Migraine
Conditions
Brief summary
This study will assess the efficacy and safety of lasmiditan in the acute treatment of a migraine attack in Japanese adult participants with or without aura.
Interventions
DRUGLasmiditan
Administered orally
DRUGPlacebo
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with migraine with or without aura fulfilling the International Classification of Headache Disorders (ICHD)-2. * History of disabling migraine for at least 1 year. * Migraine Disability Assessment Test (MIDAS) score ≥11. * Migraine onset before the age of 50 years. * History of 3-8 migraine attacks per month and \<15 headache days per month during the past 3 months.
Exclusion criteria
* Known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets. * History or evidence of hemorrhagic stroke, epilepsy, or any other condition placing the patient at increased risk of seizures. * History of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo, Meniere's disease, vestibular migraine, and other vestibular disorders. * History of diabetes mellitus with complications (diabetic retinopathy, nephropathy, or neuropathy). * History of orthostatic hypotension with syncope.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Are Headache Pain Free In High Dose Group (200 mg Lasmiditan) | 2 Hours Postdose | Percentage of participants who were headache pain free (defined as moderate or severe pain becoming none) at 2 hours postdose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Are Headache Pain Free in Each Dose Group | 2 Hours Postdose | Percentage of participants who are headache pain free in each dose group at 2 hours postdose. |
| Percentage of Participants With Headache Pain Relief | 2 Hours Postdose | Percentage of participants with headache pain relief (defined as moderate or severe headache pain becoming mild or none) at 2 hours postdose. |
| Percentage of Participants Who Are Free of Most Bothersome Symptoms (MBS) Associated With Migraine | 2 Hours Postdose | Percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing and being absent at 2 hours postdose. Missing value at a particular time point was considered as nonresponder. |
| Percentage of Participants With 48-Hour Sustained Pain Freedom | 48 Hours Postdose | Percentage of participants who are headache pain free at 2 hours postdose and 48 hours postdose with no rescue medication. |
| Percentage of Participants That Are Free of Phonophobia | 2 Hours Postdose | Percentage of participants that are free of phonophobia at 2 hours postdose. |
| Percentage of Participants That Are Free of Photophobia | 2 Hours Postdose | Percentage of participants that are free of photophobia at 2 hours postdose. |
| Percentage of Participants That Are Free of Nausea | 2 Hours Postdose | Percentage of participants that are free of nausea at 2 hours postdose. |
| Percentage of Participants With 24-Hour Sustained Pain Freedom | 24 Hours Postdose | Percentage of participants who are headache pain free at 2 hours postdose and 24 hours postdose with no rescue medication. |
| Percentage of Participants With Pain Freedom | 1 Hour Postdose | Percentage of participants with pain freedom. |
| Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) | 1 Hour Postdose | Percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing and being absent at 1 hour postdose. |
| Percentage of Participants With No Disability | 1 Hour Postdose | Disability will be measured by determining the level of interference with normal activities with 4 response options including: not at all (0); mild interference (1), marked interference (2); and need complete bed rest (3). No Disability timing is defined as the first time when severity becomes 0. Percentage of participants who are responders defined as score = 0 at 1 hours postdose. |
| Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Health Status Index Score Japan | Baseline, 24 Hours Postdose | The EQ-5D-5L was assessed based the EQ-5D-5L Health Status Index Score. The Japan specific tariffs (Japanese population-based index value) was used. The EQ-5D-5L is a participant rated, 2-part questionnaire. The first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The health state index score was calculated based on the responses to the 5 dimensions, providing a single value on a scale from less than 0 (where 0 is a health state equivalent to death; negative values are valued as worse than death) to 1 (perfect health), with higher scores indicating better health utility. |
| Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Visual Analog Scale | Baseline, 24 Hours Postdose | The EQ-5D-5L is a participant rated, 2-part questionnaire. The second part of the questionnaire consists of a visual analog scale on which the participant rates their perceived health state from 0 (the worst health you can imagine) to 100 (the best health you can imagine). |
