Migraine
Conditions
Keywords
Migraine
Brief summary
This study evaluates the efficacy of a range of intravenous doses of COL-144 in the treatment of migraine headache in order to select a dose range for further studies.
Detailed description
This study is set up: * to evaluate the efficacy (headache response at two hours) of a range of intravenous doses of COL-144 in order to select a dose range for further evaluation, * to explore the time course and effect of a range of dose levels of COL-144 on features of the migraine including: headache response, proportion of participants pain-free, headache recurrence, nausea, photophobia, phonophobia, disability, use of rescue medication, patient global impression and vomiting * to explore the safety and tolerability of a range of doses of COL-144 in terms of adverse events, physical exam, vital signs, laboratory evaluations, and ECGs * to determine key PK parameters for COL-144 and to explore the relationship between the PK of COL-144 and the time course and extent of clinical response
Interventions
DRUGLasmiditan
Administered as intravenous infusion
DRUGPlacebo
Administered as intravenous infusion
Sponsors
CoLucid Pharmaceuticals
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 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with migraine with or without aura fulfilling the IHS diagnostic criteria 1.1 and 1.2.1 (2004) * History of migraine of at least 1 year * Migraine onset before the age of 50 years * History of 1 - 8 migraine attacks per month * Male or female subjects aged 18 to 65 years * Female patients of child-bearing potential must be using a highly effective form of contraception (eg combined oral contraceptive, IUD, abstinence, vasectomized partner) * Able and willing to return to the clinic for treatment within 4 hours of the onset of a migraine headache * Able and willing to give written informed consent
Exclusion criteria
* History of life threatening or intolerable adverse reaction to any triptan * Use of prescription migraine prophylactic drugs * Pregnant or breast-feeding women * Women of child-bearing potential not using highly effective contraception * History or evidence of coronary artery disease, ischemic or hemorrhagic stroke, epilepsy or any other condition placing the patient at increased risk of seizures * History of hypertension (controlled or uncontrolled) * Sitting BP \>160mmHg systolic or \>90mmHg diastolic on 2 repeated measurements at screening * Current use of hemodynamically active cardiovascular drugs * History within the previous 3 years or current evidence of abuse of any drug, prescription or illicit, or alcohol * Significant renal impairment * Previous participation in this clinical trial * Participation in any clinical trial of an experimental drug or device in the previous 30 days * Any medical condition or laboratory test which in the judgment of the investigator makes the patient unsuitable for the study * Relatives of, or staff directly reporting to, the investigator * Patients with known hypersensitivity to COL-144, other 5HT1F receptor agonists or to any excipient of COL-144
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug | 2 hours post dose | Headache response is a binary response variable derived from the headache intensities recorded in the participant diary. Headache response is defined as a reduction in headache severity from moderate or severe at baseline to mild or no headache, at two hours after initiation of infusion of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Headache Free | 10, 20, 40, 60 90, 120, 180 and 240 minutes post dose | Headache free is defined as a reduction in headache severity from moderate or severe at baseline to no headache pain at 10 min, 20 min, 40 min, 60 min, 90 min, 120 min, 180 min, and 240 min after initiation of study drug. |
| Number of Participants With Sustained Headache Response | 2 to 24 hours post dose | Sustained headache response at 2 hours is a binary response variable derived from the headache intensities recorded in the participant diary. Sustained headache response was defined as moderate or severe headache pain at baseline which became mild or absent (pain free) at 2 hours after initiation of study drug and which did not recur (became moderate or severe) within 24 hours of initiation of study drug. If rescue medication was taken within 24 hours, this was considered a headache recurrence, even if no headache was reported. |
| Number of Participants With Sustained Pain Free | 2 to 24 hours post dose | Sustained pain free was defined as moderate or severe headache pain at baseline which became mild or absent (pain free) at 2 hours after initiation of study drug and which did not recur (became moderate or severe) within 24 hours of initiation of study drug. If rescue medication was taken within 24 hours, this was considered a headache recurrence, even if no headache was reported. |
| Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 10, 20, 40, 60 90, 120, 180 and 240 minutes post dose | Headache response is defined as a reduction in headache severity from moderate or severe at baseline to mild or no headache, at two hours after initiation of infusion of study drug. |
| Number of Participants With Clinical Disability | 2 hours post dose | Clinical disability for each participant was assessed using the Clinical Disability Questionnaire (CDQ). Participants graded their disability on the following scale: 0, no disability, able to function normally; 1, performance of daily activities mildly impaired, can still do everything but with difficulty; 2, performance of daily activities moderately impaired, unable to do some things; 3, performance of daily activities severely impaired, cannot do all or most things, bed rest may be necessary. |
| Percentage of Participants Using Rescue Medication | 24 hours post dose | Use of rescue medication up to 24 hours after initiation of study drug. |
| Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | 2 hours post dose | PGI scale is a participant-rated instrument that measures participants own global impression of their illness severity. Participants were asked to mark the box that best describes their headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point 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. |
| Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | 2 hours post dose | Number of participants with absence of nausea, vomiting, photophobia and phonophobia. |
Countries
Finland, Germany, Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received intravenous infusion of placebo solution. | 42 |
| Lasmiditan 2.5 mg Participants received 2.5 mg of lasmiditan administered as intravenous infusion. | 4 |
| Lasmiditan 5.0 mg Participants received 5 mg of lasmiditan administered as intravenous infusion. | 12 |
| Lasmiditan 10 mg Participants received 10 mg of lasmiditan administered as intravenous infusion. | 24 |
| Lasmiditan 20 mg Participants received 20 mg of lasmiditan administered as intravenous infusion. | 28 |
| Lasmiditan 30 mg Participants received 30 mg of lasmiditan administered as intravenous infusion. | 16 |
| Lasmiditan 45 mg Participants received 45 mg of lasmiditan administered as intravenous infusion. | 4 |
| Total | 130 |
Baseline characteristics
| Characteristic | Placebo | Lasmiditan 2.5 mg | Lasmiditan 5.0 mg | Lasmiditan 10 mg | Lasmiditan 20 mg | Lasmiditan 30 mg | Lasmiditan 45 mg | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 40.3 Years STANDARD_DEVIATION 13.1 | 46.8 Years STANDARD_DEVIATION 14 | 39.2 Years STANDARD_DEVIATION 8.8 | 34.5 Years STANDARD_DEVIATION 10.3 | 38.9 Years STANDARD_DEVIATION 10.1 | 40.3 Years STANDARD_DEVIATION 11.2 | 40.8 Years STANDARD_DEVIATION 11 | 39.0 Years STANDARD_DEVIATION 11.4 |
| Race/Ethnicity, Customized Black | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 42 Participants | 4 Participants | 11 Participants | 20 Participants | 28 Participants | 16 Participants | 4 Participants | 125 Participants |
| Race/Ethnicity, Customized Latin | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Romanian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized South-American | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Region of Enrollment Finland | 10 Participants | 0 Participants | 6 Participants | 4 Participants | 2 Participants | 1 Participants | 1 Participants | 24 Participants |
| Region of Enrollment Germany | 29 Participants | 4 Participants | 5 Participants | 17 Participants | 25 Participants | 15 Participants | 2 Participants | 97 Participants |
| Region of Enrollment Netherlands | 3 Participants | 0 Participants | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 1 Participants | 9 Participants |
| Sex: Female, Male Female | 38 Participants | 3 Participants | 10 Participants | 21 Participants | 24 Participants | 14 Participants | 3 Participants | 113 Participants |
| Sex: Female, Male Male | 4 Participants | 1 Participants | 2 Participants | 3 Participants | 4 Participants | 2 Participants | 1 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 4 | 0 / 12 | 0 / 24 | 0 / 28 | 0 / 16 | 0 / 4 |
| other Total, other adverse events | 18 / 42 | 2 / 4 | 3 / 12 | 17 / 24 | 19 / 28 | 13 / 16 | 3 / 4 |
| serious Total, serious adverse events | 0 / 42 | 0 / 4 | 0 / 12 | 0 / 24 | 0 / 28 | 0 / 16 | 0 / 4 |
Outcome results
Primary
Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug
Headache response is a binary response variable derived from the headache intensities recorded in the participant diary. Headache response is defined as a reduction in headache severity from moderate or severe at baseline to mild or no headache, at two hours after initiation of infusion of study drug.
Time frame: 2 hours post dose
Population: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug | No | 23 Participants |
| Placebo | Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug | Yes | 19 Participants |
| Lasmiditan 2.5 mg | Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug | No | 2 Participants |
| Lasmiditan 2.5 mg | Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug | Yes | 2 Participants |
| Lasmiditan 5.0 mg | Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug | No | 10 Participants |
| Lasmiditan 5.0 mg | Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug | Yes | 2 Participants |
| Lasmiditan 10 mg | Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug | No | 11 Participants |
| Lasmiditan 10 mg | Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug | Yes | 13 Participants |
| Lasmiditan 20 mg | Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug | No | 10 Participants |
| Lasmiditan 20 mg | Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug | Yes | 18 Participants |
| Lasmiditan 30 mg | Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug | No | 5 Participants |
| Lasmiditan 30 mg | Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug | Yes | 11 Participants |
| Lasmiditan 45 mg | Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug | No | 1 Participants |
| Lasmiditan 45 mg | Number of Participants With Headache Response at Two Hours After Initiation of Infusion of Study Drug | Yes | 3 Participants |
Comparison: Headache Responsep-value: 1Fisher Exact
Comparison: Headache Responsep-value: 0.0991Fisher Exact
Comparison: Headache Responsep-value: 0.4851Chi-squared
Comparison: Headache Responsep-value: 0.1178Chi-squared
Comparison: Headache Responsep-value: 0.1093Chi-squared
Comparison: Headache Responsep-value: 0.3364Fisher Exact
Secondary
Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia
Number of participants with absence of nausea, vomiting, photophobia and phonophobia.
Time frame: 2 hours post dose
Population: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Vomiting | 1 Participants |
| Placebo | Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Nausea | 7 Participants |
| Placebo | Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Phonophobia | 18 Participants |
| Placebo | Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Photophobia | 21 Participants |
| Lasmiditan 2.5 mg | Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Phonophobia | 1 Participants |
| Lasmiditan 2.5 mg | Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Vomiting | 0 Participants |
| Lasmiditan 2.5 mg | Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Nausea | 1 Participants |
| Lasmiditan 2.5 mg | Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Photophobia | 1 Participants |
| Lasmiditan 5.0 mg | Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Vomiting | 0 Participants |
| Lasmiditan 5.0 mg | Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Nausea | 5 Participants |
| Lasmiditan 5.0 mg | Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Photophobia | 9 Participants |
| Lasmiditan 5.0 mg | Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Phonophobia | 5 Participants |
| Lasmiditan 10 mg | Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Vomiting | 1 Participants |
| Lasmiditan 10 mg | Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Photophobia | 11 Participants |
| Lasmiditan 10 mg | Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Nausea | 3 Participants |
| Lasmiditan 10 mg | Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Phonophobia | 6 Participants |
| Lasmiditan 20 mg | Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Vomiting | 0 Participants |
| Lasmiditan 20 mg | Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Nausea | 6 Participants |
| Lasmiditan 20 mg | Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Photophobia | 12 Participants |
| Lasmiditan 20 mg | Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Phonophobia | 7 Participants |
| Lasmiditan 30 mg | Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Vomiting | 0 Participants |
| Lasmiditan 30 mg | Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Nausea | 1 Participants |
| Lasmiditan 30 mg | Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Phonophobia | 4 Participants |
| Lasmiditan 30 mg | Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Photophobia | 4 Participants |
| Lasmiditan 45 mg | Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Phonophobia | 1 Participants |
| Lasmiditan 45 mg | Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Photophobia | 1 Participants |
| Lasmiditan 45 mg | Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Nausea | 1 Participants |
| Lasmiditan 45 mg | Number of Participants With Absence of Nausea, Vomiting, Photophobia and Phonophobia | Vomiting | 0 Participants |
Secondary
Number of Participants With Clinical Disability
Clinical disability for each participant was assessed using the Clinical Disability Questionnaire (CDQ). Participants graded their disability on the following scale: 0, no disability, able to function normally; 1, performance of daily activities mildly impaired, can still do everything but with difficulty; 2, performance of daily activities moderately impaired, unable to do some things; 3, performance of daily activities severely impaired, cannot do all or most things, bed rest may be necessary.
Time frame: 2 hours post dose
Population: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Clinical Disability | No disability | 11 Participants |
| Placebo | Number of Participants With Clinical Disability | Mild disability | 10 Participants |
| Placebo | Number of Participants With Clinical Disability | Moderate disability | 14 Participants |
| Placebo | Number of Participants With Clinical Disability | Severe disability | 7 Participants |
| Lasmiditan 2.5 mg | Number of Participants With Clinical Disability | Severe disability | 1 Participants |
| Lasmiditan 2.5 mg | Number of Participants With Clinical Disability | Moderate disability | 0 Participants |
| Lasmiditan 2.5 mg | Number of Participants With Clinical Disability | No disability | 2 Participants |
| Lasmiditan 2.5 mg | Number of Participants With Clinical Disability | Mild disability | 1 Participants |
| Lasmiditan 5.0 mg | Number of Participants With Clinical Disability | Moderate disability | 6 Participants |
| Lasmiditan 5.0 mg | Number of Participants With Clinical Disability | Mild disability | 1 Participants |
| Lasmiditan 5.0 mg | Number of Participants With Clinical Disability | No disability | 1 Participants |
| Lasmiditan 5.0 mg | Number of Participants With Clinical Disability | Severe disability | 4 Participants |
| Lasmiditan 10 mg | Number of Participants With Clinical Disability | No disability | 6 Participants |
| Lasmiditan 10 mg | Number of Participants With Clinical Disability | Mild disability | 7 Participants |
| Lasmiditan 10 mg | Number of Participants With Clinical Disability | Moderate disability | 7 Participants |
| Lasmiditan 10 mg | Number of Participants With Clinical Disability | Severe disability | 4 Participants |
| Lasmiditan 20 mg | Number of Participants With Clinical Disability | No disability | 9 Participants |
| Lasmiditan 20 mg | Number of Participants With Clinical Disability | Severe disability | 1 Participants |
| Lasmiditan 20 mg | Number of Participants With Clinical Disability | Mild disability | 7 Participants |
| Lasmiditan 20 mg | Number of Participants With Clinical Disability | Moderate disability | 11 Participants |
| Lasmiditan 30 mg | Number of Participants With Clinical Disability | Mild disability | 5 Participants |
| Lasmiditan 30 mg | Number of Participants With Clinical Disability | No disability | 7 Participants |
| Lasmiditan 30 mg | Number of Participants With Clinical Disability | Moderate disability | 3 Participants |
| Lasmiditan 30 mg | Number of Participants With Clinical Disability | Severe disability | 1 Participants |
| Lasmiditan 45 mg | Number of Participants With Clinical Disability | Moderate disability | 0 Participants |
| Lasmiditan 45 mg | Number of Participants With Clinical Disability | No disability | 3 Participants |
| Lasmiditan 45 mg | Number of Participants With Clinical Disability | Mild disability | 0 Participants |
| Lasmiditan 45 mg | Number of Participants With Clinical Disability | Severe disability | 1 Participants |
Secondary
Number of Participants With Sustained Headache Response
Sustained headache response at 2 hours is a binary response variable derived from the headache intensities recorded in the participant diary. Sustained headache response was defined as moderate or severe headache pain at baseline which became mild or absent (pain free) at 2 hours after initiation of study drug and which did not recur (became moderate or severe) within 24 hours of initiation of study drug. If rescue medication was taken within 24 hours, this was considered a headache recurrence, even if no headache was reported.
Time frame: 2 to 24 hours post dose
Population: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Sustained Headache Response | No | 29 Participants |
| Placebo | Number of Participants With Sustained Headache Response | Yes | 13 Participants |
| Lasmiditan 2.5 mg | Number of Participants With Sustained Headache Response | No | 2 Participants |
| Lasmiditan 2.5 mg | Number of Participants With Sustained Headache Response | Yes | 2 Participants |
| Lasmiditan 5.0 mg | Number of Participants With Sustained Headache Response | No | 11 Participants |
| Lasmiditan 5.0 mg | Number of Participants With Sustained Headache Response | Yes | 1 Participants |
| Lasmiditan 10 mg | Number of Participants With Sustained Headache Response | No | 16 Participants |
| Lasmiditan 10 mg | Number of Participants With Sustained Headache Response | Yes | 8 Participants |
| Lasmiditan 20 mg | Number of Participants With Sustained Headache Response | No | 18 Participants |
| Lasmiditan 20 mg | Number of Participants With Sustained Headache Response | Yes | 10 Participants |
| Lasmiditan 30 mg | Number of Participants With Sustained Headache Response | No | 7 Participants |
| Lasmiditan 30 mg | Number of Participants With Sustained Headache Response | Yes | 9 Participants |
| Lasmiditan 45 mg | Number of Participants With Sustained Headache Response | No | 3 Participants |
| Lasmiditan 45 mg | Number of Participants With Sustained Headache Response | Yes | 1 Participants |
Secondary
Number of Participants With Sustained Pain Free
Sustained pain free was defined as moderate or severe headache pain at baseline which became mild or absent (pain free) at 2 hours after initiation of study drug and which did not recur (became moderate or severe) within 24 hours of initiation of study drug. If rescue medication was taken within 24 hours, this was considered a headache recurrence, even if no headache was reported.
