Trial Outcomes & Findings for A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine (NCT NCT04396574)
NCT ID: NCT04396574
Last Updated: 2026-06-25
Results Overview
An AE with an onset on or within 48 hours after a dose of study drug, or an event that worsened in intensity within 48 hours of a dose of study drug was considered a treatment-emergent adverse event (TEAE). A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
558 participants
Primary outcome timeframe
Baseline up to 12-month treatment period (Up to 12 Months)
Results posted on
2026-06-25
Participant Flow
Participants with migraine who participated in parent studies H8H MC LAHX (NCT03988088) or H8H MC LAHV (NCT04396236) were enrolled into this study H8H MC LAHW (NCT04396574) following completion of those studies, if they met eligibility criteria.
A participant who was randomly assigned but did not treat migraine with the study drug was considered to have completed the study if the participant did not discontinue during the 12-month treatment period and attended the End of Study visit, as pre-specified in the protocol.
Participant milestones
| Measure |
25/50/100 mg Lasmiditan
* Participants received lasmiditan \[50 milligram (mg) for body weight less than or equal to 40 kilogram (≤ 40 kg) or 100 mg for body weight greater than (\>)40 kg\] administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month.
* One dose reduction due to tolerability concerns (to 25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose.
|
50/100/200 mg Lasmiditan
* Participants received lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg) administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month.
* One dose reduction due to tolerability concerns (to 50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose.
|
|---|---|---|
|
Overall Study
STARTED
|
279
|
279
|
|
Overall Study
At Least One Dose of Study Drug
|
259
|
249
|
|
Overall Study
Evaluable Population by Treated Migraine Attack
|
266
|
204
|
|
Overall Study
COMPLETED
|
167
|
173
|
|
Overall Study
NOT COMPLETED
|
112
|
106
|
Reasons for withdrawal
| Measure |
25/50/100 mg Lasmiditan
* Participants received lasmiditan \[50 milligram (mg) for body weight less than or equal to 40 kilogram (≤ 40 kg) or 100 mg for body weight greater than (\>)40 kg\] administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month.
* One dose reduction due to tolerability concerns (to 25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose.
|
50/100/200 mg Lasmiditan
* Participants received lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg) administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month.
* One dose reduction due to tolerability concerns (to 50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose.
|
|---|---|---|
|
Overall Study
Adverse Event
|
11
|
14
|
|
Overall Study
Lost to Follow-up
|
17
|
16
|
|
Overall Study
Other
|
5
|
2
|
|
Overall Study
Physician Decision
|
3
|
9
|
|
Overall Study
Protocol Deviation
|
2
|
2
|
|
Overall Study
Site Terminated by Sponsor
|
4
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
8
|
14
|
|
Overall Study
Withdrawal by Parents/Guardian
|
13
|
11
|
|
Overall Study
Withdrawal by Subject
|
49
|
37
|
|
Overall Study
Screen failure
|
0
|
1
|
Baseline Characteristics
A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine
Baseline characteristics by cohort
| Measure |
25/50/100 mg Lasmiditan
n=259 Participants
* Participants received lasmiditan (50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month.
* One dose reduction due to tolerability concerns (to 25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose.
|
50/100/200 mg Lasmiditan
n=249 Participants
* Participants received lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg) administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month.
* One dose reduction due to tolerability concerns (to 50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose.
