Study in Participants With Acute Migraines Headaches
- Conditions
- Migraine Headache
- Interventions
- Registration Number
- NCT00804973
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 LY2590443 - 1 Placebo injection - 2 Placebo injection - 2 Placebo capsule - 3 Placebo capsule - 3 Sumatriptan -
- Primary Outcome Measures
Name Time Method Number of Participants With Headache Pain Free Response 2 hours after study drug administration Participants were required to assess the presence of a headache and grade the intensity of the headache as "severe," "moderate," "mild," or "none." Headache pain free response was defined as the number of participants with a migraine pain intensity score of "none."
- Secondary Outcome Measures
Name Time Method Number of Participants With Photophobia Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration. The number of participants reporting photophobia as a migraine symptom
Number of Participants With Sustained Pain Free Response 24 and 48 hours after study drug administration Participants were required to assess the presence of a headache and grade the intensity of the headache as "severe," "moderate," "mild," or "none. Sustained pain free response was defined as the number of participants with no return of a "mild," "moderate" or "severe" headache after pain intensity went down to "none" at 2 hours.
Number of Participants With Pain Free Response 30 minutes, 1 hour, 1.5 hours, 3 hours, and 4 hours after study drug administration Participants were required to assess the presence of a headache and grade the intensity of the headache as "severe," "moderate", "mild," or "none." Pain free response was defined as the number of participants with a migraine pain intensity score of "none."
Number of Participants With Pain Relief Response 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration. Participants were required to assess the presence of a headache and grade the intensity of the headache as "severe", "moderate," "mild," or "none." Pain relief response was defined as the number of participants with a migraine pain intensity score of "none."
Number of Participants With Sustained Pain Relief Response 24 and 48 hours after study drug administration Participants were required to assess the presence of a headache and grade the intensity of the headache as "severe," "moderate," "mild," or "none." Sustained pain relief response was defined as the number of participants with no return of a "moderate" or "severe" headache after pain went down to "mild" or "none" at 2 hours.
Number of Participants With Recurrent Migraine Headache Within 24 or 48 Hours Up to 24 and 48 hours after study drug administration The time to headache recurrence is presented as the number of participants experiencing at least 1 recurring headache within 24 or 48 hours of receiving study drug.
Number of Participants With Nausea Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration. The number of participants reporting nausea as a migraine symptom
Number of Participants With Vomiting Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration. The number of participants reporting vomiting as a migraine symptom
Number of Participants With Phonophobia Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration. The number of participants reporting phonophobia as a migraine symptom
Trial Locations
- Locations (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.
🇺🇸Norfolk, Virginia, United States