Status:
TERMINATED
Study in Participants With Acute Migraines Headaches
Lead Sponsor:
Eli Lilly and Company
Conditions:
Migraine Headache
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00804973
Start Date
November 1 2008
End Date
May 1 2009
Last Update
May 19 2020
Active Locations (19)
Enter a location and click search to find clinical trials sorted by distance.
1
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, 90211
2
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, United States, 91910
3
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, United States, 93720
4
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, United States, 92845