Time frame: 2 to 24 hours post dose
Population: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Sustained Pain Free | No | 35 Participants |
| Placebo | Number of Participants With Sustained Pain Free | Yes | 7 Participants |
| Lasmiditan 2.5 mg | Number of Participants With Sustained Pain Free | No | 4 Participants |
| Lasmiditan 2.5 mg | Number of Participants With Sustained Pain Free | Yes | 0 Participants |
| Lasmiditan 5.0 mg | Number of Participants With Sustained Pain Free | No | 12 Participants |
| Lasmiditan 5.0 mg | Number of Participants With Sustained Pain Free | Yes | 0 Participants |
| Lasmiditan 10 mg | Number of Participants With Sustained Pain Free | No | 21 Participants |
| Lasmiditan 10 mg | Number of Participants With Sustained Pain Free | Yes | 3 Participants |
| Lasmiditan 20 mg | Number of Participants With Sustained Pain Free | No | 23 Participants |
| Lasmiditan 20 mg | Number of Participants With Sustained Pain Free | Yes | 5 Participants |
| Lasmiditan 30 mg | Number of Participants With Sustained Pain Free | No | 13 Participants |
| Lasmiditan 30 mg | Number of Participants With Sustained Pain Free | Yes | 3 Participants |
| Lasmiditan 45 mg | Number of Participants With Sustained Pain Free | No | 3 Participants |
| Lasmiditan 45 mg | Number of Participants With Sustained Pain Free | Yes | 1 Participants |
Secondary
Percentage of Participants Headache Free
Headache free is defined as a reduction in headache severity from moderate or severe at baseline to no headache pain at 10 min, 20 min, 40 min, 60 min, 90 min, 120 min, 180 min, and 240 min after initiation of study drug.
Time frame: 10, 20, 40, 60 90, 120, 180 and 240 minutes post dose
Population: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Headache Free | 40 min | 2.4 Percentage of participants |
| Placebo | Percentage of Participants Headache Free | 10 min | 0 Percentage of participants |
| Placebo | Percentage of Participants Headache Free | 20 min | 2.4 Percentage of participants |
| Placebo | Percentage of Participants Headache Free | 60 min | 7.1 Percentage of participants |
| Placebo | Percentage of Participants Headache Free | 90 min | 14.3 Percentage of participants |
| Placebo | Percentage of Participants Headache Free | 120 min | 19.0 Percentage of participants |
| Placebo | Percentage of Participants Headache Free | 180 min | 21.4 Percentage of participants |
| Placebo | Percentage of Participants Headache Free | 240 min | 21.4 Percentage of participants |
| Lasmiditan 2.5 mg | Percentage of Participants Headache Free | 20 min | 0 Percentage of participants |
| Lasmiditan 2.5 mg | Percentage of Participants Headache Free | 10 min | 0 Percentage of participants |
| Lasmiditan 2.5 mg | Percentage of Participants Headache Free | 40 min | 0 Percentage of participants |
| Lasmiditan 2.5 mg | Percentage of Participants Headache Free | 60 min | 0 Percentage of participants |
| Lasmiditan 2.5 mg | Percentage of Participants Headache Free | 90 min | 0 Percentage of participants |
| Lasmiditan 2.5 mg | Percentage of Participants Headache Free | 120 min | 0 Percentage of participants |
| Lasmiditan 2.5 mg | Percentage of Participants Headache Free | 180 min | 0 Percentage of participants |
| Lasmiditan 2.5 mg | Percentage of Participants Headache Free | 240 min | 25.0 Percentage of participants |
| Lasmiditan 5.0 mg | Percentage of Participants Headache Free | 120 min | 0 Percentage of participants |
| Lasmiditan 5.0 mg | Percentage of Participants Headache Free | 40 min | 0 Percentage of participants |
| Lasmiditan 5.0 mg | Percentage of Participants Headache Free | 90 min | 0 Percentage of participants |
| Lasmiditan 5.0 mg | Percentage of Participants Headache Free | 10 min | 0 Percentage of participants |
| Lasmiditan 5.0 mg | Percentage of Participants Headache Free | 180 min | 0 Percentage of participants |
| Lasmiditan 5.0 mg | Percentage of Participants Headache Free | 20 min | 0 Percentage of participants |
