postdose
|
-3.25 milliseconds
Standard Deviation 8.07
|
3.27 milliseconds
Standard Deviation 8.44
|
-1.19 milliseconds
Standard Deviation 6.37
|
10.28 milliseconds
Standard Deviation 6.50
|
|
Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin
6 hours postdose
|
-4.84 milliseconds
Standard Deviation 7.00
|
-1.27 milliseconds
Standard Deviation 6.65
|
-3.13 milliseconds
Standard Deviation 6.61
|
4.85 milliseconds
Standard Deviation 7.37
|
|
Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin
8 hours postdose
|
-7.10 milliseconds
Standard Deviation 7.76
|
-3.08 milliseconds
Standard Deviation 8.23
|
-3.89 milliseconds
Standard Deviation 6.77
|
4.04 milliseconds
Standard Deviation 7.01
|
|
Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin
12 hours postdose
|
-4.08 milliseconds
Standard Deviation 5.88
|
-0.64 milliseconds
Standard Deviation 6.86
|
-1.65 milliseconds
Standard Deviation 6.09
|
4.87 milliseconds
Standard Deviation 7.14
|
|
Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin
24 hours postdose
|
1.60 milliseconds
Standard Deviation 6.84
|
0.45 milliseconds
Standard Deviation 6.85
|
0.81 milliseconds
Standard Deviation 6.22
|
6.74 milliseconds
Standard Deviation 8.14
|
|
Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin
3 hours postdose
|
-5.08 milliseconds
Standard Deviation 8.29
|
-0.13 milliseconds
Standard Deviation 8.63
|
-1.70 milliseconds
Standard Deviation 6.10
|
11.01 milliseconds
Standard Deviation 6.89
|
SECONDARY outcome
Timeframe: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdosePopulation: All randomized participants who received at least 1 dose of study drug and have evaluable RR interval data.
ECGs were used to calculate cardiac intervals. The RR interval is the time between two R waves.
Outcome measures
| Measure |
100 mg Lasmiditan
n=52 Participants
100 mg lasmiditan administered PO in 1 of 4 treatment periods
|
400 mg Lasmiditan
n=55 Participants
400 mg lasmiditan administered PO in 1 of 4 treatment periods
|
Placebo
n=54 Participants
Placebo administered PO in 1 of 4 treatment periods.
|
Moxifloxacin
n=52 Participants
Moxifloxacin administered PO in 1 of 4 treatment periods.
|
|---|---|---|---|---|
|
Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin
30 minutes postdose
|
74.40 milliseconds
Standard Deviation 76.26
|
98.52 milliseconds
Standard Deviation 72.99
|
42.13 milliseconds
Standard Deviation 56.00
|
18.66 milliseconds
Standard Deviation 61.84
|
|
Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin
1 hour postdose
|
149.22 milliseconds
Standard Deviation 77.73
|
153.15 milliseconds
Standard Deviation 65.13
|
49.87 milliseconds
Standard Deviation 62.40
|
9.63 milliseconds
Standard Deviation 63.32
|
|
Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin
1.5 hours postdose
|
143.29 milliseconds
Standard Deviation 80.63
|
130.79 milliseconds
Standard Deviation 55.91
|
36.84 milliseconds
Standard Deviation 66.52
|
13.44 milliseconds
Standard Deviation 61.66
|
|
Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin
2 hours postdose
|
118.39 milliseconds
Standard Deviation 60.84
|
128.10 milliseconds
Standard Deviation 48.50
|
44.69 milliseconds
Standard Deviation 53.70
|
26.01 milliseconds
Standard Deviation 54.44
|
|
Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin
2.5 hours postdose
|
117.90 milliseconds
Standard Deviation 73.85
|
132.86 milliseconds
Standard Deviation 54.35
|
29.28 milliseconds
Standard Deviation 51.39
|
26.90 milliseconds
Standard Deviation 68.18
|
|
Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin
3 hours postdose
|
105.56 milliseconds
Standard Deviation 63.82
|
119.52 milliseconds
Standard Deviation 60.66
|
30.84 milliseconds
Standard Deviation 57.28
|
24.87 milliseconds
Standard Deviation 66.41
|
|
Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin
3.5 hours postdose
|
89.85 milliseconds
Standard Deviation 56.54
|
101.86 milliseconds
Standard Deviation 59.04
|