|
Total
n=508 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.60 years
STANDARD_DEVIATION 2.79 • n=20 Participants
|
13.60 years
STANDARD_DEVIATION 2.68 • n=20 Participants
|
13.60 years
STANDARD_DEVIATION 2.74 • n=40 Participants
|
|
Sex: Female, Male
Female
|
164 Participants
n=20 Participants
|
159 Participants
n=20 Participants
|
323 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=20 Participants
|
90 Participants
n=20 Participants
|
185 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
38 Participants
n=20 Participants
|
36 Participants
n=20 Participants
|
74 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
208 Participants
n=20 Participants
|
204 Participants
n=20 Participants
|
412 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
22 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
91 Participants
n=20 Participants
|
84 Participants
n=20 Participants
|
175 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=20 Participants
|
21 Participants
n=20 Participants
|
31 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
149 Participants
n=20 Participants
|
135 Participants
n=20 Participants
|
284 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Region of Enrollment
Belgium
|
3 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Region of Enrollment
Canada
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Region of Enrollment
France
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Region of Enrollment
Germany
|
3 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Region of Enrollment
India
|
9 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Region of Enrollment
Italy
|
6 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
16 Participants
n=40 Participants
|
|
Region of Enrollment
Japan
|
76 Participants
n=20 Participants
|
75 Participants
n=20 Participants
|
151 Participants
n=40 Participants
|
|
Region of Enrollment
Mexico
|
2 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Region of Enrollment
Netherlands
|
3 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
|
Region of Enrollment
Romania
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Region of Enrollment
Russia
|
2 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Region of Enrollment
Spain
|
15 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
27 Participants
n=40 Participants
|
|
Region of Enrollment
United Kingdom
|
5 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
131 Participants
n=20 Participants
|
119 Participants
n=20 Participants
|
250 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 12-month treatment period (Up to 12 Months)Population: All randomized participants who received at least one dose of study drug and were analyzed by randomized treatment regimen, as pre-specified in the SAP.
An AE with an onset on or within 48 hours after a dose of study drug, or an event that worsened in intensity within 48 hours of a dose of study drug was considered a treatment-emergent adverse event (TEAE). A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.
Outcome measures
| Measure |
25/50/100 mg Lasmiditan
n=259 Participants
* Participants received lasmiditan (50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month.
* One dose reduction due to tolerability concerns (to 25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose.
|
50/100/200 mg Lasmiditan
n=249 Participants
* Participants received lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg) administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month.
* One dose reduction due to tolerability concerns (to 50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose.
|
200 mg Lasmiditan
Participants who received 200 mg lasmiditan administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month were included in this arm.
|
|---|---|---|---|
|
Number of Participants With at Least One Treatment Emergent Adverse Events (TEAEs)
|
109 Participants
|
133 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline up to 12-month treatment period (Up to 12 Months)Population: All randomized participants who received at least one dose of study drug and were analyzed by randomized treatment regimen, as pre-specified in the SAP.
Participants who discontinued due to adverse events were reported in this outcome measure.
Outcome measures
| Measure |
25/50/100 mg Lasmiditan
n=259 Participants
* Participants received lasmiditan (50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month.
* One dose reduction due to tolerability concerns (to 25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose.
|
50/100/200 mg Lasmiditan
n=249 Participants
* Participants received lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg) administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month.
* One dose reduction due to tolerability concerns (to 50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose.
|
200 mg Lasmiditan
Participants who received 200 mg lasmiditan administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month were included in this arm.
|
|---|---|---|---|
|
Number of Participants With Discontinuations Due to Adverse Events (AEs)
|
11 Participants
|
13 Participants
|
—
|
SECONDARY outcome
Timeframe: 2 hours post-dose (for each treated migraine attack, up to 12-month treatment period)Population: Evaluable population by treated migraine attack included all migraine attacks treated with study drug among participants who were randomized and received at least one dose of study drug. Each treated migraine attack was analyzed according to the exposure of lasmiditan. As pre-specified in the SAP, efficacy data were censored after rescue medication use; missing data were handled using observed data, with non-responder imputation.
Pain relief at 2 hours post-dose was defined as having a pain intensity of none or mild at that time point. The 5-Face Pain Scale is a single-item, self-report tool assessing pain intensity along a single domain. Participants select one face from five options to represent their current pain level; no score aggregation or calculation is performed- the selected face directly represents the pain intensity score. The five faces correspond to: Face 1= none, Face 2= mild, Faces 3-4= moderate (both faces represent moderate pain as defined by this scale, with Face 3 reflecting lower-moderate and Face 4 reflecting upper-moderate intensity) and Face 5= severe. The scale ranges from a minimum value of 1 (no pain) to a maximum value of 5 (severe pain); higher scores indicate worse outcome. Participants with a reduction in baseline pain from moderate (Faces 3 or 4) or severe (Face 5) to no pain (Face 1) at 2 hours post-dose were considered to have achieved pain freedom.