| Lasmiditan 5.0 mg | Percentage of Participants Headache Free | 240 min | 0 Percentage of participants |
| Lasmiditan 5.0 mg | Percentage of Participants Headache Free | 60 min | 0 Percentage of participants |
| Lasmiditan 10 mg | Percentage of Participants Headache Free | 240 min | 20.8 Percentage of participants |
| Lasmiditan 10 mg | Percentage of Participants Headache Free | 180 min | 20.8 Percentage of participants |
| Lasmiditan 10 mg | Percentage of Participants Headache Free | 10 min | 0 Percentage of participants |
| Lasmiditan 10 mg | Percentage of Participants Headache Free | 60 min | 20.8 Percentage of participants |
| Lasmiditan 10 mg | Percentage of Participants Headache Free | 90 min | 20.8 Percentage of participants |
| Lasmiditan 10 mg | Percentage of Participants Headache Free | 40 min | 8.3 Percentage of participants |
| Lasmiditan 10 mg | Percentage of Participants Headache Free | 20 min | 8.3 Percentage of participants |
| Lasmiditan 10 mg | Percentage of Participants Headache Free | 120 min | 20.8 Percentage of participants |
| Lasmiditan 20 mg | Percentage of Participants Headache Free | 90 min | 25.0 Percentage of participants |
| Lasmiditan 20 mg | Percentage of Participants Headache Free | 180 min | 32.1 Percentage of participants |
| Lasmiditan 20 mg | Percentage of Participants Headache Free | 120 min | 28.6 Percentage of participants |
| Lasmiditan 20 mg | Percentage of Participants Headache Free | 240 min | 28.6 Percentage of participants |
| Lasmiditan 20 mg | Percentage of Participants Headache Free | 20 min | 3.6 Percentage of participants |
| Lasmiditan 20 mg | Percentage of Participants Headache Free | 10 min | 3.6 Percentage of participants |
| Lasmiditan 20 mg | Percentage of Participants Headache Free | 40 min | 14.3 Percentage of participants |
| Lasmiditan 20 mg | Percentage of Participants Headache Free | 60 min | 21.4 Percentage of participants |
| Lasmiditan 30 mg | Percentage of Participants Headache Free | 10 min | 0 Percentage of participants |
| Lasmiditan 30 mg | Percentage of Participants Headache Free | 40 min | 18.8 Percentage of participants |
| Lasmiditan 30 mg | Percentage of Participants Headache Free | 60 min | 25.0 Percentage of participants |
| Lasmiditan 30 mg | Percentage of Participants Headache Free | 90 min | 37.5 Percentage of participants |
| Lasmiditan 30 mg | Percentage of Participants Headache Free | 120 min | 37.5 Percentage of participants |
| Lasmiditan 30 mg | Percentage of Participants Headache Free | 240 min | 31.3 Percentage of participants |
| Lasmiditan 30 mg | Percentage of Participants Headache Free | 180 min | 37.5 Percentage of participants |
| Lasmiditan 30 mg | Percentage of Participants Headache Free | 20 min | 0 Percentage of participants |
| Lasmiditan 45 mg | Percentage of Participants Headache Free | 180 min | 25.0 Percentage of participants |
| Lasmiditan 45 mg | Percentage of Participants Headache Free | 120 min | 25.0 Percentage of participants |
| Lasmiditan 45 mg | Percentage of Participants Headache Free | 90 min | 25.0 Percentage of participants |
| Lasmiditan 45 mg | Percentage of Participants Headache Free | 60 min | 25.0 Percentage of participants |
| Lasmiditan 45 mg | Percentage of Participants Headache Free | 240 min | 25.0 Percentage of participants |
| Lasmiditan 45 mg | Percentage of Participants Headache Free | 20 min | 25.0 Percentage of participants |
| Lasmiditan 45 mg | Percentage of Participants Headache Free | 10 min | 25.0 Percentage of participants |
| Lasmiditan 45 mg | Percentage of Participants Headache Free | 40 min | 25.0 Percentage of participants |
Secondary
Percentage of Participants Reporting a Score on the Patient Global Impression (PGI)
PGI scale is a participant-rated instrument that measures participants own global impression of their illness severity. Participants were asked to mark the box that best describes their headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point 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.