36.77 milliseconds
Standard Deviation 50.34
|
19.01 milliseconds
Standard Deviation 65.56
|
|
Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin
4 hours postdose
|
72.22 milliseconds
Standard Deviation 57.19
|
83.00 milliseconds
Standard Deviation 56.84
|
30.32 milliseconds
Standard Deviation 51.11
|
13.64 milliseconds
Standard Deviation 68.55
|
|
Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin
6 hours postdose
|
-26.01 milliseconds
Standard Deviation 69.03
|
-3.07 milliseconds
Standard Deviation 63.34
|
-88.95 milliseconds
Standard Deviation 60.15
|
-84.12 milliseconds
Standard Deviation 63.34
|
|
Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin
8 hours postdose
|
5.63 milliseconds
Standard Deviation 73.58
|
29.01 milliseconds
Standard Deviation 66.89
|
-50.89 milliseconds
Standard Deviation 75.72
|
-49.70 milliseconds
Standard Deviation 52.21
|
|
Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin
12 hours postdose
|
-26.70 milliseconds
Standard Deviation 77.94
|
5.19 milliseconds
Standard Deviation 73.16
|
-61.53 milliseconds
Standard Deviation 76.51
|
-74.80 milliseconds
Standard Deviation 70.71
|
|
Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin
24 hours postdose
|
-16.37 milliseconds
Standard Deviation 68.00
|
-5.64 milliseconds
Standard Deviation 63.34
|
-11.66 milliseconds
Standard Deviation 60.48
|
-13.02 milliseconds
Standard Deviation 52.97
|
SECONDARY outcome
Timeframe: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdosePopulation: All randomized participants who received at least 1 dose of study drug and have evaluable QRS data.
ECGs were used to calculate cardiac intervals. The QRS interval is the time the segment of the ECG that corresponds to depolarization of the ventricles.
Outcome measures
| Measure |
100 mg Lasmiditan
n=52 Participants
100 mg lasmiditan administered PO in 1 of 4 treatment periods
|
400 mg Lasmiditan
n=55 Participants
400 mg lasmiditan administered PO in 1 of 4 treatment periods
|
Placebo
n=54 Participants
Placebo administered PO in 1 of 4 treatment periods.
|
Moxifloxacin
n=52 Participants
Moxifloxacin administered PO in 1 of 4 treatment periods.
|
|---|---|---|---|---|
|
Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin
30 minutes postdose
|
0.11 milliseconds
Standard Deviation 1.12
|
-0.10 milliseconds
Standard Deviation 1.23
|
0.09 milliseconds
Standard Deviation 1.28
|
-0.00 milliseconds
Standard Deviation 0.97
|
|
Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin
1 hours postdose
|
-0.24 milliseconds
Standard Deviation 1.21
|
0.45 milliseconds
Standard Deviation 1.35
|
-0.02 milliseconds
Standard Deviation 1.20
|
-0.12 milliseconds
Standard Deviation 1.07
|
|
Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin
3.5 hours postdose
|
-0.58 milliseconds
Standard Deviation 1.00
|
0.15 milliseconds
Standard Deviation 1.15
|
-0.17 milliseconds
Standard Deviation 0.98
|
-0.57 milliseconds
Standard Deviation 1.34
|
|
Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin
4 hours postdose
|
-0.54 milliseconds
Standard Deviation 1.03
|
0.29 milliseconds
Standard Deviation 1.17
|
-0.20 milliseconds
Standard Deviation 0.95
|
-0.58 milliseconds
Standard Deviation 1.25
|
|
Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin
6 hours postdose
|
0.20 milliseconds
Standard Deviation 1.43
|
0.64 milliseconds
Standard Deviation 1.50
|
0.73 milliseconds
Standard Deviation 1.34
|
0.13 milliseconds
Standard Deviation 1.39
|
|
Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin
8 hours postdose
|
-0.41 milliseconds
Standard Deviation 1.36
|
-0.39 milliseconds
Standard Deviation 1.43
|
-0.28 milliseconds
Standard Deviation 1.38
|
-0.67 milliseconds
Standard Deviation 1.34
|
|
Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin
12 hours postdose
|
0.34 milliseconds
Standard Deviation 1.46
|
0.24 milliseconds
Standard Deviation 1.67
|
0.63 milliseconds
Standard Deviation 1.05
|
0.32 milliseconds