Outcome measures
| Measure |
25/50/100 mg Lasmiditan
n=384 Treated Migraine Attacks
* Participants received lasmiditan (50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month.
* One dose reduction due to tolerability concerns (to 25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose.
|
50/100/200 mg Lasmiditan
n=2410 Treated Migraine Attacks
* Participants received lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg) administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month.
* One dose reduction due to tolerability concerns (to 50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose.
|
200 mg Lasmiditan
n=1575 Treated Migraine Attacks
Participants who received 200 mg lasmiditan administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month were included in this arm.
|
|---|---|---|---|
|
Percentage of Treated Migraine Attacks With Pain Freedom (PF) at 2 Hours Post-Dose
|
55.73 % of treated migraine attacks with PF
|
46.14 % of treated migraine attacks with PF
|
41.90 % of treated migraine attacks with PF
|
SECONDARY outcome
Timeframe: 2 hours post-dose (for each treated migraine attack, up to 12-month treatment period)Population: Evaluable population by treated migraine attack included all migraine attacks treated with study drug among participants who were randomized and received at least one dose of study drug. Each treated migraine attack was analyzed according to the exposure of lasmiditan. As pre-specified in the SAP, efficacy data were censored after rescue medication use; missing data were handled using observed data, with non-responder imputation.
Pain relief at 2 hours post-dose was defined as having a pain intensity of none or mild at that time point. The 5-Face Pain Scale is a single-item, self-report tool assessing pain intensity along a single domain. Participants select one face from five options to represent their current pain level; no score aggregation or calculation is performed- the selected face directly represents the pain intensity score. The five faces correspond to: Face 1= none, Face 2= mild, Faces 3-4= moderate (both faces represent moderate pain as defined by this scale, with Face 3 reflecting lower-moderate and Face 4 reflecting upper-moderate intensity) and Face 5= severe. The scale ranges from a minimum value of 1 (no pain) to a maximum value of 5 (severe pain); higher scores indicate worse outcome. Participants with reduction from baseline moderate (Faces 3 or 4) or severe (Face 5) to mild or none (Face 1 or 2), or those reported as asleep at 2 hours post-dose were considered to have achieved pain relief.
Outcome measures
| Measure |
25/50/100 mg Lasmiditan
n=384 Treated Migraine Attacks
* Participants received lasmiditan (50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month.
* One dose reduction due to tolerability concerns (to 25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose.
|
50/100/200 mg Lasmiditan
n=2410 Treated Migraine Attacks
* Participants received lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg) administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month.
* One dose reduction due to tolerability concerns (to 50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose.
|
200 mg Lasmiditan
n=1575 Treated Migraine Attacks
Participants who received 200 mg lasmiditan administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month were included in this arm.
|
|---|---|---|---|
|
Percentage of Treated Migraine Attacks With Pain Relief (PR) at 2 Hours Post-Dose
|
75.00 % of treated migraine attacks with PR
|
65.56 % of treated migraine attacks with PR
|
66.22 % of treated migraine attacks with PR
|
SECONDARY outcome
Timeframe: 2 hours post-dose (for each treated migraine attack, up to 12-month treatment period)Population: Evaluable population by treated migraine attack included all migraine attacks treated with study drug among participants who were randomized and received at least one dose of study drug. Each treated migraine attack was analyzed according to the exposure of lasmiditan. As pre-specified in the SAP, efficacy data were censored after rescue medication use; missing data were handled using observed data, with non-responder imputation.
Participants identified one pre-specified most bothersome symptom (MBS) prior to each migraine dose from three options (nausea, photophobia, or phonophobia). The same pre-selected MBS was assessed at baseline (pre-dose) and at 2 hours post-dose using a binary scale recorded via electronic diary (e-Diary), where "Yes" = MBS present and "No" = MBS absent. MBS freedom was defined as a change from MBS present ("Yes") at baseline to MBS absent ("No") at 2 hours post-dose. A response of "No" at 2 hours post-dose represents a favorable outcome. Only migraine attacks in which the MBS was reported as present at baseline were included in the analysis. No aggregation, transformation, or total score calculation was performed, as this is a single-item dichotomous assessment per attack.