Time frame: 2 hours post dose
Population: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | No change | 19.0 Percentage of Participants |
| Placebo | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | Very much better | 9.5 Percentage of Participants |
| Placebo | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | Very much worse | 2.4 Percentage of Participants |
| Placebo | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | Much better | 19.0 Percentage of Participants |
| Placebo | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | Much worse | 11.9 Percentage of Participants |
| Placebo | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | A little better | 23.8 Percentage of Participants |
| Placebo | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | A little worse | 14.3 Percentage of Participants |
| Lasmiditan 2.5 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | Very much better | 0 Percentage of Participants |
| Lasmiditan 2.5 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | Much better | 75.0 Percentage of Participants |
| Lasmiditan 2.5 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | Much worse | 0 Percentage of Participants |
| Lasmiditan 2.5 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | A little worse | 0 Percentage of Participants |
| Lasmiditan 2.5 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | No change | 0 Percentage of Participants |
| Lasmiditan 2.5 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | A little better | 0 Percentage of Participants |
| Lasmiditan 2.5 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | Very much worse | 25.0 Percentage of Participants |
| Lasmiditan 5.0 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | A little better | 41.7 Percentage of Participants |
| Lasmiditan 5.0 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | Very much worse | 16.7 Percentage of Participants |
| Lasmiditan 5.0 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | Much better | 8.3 Percentage of Participants |
| Lasmiditan 5.0 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | Very much better | 0 Percentage of Participants |
| Lasmiditan 5.0 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | Much worse | 0 Percentage of Participants |
| Lasmiditan 5.0 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | No change | 25.0 Percentage of Participants |
| Lasmiditan 5.0 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | A little worse | 8.3 Percentage of Participants |
| Lasmiditan 10 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | No change | 29.2 Percentage of Participants |
| Lasmiditan 10 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | Very much better | 8.3 Percentage of Participants |
| Lasmiditan 10 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | Much better | 29.2 Percentage of Participants |
| Lasmiditan 10 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | A little better | 29.2 Percentage of Participants |
| Lasmiditan 10 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | A little worse | 4.2 Percentage of Participants |
| Lasmiditan 10 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | Much worse | 0 Percentage of Participants |
| Lasmiditan 10 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | Very much worse | 0 Percentage of Participants |
| Lasmiditan 20 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | Very much worse | 0 Percentage of Participants |
| Lasmiditan 20 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | Very much better | 25.0 Percentage of Participants |
| Lasmiditan 20 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | No change | 7.1 Percentage of Participants |
| Lasmiditan 20 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | A little better | 42.9 Percentage of Participants |
| Lasmiditan 20 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | Much better | 17.9 Percentage of Participants |
| Lasmiditan 20 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | Much worse | 0 Percentage of Participants |
| Lasmiditan 20 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | A little worse | 7.1 Percentage of Participants |
| Lasmiditan 30 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | Very much worse | 0 Percentage of Participants |
| Lasmiditan 30 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | Very much better | 37.5 Percentage of Participants |
| Lasmiditan 30 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | Much better | 31.3 Percentage of Participants |
| Lasmiditan 30 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | A little worse | 0 Percentage of Participants |
| Lasmiditan 30 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | Much worse | 0 Percentage of Participants |
| Lasmiditan 30 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | No change | 12.5 Percentage of Participants |
| Lasmiditan 30 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | A little better | 18.8 Percentage of Participants |
| Lasmiditan 45 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | No change | 25.0 Percentage of Participants |
| Lasmiditan 45 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | A little worse | 0 Percentage of Participants |
| Lasmiditan 45 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | Much better | 50.0 Percentage of Participants |
| Lasmiditan 45 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | Much worse | 0 Percentage of Participants |
| Lasmiditan 45 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | Very much better | 0 Percentage of Participants |
| Lasmiditan 45 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | Very much worse | 0 Percentage of Participants |
| Lasmiditan 45 mg | Percentage of Participants Reporting a Score on the Patient Global Impression (PGI) | A little better | 25.0 Percentage of Participants |
Secondary
Percentage of Participants Using Rescue Medication
Use of rescue medication up to 24 hours after initiation of study drug.
Time frame: 24 hours post dose
Population: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Using Rescue Medication | 69.0 Percentage of participants |
| Lasmiditan 2.5 mg | Percentage of Participants Using Rescue Medication | 25.0 Percentage of participants |
| Lasmiditan 5.0 mg | Percentage of Participants Using Rescue Medication | 91.7 Percentage of participants |
| Lasmiditan 10 mg | Percentage of Participants Using Rescue Medication | 58.3 Percentage of participants |
| Lasmiditan 20 mg | Percentage of Participants Using Rescue Medication | 53.6 Percentage of participants |
| Lasmiditan 30 mg | Percentage of Participants Using Rescue Medication | 37.5 Percentage of participants |
| Lasmiditan 45 mg | Percentage of Participants Using Rescue Medication | 25.0 Percentage of participants |
Secondary
Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose
Headache response is defined as a reduction in headache severity from moderate or severe at baseline to mild or no headache, at two hours after initiation of infusion of study drug.