Standard Deviation 1.52
|
|
Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin
24 hours postdose
|
0.33 milliseconds
Standard Deviation 1.22
|
-0.07 milliseconds
Standard Deviation 1.22
|
-0.10 milliseconds
Standard Deviation 1.32
|
0.09 milliseconds
Standard Deviation 1.28
|
|
Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin
1.5 hours postdose
|
-0.48 milliseconds
Standard Deviation 1.13
|
0.19 milliseconds
Standard Deviation 1.24
|
-0.37 milliseconds
Standard Deviation 1.06
|
-0.12 milliseconds
Standard Deviation 1.09
|
|
Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin
2 hours postdose
|
-0.73 milliseconds
Standard Deviation 1.12
|
0.10 milliseconds
Standard Deviation 1.08
|
-0.30 milliseconds
Standard Deviation 1.22
|
-0.29 milliseconds
Standard Deviation 1.14
|
|
Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin
2.5 hours postdose
|
-0.75 milliseconds
Standard Deviation 1.41
|
0.30 milliseconds
Standard Deviation 1.22
|
-0.21 milliseconds
Standard Deviation 1.08
|
-0.20 milliseconds
Standard Deviation 1.11
|
|
Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin
3 hours postdose
|
-0.63 milliseconds
Standard Deviation 1.21
|
0.08 milliseconds
Standard Deviation 1.19
|
-0.26 milliseconds
Standard Deviation 1.19
|
-0.35 milliseconds
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdosePopulation: All randomized participants who received at least 1 dose of study drug and have evaluable HR data.
Heart rate was determined during ambulatory blood pressure monitoring (ABPM).
Outcome measures
| Measure |
100 mg Lasmiditan
n=52 Participants
100 mg lasmiditan administered PO in 1 of 4 treatment periods
|
400 mg Lasmiditan
n=55 Participants
400 mg lasmiditan administered PO in 1 of 4 treatment periods
|
Placebo
n=54 Participants
Placebo administered PO in 1 of 4 treatment periods.
|
Moxifloxacin
n=52 Participants
Moxifloxacin administered PO in 1 of 4 treatment periods.
|
|---|---|---|---|---|
|
Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin
1 hour postdose
|
-7.82 beats per minute
Standard Deviation 3.95
|
-8.40 beats per minute
Standard Deviation 3.21
|
-2.77 beats per minute
Standard Deviation 3.55
|
-0.42 beats per minute
Standard Deviation 4.05
|
|
Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin
1.5 hours postdose
|
-7.55 beats per minute
Standard Deviation 4.16
|
-7.41 beats per minute
Standard Deviation 3.14
|
-2.01 beats per minute
Standard Deviation 3.53
|
-0.67 beats per minute
Standard Deviation 3.73
|
|
Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin
2 hours postdose
|
-6.62 beats per minute
Standard Deviation 3.22
|
-7.30 beats per minute
Standard Deviation 2.93
|
-2.65 beats per minute
Standard Deviation 3.17
|
-1.52 beats per minute
Standard Deviation 3.19
|
|
Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin
2.5 hours postdose
|
-6.49 beats per minute
Standard Deviation 4.07
|
-7.59 beats per minute
Standard Deviation 3.27
|
-1.75 beats per minute
Standard Deviation 2.97
|
-1.48 beats per minute
Standard Deviation 4.07
|
|
Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin
3 hours postdose
|
-5.96 beats per minute
Standard Deviation 3.32
|
-6.82 beats per minute
Standard Deviation 3.53
|
-1.83 beats per minute
Standard Deviation 3.35
|
-1.26 beats per minute
Standard Deviation 3.95
|
|
Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin
8 hours postdose
|
-0.43 beats per minute
Standard Deviation 4.73
|
-1.96 beats per minute
Standard Deviation 3.93
|
3.42 beats per minute
Standard Deviation 5.05
|
3.10 beats per minute
Standard Deviation 3.42
|
|
Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin
12 hours postdose
|
1.58 beats per minute
Standard Deviation 5.31
|
-0.50 beats per minute
Standard Deviation 4.66
|
4.17 beats per minute
Standard Deviation 5.46
|
4.95 beats per minute
Standard Deviation 5.12
|
|
Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin
30 minutes postdose
|
-3.90 beats per minute