| Percentage of Participants With Very Much or Much Better as Measured by the Patient Global Impression of Change (PGI-C) | 2 Hours Postdose | The PGI-C is a one-item questionnaire that asks participants to provide their impression of change since taking the medicine. The PGI-C is measured using a 7-point Likert scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants who are responders defined as having rated their impression of change as very much better or much better at 2 hours postdose. |
| Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ) | 24 Hours Postdose | The HRQoL is a 15-item, self-administered questionnaire. The items cover 5 domains (work functioning, social functioning, energy and vitality, feelings and concerns, and migraine symptoms). Each domain consists of 3 questions answered on a 7-point scale there 1 indicates maximum impairment and 7 indicating no impairment. A domain score is calculated by summing the responses to the 3 questions and the domain score ranges from 3 to 21, where a lower score indicates greater impairment, and a higher score indicates less impairment. The questionnaire will be administered 24 hours after the study drug. |
| Percentage of Participants That Are Free of Vomiting | 2 Hours Postdose | Percentage of participants that are free of vomiting at 2 hours postdose. |
Countries
Japan
Participant flow
Pre-assignment details
A participant who was randomized but did not treat with the study intervention was considered to have completed the study if they did not discontinue throughout the 8 weeks of treatment period and attended Visit 3 End of Study (EoS) or Early Discontinuation (EDC).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack. | 214 |
| 50 mg Lasmiditan 50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack. | 87 |
| 100 mg Lasmiditan 100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack. | 208 |
| 200 mg Lasmiditan 200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack. | 182 |
| Total | 691 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 |
| Overall Study | Protocol Deviation | 3 | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | 200 mg Lasmiditan | 100 mg Lasmiditan | 50 mg Lasmiditan | Placebo |
|---|---|---|---|---|---|
| Age, Continuous | 45.2 years STANDARD_DEVIATION 9.7 | 44.7 years STANDARD_DEVIATION 10.36 | 45.7 years STANDARD_DEVIATION 9.66 | 44.9 years STANDARD_DEVIATION 10.2 | 45.2 years STANDARD_DEVIATION 8.95 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 691 Participants | 182 Participants | 208 Participants | 87 Participants | 214 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Japan | 691 Participants | 182 Participants | 208 Participants | 87 Participants | 214 Participants |
| Sex: Female, Male Female | 574 Participants | 145 Participants | 176 Participants | 75 Participants | 178 Participants |
| Sex: Female, Male Male | 117 Participants | 37 Participants | 32 Participants | 12 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 214 | 0 / 87 | 0 / 208 | 0 / 182 |
| other Total, other adverse events | 50 / 214 | 44 / 87 | 147 / 208 | 147 / 182 |
| serious Total, serious adverse events | 0 / 214 | 0 / 87 | 0 / 208 | 0 / 182 |
Outcome results
Primary
Percentage of Participants Who Are Headache Pain Free In High Dose Group (200 mg Lasmiditan)
Percentage of participants who were headache pain free (defined as moderate or severe pain becoming none) at 2 hours postdose.
Time frame: 2 Hours Postdose
Population: All randomized participants who received at least one dose of study drug to treat a migraine attack within 4 hours of onset and had postdose headache severity or symptom assessments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Are Headache Pain Free In High Dose Group (200 mg Lasmiditan) | 16.6 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants Who Are Headache Pain Free In High Dose Group (200 mg Lasmiditan) | 40.8 percentage of participants |
p-value: <0.00195% CI: [2.17, 5.54]Regression, Logistic
Secondary
Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Health Status Index Score Japan
The EQ-5D-5L was assessed based the EQ-5D-5L Health Status Index Score. The Japan specific tariffs (Japanese population-based index value) was used. The EQ-5D-5L is a participant rated, 2-part questionnaire. The first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The health state index score was calculated based on the responses to the 5 dimensions, providing a single value on a scale from less than 0 (where 0 is a health state equivalent to death; negative values are valued as worse than death) to 1 (perfect health), with higher scores indicating better health utility.