Time frame: 10, 20, 40, 60 90, 120, 180 and 240 minutes post dose
Population: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 40 min | 35.7 Percentage of participants |
| Placebo | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 20 min | 26.2 Percentage of participants |
| Placebo | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 10 min | 11.9 Percentage of participants |
| Placebo | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 60 min | 33.3 Percentage of participants |
| Placebo | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 90 min | 47.6 Percentage of participants |
| Placebo | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 120 min | 45.2 Percentage of participants |
| Placebo | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 180 min | 33.3 Percentage of participants |
| Placebo | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 240 min | 31.0 Percentage of participants |
| Lasmiditan 2.5 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 180 min | 50.0 Percentage of participants |
| Lasmiditan 2.5 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 120 min | 50.0 Percentage of participants |
| Lasmiditan 2.5 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 90 min | 50.0 Percentage of participants |
| Lasmiditan 2.5 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 20 min | 0 Percentage of participants |
| Lasmiditan 2.5 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 40 min | 0 Percentage of participants |
| Lasmiditan 2.5 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 240 min | 75.0 Percentage of participants |
| Lasmiditan 2.5 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 60 min | 50.0 Percentage of participants |
| Lasmiditan 2.5 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 10 min | 0 Percentage of participants |
| Lasmiditan 5.0 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 60 min | 25.0 Percentage of participants |
| Lasmiditan 5.0 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 20 min | 16.7 Percentage of participants |
| Lasmiditan 5.0 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 240 min | 33.3 Percentage of participants |
| Lasmiditan 5.0 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 90 min | 25.0 Percentage of participants |
| Lasmiditan 5.0 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 40 min | 25.0 Percentage of participants |
| Lasmiditan 5.0 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 120 min | 16.7 Percentage of participants |
| Lasmiditan 5.0 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 10 min | 8.3 Percentage of participants |
| Lasmiditan 5.0 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 180 min | 25.0 Percentage of participants |
| Lasmiditan 10 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 90 min | 45.8 Percentage of participants |
| Lasmiditan 10 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 120 min | 54.2 Percentage of participants |
| Lasmiditan 10 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 240 min | 54.2 Percentage of participants |
| Lasmiditan 10 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 40 min | 37.5 Percentage of participants |
| Lasmiditan 10 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 20 min | 25.0 Percentage of participants |
| Lasmiditan 10 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 180 min | 54.2 Percentage of participants |
| Lasmiditan 10 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 60 min | 50.0 Percentage of participants |
| Lasmiditan 10 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 10 min | 8.3 Percentage of participants |
| Lasmiditan 20 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 240 min | 57.1 Percentage of participants |
| Lasmiditan 20 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 20 min | 39.3 Percentage of participants |
| Lasmiditan 20 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 40 min | 50.0 Percentage of participants |
| Lasmiditan 20 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 60 min | 53.6 Percentage of participants |
| Lasmiditan 20 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 90 min | 53.6 Percentage of participants |
| Lasmiditan 20 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 120 min | 64.3 Percentage of participants |
| Lasmiditan 20 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 180 min | 60.7 Percentage of participants |
| Lasmiditan 20 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 10 min | 14.3 Percentage of participants |
| Lasmiditan 30 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 10 min | 12.5 Percentage of participants |
| Lasmiditan 30 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 120 min | 68.8 Percentage of participants |
| Lasmiditan 30 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 60 min | 75.0 Percentage of participants |
| Lasmiditan 30 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 40 min | 75.0 Percentage of participants |
| Lasmiditan 30 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 180 min | 68.8 Percentage of participants |
| Lasmiditan 30 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 240 min | 68.8 Percentage of participants |
| Lasmiditan 30 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 20 min | 50.0 Percentage of participants |
| Lasmiditan 30 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 90 min | 68.8 Percentage of participants |
| Lasmiditan 45 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 180 min | 75.0 Percentage of participants |
| Lasmiditan 45 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 90 min | 75.0 Percentage of participants |
| Lasmiditan 45 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 120 min | 75.0 Percentage of participants |
| Lasmiditan 45 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 60 min | 50.0 Percentage of participants |
| Lasmiditan 45 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 20 min | 75.0 Percentage of participants |
| Lasmiditan 45 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 40 min | 75.0 Percentage of participants |
| Lasmiditan 45 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 240 min | 25.0 Percentage of participants |
| Lasmiditan 45 mg | Percentage of Participants With Headache Response 10 to 240 Minutes (Min) Post Dose | 10 min | 75.0 Percentage of participants |