Standard Deviation 5.05
|
-5.51 beats per minute
Standard Deviation 3.74
|
-2.41 beats per minute
Standard Deviation 3.22
|
-1.02 beats per minute
Standard Deviation 3.75
|
|
Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin
3.5 hours postdose
|
-5.26 beats per minute
Standard Deviation 3.02
|
-6.02 beats per minute
Standard Deviation 3.50
|
-2.32 beats per minute
Standard Deviation 3.06
|
-0.91 beats per minute
Standard Deviation 4.23
|
|
Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin
4 hours postdose
|
-4.22 beats per minute
Standard Deviation 3.06
|
-5.02 beats per minute
Standard Deviation 3.42
|
-1.82 beats per minute
Standard Deviation 3.19
|
-0.55 beats per minute
Standard Deviation 4.37
|
|
Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin
6 hours postdose
|
1.65 beats per minute
Standard Deviation 4.52
|
-0.10 beats per minute
Standard Deviation 3.77
|
6.29 beats per minute
Standard Deviation 5.18
|
5.84 beats per minute
Standard Deviation 4.84
|
|
Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin
24 hours postdose
|
1.01 beats per minute
Standard Deviation 4.45
|
0.42 beats per minute
Standard Deviation 4.09
|
0.89 beats per minute
Standard Deviation 3.96
|
0.81 beats per minute
Standard Deviation 3.60
|
SECONDARY outcome
Timeframe: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdosePopulation: All randomized participants who received at least 1 dose of study drug.
ECGs were assessed for morphology abnormalities or changes in QTcf interval greater than 450 milliseconds by a board-certified cardiologist
Outcome measures
| Measure |
100 mg Lasmiditan
n=52 Participants
100 mg lasmiditan administered PO in 1 of 4 treatment periods
|
400 mg Lasmiditan
n=55 Participants
400 mg lasmiditan administered PO in 1 of 4 treatment periods
|
Placebo
n=54 Participants
Placebo administered PO in 1 of 4 treatment periods.
|
Moxifloxacin
n=52 Participants
Moxifloxacin administered PO in 1 of 4 treatment periods.
|
|---|---|---|---|---|
|
Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds
6 hours postdose
|
0 Incidents
|
0 Incidents
|
0 Incidents
|
0 Incidents
|
|
Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds
30 minutes postdose
|
0 Incidents
|
0 Incidents
|
0 Incidents
|
1 Incidents
|
|
Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds
2.5 hours postdose
|
1 Incidents
|
1 Incidents
|
0 Incidents
|
2 Incidents
|
|
Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds
3 hours postdose
|
1 Incidents
|
1 Incidents
|
0 Incidents
|
2 Incidents
|
|
Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds
4 hours postdose
|
1 Incidents
|
1 Incidents
|
0 Incidents
|
3 Incidents
|
|
Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds
Predose
|
0 Incidents
|
0 Incidents
|
0 Incidents
|
0 Incidents
|
|
Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds
1 hour postdose
|
2 Incidents
|
0 Incidents
|
0 Incidents
|
2 Incidents
|
|
Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds
1.5 hours postdose
|
0 Incidents
|
1 Incidents
|
0 Incidents
|
2 Incidents
|
|
Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds
2 hours postdose
|
1 Incidents
|
1 Incidents
|
0 Incidents
|
3 Incidents
|
|
Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds
3.5 hours postdose
|
1 Incidents
|
2 Incidents
|
0 Incidents
|
3 Incidents
|
|
Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds
8 hours postdose
|
0 Incidents
|
1 Incidents
|
0 Incidents
|
0 Incidents
|
|
Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds
12 hours postdose
|
0 Incidents
|
0 Incidents
|
0 Incidents
|
0 Incidents
|
|
Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds
24 hours postdose
|
0 Incidents
|
0 Incidents
|
0 Incidents
|
0 Incidents
|
SECONDARY outcome
Timeframe: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdosePopulation: All randomized participants who received at least 1 dose of lasmiditan.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan.