Outcome measures
| Measure |
25/50/100 mg Lasmiditan
n=152 Treated Migraine Attacks
* Participants received lasmiditan (50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month.
* One dose reduction due to tolerability concerns (to 25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose.
|
50/100/200 mg Lasmiditan
n=808 Treated Migraine Attacks
* Participants received lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg) administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month.
* One dose reduction due to tolerability concerns (to 50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose.
|
200 mg Lasmiditan
n=546 Treated Migraine Attacks
Participants who received 200 mg lasmiditan administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month were included in this arm.
|
|---|---|---|---|
|
Percentage of Treated Migraine Attacks With Freedom From Most Bothersome Symptom (MBS) at 2 Hours After Dose
|
51.97 % of MBS-free treated migraine attacks
|
40.47 % of MBS-free treated migraine attacks
|
47.25 % of MBS-free treated migraine attacks
|
Adverse Events
25/50/100 mg Lasmiditan
Serious events: 6 serious events
Other events: 66 other events
Deaths: 0 deaths
50/100/200 mg Lasmiditan
Serious events: 7 serious events
Other events: 91 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
25/50/100 mg Lasmiditan
n=259 participants at risk
* Participants received lasmiditan (50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month.
* One dose reduction due to tolerability concerns (to 25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose.
|
50/100/200 mg Lasmiditan
n=249 participants at risk
* Participants received lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg) administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month.
* One dose reduction due to tolerability concerns (to 50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose.
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.39%
1/259 • Number of events 1 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
0.00%
0/249 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
|
Infections and infestations
Covid-19
|
0.39%
1/259 • Number of events 1 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
0.00%
0/249 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/259 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
0.40%
1/249 • Number of events 1 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
|
Nervous system disorders
Orthostatic intolerance
|
0.39%
1/259 • Number of events 1 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
0.00%
0/249 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/259 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
0.40%
1/249 • Number of events 1 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
|
Nervous system disorders
Syncope
|
0.39%
1/259 • Number of events 1 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
0.00%
0/249 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
|
Psychiatric disorders
Delirium febrile
|
0.00%
0/259 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
0.40%
1/249 • Number of events 1 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
|
Psychiatric disorders
Intentional self-injury
|
0.00%
0/259 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
0.40%
1/249 • Number of events 1 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/259 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
0.40%
1/249 • Number of events 1 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
|
Immune system disorders
Drug hypersensitivity
|
0.39%
1/259 • Number of events 1 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
0.00%
0/249 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Colitis
|
0.39%
1/259 • Number of events 1 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
0.00%
0/249 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/259 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
0.40%
1/249 • Number of events 1 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
|
General disorders
Chest pain
|
0.00%
0/259 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
0.40%
1/249 • Number of events 1 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
Other adverse events
| Measure |
25/50/100 mg Lasmiditan
n=259 participants at risk
* Participants received lasmiditan (50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month.
* One dose reduction due to tolerability concerns (to 25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose.
|
50/100/200 mg Lasmiditan
n=249 participants at risk
* Participants received lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg) administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month.
* One dose reduction due to tolerability concerns (to 50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
8.1%
21/259 • Number of events 34 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
8.4%
21/249 • Number of events 36 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
|
General disorders
Fatigue
|
3.5%
9/259 • Number of events 27 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
5.6%
14/249 • Number of events 19 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
|
Nervous system disorders
Dizziness
|
16.2%
42/259 • Number of events 90 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
24.9%
62/249 • Number of events 143 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
|
Nervous system disorders
Somnolence
|
8.1%
21/259 • Number of events 51 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, as pre-specified in the SAP.
|
10.4%
26/249 • Number of events 55 • Baseline up to 12-month treatment period (Up to 12 Months)
All randomized participants who received at least one dose of study drug. Adverse events were collected and reported by randomized treatment regimen, irrespective of each dose level, 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