Study in Participants With Acute Migraines Headaches

• Status: Terminated
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Sumatriptan

Criteria

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.