Time frame: Baseline, 24 Hours Postdose
Population: All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Health Status Index Score Japan | 0.200 score on a scale | Standard Deviation 0.218 |
| 200 mg Lasmiditan | Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Health Status Index Score Japan | 0.192 score on a scale | Standard Deviation 0.192 |
| 100 mg Lasmiditan | Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Health Status Index Score Japan | 0.224 score on a scale | Standard Deviation 0.198 |
| 200 mg Lasmiditan | Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Health Status Index Score Japan | 0.186 score on a scale | Standard Deviation 0.192 |
p-value: 0.724ANCOVA
p-value: 0.24ANCOVA
p-value: 0.548ANCOVA
Secondary
Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Visual Analog Scale
The EQ-5D-5L is a participant rated, 2-part questionnaire. The second part of the questionnaire consists of a visual analog scale on which the participant rates their perceived health state from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
Time frame: Baseline, 24 Hours Postdose
Population: All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Visual Analog Scale | 20.785 score on a scale | Standard Deviation 26.094 |
| 200 mg Lasmiditan | Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Visual Analog Scale | 19.640 score on a scale | Standard Deviation 25.927 |
| 100 mg Lasmiditan | Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Visual Analog Scale | 21.341 score on a scale | Standard Deviation 26.92 |
| 200 mg Lasmiditan | Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Visual Analog Scale | 19.320 score on a scale | Standard Deviation 24.86 |
p-value: 0.719ANCOVA
p-value: 0.823ANCOVA
p-value: 0.612ANCOVA
Secondary
Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ)
The HRQoL is a 15-item, self-administered questionnaire. The items cover 5 domains (work functioning, social functioning, energy and vitality, feelings and concerns, and migraine symptoms). Each domain consists of 3 questions answered on a 7-point scale there 1 indicates maximum impairment and 7 indicating no impairment. A domain score is calculated by summing the responses to the 3 questions and the domain score ranges from 3 to 21, where a lower score indicates greater impairment, and a higher score indicates less impairment. The questionnaire will be administered 24 hours after the study drug.
Time frame: 24 Hours Postdose
Population: All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ) | Energy and Vitality | 12.652 score on a scale | Standard Deviation 4.412 |
| Placebo | Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ) | Work Functioning | 12.594 score on a scale | Standard Deviation 4.129 |
| Placebo | Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ) | Social Functioning | 13.235 score on a scale | Standard Deviation 4.915 |
| Placebo | Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ) | Migraine Symptoms | 14.070 score on a scale | Standard Deviation 3.87 |
| Placebo | Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ) | Feelings and Concerns | 11.674 score on a scale | Standard Deviation 4.145 |
| 200 mg Lasmiditan | Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ) | Energy and Vitality | 12.905 score on a scale | Standard Deviation 4.224 |
| 200 mg Lasmiditan | Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ) | Feelings and Concerns | 11.622 score on a scale | Standard Deviation 4.19 |
| 200 mg Lasmiditan | Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ) | Work Functioning | 13.392 score on a scale | Standard Deviation 3.93 |
| 200 mg Lasmiditan | Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ) | Migraine Symptoms | 14.703 score on a scale | Standard Deviation 3.877 |
| 200 mg Lasmiditan | Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ) | Social Functioning | 13.865 score on a scale | Standard Deviation 4.336 |
| 100 mg Lasmiditan | Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ) | Energy and Vitality | 12.723 score on a scale | Standard Deviation 4.58 |
| 100 mg Lasmiditan | Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ) | Social Functioning | 13.429 score on a scale | Standard Deviation 4.857 |
| 100 mg Lasmiditan | Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ) | Work Functioning | 13.034 score on a scale | Standard Deviation 4.176 |
| 100 mg Lasmiditan | Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ) | Feelings and Concerns | 12.028 score on a scale | Standard Deviation 4.181 |
| 100 mg Lasmiditan | Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ) | Migraine Symptoms | 14.949 score on a scale | Standard Deviation 3.544 |
| 200 mg Lasmiditan | Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ) | Feelings and Concerns | 12.099 score on a scale | Standard Deviation 4.197 |
| 200 mg Lasmiditan | Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ) | Social Functioning | 13.118 score on a scale | Standard Deviation 4.803 |
| 200 mg Lasmiditan | Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ) | Work Functioning | 12.368 score on a scale | Standard Deviation 4.197 |
| 200 mg Lasmiditan | Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ) | Energy and Vitality | 12.309 score on a scale | Standard Deviation 4.277 |
| 200 mg Lasmiditan | Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ) | Migraine Symptoms | 14.895 score on a scale | Standard Deviation 3.754 |
Comparison: Work Functioningp-value: 0.162ANOVA
Comparison: Social Functioningp-value: 0.356ANOVA
Comparison: Energy and Vitalityp-value: 0.696ANOVA
Comparison: Feelings and Concernsp-value: 0.914ANOVA
Comparison: Migraine Symptomsp-value: 0.226ANOVA
Comparison: Work Functioningp-value: 0.31ANOVA
Comparison: Social Functioningp-value: 0.684ANOVA
Comparison: Energy and Vitalityp-value: 0.864ANOVA
Comparison: Feelings and Concernsp-value: 0.412ANOVA
Comparison: Migraine Symptomsp-value: 0.025ANOVA
Comparison: Work Functioningp-value: 0.619ANOVA
Comparison: Social Functioningp-value: 0.824ANOVA
Comparison: Energy and Vitalityp-value: 0.476ANOVA
Comparison: Feelings and Concernsp-value: 0.352ANOVA
Comparison: Migraine Symptomsp-value: 0.044ANOVA
Secondary
Percentage of Participants That Are Free of Nausea
Percentage of participants that are free of nausea at 2 hours postdose.
Time frame: 2 Hours Postdose
Population: All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants That Are Free of Nausea | 78.8 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants That Are Free of Nausea | 83.7 percentage of participants |
| 100 mg Lasmiditan | Percentage of Participants That Are Free of Nausea | 82.3 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants That Are Free of Nausea | 79.5 percentage of participants |
p-value: 0.34295% CI: [0.71, 2.67]Regression, Logistic
p-value: 0.37795% CI: [0.76, 2.04]Regression, Logistic
p-value: 0.86295% CI: [0.63, 1.72]Regression, Logistic
Secondary
Percentage of Participants That Are Free of Phonophobia
Percentage of participants that are free of phonophobia at 2 hours postdose.
Time frame: 2 Hours Postdose
Population: All randomized participants who received at least one dose of drug and had any postdose headache severity or symptom assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants That Are Free of Phonophobia | 83.7 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants That Are Free of Phonophobia | 89.5 percentage of participants |
| 100 mg Lasmiditan | Percentage of Participants That Are Free of Phonophobia | 87.2 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants That Are Free of Phonophobia | 86.5 percentage of participants |
p-value: 0.19995% CI: [0.76, 3.65]Regression, Logistic
p-value: 0.30595% CI: [0.77, 2.32]Regression, Logistic
p-value: 0.42695% CI: [0.71, 2.24]Regression, Logistic
Secondary
Percentage of Participants That Are Free of Photophobia
Percentage of participants that are free of photophobia at 2 hours postdose.
Time frame: 2 Hours Postdose
Population: All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants That Are Free of Photophobia | 69.2 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants That Are Free of Photophobia | 77.9 percentage of participants |
| 100 mg Lasmiditan | Percentage of Participants That Are Free of Photophobia | 76.8 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants That Are Free of Photophobia | 77.8 percentage of participants |
p-value: 0.13595% CI: [0.87, 2.82]Regression, Logistic
p-value: 0.0895% CI: [0.95, 2.3]Regression, Logistic
p-value: 0.06195% CI: [0.98, 2.49]Regression, Logistic
Secondary
Percentage of Participants That Are Free of Vomiting
Percentage of participants that are free of vomiting at 2 hours postdose.
Time frame: 2 Hours Postdose
Population: All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants That Are Free of Vomiting | 99.0 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants That Are Free of Vomiting | 97.7 percentage of participants |
| 100 mg Lasmiditan | Percentage of Participants That Are Free of Vomiting | 99.5 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants That Are Free of Vomiting | 100.0 percentage of participants |
Secondary
Percentage of Participants Who Are Free of Most Bothersome Symptoms (MBS) Associated With Migraine
Percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing and being absent at 2 hours postdose. Missing value at a particular time point was considered as nonresponder.
Time frame: 2 Hours Postdose
Population: All randomized participants who received at least one dose of study drug to treat a single migraine attack within 4 hours of onset and had postdose headache severity or symptom assessments. Participants with no symptoms at pre-dose were excluded from the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Are Free of Most Bothersome Symptoms (MBS) Associated With Migraine | 46.5 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants Who Are Free of Most Bothersome Symptoms (MBS) Associated With Migraine | 55.9 percentage of participants |
| 100 mg Lasmiditan | Percentage of Participants Who Are Free of Most Bothersome Symptoms (MBS) Associated With Migraine | 58.0 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants Who Are Free of Most Bothersome Symptoms (MBS) Associated With Migraine | 60.3 percentage of participants |
p-value: 0.19795% CI: [0.81, 2.72]Regression, Logistic
p-value: 0.04495% CI: [1.01, 2.5]Regression, Logistic
p-value: 0.02395% CI: [1.08, 2.83]Regression, Logistic
Secondary
Percentage of Participants Who Are Headache Pain Free in Each Dose Group
Percentage of participants who are headache pain free in each dose group at 2 hours postdose.
