Clinical trial NCT00804973: Study in Participants With Acute Migraines Headaches
Official title: A Safety, Tolerability, and Efficacy Study of LY2590443 in the Treatment of Acute Migraine Headache
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Migraine Headache
Keywords: Migraine
Headache
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2008-12-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Number of Participants With Headache Pain Free Response
timeFrame: 2 hours after study drug administration
Secondary outcomes:
measure: Number of Participants With Pain Free Response
timeFrame: 30 minutes, 1 hour, 1.5 hours, 3 hours, and 4 hours after study drug administration
measure: Number of Participants With Pain Relief Response
timeFrame: 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.
measure: Number of Participants With Sustained Pain Relief Response
timeFrame: 24 and 48 hours after study drug administration
measure: Number of Participants With Recurrent Migraine Headache Within 24 or 48 Hours
timeFrame: Up to 24 and 48 hours after study drug administration
measure: Number of Participants With Nausea
timeFrame: Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.
measure: Number of Participants With Phonophobia
timeFrame: Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.
measure: Number of Participants With Photophobia
timeFrame: Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.
measure: Number of Participants With Vomiting
timeFrame: Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.
measure: Number of Participants With Sustained Pain Free Response
timeFrame: 24 and 48 hours after study drug administration
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: 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.
state: California
city: Chula Vista
country: United States
facility: 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.
state: California
city: Fresno
country: United States
facility: 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.
state: California
city: Garden Grove
country: United States
facility: 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.
state: California
city: Imperial
country: United States
facility: 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.
state: California
city: San Diego
country: United States
facility: 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.
state: California
city: San Francisco
country: United States
facility: 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.
state: California
city: Santa Monica
country: United States
facility: 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.
state: California
city: West Palm Beach
country: United States
facility: 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.
state: Florida
city: Chicago
country: United States
facility: 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.
state: Illinois
city: Wellesley Hills
country: United States
facility: 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.
state: Massachusetts
city: Ann Arbor
country: United States
facility: 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.
state: Michigan
city: Mount Vernon
country: United States
facility: 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.
state: New York
city: West Chester
country: United States
facility: 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.
state: Ohio
city: Philadelphia
country: United States
facility: 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.
state: Pennsylvania
city: Memphis
country: United States
facility: 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.
state: Tennessee
city: Austin
country: United States
facility: 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.
state: Texas
city: Houston
country: United States
facility: 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.
state: Texas
city: Norfolk
country: United States
facility: 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.
state: Virginia
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: