Study in Participants With Acute Migraines Headaches

Study Overview
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Brief Summary
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This is a Phase 2, multicenter, randomized, double-blind, placebo and active comparator-controlled study of LY2590443 in approximately 200 participants with migraines.

Official Title
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A Safety, Tolerability, and Efficacy Study of LY2590443 in the Treatment of Acute Migraine Headache

Conditions
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Migraine Headache

Intervention / Treatment
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* Drug: LY2590443
* Drug: Placebo injection
* Drug: Sumatriptan
* Drug: Placebo capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female participants between the ages of 18 and 65 years, inclusive. Participants who have migraine headaches, with or without aura (diagnosis according the International Classification of Headache Disorders-II), for at least 1 year. Participants who have had 2-8 migraine attacks on average per month for the last 3 months (but less than 15 headache days per month). Participants who are willing and able to comply with the study schedule and requirements. Participants who speak, read, and understand English sufficiently well and are willing to provide written informed consent. Participants who in the opinion of the principal investigator are in good general health. Venous access should be sufficient to allow blood sampling as per protocol. Exclusion Criteria: Participants who do not or may not tolerate 5HT1 agonist treatments, with known hypersensitivity to sumatriptan (as discussed with the investigator). Female participants who have a positive pregnancy test at screening or pre- dose evaluation, or are breastfeeding. History or presence of significant medical illnesses as determined by the investigator. Participants with a current clinical diagnosis of major psychiatric disease. Regular use of known drugs of abuse; use of opiates for migraine rescue (no more than two times per month) is permissible. Blood donation of 500 milliliter (mL) or greater of whole blood products within 4 weeks of study commencement, during the study, or 4 weeks following the study. Investigator site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. Consumption of more than three units of alcohol per day where one unit is defined as a 12 ounces (oz) beer, 4 oz wine, or 2 oz of alcohol spirit liquor. Are unwilling or unable to comply with the use of a diary to directly record data from the participant.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: LY2590443<br>* 200 milligrams (mg) as four 50-mg capsules, oral, once<br>Drug: Placebo injection<br>* saline solution, injection, once<br>|
| Placebo Comparator: 2<br> | Drug: Placebo injection<br>* saline solution, injection, once<br>Drug: Placebo capsule<br>* 4 capsules, once<br>|
| Active Comparator: 3<br> | Drug: Sumatriptan<br>* 6 milligrams (mg) injection (0.5 milliliter [mL] of 12 mg/mL solution), once<br>Drug: Placebo capsule<br>* 4 capsules, once<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Headache Pain Free Response | Participants were required to assess the presence of a headache and grade the intensity of the headache as severe, moderate, mild, or none. Headache pain free response was defined as the number of participants with a migraine pain intensity score of none. | 2 hours after study drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Pain Free Response | Participants were required to assess the presence of a headache and grade the intensity of the headache as severe, moderate, mild, or none. Pain free response was defined as the number of participants with a migraine pain intensity score of none. | 30 minutes, 1 hour, 1.5 hours, 3 hours, and 4 hours after study drug administration | 
| Number of Participants With Pain Relief Response | Participants were required to assess the presence of a headache and grade the intensity of the headache as severe, moderate, mild, or none. Pain relief response was defined as the number of participants with a migraine pain intensity score of none. | 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration. | 
| Number of Participants With Sustained Pain Relief Response | Participants were required to assess the presence of a headache and grade the intensity of the headache as severe, moderate, mild, or none. Sustained pain relief response was defined as the number of participants with no return of a moderate or severe headache after pain went down to mild or none at 2 hours. | 24 and 48 hours after study drug administration | 
| Number of Participants With Recurrent Migraine Headache Within 24 or 48 Hours | The time to headache recurrence is presented as the number of participants experiencing at least 1 recurring headache within 24 or 48 hours of receiving study drug. | Up to 24 and 48 hours after study drug administration | 
| Number of Participants With Nausea | The number of participants reporting nausea as a migraine symptom | Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration. | 
| Number of Participants With Phonophobia | The number of participants reporting phonophobia as a migraine symptom | Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration. | 
| Number of Participants With Photophobia | The number of participants reporting photophobia as a migraine symptom | Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration. | 
| Number of Participants With Vomiting | The number of participants reporting vomiting as a migraine symptom | Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration. | 
| Number of Participants With Sustained Pain Free Response | Participants were required to assess the presence of a headache and grade the intensity of the headache as severe, moderate, mild, or none. Sustained pain free response was defined as the number of participants with no return of a mild, moderate or severe headache after pain intensity went down to none at 2 hours. | 24 and 48 hours after study drug administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, Headache