Time frame: 2 Hours Postdose
Population: All randomized participants who received one dose of study drug to treat a single migraine attack within 4 hours of onset and had postdose headache severity or symptom assessments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Are Headache Pain Free in Each Dose Group | 16.6 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants Who Are Headache Pain Free in Each Dose Group | 23.5 percentage of participants |
| 100 mg Lasmiditan | Percentage of Participants Who Are Headache Pain Free in Each Dose Group | 32.4 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants Who Are Headache Pain Free in Each Dose Group | 40.8 percentage of participants |
p-value: <0.001Cochran-Armitage Trend Test
Secondary
Percentage of Participants With 24-Hour Sustained Pain Freedom
Percentage of participants who are headache pain free at 2 hours postdose and 24 hours postdose with no rescue medication.
Time frame: 24 Hours Postdose
Population: All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With 24-Hour Sustained Pain Freedom | 10.4 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants With 24-Hour Sustained Pain Freedom | 14.9 percentage of participants |
| 100 mg Lasmiditan | Percentage of Participants With 24-Hour Sustained Pain Freedom | 20.2 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants With 24-Hour Sustained Pain Freedom | 23.2 percentage of participants |
p-value: 0.26895% CI: [0.73, 3.17]Regression, Logistic
p-value: 0.00695% CI: [1.26, 3.82]Regression, Logistic
p-value: <0.00195% CI: [1.5, 4.61]Regression, Logistic
Secondary
Percentage of Participants With 48-Hour Sustained Pain Freedom
Percentage of participants who are headache pain free at 2 hours postdose and 48 hours postdose with no rescue medication.
Time frame: 48 Hours Postdose
Population: All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With 48-Hour Sustained Pain Freedom | 12.3 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants With 48-Hour Sustained Pain Freedom | 14.9 percentage of participants |
| 100 mg Lasmiditan | Percentage of Participants With 48-Hour Sustained Pain Freedom | 19.7 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants With 48-Hour Sustained Pain Freedom | 21.1 percentage of participants |
p-value: 0.53595% CI: [0.61, 2.58]Regression, Logistic
p-value: 0.03695% CI: [1.04, 3.03]Regression, Logistic
p-value: 0.01895% CI: [1.12, 3.33]Regression, Logistic
Secondary
Percentage of Participants With Freedom From Most Bothersome Symptom (MBS)
Percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing and being absent at 1 hour postdose.
Time frame: 1 Hour Postdose
Population: All randomized participants who received one dose of study drug to treat a single migraine attack within 4 hours of onset and have postdose headache severity or symptom assessments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) | 28.7 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) | 32.2 percentage of participants |
| 100 mg Lasmiditan | Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) | 42.0 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) | 33.1 percentage of participants |
p-value: 0.60595% CI: [0.62, 2.26]Regression, Logistic
p-value: 0.01595% CI: [1.12, 2.9]Regression, Logistic
p-value: 0.43295% CI: [0.74, 2.05]Regression, Logistic
Secondary
Percentage of Participants With Headache Pain Relief
Percentage of participants with headache pain relief at 1 hour postdose.
Time frame: 1 Hour Postdose
Population: All randomized participants who received one dose of study drug to treat a single migraine attack within 4 hours of onset and have postdose headache severity or symptom assessments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Headache Pain Relief | 41.2 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants With Headache Pain Relief | 35.3 percentage of participants |
| 100 mg Lasmiditan | Percentage of Participants With Headache Pain Relief | 58.5 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants With Headache Pain Relief | 59.8 percentage of participants |
p-value: 0.34395% CI: [0.46, 1.31]Regression, Logistic
p-value: <0.00195% CI: [1.37, 2.98]Regression, Logistic
p-value: <0.00195% CI: [1.42, 3.2]Regression, Logistic
Secondary
Percentage of Participants With Headache Pain Relief
Percentage of participants with headache pain relief (defined as moderate or severe headache pain becoming mild or none) at 2 hours postdose.
