Study in Subjects With Acute Migraines Headaches.

Condition(s) targeted: Migraine Headache

Intervention: LY2590443 (Drug); Placebo injection (Drug); Sumatriptan (Drug); Placebo capsule (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company

Overall contact:
There may be multiple sites in this clinical trial 1-877-CTLILLY, Phone: 1-317-615-4559

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

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Headache pain free response.

Secondary outcome:

Pain free response

Pain relief response.

Sustained pain relief response.

Time to headache recurrence.

Change in nausea.

Change in phonophobia.

Change in photophobia.

Change in vomiting.

Sustained pain free response

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male and female subjects between the ages of 18 and 65 years, inclusive.

- Subjects who have migraine headaches, with or without aura (diagnosis according the

International Classification of Headache Disorders-II), for at least 1 year.

- Subjects who have had 2-8 migraine attacks on average per month for the last 3 months

(but less than 15 headache days per month).

- Subjects who are willing and able to comply with the study schedule and requirements.

- Subjects who speak, read and understand English sufficiently well and are willing to

provide written informed consent.

- Subjects 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:

- Subjects who do not or may not tolerate 5HT1 agonist treatments, with known

hypersensitivity to sumatriptan (as discussed with the investigator).

- Female subjects 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.

- Subjects 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 500mL 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 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 subject.

There may be multiple sites in this clinical trial 1-877-CTLILLY, Phone: 1-317-615-4559

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 90211, United States; Not yet recruiting
Eli Lilly

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., Chula Vista, California 91910, United States; Recruiting
Eli Lilly

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., Fresno, California 93720, United States; Not yet recruiting
Eli Lilly

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., Garden Grove, California 92845, United States; Not yet recruiting
Eli Lilly

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., San Francisco, California 94109, United States; Not yet recruiting
Eli Lilly

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., San Diego, California 92123, United States; Not yet recruiting
Eli Lilly

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., Santa Monica, California 90404, United States; Not yet recruiting
Eli Lilly

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., West Palm Beach, Florida 33407, United States; Not yet recruiting
Eli Lilly

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., Decatur, Georgia 30033, United States; Not yet recruiting
Eli Lilly

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., Chicago, Illinois 60625, United States; Not yet recruiting
Eli Lilly

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., Wellesley Hills, Massachusetts 02481, United States; Not yet recruiting
Eli Lilly

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., Ann Arbor, Michigan 48104, United States; Not yet recruiting
Eli Lilly

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., Minneapolis, Minnesota 55402, United States; Not yet recruiting
Eli Lilly

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., Mount Vernon, New York 10550, United States; Not yet recruiting
Eli Lilly

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., Philadelphia, Pennsylvania 19107, United States; Not yet recruiting
Eli Lilly

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., Memphis, Tennessee 38119, United States; Not yet recruiting
Eli Lilly

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., Austin, Texas 78759, United States; Not yet recruiting
Eli Lilly

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., Houston, Texas 77004, United States; Not yet recruiting
Eli Lilly

Starting date: November 2008
Ending date: November 2009
Last updated: February 12, 2009