Trial Outcomes & Findings for A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine (NCT NCT04396236)
NCT ID: NCT04396236
Last Updated: 2026-09-02
Results Overview
Pain freedom at 2 hours post-dose was defined as having a pain intensity of none at that time point. Pain was measured on a 5-face pain scale, with following scores: 1= none, 2= mild, 3 and 4= moderate, 5= severe. Participants with a reduction in baseline pain as measured on a 5-Face Pain Scale from moderate (Faces 3 and 4) or severe (Face 5) to no pain (Face 1) were considered as pain freedom. 5-Face Pain Scale; minimum value: 1 (no pain); maximum value: 5 (severe pain); higher scores indicate worse outcome.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
847 participants
Primary outcome timeframe
2 hours post dose
Results posted on
2026-09-02
Participant Flow
A participant who was randomly assigned but did not treat a qualifying migraine with the study drug was considered to have completed the study if the participant did not discontinue during the 12-week treatment period (stage 1 and stage 2) and attended the End of Study visit, as pre-specified in the protocol.
Participant milestones
| Measure |
Stage 1: Placebo
Participants received placebo administered orally to treat a qualifying migraine attack.
|
Stage 1: 50/100 mg Lasmiditan
Participants received lasmiditan (50 milligram (mg) for body weight ≤40 kg or 100 mg for body weight \>40 kg) administered orally to treat a qualifying migraine attack.
|
Stage 2: Placebo (Stage 1 Lasmiditan Non-responders)
Participants who did not respond to lasmiditan in stage 1 were randomized in stage 2 to receive placebo administered orally to treat a single migraine attack.
|
Stage 2: Placebo (Stage 1 Placebo Non-responders)
Participants who did not respond to placebo in stage 1 were randomized in stage 2 to receive placebo administered once orally to treat a single migraine attack.
|
Stage 2: 25/50 mg Lasmiditan (Stage 1 Placebo Non-responders)
Participants who did not respond to placebo in stage 1 were randomized in stage 2 to receive lasmiditan (25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg), administered orally to treat a single migraine attack.
|
Stage 2: 50/ 100mg Lasmiditan (Stage 1 Placebo Non-responders)
Participants who did not respond to placebo in stage 1 were randomized in stage 2 to receive lasmiditan (50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg), administered once orally to treat a single migraine attack.
|
Stage 2: 100/200 mg Lasmiditan (Stage 1 Placebo Non-responders)
Participants who did not respond to placebo in stage 1 were randomized in stage 2 to receive lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg), administered once orally to treat a single migraine attack.
|
|---|---|---|---|---|---|---|---|
|
Double-blind Placebo Challenge: Stage 1
STARTED
|
827
|
20
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Placebo Challenge: Stage 1
Received at Least One Dose of Study Drug
|
610
|
16
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Placebo Challenge: Stage 1
Not Treated
|
217
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Placebo Challenge: Stage 1
Responder
|
67
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Placebo Challenge: Stage 1
Non-Responder
|
521
|
10
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Placebo Challenge: Stage 1
Missing 15-minute Assessment
|
22
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Placebo Challenge: Stage 1
COMPLETED
|
772
|
19
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Placebo Challenge: Stage 1
NOT COMPLETED
|
55
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Efficacy Analysis Period: Stage 2
STARTED
|
0
|
0
|
10
|
209
|
104
|
105
|
103
|
|
Efficacy Analysis Period: Stage 2
Efficacy Analysis Population
|
0
|
0
|
0
|
209
|
104
|
105
|
103
|
|
Efficacy Analysis Period: Stage 2
Safety Population
|
0
|
0
|
0
|
298
|
104
|
121
|
103
|
|
Efficacy Analysis Period: Stage 2
COMPLETED
|
0
|
0
|
10
|
206
|
103
|
102
|
102
|
|
Efficacy Analysis Period: Stage 2
NOT COMPLETED
|
0
|
0
|
0
|
3
|
1
|
3
|
1
|
Reasons for withdrawal
| Measure |
Stage 1: Placebo
Participants received placebo administered orally to treat a qualifying migraine attack.
|
Stage 1: 50/100 mg Lasmiditan
Participants received lasmiditan (50 milligram (mg) for body weight ≤40 kg or 100 mg for body weight \>40 kg) administered orally to treat a qualifying migraine attack.
|
Stage 2: Placebo (Stage 1 Lasmiditan Non-responders)
Participants who did not respond to lasmiditan in stage 1 were randomized in stage 2 to receive placebo administered orally to treat a single migraine attack.
|
Stage 2: Placebo (Stage 1 Placebo Non-responders)
Participants who did not respond to placebo in stage 1 were randomized in stage 2 to receive placebo administered once orally to treat a single migraine attack.
|
Stage 2: 25/50 mg Lasmiditan (Stage 1 Placebo Non-responders)
Participants who did not respond to placebo in stage 1 were randomized in stage 2 to receive lasmiditan (25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg), administered orally to treat a single migraine attack.
|
Stage 2: 50/ 100mg Lasmiditan (Stage 1 Placebo Non-responders)
Participants who did not respond to placebo in stage 1 were randomized in stage 2 to receive lasmiditan (50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg), administered once orally to treat a single migraine attack.
|
Stage 2: 100/200 mg Lasmiditan (Stage 1 Placebo Non-responders)
Participants who did not respond to placebo in stage 1 were randomized in stage 2 to receive lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg), administered once orally to treat a single migraine attack.
|
|---|---|---|---|---|---|---|---|
|
Double-blind Placebo Challenge: Stage 1
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Placebo Challenge: Stage 1
Lost to Follow-up
|
24
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Placebo Challenge: Stage 1
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Placebo Challenge: Stage 1
Protocol Deviation
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Placebo Challenge: Stage 1
Study Terminated by Sponsor
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Placebo Challenge: Stage 1
Withdrawal by Subject
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Placebo Challenge: Stage 1
Withdrawal by parent/Guardian
|
10
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Double-blind Placebo Challenge: Stage 1
Other
|
7
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Efficacy Analysis Period: Stage 2
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
3
|
0
|
|
Efficacy Analysis Period: Stage 2
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Efficacy Analysis Period: Stage 2
Withdrawal by parent/Guardian
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Efficacy Analysis Period: Stage 2
Other
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine
Baseline characteristics by cohort
| Measure |
Stage 1 Placebo Responders + Stage 1 and Stage 2 Placebo
n=298 Participants
Participants who responded to placebo during Stage 1, including participants with a missing 15-minute assessment in Stage 1, and participants who received placebo during Stage 2 following Stage 1 placebo treatment were included in this arm.
|
Stage 2: 25/50 mg Lasmiditan
n=104 Participants
Participants who did not respond to placebo during Stage 1 and were randomized to receive lasmiditan during Stage 2 (25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg) following Stage 1 placebo treatment were included in this arm.
|
Stage 1 Lasmiditan Responders + Stage 2 50/100 mg Lasmiditan
n=121 Participants
Participants who responded to lasmiditan during Stage 1, including participants with a missing 15-minute assessment in Stage 1, and participants who received lasmiditan during Stage 2 (50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) following Stage 1 lasmiditan treatment were included in this arm.
|
Stage 2: 100/200 mg Lasmiditan
n=103 Participants
Participants who did not respond to placebo during Stage 1 and were randomized to receive lasmiditan during Stage 2 (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg) following Stage 1 placebo treatment were included in this arm.
|
Total
n=626 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
13.30 years
STANDARD_DEVIATION 2.75 • n=136 Participants
|
13.40 years
STANDARD_DEVIATION 2.58 • n=136 Participants
|
13.50 years
STANDARD_DEVIATION 2.58 • n=272 Participants
|
13.60 years
STANDARD_DEVIATION 2.77 • n=60 Participants
|
13.40 years
STANDARD_DEVIATION 2.69 • n=24 Participants
|
|
Sex: Female, Male
Female
|
192 Participants
n=136 Participants
|
63 Participants
n=136 Participants
|
86 Participants
n=272 Participants
|
66 Participants
n=60 Participants
|
407 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=136 Participants
|
41 Participants
n=136 Participants
|
35 Participants
n=272 Participants
|
37 Participants
n=60 Participants
|
219 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
48 Participants
n=136 Participants
|
14 Participants
n=136 Participants
|
12 Participants
n=272 Participants
|
14 Participants
n=60 Participants
|
88 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
238 Participants
n=136 Participants
|
83 Participants
n=136 Participants
|
104 Participants
n=272 Participants
|
86 Participants
n=60 Participants
|
511 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=136 Participants
|
7 Participants
n=136 Participants
|
5 Participants
n=272 Participants
|
3 Participants
n=60 Participants
|
27 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
1 Participants
n=272 Participants
|
2 Participants
n=60 Participants
|
8 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
71 Participants
n=136 Participants
|
35 Participants
n=136 Participants
|
41 Participants
n=272 Participants
|
28 Participants
n=60 Participants
|
175 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=136 Participants
|
4 Participants
n=136 Participants
|
8 Participants
n=272 Participants
|
7 Participants
n=60 Participants
|
34 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
194 Participants
n=136 Participants
|
59 Participants
n=136 Participants
|
70 Participants
n=272 Participants
|
64 Participants
n=60 Participants
|
387 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=136 Participants
|
3 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
2 Participants
n=60 Participants
|
15 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
1 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
6 Participants
n=24 Participants
|
|
Region of Enrollment
Belgium
|
2 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
2 Participants
n=24 Participants
|
|
Region of Enrollment
Canada
|
1 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=24 Participants
|
|
Region of Enrollment
France
|
1 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
1 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
3 Participants
n=24 Participants
|
|
Region of Enrollment
Germany
|
2 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=272 Participants
|
1 Participants
n=60 Participants
|
4 Participants
n=24 Participants
|
|
Region of Enrollment
India
|
8 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
5 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
14 Participants
n=24 Participants
|
|
Region of Enrollment
Italy
|
5 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
5 Participants
n=272 Participants
|
3 Participants
n=60 Participants
|
13 Participants
n=24 Participants
|
|
Region of Enrollment
Japan
|
61 Participants
n=136 Participants
|
32 Participants
n=136 Participants
|
33 Participants
n=272 Participants
|
26 Participants
n=60 Participants
|
152 Participants
n=24 Participants
|
|
Region of Enrollment
Mexico
|
7 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=272 Participants
|
1 Participants
n=60 Participants
|
9 Participants
n=24 Participants
|
|
Region of Enrollment
Netherlands
|
4 Participants
n=136 Participants
|
4 Participants
n=136 Participants
|
1 Participants
n=272 Participants
|
1 Participants
n=60 Participants
|
10 Participants
n=24 Participants
|
|
Region of Enrollment
Romania
|
2 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
1 Participants
n=272 Participants
|
1 Participants
n=60 Participants
|
5 Participants
n=24 Participants
|
|
Region of Enrollment
Russia
|
8 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
9 Participants
n=24 Participants
|
|
Region of Enrollment
Spain
|
20 Participants
n=136 Participants
|
6 Participants
n=136 Participants
|
5 Participants
n=272 Participants
|
5 Participants
n=60 Participants
|
36 Participants
n=24 Participants
|
|
Region of Enrollment
United Kingdom
|
8 Participants
n=136 Participants
|
2 Participants
n=136 Participants
|
2 Participants
n=272 Participants
|
3 Participants
n=60 Participants
|
15 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
169 Participants
n=136 Participants
|
56 Participants
n=136 Participants
|
66 Participants
n=272 Participants
|
62 Participants
n=60 Participants
|
353 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 2 hours post dosePopulation: The efficacy analysis population was used. As pre-specified in the SAP, only Stage 1 placebo non-responders who were randomized and treated in Stage 2 were included in the efficacy population and were assessed for this outcome measure. Participants with missing data were excluded from this analysis and participants who used rescue medication were classified as non-responders.
Pain freedom at 2 hours post-dose was defined as having a pain intensity of none at that time point. Pain was measured on a 5-face pain scale, with following scores: 1= none, 2= mild, 3 and 4= moderate, 5= severe. Participants with a reduction in baseline pain as measured on a 5-Face Pain Scale from moderate (Faces 3 and 4) or severe (Face 5) to no pain (Face 1) were considered as pain freedom. 5-Face Pain Scale; minimum value: 1 (no pain); maximum value: 5 (severe pain); higher scores indicate worse outcome.
Outcome measures
| Measure |
Stage 2: Placebo (Stage 1 Placebo Non-responders)
n=204 Participants
Participants received placebo (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered orally once during stage 2 to treat a single migraine attack.
|
Stage 2: 25/50 mg Lasmiditan (Stage 1 Placebo Non-responders)
n=99 Participants
Participants received lasmiditan (25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: 50/100mg Lasmiditan (Stage 1 Placebo Non-responders)
n=103 Participants
Participants received lasmiditan (50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: 100/200 mg Lasmiditan (Stage 1 Placebo Non-responders)
n=102 Participants
Participants received lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: All Lasmiditan (Stage 1 Placebo Non-responders)
n=304 Participants
All participants who received lasmiditan at any dose during stage 2 were included in this arm.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-Dose
|
28.922 Percentage of participants
|
30.303 Percentage of participants
|
29.126 Percentage of participants
|
43.137 Percentage of participants
|
34.21 Percentage of participants
|
SECONDARY outcome
Timeframe: 2 hours post-dosePopulation: The efficacy analysis population was used. As pre-specified in the SAP, only Stage 1 placebo non-responders who were randomized and treated in Stage 2 were included in the efficacy population and were assessed for this outcome measure. Participants with missing data were excluded from this analysis and participants who used rescue medication were classified as non-responders.
Pain freedom at 2 hours post-dose was defined as having a pain intensity of none at that time point. Pain was measured on a 5-face pain scale, with following scores: 1= none, 2= mild, 3 and 4= moderate, 5= severe. Participants with a reduction in baseline pain as measured on a 5-Face Pain Scale from moderate (Faces 3 and 4) or severe (Face 5) to no pain (Face 1) were considered as pain freedom. 5-Face Pain Scale; minimum value: 1 (no pain); maximum value: 5 (severe pain); higher scores indicate worse outcome.
Outcome measures
| Measure |
Stage 2: Placebo (Stage 1 Placebo Non-responders)
n=204 Participants
Participants received placebo (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered orally once during stage 2 to treat a single migraine attack.
|
Stage 2: 25/50 mg Lasmiditan (Stage 1 Placebo Non-responders)
n=99 Participants
Participants received lasmiditan (25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: 50/100mg Lasmiditan (Stage 1 Placebo Non-responders)
n=103 Participants
Participants received lasmiditan (50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: 100/200 mg Lasmiditan (Stage 1 Placebo Non-responders)
n=102 Participants
Participants received lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: All Lasmiditan (Stage 1 Placebo Non-responders)
n=304 Participants
All participants who received lasmiditan at any dose during stage 2 were included in this arm.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-Dose (Age Sub-Groups)
12 to < 18 years
|
24.691 Percentage of participants
|
29.333 Percentage of participants
|
30.263 Percentage of participants
|
40.000 Percentage of participants
|
33.333 Percentage of participants
|
|
Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-Dose (Age Sub-Groups)
>= 6 to < 12 years
|
45.238 Percentage of participants
|
33.333 Percentage of participants
|
25.926 Percentage of participants
|
54.545 Percentage of participants
|
36.986 Percentage of participants
|
SECONDARY outcome
Timeframe: 2 hours post-dosePopulation: The efficacy analysis population was used. As pre-specified in the SAP, only Stage 1 placebo non-responders who were randomized and treated in Stage 2 were included in the efficacy population and were assessed for this outcome measure. Participants with missing data were excluded from this analysis and participants who used rescue medication were classified as non-responders.
Pain relief at 2 hours post-dose was defined as a pain intensity of none or mild at that time point. Pain was measured on a 5-face pain scale, with following scores: 1= none, 2= mild, 3 and 4= moderate, 5= severe. Participants with a reduction in baseline pain from moderate (Faces 3 and 4) or severe (Face 5) to mild or no pain (Face 1 or 2) or patient is asleep were considered to have pain relief. 5-Face Pain Scale; minimum value: 1 (no pain); maximum value: 5 (severe pain); higher scores indicate worse outcome.
Outcome measures
| Measure |
Stage 2: Placebo (Stage 1 Placebo Non-responders)
n=204 Participants
Participants received placebo (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered orally once during stage 2 to treat a single migraine attack.
|
Stage 2: 25/50 mg Lasmiditan (Stage 1 Placebo Non-responders)
n=99 Participants
Participants received lasmiditan (25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: 50/100mg Lasmiditan (Stage 1 Placebo Non-responders)
n=103 Participants
Participants received lasmiditan (50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: 100/200 mg Lasmiditan (Stage 1 Placebo Non-responders)
n=102 Participants
Participants received lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: All Lasmiditan (Stage 1 Placebo Non-responders)
n=304 Participants
All participants who received lasmiditan at any dose during stage 2 were included in this arm.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Pain Relief at 2 Hours Post-Dose
|
51.471 Percentage of participants
|
66.667 Percentage of participants
|
60.194 Percentage of participants
|
73.529 Percentage of participants
|
66.776 Percentage of participants
|
SECONDARY outcome
Timeframe: 2 hours post-dosePopulation: The efficacy analysis population was used. As pre-specified in the SAP, only Stage 1 placebo non-responders who were randomized and treated in Stage 2 were included in the efficacy population and were assessed for this outcome measure. Only participants with evaluable MBS data were included in the analysis. Participants with no associated symptoms of migraine at baseline were excluded from the analysis.
MBS freedom was defined as MBS reported before dosing that was absent post-dose. MBS included nausea, photophobia, or phonophobia. MBS were measured using a binary scale (Yes/No) using electronic diary (e-Diary) at 2-hours post-dose. Participants who captured as "No" (MBS absent) were considered to have freedom from MBS.
Outcome measures
| Measure |
Stage 2: Placebo (Stage 1 Placebo Non-responders)
n=178 Participants
Participants received placebo (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered orally once during stage 2 to treat a single migraine attack.
|
Stage 2: 25/50 mg Lasmiditan (Stage 1 Placebo Non-responders)
n=80 Participants
Participants received lasmiditan (25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: 50/100mg Lasmiditan (Stage 1 Placebo Non-responders)
n=87 Participants
Participants received lasmiditan (50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: 100/200 mg Lasmiditan (Stage 1 Placebo Non-responders)
n=86 Participants
Participants received lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: All Lasmiditan (Stage 1 Placebo Non-responders)
n=253 Participants
All participants who received lasmiditan at any dose during stage 2 were included in this arm.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Had Freedom From Most Bothersome Symptom (MBS) Associated With Migraine at 2 Hours Post-Dose
|
41.011 Percentage of participants
|
46.250 Percentage of participants
|
51.724 Percentage of participants
|
63.953 Percentage of participants
|
54.150 Percentage of participants
|
SECONDARY outcome
Timeframe: 2 hours post-dosePopulation: The efficacy analysis population was used. As pre-specified in the SAP, only Stage 1 placebo non-responders who were randomized and treated in Stage 2 were included in the efficacy population and were assessed for this outcome measure. Only participants with evaluable nausea data were included in the analysis. Participants with no symptoms at baseline were excluded from the analysis.
Nausea status was measured as absent or present in the e-Diary. Freedom from nausea was defined as nausea absent. Participants who captured as "No" (Nausea absent) were considered to have freedom from nausea.
Outcome measures
| Measure |
Stage 2: Placebo (Stage 1 Placebo Non-responders)
n=194 Participants
Participants received placebo (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered orally once during stage 2 to treat a single migraine attack.
|
Stage 2: 25/50 mg Lasmiditan (Stage 1 Placebo Non-responders)
n=93 Participants
Participants received lasmiditan (25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: 50/100mg Lasmiditan (Stage 1 Placebo Non-responders)
n=100 Participants
Participants received lasmiditan (50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: 100/200 mg Lasmiditan (Stage 1 Placebo Non-responders)
n=94 Participants
Participants received lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: All Lasmiditan (Stage 1 Placebo Non-responders)
n=287 Participants
All participants who received lasmiditan at any dose during stage 2 were included in this arm.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Freedom From Nausea at 2 Hours Post-Dose
|
22.680 Percentage of participants
|
22.581 Percentage of participants
|
26.000 Percentage of participants
|
19.149 Percentage of participants
|
22.648 Percentage of participants
|
SECONDARY outcome
Timeframe: 2 hours post-dosePopulation: The efficacy analysis population was used. As pre-specified in the SAP, only Stage 1 placebo non-responders who were randomized and treated in Stage 2 were included in the efficacy population and were assessed for this outcome measure. Only participants with evaluable photophobia data were included in the analysis. Participants with no symptoms at baseline were excluded from the analysis.
Photophobia (sensitivity to light) status was measured as absent or present in the e-Diary. Freedom from photophobia was defined as photophobia absent. Participants who captured as "No" (Photophobia absent) were considered to have freedom from photophobia.
Outcome measures
| Measure |
Stage 2: Placebo (Stage 1 Placebo Non-responders)
n=194 Participants
Participants received placebo (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered orally once during stage 2 to treat a single migraine attack.
|
Stage 2: 25/50 mg Lasmiditan (Stage 1 Placebo Non-responders)
n=93 Participants
Participants received lasmiditan (25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: 50/100mg Lasmiditan (Stage 1 Placebo Non-responders)
n=100 Participants
Participants received lasmiditan (50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: 100/200 mg Lasmiditan (Stage 1 Placebo Non-responders)
n=94 Participants
Participants received lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: All Lasmiditan (Stage 1 Placebo Non-responders)
n=287 Participants
All participants who received lasmiditan at any dose during stage 2 were included in this arm.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Freedom From Photophobia at 2 Hours Post-Dose
|
53.093 Percentage of participants
|
32.258 Percentage of participants
|
46.000 Percentage of participants
|
31.915 Percentage of participants
|
36.934 Percentage of participants
|
SECONDARY outcome
Timeframe: 2 hours post-dosePopulation: The efficacy analysis population was used. As pre-specified in the SAP, only Stage 1 placebo non-responders who were randomized and treated in Stage 2 were included in the efficacy population and were assessed for this outcome measure. Only participants with evaluable phonophobia data were included in the analysis. Participants with no symptoms at baseline were excluded from the analysis.
Phonophobia (sensitivity to sound) status was measured as absent or present in the e-Diary. Freedom from phonophobia was defined as phonophobia absent. Participants who captured as "No" (phonophobia absent) were considered to have freedom from phonophobia.
Outcome measures
| Measure |
Stage 2: Placebo (Stage 1 Placebo Non-responders)
n=194 Participants
Participants received placebo (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered orally once during stage 2 to treat a single migraine attack.
|
Stage 2: 25/50 mg Lasmiditan (Stage 1 Placebo Non-responders)
n=93 Participants
Participants received lasmiditan (25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: 50/100mg Lasmiditan (Stage 1 Placebo Non-responders)
n=100 Participants
Participants received lasmiditan (50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: 100/200 mg Lasmiditan (Stage 1 Placebo Non-responders)
n=94 Participants
Participants received lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: All Lasmiditan (Stage 1 Placebo Non-responders)
n=287 Participants
All participants who received lasmiditan at any dose during stage 2 were included in this arm.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-Dose
|
35.052 Percentage of participants
|
22.581 Percentage of participants
|
33.000 Percentage of participants
|
24.468 Percentage of participants
|
26.829 Percentage of participants
|
SECONDARY outcome
Timeframe: 2 through 24 hours post-dosePopulation: The efficacy analysis population was used. As pre-specified in the SAP, only Stage 1 placebo non-responders who were randomized and treated in Stage 2 were included in the efficacy population and were assessed for this outcome measure. Participants with missing data or who used rescue medication were classified as non-responders.
Sustained pain freedom from 2 through 24 hours post-dose was defined as a pain intensity of none at all time points with 24 hours post-dose. Pain intensity was assessed using a 5-Face Pain Scale (1 = none, 2 = mild, 3 or 4 = moderate, 5 = severe). Participants with score of 1 (with no pain) through 2 to 24 hours post-dose with no use of rescue medication or no relapse within the 24 hours of the initial treatment were considered to have sustained pain freedom. 5-Face Pain Scale; minimum value: 1 (no pain); maximum value: 5 (severe pain); higher scores indicate worse outcome.
Outcome measures
| Measure |
Stage 2: Placebo (Stage 1 Placebo Non-responders)
n=209 Participants
Participants received placebo (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered orally once during stage 2 to treat a single migraine attack.
|
Stage 2: 25/50 mg Lasmiditan (Stage 1 Placebo Non-responders)
n=104 Participants
Participants received lasmiditan (25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: 50/100mg Lasmiditan (Stage 1 Placebo Non-responders)
n=105 Participants
Participants received lasmiditan (50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: 100/200 mg Lasmiditan (Stage 1 Placebo Non-responders)
n=103 Participants
Participants received lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: All Lasmiditan (Stage 1 Placebo Non-responders)
n=312 Participants
All participants who received lasmiditan at any dose during stage 2 were included in this arm.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Pain Freedom From 2 Through 24 Hours Post-Dose
|
18.660 percentage of participants
|
23.077 percentage of participants
|
17.143 percentage of participants
|
28.155 percentage of participants
|
22.756 percentage of participants
|
SECONDARY outcome
Timeframe: 2 through 24 hours post-dosePopulation: The efficacy analysis population was used. As pre-specified in the SAP, only Stage 1 placebo non-responders who were randomized and treated in Stage 2 were included in the efficacy population and were assessed for this outcome measure. Participants with missing rescue medication data were classified as users of rescue medication.
Rescue medication was permitted after completion of the 2-hour assessment if the migraine did not respond (participant was not pain free).
Outcome measures
| Measure |
Stage 2: Placebo (Stage 1 Placebo Non-responders)
n=209 Participants
Participants received placebo (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered orally once during stage 2 to treat a single migraine attack.
|
Stage 2: 25/50 mg Lasmiditan (Stage 1 Placebo Non-responders)
n=104 Participants
Participants received lasmiditan (25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: 50/100mg Lasmiditan (Stage 1 Placebo Non-responders)
n=105 Participants
Participants received lasmiditan (50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: 100/200 mg Lasmiditan (Stage 1 Placebo Non-responders)
n=103 Participants
Participants received lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: All Lasmiditan (Stage 1 Placebo Non-responders)
n=312 Participants
All participants who received lasmiditan at any dose during stage 2 were included in this arm.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Used Rescue Medication for Migraine From 2 Through 24 Hours Post-Dose
|
26.316 Percentage of participants
|
17.308 Percentage of participants
|
30.476 Percentage of participants
|
16.505 Percentage of participants
|
21.474 Percentage of participants
|
SECONDARY outcome
Timeframe: 2 through 48 hours post-dosePopulation: The efficacy analysis population was used. As pre-specified in the SAP, only Stage 1 placebo non-responders who were randomized and treated in Stage 2 were included in the efficacy population and were assessed for this outcome measure. Participants with missing data or who used rescue medication were classified as non-responders.
Sustained pain freedom from 2 through 48 hours post-dose was defined as a pain intensity of none at all time points with 48 hours post-dose. Pain intensity was assessed using a 5-Face Pain Scale (1 = none, 2 = mild, 3 or 4 = moderate, 5 = severe). Participants with score of 1 (with no pain) through 2 to 48 hours post-dose with no use of rescue medication or no relapse within the 48 hours of the initial treatment were considered to have sustained pain freedom. 5-Face Pain Scale; minimum value: 1 (no pain); maximum value: 5 (severe pain); higher scores indicate worse outcome.
Outcome measures
| Measure |
Stage 2: Placebo (Stage 1 Placebo Non-responders)
n=209 Participants
Participants received placebo (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered orally once during stage 2 to treat a single migraine attack.
|
Stage 2: 25/50 mg Lasmiditan (Stage 1 Placebo Non-responders)
n=104 Participants
Participants received lasmiditan (25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: 50/100mg Lasmiditan (Stage 1 Placebo Non-responders)
n=105 Participants
Participants received lasmiditan (50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: 100/200 mg Lasmiditan (Stage 1 Placebo Non-responders)
n=103 Participants
Participants received lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: All Lasmiditan (Stage 1 Placebo Non-responders)
n=312 Participants
All participants who received lasmiditan at any dose during stage 2 were included in this arm.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Pain Freedom From 2 Through 48 Hours Post-Dose
|
11.962 Percentage of participants
|
11.538 Percentage of participants
|
11.429 Percentage of participants
|
18.447 Percentage of participants
|
13.782 Percentage of participants
|
SECONDARY outcome
Timeframe: 2 through 48 hours post-dosePopulation: The efficacy analysis population was used. As pre-specified in the SAP, only Stage 1 placebo non-responders who were randomized and treated in Stage 2 were included in the efficacy population and were assessed for this outcome measure. Participants with missing rescue medication data were classified as users of rescue medication.
Rescue medication was permitted after completion of the 2-hour assessment if the migraine did not respond (participant was not pain free).
Outcome measures
| Measure |
Stage 2: Placebo (Stage 1 Placebo Non-responders)
n=209 Participants
Participants received placebo (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered orally once during stage 2 to treat a single migraine attack.
|
Stage 2: 25/50 mg Lasmiditan (Stage 1 Placebo Non-responders)
n=104 Participants
Participants received lasmiditan (25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: 50/100mg Lasmiditan (Stage 1 Placebo Non-responders)
n=105 Participants
Participants received lasmiditan (50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: 100/200 mg Lasmiditan (Stage 1 Placebo Non-responders)
n=103 Participants
Participants received lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: All Lasmiditan (Stage 1 Placebo Non-responders)
n=312 Participants
All participants who received lasmiditan at any dose during stage 2 were included in this arm.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Used Rescue Medication for Migraine From 2 Through 48 Hours Post-Dose
|
33.493 Percentage of participants
|
25.000 Percentage of participants
|
36.190 Percentage of participants
|
22.330 Percentage of participants
|
27.885 Percentage of participants
|
SECONDARY outcome
Timeframe: 2 hours post-dosePopulation: The efficacy analysis population was used. As pre-specified in the SAP, only Stage 1 placebo non-responders who were randomized and treated in Stage 2 were included in the efficacy population and were assessed for this outcome measure. Participants with missing data at 2 hours post-dose were excluded from the analysis for this specific outcome measure.
Disability was assessed by the level of interference with normal activities using an electronic diary. Participants rated how much their migraine interfered with usual activities (e.g., play, schoolwork, or other work) using a 4 point numeric rating scale, where 0 = not at all, 1 = a little, 2 = a lot, and 3 = complete interference (required bed rest). No Disability was defined as the first time point at which a score of 0 (no interference) was reported. 4-Point Numeric Rating Scale; minimum value: 0 (not at all); maximum value: 3 (complete interference/bed rest required); higher scores indicate worse outcome. Percentages for each response category were estimated using a repeated-measures logistic mixed-effects model (treatment + time + age group + treatment\*time + preventive treatment), not as a simple count divided by the Overall Number of Participants Analyzed (N). As a result, individual percentages may not correspond to a whole number of participants out of N.
Outcome measures
| Measure |
Stage 2: Placebo (Stage 1 Placebo Non-responders)
n=194 Participants
Participants received placebo (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered orally once during stage 2 to treat a single migraine attack.
|
Stage 2: 25/50 mg Lasmiditan (Stage 1 Placebo Non-responders)
n=93 Participants
Participants received lasmiditan (25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: 50/100mg Lasmiditan (Stage 1 Placebo Non-responders)
n=100 Participants
Participants received lasmiditan (50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: 100/200 mg Lasmiditan (Stage 1 Placebo Non-responders)
n=94 Participants
Participants received lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: All Lasmiditan (Stage 1 Placebo Non-responders)
n=287 Participants
All participants who received lasmiditan at any dose during stage 2 were included in this arm.
|
|---|---|---|---|---|---|
|
Percentage of Participants With No Disability at 2 Hours Post-Dose
Not at all
|
35.44 Percentage of participants
|
39.16 Percentage of participants
|
31.30 Percentage of participants
|
44.52 Percentage of participants
|
38.21 Percentage of participants
|
|
Percentage of Participants With No Disability at 2 Hours Post-Dose
A little
|
29.70 Percentage of participants
|
39.26 Percentage of participants
|
30.59 Percentage of participants
|
31.75 Percentage of participants
|
33.81 Percentage of participants
|
|
Percentage of Participants With No Disability at 2 Hours Post-Dose
A lot
|
24.85 Percentage of participants
|
15.78 Percentage of participants
|
23.76 Percentage of participants
|
16.30 Percentage of participants
|
18.94 Percentage of participants
|
|
Percentage of Participants With No Disability at 2 Hours Post-Dose
Completely
|
10.01 Percentage of participants
|
5.80 Percentage of participants
|
14.35 Percentage of participants
|
7.43 Percentage of participants
|
9.04 Percentage of participants
|
SECONDARY outcome
Timeframe: 24 hours post-dosePopulation: The efficacy analysis population was used. As pre-specified in the SAP, only Stage 1 placebo non-responders who were randomized and treated in Stage 2 were included in the efficacy population and had evaluable data for this outcome measure.
Acceptability of the lasmiditan oral formulation (single tablet) was assessed using an electronic diary at the 24 hour post dose assessment. Participants were asked to report their experience of swallowing the study medication by responding to the question: "Think about the experience of swallowing the study medicine. How easy or hard was it for you to swallow one of the pills?" Responses were recorded on a 5 point ordinal scale: Very easy, Easy, Neither easy nor hard, Hard, or Very hard. 5-Point Ordinal Scale; minimum value: 1 (Very Easy); maximum value: 5 (Very Difficult); higher scores indicate worse outcome.
Outcome measures
| Measure |
Stage 2: Placebo (Stage 1 Placebo Non-responders)
n=147 Participants
Participants received placebo (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered orally once during stage 2 to treat a single migraine attack.
|
Stage 2: 25/50 mg Lasmiditan (Stage 1 Placebo Non-responders)
n=77 Participants
Participants received lasmiditan (25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: 50/100mg Lasmiditan (Stage 1 Placebo Non-responders)
n=86 Participants
Participants received lasmiditan (50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: 100/200 mg Lasmiditan (Stage 1 Placebo Non-responders)
n=73 Participants
Participants received lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg) administered orally once during stage 2 to treat a single migraine attack. Matching placebo tablets were used to maintain blinding.
|
Stage 2: All Lasmiditan (Stage 1 Placebo Non-responders)
n=236 Participants
All participants who received lasmiditan at any dose during stage 2 were included in this arm.
|
|---|---|---|---|---|---|
|
Acceptability of Tablet Formulation (Ease of Swallowing) at 24 Hours Post-Dose
Very Easy
|
95 Participants
|
52 Participants
|
58 Participants
|
56 Participants
|
166 Participants
|
|
Acceptability of Tablet Formulation (Ease of Swallowing) at 24 Hours Post-Dose
Easy
|
38 Participants
|
9 Participants
|
21 Participants
|
8 Participants
|
38 Participants
|
|
Acceptability of Tablet Formulation (Ease of Swallowing) at 24 Hours Post-Dose
Neither Easy Nor Hard
|
13 Participants
|
13 Participants
|
2 Participants
|
7 Participants
|
22 Participants
|
|
Acceptability of Tablet Formulation (Ease of Swallowing) at 24 Hours Post-Dose
Difficult (Or Hard)
|
1 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
8 Participants
|
|
Acceptability of Tablet Formulation (Ease of Swallowing) at 24 Hours Post-Dose
Very Difficult (Or Hard)
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
Adverse Events
Stage 1 Placebo Responders + Stage 1 and Stage 2 Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Stage 2: 25/ 50 mg Lasmiditan
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Stage 1 Lasmiditan Responders + Stage 2 50/100 mg Lasmiditan
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Stage 2: 100/200 mg Lasmiditan
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Stage 1 or Stage 2: All Lasmiditan
Serious events: 2 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage 1 Placebo Responders + Stage 1 and Stage 2 Placebo
n=298 participants at risk
Participants who responded to placebo during Stage 1, including participants with a missing 15-minute assessment in Stage 1, and participants who received placebo during Stage 2 following Stage 1 placebo treatment were included in this arm.
|
Stage 2: 25/ 50 mg Lasmiditan
n=104 participants at risk
Participants who did not respond to placebo during Stage 1 and were randomized to receive lasmiditan during Stage 2 (25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg) following Stage 1 placebo treatment were included in this arm.
|
Stage 1 Lasmiditan Responders + Stage 2 50/100 mg Lasmiditan
n=121 participants at risk
Participants who responded to lasmiditan during Stage 1, including participants with a missing 15-minute assessment in Stage 1, and participants who received lasmiditan during Stage 2 (50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) following Stage 1 lasmiditan treatment were included in this arm.
|
Stage 2: 100/200 mg Lasmiditan
n=103 participants at risk
Participants who did not respond to placebo during Stage 1 and were randomized to receive lasmiditan during Stage 2 (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg) following Stage 1 placebo treatment were included in this arm.
|
Stage 1 or Stage 2: All Lasmiditan
n=328 participants at risk
Participants who received lasmiditan in either stage, regardless of dose, were included in this arm.
|
|---|---|---|---|---|---|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/298 • Baseline up to end of follow up (Up to 16 Weeks)
Adverse events were reported for the Safety Population, comprising all randomly assigned participants who received at least one dose of study drug in Stage 1 or Stage 2. Participants were grouped by lasmiditan dose received across both stages, regardless of which stage the dose was received, as pre-specified in the SAP.
|
0.00%
0/104 • Baseline up to end of follow up (Up to 16 Weeks)
Adverse events were reported for the Safety Population, comprising all randomly assigned participants who received at least one dose of study drug in Stage 1 or Stage 2. Participants were grouped by lasmiditan dose received across both stages, regardless of which stage the dose was received, as pre-specified in the SAP.
|
0.00%
0/121 • Baseline up to end of follow up (Up to 16 Weeks)
Adverse events were reported for the Safety Population, comprising all randomly assigned participants who received at least one dose of study drug in Stage 1 or Stage 2. Participants were grouped by lasmiditan dose received across both stages, regardless of which stage the dose was received, as pre-specified in the SAP.
|
0.97%
1/103 • Number of events 1 • Baseline up to end of follow up (Up to 16 Weeks)
Adverse events were reported for the Safety Population, comprising all randomly assigned participants who received at least one dose of study drug in Stage 1 or Stage 2. Participants were grouped by lasmiditan dose received across both stages, regardless of which stage the dose was received, as pre-specified in the SAP.
|
0.30%
1/328 • Number of events 1 • Baseline up to end of follow up (Up to 16 Weeks)
Adverse events were reported for the Safety Population, comprising all randomly assigned participants who received at least one dose of study drug in Stage 1 or Stage 2. Participants were grouped by lasmiditan dose received across both stages, regardless of which stage the dose was received, as pre-specified in the SAP.
|
|
Psychiatric disorders
Self-destructive behaviour
|
0.00%
0/298 • Baseline up to end of follow up (Up to 16 Weeks)
Adverse events were reported for the Safety Population, comprising all randomly assigned participants who received at least one dose of study drug in Stage 1 or Stage 2. Participants were grouped by lasmiditan dose received across both stages, regardless of which stage the dose was received, as pre-specified in the SAP.
|
0.00%
0/104 • Baseline up to end of follow up (Up to 16 Weeks)
Adverse events were reported for the Safety Population, comprising all randomly assigned participants who received at least one dose of study drug in Stage 1 or Stage 2. Participants were grouped by lasmiditan dose received across both stages, regardless of which stage the dose was received, as pre-specified in the SAP.
|
0.83%
1/121 • Number of events 1 • Baseline up to end of follow up (Up to 16 Weeks)
Adverse events were reported for the Safety Population, comprising all randomly assigned participants who received at least one dose of study drug in Stage 1 or Stage 2. Participants were grouped by lasmiditan dose received across both stages, regardless of which stage the dose was received, as pre-specified in the SAP.
|
0.00%
0/103 • Baseline up to end of follow up (Up to 16 Weeks)
Adverse events were reported for the Safety Population, comprising all randomly assigned participants who received at least one dose of study drug in Stage 1 or Stage 2. Participants were grouped by lasmiditan dose received across both stages, regardless of which stage the dose was received, as pre-specified in the SAP.
|
0.30%
1/328 • Number of events 1 • Baseline up to end of follow up (Up to 16 Weeks)
Adverse events were reported for the Safety Population, comprising all randomly assigned participants who received at least one dose of study drug in Stage 1 or Stage 2. Participants were grouped by lasmiditan dose received across both stages, regardless of which stage the dose was received, as pre-specified in the SAP.
|
Other adverse events
| Measure |
Stage 1 Placebo Responders + Stage 1 and Stage 2 Placebo
n=298 participants at risk
Participants who responded to placebo during Stage 1, including participants with a missing 15-minute assessment in Stage 1, and participants who received placebo during Stage 2 following Stage 1 placebo treatment were included in this arm.
|
Stage 2: 25/ 50 mg Lasmiditan
n=104 participants at risk
Participants who did not respond to placebo during Stage 1 and were randomized to receive lasmiditan during Stage 2 (25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg) following Stage 1 placebo treatment were included in this arm.
|
Stage 1 Lasmiditan Responders + Stage 2 50/100 mg Lasmiditan
n=121 participants at risk
Participants who responded to lasmiditan during Stage 1, including participants with a missing 15-minute assessment in Stage 1, and participants who received lasmiditan during Stage 2 (50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) following Stage 1 lasmiditan treatment were included in this arm.
|
Stage 2: 100/200 mg Lasmiditan
n=103 participants at risk
Participants who did not respond to placebo during Stage 1 and were randomized to receive lasmiditan during Stage 2 (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg) following Stage 1 placebo treatment were included in this arm.
|
Stage 1 or Stage 2: All Lasmiditan
n=328 participants at risk
Participants who received lasmiditan in either stage, regardless of dose, were included in this arm.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
2.7%
8/298 • Number of events 8 • Baseline up to end of follow up (Up to 16 Weeks)
Adverse events were reported for the Safety Population, comprising all randomly assigned participants who received at least one dose of study drug in Stage 1 or Stage 2. Participants were grouped by lasmiditan dose received across both stages, regardless of which stage the dose was received, as pre-specified in the SAP.
|
0.96%
1/104 • Number of events 1 • Baseline up to end of follow up (Up to 16 Weeks)
Adverse events were reported for the Safety Population, comprising all randomly assigned participants who received at least one dose of study drug in Stage 1 or Stage 2. Participants were grouped by lasmiditan dose received across both stages, regardless of which stage the dose was received, as pre-specified in the SAP.
|
10.7%
13/121 • Number of events 13 • Baseline up to end of follow up (Up to 16 Weeks)
Adverse events were reported for the Safety Population, comprising all randomly assigned participants who received at least one dose of study drug in Stage 1 or Stage 2. Participants were grouped by lasmiditan dose received across both stages, regardless of which stage the dose was received, as pre-specified in the SAP.
|
2.9%
3/103 • Number of events 3 • Baseline up to end of follow up (Up to 16 Weeks)
Adverse events were reported for the Safety Population, comprising all randomly assigned participants who received at least one dose of study drug in Stage 1 or Stage 2. Participants were grouped by lasmiditan dose received across both stages, regardless of which stage the dose was received, as pre-specified in the SAP.
|
5.2%
17/328 • Number of events 17 • Baseline up to end of follow up (Up to 16 Weeks)
Adverse events were reported for the Safety Population, comprising all randomly assigned participants who received at least one dose of study drug in Stage 1 or Stage 2. Participants were grouped by lasmiditan dose received across both stages, regardless of which stage the dose was received, as pre-specified in the SAP.
|
|
Nervous system disorders
Dizziness
|
2.0%
6/298 • Number of events 6 • Baseline up to end of follow up (Up to 16 Weeks)
Adverse events were reported for the Safety Population, comprising all randomly assigned participants who received at least one dose of study drug in Stage 1 or Stage 2. Participants were grouped by lasmiditan dose received across both stages, regardless of which stage the dose was received, as pre-specified in the SAP.
|
8.7%
9/104 • Number of events 10 • Baseline up to end of follow up (Up to 16 Weeks)
Adverse events were reported for the Safety Population, comprising all randomly assigned participants who received at least one dose of study drug in Stage 1 or Stage 2. Participants were grouped by lasmiditan dose received across both stages, regardless of which stage the dose was received, as pre-specified in the SAP.
|
10.7%
13/121 • Number of events 13 • Baseline up to end of follow up (Up to 16 Weeks)
Adverse events were reported for the Safety Population, comprising all randomly assigned participants who received at least one dose of study drug in Stage 1 or Stage 2. Participants were grouped by lasmiditan dose received across both stages, regardless of which stage the dose was received, as pre-specified in the SAP.
|
15.5%
16/103 • Number of events 17 • Baseline up to end of follow up (Up to 16 Weeks)
Adverse events were reported for the Safety Population, comprising all randomly assigned participants who received at least one dose of study drug in Stage 1 or Stage 2. Participants were grouped by lasmiditan dose received across both stages, regardless of which stage the dose was received, as pre-specified in the SAP.
|
11.6%
38/328 • Number of events 40 • Baseline up to end of follow up (Up to 16 Weeks)
Adverse events were reported for the Safety Population, comprising all randomly assigned participants who received at least one dose of study drug in Stage 1 or Stage 2. Participants were grouped by lasmiditan dose received across both stages, regardless of which stage the dose was received, as pre-specified in the SAP.
|
|
Nervous system disorders
Somnolence
|
1.3%
4/298 • Number of events 4 • Baseline up to end of follow up (Up to 16 Weeks)
Adverse events were reported for the Safety Population, comprising all randomly assigned participants who received at least one dose of study drug in Stage 1 or Stage 2. Participants were grouped by lasmiditan dose received across both stages, regardless of which stage the dose was received, as pre-specified in the SAP.
|
3.8%
4/104 • Number of events 4 • Baseline up to end of follow up (Up to 16 Weeks)
Adverse events were reported for the Safety Population, comprising all randomly assigned participants who received at least one dose of study drug in Stage 1 or Stage 2. Participants were grouped by lasmiditan dose received across both stages, regardless of which stage the dose was received, as pre-specified in the SAP.
|
6.6%
8/121 • Number of events 8 • Baseline up to end of follow up (Up to 16 Weeks)
Adverse events were reported for the Safety Population, comprising all randomly assigned participants who received at least one dose of study drug in Stage 1 or Stage 2. Participants were grouped by lasmiditan dose received across both stages, regardless of which stage the dose was received, as pre-specified in the SAP.
|
6.8%
7/103 • Number of events 7 • Baseline up to end of follow up (Up to 16 Weeks)
Adverse events were reported for the Safety Population, comprising all randomly assigned participants who received at least one dose of study drug in Stage 1 or Stage 2. Participants were grouped by lasmiditan dose received across both stages, regardless of which stage the dose was received, as pre-specified in the SAP.
|
5.8%
19/328 • Number of events 19 • Baseline up to end of follow up (Up to 16 Weeks)
Adverse events were reported for the Safety Population, comprising all randomly assigned participants who received at least one dose of study drug in Stage 1 or Stage 2. Participants were grouped by lasmiditan dose received across both stages, regardless of which stage the dose was received, as pre-specified in the SAP.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60