Time frame: 2 Hours Postdose
Population: All randomized participants who received one dose of study drug to treat a single migraine attack within 4 hours of onset and had postdose headache severity or symptom assessments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Headache Pain Relief | 55.0 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants With Headache Pain Relief | 68.2 percentage of participants |
| 100 mg Lasmiditan | Percentage of Participants With Headache Pain Relief | 80.2 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants With Headache Pain Relief | 78.2 percentage of participants |
p-value: 0.03795% CI: [1.03, 2.99]Regression, Logistic
p-value: <0.00195% CI: [2.16, 5.17]Regression, Logistic
p-value: <0.00195% CI: [1.89, 4.62]Regression, Logistic
Secondary
Percentage of Participants With No Disability
Disability will be measured by determining the level of interference with normal activities with 4 response options including not at all (0); mild interference (1), marked interference (2); and need complete bed rest (3). No Disability timing is defined as the first time when severity becomes 0. Percentage of participants who are responders defined as score = 0 at 2 hours postdose.
Time frame: 2 Hours Postdose
Population: All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessments. Participants with 0 severity at baseline are excluded from the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With No Disability | 18.4 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants With No Disability | 24.7 percentage of participants |
| 100 mg Lasmiditan | Percentage of Participants With No Disability | 25.4 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants With No Disability | 28.7 percentage of participants |
p-value: 0.23395% CI: [0.79, 2.64]Regression, Logistic
p-value: 0.09295% CI: [0.94, 2.41]Regression, Logistic
p-value: 0.01795% CI: [1.11, 2.92]Regression, Logistic
Secondary
Percentage of Participants With No Disability
Disability will be measured by determining the level of interference with normal activities with 4 response options including: not at all (0); mild interference (1), marked interference (2); and need complete bed rest (3). No Disability timing is defined as the first time when severity becomes 0. Percentage of participants who are responders defined as score = 0 at 1 hours postdose.
Time frame: 1 Hour Postdose
Population: All randomized participants who received one dose of study drug and had any postdose headache severity or symptom assessments. Participants with 0 severity at baseline are excluded from the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With No Disability | 8.1 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants With No Disability | 13.6 percentage of participants |
| 100 mg Lasmiditan | Percentage of Participants With No Disability | 10.6 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants With No Disability | 12.1 percentage of participants |
p-value: 0.16695% CI: [0.79, 3.96]Regression, Logistic
p-value: 0.39695% CI: [0.68, 2.62]Regression, Logistic
p-value: 0.18195% CI: [0.81, 3.11]Regression, Logistic
Secondary
Percentage of Participants With Pain Freedom
Percentage of participants with pain freedom.
Time frame: 1 Hour Postdose
Population: All randomized participants who received one dose of study drug to treat a single migraine attack within 4 hours of onset and have postdose headache severity or symptom assessments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Pain Freedom | 1.4 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants With Pain Freedom | 4.7 percentage of participants |
| 100 mg Lasmiditan | Percentage of Participants With Pain Freedom | 11.6 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants With Pain Freedom | 12.8 percentage of participants |
p-value: 0.11295% CI: [0.75, 15.65]Regression, Logistic
p-value: <0.00195% CI: [2.68, 30.55]Regression, Logistic
p-value: <0.00195% CI: [3.01, 34.55]Regression, Logistic
Secondary
Percentage of Participants With Very Much or Much Better as Measured by the Patient Global Impression of Change (PGI-C)
The PGI-C is a one-item questionnaire that asks participants to provide their impression of change since taking the medicine. The PGI-C is measured using a 7-point Likert scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants who are responders defined as having rated their impression of change as very much better or much better at 2 hours postdose.
Time frame: 2 Hours Postdose
Population: All randomized participants who received at least one dose of study drug and had any postdose headache severity or symptom assessments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Very Much or Much Better as Measured by the Patient Global Impression of Change (PGI-C) | 23.6 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants With Very Much or Much Better as Measured by the Patient Global Impression of Change (PGI-C) | 35.6 percentage of participants |
| 100 mg Lasmiditan | Percentage of Participants With Very Much or Much Better as Measured by the Patient Global Impression of Change (PGI-C) | 44.7 percentage of participants |
| 200 mg Lasmiditan | Percentage of Participants With Very Much or Much Better as Measured by the Patient Global Impression of Change (PGI-C) | 48.3 percentage of participants |
p-value: 0.03795% CI: [1.04, 3.07]Regression, Logistic
p-value: <0.00195% CI: [1.75, 4.06]Regression, Logistic
p-value: <0.00195% CI: [2.11, 5.06]Regression, Logistic