Lasmiditan Compared to Placebo in the Acute Treatment of Migraine:

Conditions

Acute Migraine

Brief summary

This is a prospective randomized, double-blind, placebo-controlled study in participants with disabling migraine (Migraine Disability Assessment (MIDAS) score ≥ 11).

Detailed description

Participants will be asked to treat a migraine attack with study drug on an outpatient basis. Participants will be provided with a dosing card containing a dose for initial treatment and a second dose to be used for rescue or recurrence of migraine. Each participant's study participation will consist of a screening visit (Visit 1) with a telephone contact within 7 days to confirm eligibility, a Treatment Period of up to 8 weeks, and an End-of-Study (EoS) visit (Visit 2) within one week (7 days) of treating a single migraine attack. The total time on study is approximately 11 weeks.

Karissa Johnston, Lauren Powell, Evan Popoff, Linda Harris, Robert Croop et al. (7 authors)

Clinical Journal of Pain2022-09-2010 citations

10.1097/ajp.0000000000001072

The Association Between the Occurrence of Common Treatment-Emergent Adverse Events and Efficacy Outcomes After Lasmiditan Treatment of a Single Migraine Attack: Secondary Analyses from Four Pooled Randomized Clinical Trials

Erin Doty, Paula M. Hauck, John H. Krege, Mika Komori, Ann Marie Hake et al. (7 authors)

CNS Drugs2022-07-013 citations

10.1007/s40263-022-00928-y

Migraine history and response to lasmiditan across racial and ethnic groups.

Charleston L, Savage-Edwards B, Bragg SM, Baygani SK, Dennehy EB.

2022-04-031 citations

10.1080/03007995.2022.2057152

Lasmiditan efficacy in the acute treatment of migraine was independent of prior response to triptans: Findings from the CENTURION study

Uwe Reuter, John H. Krege, Louise Lombard, Elisa Gomez Valderas, Judith Krikke-Workel et al. (8 authors)

Cephalalgia2021-10-1320 citations

10.1177/03331024211048507

A close association of freedom from pain, migraine-related functional disability, and other outcomes: results of a post hoc analysis of randomized lasmiditan studies SAMURAI and SPARTAN

Richard B. Lipton, Simin Baygani, Stewart J. Tepper, John H. Krege, Raghavendra Vasudeva et al. (8 authors)

The Journal of Headache and Pain2021-08-283 citations

10.1186/s10194-021-01303-w

Tolerability and Safety of Lasmiditan Treatment in Elderly Patients With Migraine: Post Hoc Analyses From Randomized Studies.

Martin VT, Ahmed Z, Hochstetler HM, Baygani SK, Dong Y, Hauck PM, Khanna R.

2021-06-0113 citations

10.1016/j.clinthera.2021.04.004

Lasmiditan efficacy in migraine attacks with mild vs. moderate or severe pain.

Peres MFP, Vasudeva R, Baygani SK, Dennehy EB, Vincent M, Friedman DI.

2021-04-075 citations

10.1080/03007995.2021.1903846

Effect of a change in lasmiditan dose on efficacy and safety in patients with migraine

David B. Clemow, Helen Hochstetler, Yanhong Dong, Paula M. Hauck, Mário Fernando Prieto Peres et al. (6 authors)

Postgraduate Medicine2021-03-175 citations

10.1080/00325481.2020.1860619

Lasmiditan in patients with common migraine comorbidities: a <i>post hoc</i> efficacy and safety analysis of two phase 3 randomized clinical trials.

Clemow DB, Baygani SK, Hauck PM, Hultman CB.

2020-10-066 citations

10.1080/03007995.2020.1808780

Improvement in Function after Lasmiditan Treatment: Post Hoc Analysis of Data from Phase 3 Studies.

Smith T, Krege JH, Rathmann SS, Dowsett SA, Hake A, Nery ESM, Matthews BR, Doty EG.

2020-05-237 citations

10.1007/s40120-020-00185-5

Trajectory of migraine-related disability following long-term treatment with lasmiditan: results of the GLADIATOR study.

Lipton RB, Lombard L, Ruff DD, Krege JH, Loo LS, Buchanan A, Melby TE, Buse DC.

2020-02-2426 citations

10.1186/s10194-020-01088-4

Lasmiditan for the acute treatment of migraine: Subgroup analyses by prior response to triptans

Kerry Knievel, Andrew Buchanan, Louise Lombard, Simin Baygani, Joel Raskin et al. (9 authors)

Cephalalgia2019-11-1952 citations

10.1177/0333102419889350

Lasmiditan for acute treatment of migraine in patients with cardiovascular risk factors: post-hoc analysis of pooled results from 2 randomized, double-blind, placebo-controlled, phase 3 trials.

