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Study in Participants With Acute Migraines Headaches | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Study in Participants With Acute Migraines Headaches

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

NCT00804973•Eli Lilly and Company

Summary

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

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (19)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Beverly Hills, California, United States

Chula Vista, California, United States

Fresno, California, United States

Garden Grove, California, United States

Imperial, California, United States

San Diego, California, United States

San Francisco, California, United States

Santa Monica, California, United States

West Palm Beach, Florida, United States

Chicago, Illinois, United States

Key Dates

Start Date

November 1, 2008

Primary Completion Date

May 1, 2009

Completion Date

May 1, 2009

Last Updated

May 19, 2020

Enrollment

120

ACTUAL participants

Conditions

Migraine Headache

Interventions

LY2590443

DRUG

Placebo injection

DRUG

Sumatriptan

DRUG

Placebo capsule

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 19, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study in Participants With Acute Migraines Headaches

Inclusion Criteria

Exclusion Criteria

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