Study in Participants With Acute Migraines Headaches

Phase 2TerminatedNCT00804973

Eli Lilly and Company120 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

120

Conditions

Migraine Headache

Interventions

LY2590443DRUG

200 milligrams (mg) as four 50-mg capsules, oral, once

Placebo injectionDRUG

saline solution, injection, once

SumatriptanDRUG

6 milligrams (mg) injection (0.5 milliliter \[mL\] of 12 mg/mL solution), once

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Number of Participants With Headache Pain Free Response

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."

Time frame: 2 hours after study drug administration

Secondary Outcomes

Number of Participants With Pain Free Response

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."

Time frame: 30 minutes, 1 hour, 1.5 hours, 3 hours, and 4 hours after study drug administration

Number of Participants With Pain Relief Response

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."

Time frame: 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.

Number of Participants With Sustained Pain Relief Response

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.

Time frame: 24 and 48 hours after study drug administration

Number of Participants With Recurrent Migraine Headache Within 24 or 48 Hours

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.

Data from ClinicalTrials.gov

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