Shapiro RE, Hochstetler HM, Dennehy EB, Khanna R, Doty EG, Berg PH, Starling AJ.

2019-08-2962 citations

10.1186/s10194-019-1044-6

Interim results of a prospective, randomized, open-label, Phase 3 study of the long-term safety and efficacy of lasmiditan for acute treatment of migraine (the GLADIATOR study)

Jan Lewis Brandes, Suzanne Klise, John H. Krege, Michael Case, Rashna Khanna et al. (9 authors)

Cephalalgia2019-08-2195 citations

10.1177/0333102419864132

Effect of a rescue or recurrence dose of lasmiditan on efficacy and safety in the acute treatment of migraine: findings from the phase 3 trials (SAMURAI and SPARTAN)

Li Shen Loo, Brian M. Plato, Ira Turner, Michael Case, Joel Raskin et al. (7 authors)

BMC Neurology2019-08-1328 citations

10.1186/s12883-019-1420-5

Efficacy and safety of lasmiditan in patients using concomitant migraine preventive medications: findings from SAMURAI and SPARTAN, two randomized phase 3 trials

Li Shen Loo, Jessica Ailani, Jack Schim, Simin Baygani, Hans‐Peter Hundemer et al. (7 authors)

The Journal of Headache and Pain2019-07-2441 citations

10.1186/s10194-019-1032-x

Sustained responses to lasmiditan: Results from post-hoc analyses of two Phase 3 randomized clinical trials for acute treatment of migraine

Erin Doty, John H. Krege, Leah Jin, Joel Raskin, Rashmi B. Halker Singh et al. (6 authors)

Cephalalgia2019-07-0326 citations

10.1177/0333102419859313

Safety findings from Phase 3 lasmiditan studies for acute treatment of migraine: Results from SAMURAI and SPARTAN

John H. Krege, Paul Rizzoli, Emily Liffick, Erin Doty, Sherie A. Dowsett et al. (7 authors)

Cephalalgia2019-06-0571 citations

10.1177/0333102419855080

Lasmiditan is an effective acute treatment for migraine: A phase 3 randomized study.

Kuca B, Silberstein SD, Wietecha L, Berg PH, Dozier G, Lipton RB, COL MIG-301 Study Group.

2018-11-16171 citations

10.1212/wnl.0000000000006641

Interventions

DRUGLasmiditan 100 mg

DRUGLasmiditan 200 mg

DRUGPlacebo (matches lasmiditan doses)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Able and willing to give written informed consent. * Participants with migraine with or without aura fulfilling the International Headache Society (IHS) diagnostic criteria 1.1 and 1.2.1 (International Headache Classification (ICHD) 2004). * History of disabling migraine for at least 1 year. * MIDAS score ≥11. * Migraine onset before the age of 50 years. * History of 3 - 8 migraine attacks per month (\< 15 headache days per month). * Male or female, aged 18 years or above. * Females of child-bearing potential must be using or willing to use a highly effective form of contraception (e.g. combined oral contraceptive, intrauterine device (IUD), abstinence or vasectomized partner). * Able and willing to complete an electronic diary.

Exclusion criteria

* Pregnant or breast-feeding women. * Women of child-bearing potential not using or not willing to use highly effective contraception. * Known coronary artery disease, clinically significant arrhythmia or uncontrolled hypertension. * History or evidence of hemorrhagic stroke, epilepsy or any other condition placing the participant at increased risk of seizures. * History of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo (BPPV), Meniere's disease, vestibular migraine, and other vestibular disorders. * History of diabetes mellitus with complications (diabetic retinopathy, nephropathy or neuropathy). * History within the previous three years or current evidence of abuse of any drug, prescription or illicit, or alcohol. * History of orthostatic hypotension with syncope. * Significant renal or hepatic impairment. * Participant is at imminent risk of suicide (positive response to question 4 or 5 on the C-SSRS) or had a suicide attempt within six months prior to the screening visit. * Known Hepatitis B or C or HIV infection. * History, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (e.g. hemicranias continua, medication overuse headache) where headache frequency is greater than 15 headache days per month. * Use of more than 3 doses per month of either opiates or barbiturates. * Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within three (3) months prior to Screening/Visit 1.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free	2 hours post dose	The percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing being absent.
Percentage of Participants Who Are Headache Pain Free	2 hours post dose	The percentage of participants defined as mild, moderate, or severe headache pain becoming none.