Outcome measures
| Measure |
100 mg Lasmiditan
n=52 Participants
100 mg lasmiditan administered PO in 1 of 4 treatment periods
|
400 mg Lasmiditan
n=55 Participants
400 mg lasmiditan administered PO in 1 of 4 treatment periods
|
Placebo
Placebo administered PO in 1 of 4 treatment periods.
|
Moxifloxacin
Moxifloxacin administered PO in 1 of 4 treatment periods.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan
|
104.55 nanogram per milliliter
Standard Deviation 41.452
|
526.15 nanogram per milliliter
Standard Deviation 240.997
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdosePopulation: All randomized participants who received at least 1 dose of lasmiditan.
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC-t) of Lasmiditan.
Outcome measures
| Measure |
100 mg Lasmiditan
n=52 Participants
100 mg lasmiditan administered PO in 1 of 4 treatment periods
|
400 mg Lasmiditan
n=55 Participants
400 mg lasmiditan administered PO in 1 of 4 treatment periods
|
Placebo
Placebo administered PO in 1 of 4 treatment periods.
|
Moxifloxacin
Moxifloxacin administered PO in 1 of 4 treatment periods.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC-t) of Lasmiditan
|
684.66 hours*nanogram per milliliter
Geometric Coefficient of Variation 278.258
|
3189.08 hours*nanogram per milliliter
Geometric Coefficient of Variation 1152.338
|
—
|
—
|
Adverse Events
100 mg Lasmiditan
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
400 mg Lasmiditan
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Moxifloxacin
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
100 mg Lasmiditan
n=52 participants at risk
100 mg lasmiditan administered PO in 1 of 4 treatment periods.
|
400 mg Lasmiditan
n=55 participants at risk
400 mg lasmiditan administered PO in 1 of 4 treatment periods.
|
Placebo
n=54 participants at risk
Placebo administered PO in 1 of 4 treatment periods.
|
Moxifloxacin
n=52 participants at risk
Moxifloxacin administered PO in 1 of 4 treatment periods.
|
|---|---|---|---|---|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/52 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/55 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
1.9%
1/52 • Number of events 1 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
100 mg Lasmiditan
n=52 participants at risk
100 mg lasmiditan administered PO in 1 of 4 treatment periods.
|
400 mg Lasmiditan
n=55 participants at risk
400 mg lasmiditan administered PO in 1 of 4 treatment periods.
|
Placebo
n=54 participants at risk
Placebo administered PO in 1 of 4 treatment periods.
|
Moxifloxacin
n=52 participants at risk
Moxifloxacin administered PO in 1 of 4 treatment periods.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
7.7%
4/52 • Number of events 4 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
3.6%
2/55 • Number of events 2 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
7.7%
4/52 • Number of events 4 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/52 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
7.3%
4/55 • Number of events 4 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/52 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Discomfort
|
0.00%
0/52 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Number of events 3 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/52 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
1.9%
1/52 • Number of events 1 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
3.6%
2/55 • Number of events 2 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
3.7%
2/54 • Number of events 2 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
5.8%
3/52 • Number of events 3 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/52 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Number of events 3 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/52 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
26.9%
14/52 • Number of events 18 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
41.8%
23/55 • Number of events 26 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
5.6%
3/54 • Number of events 4 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/52 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/52 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Number of events 3 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/52 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
9.6%
5/52 • Number of events 5 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
14.5%
8/55 • Number of events 8 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/52 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/52 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Number of events 3 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/54 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/52 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Somnolence
|
25.0%
13/52 • Number of events 13 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
40.0%
22/55 • Number of events 22 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
5.6%
3/54 • Number of events 3 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
7.7%
4/52 • Number of events 4 • 75 days
All randomized participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60