Study in Participants With Acute Migraines Headaches

Lilly

Status and phase

Terminated

Phase 2

Conditions

Migraine Headache

Treatments

Drug: Placebo injection

Drug: Placebo capsule

Drug: LY2590443

Drug: Sumatriptan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00804973

I2W-MC-DMAB (Other Identifier)

12258

Details and patient eligibility

About

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

Enrollment

120 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.