Secondary

Measure	Time frame	Description
Percentage of Participants With Headache Recurrence	From 2 hours post dose up to 48 hours	Participants who received study drug and which became pain free at 2 hours post-dose and worsened again up to 48 hours post-dose.
Percentage of Participants Who Used Rescue Medication	2 hours post dose	Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).
Percentage of Participants Nausea Free	2 hours post dose	The percentage of participants without nausea.
Percentage of Participants Photophobia Free	2 hours post dose	The percentage of participants without photophobia.
Participants With Serious Adverse Events (SAE)	Baseline up to 11 weeks	Safety and Tolerability was assessed by the number of participants with at least 1 treatment emergent event (TEAE). A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section
Percentage of Participants Phonophobia Free	2 hours post dose	The percentage of participants without phonophobia.
Percentage of Participants Who Have Headache Relief After First Dose	2 hours post dose	The percentage of participants with headache pain moderate or severe which became mild or none or with headache pain mild which became none.

Other

Measure	Time frame	Description
Percentage of Participants With Resource Utilization	6 months prior to enrolling in study to end of study (Up to 11 Weeks) within 7 days of treating a single migraine attack	Use of health care for treatment 6 months prior to enrolling in the study and information reported during time on study

Countries

United States

Participant flow

Pre-assignment details

Participants were randomized in a double-blind, placebo-controlled parallel group study.

Participants by arm

Arm	Count
100 mg Lasmiditan 100 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose	630
200 mg Lasmiditan 200 milligrams (mg) lasmiditan administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	609
Placebo Placebo administered PO within 4 hours of onset of migraine attack. If the migraine did not respond 2 hours postdose a second dose of study drug can be taken up to 24 hours after the first dose.	617
Total	1,856

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	0	2	0
Overall Study	Death	0	1	0
Overall Study	Lost to Follow-up	37	34	42
Overall Study	Noncompliance with Protocol	10	11	7
Overall Study	Physician Decision	2	1	0
Overall Study	Pregnancy	0	1	1
Overall Study	Randomization Failure	35	46	34
Overall Study	Sponsor Request	0	2	1
Overall Study	Withdrawal by Subject	12	16	14

Baseline characteristics

Characteristic	100 mg Lasmiditan	200 mg Lasmiditan	Placebo	Total
Age, Continuous	42.2 years STANDARD_DEVIATION 11.67	41.4 years STANDARD_DEVIATION 12.04	42.4 years STANDARD_DEVIATION 12.3	42.0 years STANDARD_DEVIATION 12
Duration of Migraine History	19.7 years STANDARD_DEVIATION 12.98	18.9 years STANDARD_DEVIATION 13.12	19.3 years STANDARD_DEVIATION 12.65	19.3 years STANDARD_DEVIATION 12.92
Ethnicity (NIH/OMB) Hispanic or Latino	82 Participants	77 Participants	84 Participants	243 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	544 Participants	527 Participants	529 Participants	1600 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants	5 Participants	4 Participants	13 Participants
Race (NIH/OMB) American Indian or Alaska Native	7 Participants	7 Participants	1 Participants	15 Participants
Race (NIH/OMB) Asian	4 Participants	4 Participants	2 Participants	10 Participants
Race (NIH/OMB) Black or African American	122 Participants	125 Participants	119 Participants	366 Participants
Race (NIH/OMB) More than one race	11 Participants	6 Participants	6 Participants	23 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants	3 Participants	2 Participants	6 Participants
Race (NIH/OMB) Unknown or Not Reported	14 Participants	14 Participants	8 Participants	36 Participants
Race (NIH/OMB) White	471 Participants	450 Participants	479 Participants	1400 Participants
Region of Enrollment United States	630 Participants	609 Participants	617 Participants	1856 Participants
Sex: Female, Male Female	512 Participants	515 Participants	525 Participants	1552 Participants
Sex: Female, Male Male	118 Participants	94 Participants	92 Participants	304 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 630	0 / 609	0 / 617
other Total, other adverse events	258 / 630	280 / 609	113 / 617
serious Total, serious adverse events	0 / 630	2 / 609	1 / 617

Outcome results

Primary

Percentage of Participants Who Are Headache Pain Free

The percentage of participants defined as mild, moderate, or severe headache pain becoming none.

Time frame: 2 hours post dose

Population: All randomized participants who received at least one dose of study drug and had evaluable headache pain free data.

Arm	Measure	Value (NUMBER)
100 mg Lasmiditan	Percentage of Participants Who Are Headache Pain Free	28.2 percentage of participants
200 mg Lasmiditan	Percentage of Participants Who Are Headache Pain Free	32.2 percentage of participants
Placebo	Percentage of Participants Who Are Headache Pain Free	15.3 percentage of participants

p-value: <0.00195% CI: [1.6, 3]Regression, Logistic

p-value: <0.00195% CI: [2, 3.6]Regression, Logistic

Primary

Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free

The percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing being absent.

Time frame: 2 hours post dose

Population: All randomized participants who received at least one dose of study drug and had evaluable MBS data.

Arm	Measure	Value (NUMBER)
100 mg Lasmiditan	Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free	40.9 percentage of participants
200 mg Lasmiditan	Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free	40.7 percentage of participants
Placebo	Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free	29.5 percentage of participants

p-value: <0.00195% CI: [1.3, 2.2]Regression, Logistic

p-value: <0.00195% CI: [1.3, 2.1]Regression, Logistic

Secondary

Participants With Serious Adverse Events (SAE)

Safety and Tolerability was assessed by the number of participants with at least 1 treatment emergent event (TEAE). A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section

Time frame: Baseline up to 11 weeks

Population: All randomized participants who had received at least one dose of study drug. Results are displayed by the first dose taken.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
100 mg Lasmiditan	Participants With Serious Adverse Events (SAE)	0 Participants
200 mg Lasmiditan	Participants With Serious Adverse Events (SAE)	2 Participants
Placebo	Participants With Serious Adverse Events (SAE)	1 Participants

Secondary

Percentage of Participants Nausea Free

The percentage of participants without nausea.

Time frame: 2 hours post dose

Population: All randomized participants who used at least 1 dose of study drug and had any post-dose headache severity or symptom assessments.

Arm	Measure	Value (NUMBER)
100 mg Lasmiditan	Percentage of Participants Nausea Free	64.6 percentage of participants
200 mg Lasmiditan	Percentage of Participants Nausea Free	64.1 percentage of participants
Placebo	Percentage of Participants Nausea Free	62.1 percentage of participants

p-value: 0.38695% CI: [0.9, 1.4]Regression, Linear

p-value: 0.4795% CI: [0.9, 1.4]Regression, Linear

Secondary

Percentage of Participants Phonophobia Free

The percentage of participants without phonophobia.

Time frame: 2 hours post dose

Population: All randomized participants who used at least 1 dose of study drug and had any post-dose headache severity or symptom assessments.

Arm	Measure	Value (NUMBER)
100 mg Lasmiditan	Percentage of Participants Phonophobia Free	60.7 percentage of participants
200 mg Lasmiditan	Percentage of Participants Phonophobia Free	58.7 percentage of participants
Placebo	Percentage of Participants Phonophobia Free	52.5 percentage of participants

p-value: 0.00695% CI: [1.1, 1.8]Regression, Logistic

p-value: 0.03795% CI: [1, 1.6]Regression, Logistic

Secondary

Percentage of Participants Photophobia Free

The percentage of participants without photophobia.

Time frame: 2 hours post dose

Population: All randomized participants who received at least one dose of study drug and had evaluable photophobia free data.

Arm	Measure	Value (NUMBER)
100 mg Lasmiditan	Percentage of Participants Photophobia Free	53.9 percentage of participants
200 mg Lasmiditan	Percentage of Participants Photophobia Free	51.5 percentage of participants
Placebo	Percentage of Participants Photophobia Free	38.1 percentage of participants

p-value: <0.00195% CI: [1.5, 2.4]Regression, Logistic

p-value: <0.00195% CI: [1.4, 2.2]Regression, Logistic

Secondary

Percentage of Participants Who Have Headache Relief After First Dose

The percentage of participants with headache pain moderate or severe which became mild or none or with headache pain mild which became none.

Time frame: 2 hours post dose

Population: All randomized participants who received at least one dose of study drug and had evaluable headache relief data.

Arm	Measure	Value (NUMBER)
100 mg Lasmiditan	Percentage of Participants Who Have Headache Relief After First Dose	59.4 percentage of participants
200 mg Lasmiditan	Percentage of Participants Who Have Headache Relief After First Dose	59.5 percentage of participants
Placebo	Percentage of Participants Who Have Headache Relief After First Dose	42.2 percentage of participants

p-value: <0.00195% CI: [1.8, 3.1]Regression, Logistic

p-value: <0.00195% CI: [1.9, 3.3]Regression, Logistic

Secondary

Percentage of Participants Who Used Rescue Medication

Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).

Time frame: Anytime 24-48 hours post dose

Population: All randomized participants who received at least one dose of study drug and had evaluable use of rescue medication data.

