Study in Participants With Acute Migraines Headaches

Launched by ELI LILLY AND COMPANY · Dec 5, 2008

Keywords

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Gender

ALL

Eligibility 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.