Arm	Measure	Value (NUMBER)
100 mg Lasmiditan	Percentage of Participants Who Used Rescue Medication	0 percentage of participants
200 mg Lasmiditan	Percentage of Participants Who Used Rescue Medication	0 percentage of participants
Placebo	Percentage of Participants Who Used Rescue Medication	0 percentage of participants

Secondary

Percentage of Participants Who Used Rescue Medication

Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).

Time frame: 2 hours post dose

Population: Randomized participants who received a dose of study drug and had postdose headache severity or symptom assessments.

Arm	Measure	Value (NUMBER)
100 mg Lasmiditan	Percentage of Participants Who Used Rescue Medication	26.2 percentage of participants
200 mg Lasmiditan	Percentage of Participants Who Used Rescue Medication	20.7 percentage of participants
Placebo	Percentage of Participants Who Used Rescue Medication	46.0 percentage of participants

p-value: <0.00195% CI: [0.3, 0.5]Regression, Logistic

p-value: <0.00195% CI: [0.2, 0.4]Regression, Logistic

Secondary

Percentage of Participants Who Used Rescue Medication

Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).

Time frame: Anytime between 2-24 hours post dose

Population: Randomized participants who received a dose of study drug and had postdose headache severity or symptom assessments.

Arm	Measure	Value (NUMBER)
100 mg Lasmiditan	Percentage of Participants Who Used Rescue Medication	8.9 percentage of participants
200 mg Lasmiditan	Percentage of Participants Who Used Rescue Medication	7.9 percentage of participants
Placebo	Percentage of Participants Who Used Rescue Medication	11.7 percentage of participants

p-value: 0.1295% CI: [0.5, 1.1]Regression, Logistic

p-value: 0.03595% CI: [0.4, 1]Regression, Logistic

Secondary

Percentage of Participants With Headache Recurrence

Participants who received study drug and which became pain free at 2 hours post-dose and worsened again up to 48 hours post-dose.

Time frame: From 2 hours post dose up to 48 hours

Population: Randomized participants who received a dose of study drug and had postdose headache severity or symptom assessments.

Arm	Measure	Value (NUMBER)
100 mg Lasmiditan	Percentage of Participants With Headache Recurrence	8.4 percentage of participants
200 mg Lasmiditan	Percentage of Participants With Headache Recurrence	10.1 percentage of participants
Placebo	Percentage of Participants With Headache Recurrence	5.1 percentage of participants

p-value: =0.02995% CI: [1.1, 2.8]Regression, Logistic

p-value: =0.00295% CI: [1.3, 3.4]Regression, Logistic

Other Pre-specified

Percentage of Participants With Resource Utilization

Use of health care for treatment 6 months prior to enrolling in the study and information reported during time on study

Time frame: 6 months prior to enrolling in study to end of study (Up to 11 Weeks) within 7 days of treating a single migraine attack

Population: All randomized participants who used at least 1 dose of study drug, regardless of whether or not they underwent any study assessments.

Arm	Measure	Group	Value (NUMBER)
100 mg Lasmiditan	Percentage of Participants With Resource Utilization	6 Months prior to enrolling	4.4 percentage of participants
100 mg Lasmiditan	Percentage of Participants With Resource Utilization	During time of study	0.9 percentage of participants
200 mg Lasmiditan	Percentage of Participants With Resource Utilization	During time of study	0.5 percentage of participants
200 mg Lasmiditan	Percentage of Participants With Resource Utilization	6 Months prior to enrolling	4.6 percentage of participants
Placebo	Percentage of Participants With Resource Utilization	During time of study	0.2 percentage of participants
Placebo	Percentage of Participants With Resource Utilization	6 Months prior to enrolling	3.0 percentage of participants
200 mg Lasmiditan/Placebo	Percentage of Participants With Resource Utilization	6 Months prior to enrolling	2.5 percentage of participants
200 mg Lasmiditan/Placebo	Percentage of Participants With Resource Utilization	During time of study	0.5 percentage of participants
Placebo/Placebo	Percentage of Participants With Resource Utilization	During time of study	0.6 percentage of participants
Placebo/Placebo	Percentage of Participants With Resource Utilization	6 Months prior to enrolling	2.8 percentage of participants

Lasmiditan Compared to Placebo in the Acute Treatment of Migraine:

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Other

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percentage of Participants Who Are Headache Pain Free

Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free

Participants With Serious Adverse Events (SAE)

Percentage of Participants Nausea Free

Percentage of Participants Phonophobia Free

Percentage of Participants Photophobia Free

Percentage of Participants Who Have Headache Relief After First Dose

Percentage of Participants Who Used Rescue Medication

Percentage of Participants Who Used Rescue Medication

Percentage of Participants Who Used Rescue Medication

Percentage of Participants With Headache Recurrence

Percentage of Participants With Resource Utilization