Study in Participants With Acute Migraines Headaches

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

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

Study Overview

• Status: Terminated
• Conditions: Migraine Headache
• Intervention / Treatment: Drug: LY2590443; Drug: Placebo injection; Drug: Placebo capsule; Drug: Sumatriptan

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90211
      • 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
      • 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
      • 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
      • 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.
    • Imperial, California, United States, 92251
      • 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, United States, 92123
      • 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, United States, 94109
      • 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, United States, 90404
      • 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.
  • Florida
    • West Palm Beach, Florida, United States, 33407
      • 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.
  • Illinois
    • Chicago, Illinois, United States, 60625
      • 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.
  • Massachusetts
    • Wellesley Hills, Massachusetts, United States, 02481
      • 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.
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • 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.
  • New York
    • Mount Vernon, New York, United States, 10550
      • 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.
  • Ohio
    • West Chester, Ohio, United States, 45069
      • 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.
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • 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.
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • 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.
  • Texas
    • Austin, Texas, United States, 78759
      • 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, United States, 77004
      • 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.
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 2	Drug: Placebo injection; saline solution, injection, once; Drug: Placebo capsule; 4 capsules, once
EXPERIMENTAL: 1	Drug: LY2590443; 200 milligrams (mg) as four 50-mg capsules, oral, once; Drug: Placebo injection; saline solution, injection, once
ACTIVE_COMPARATOR: 3	Drug: Placebo capsule; 4 capsules, once; Drug: Sumatriptan; 6 milligrams (mg) injection (0.5 milliliter [mL] of 12 mg/mL solution), once

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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."	2 hours after study drug administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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."	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."	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.	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.	Up to 24 and 48 hours after study drug administration
Number of Participants With Nausea	The number of participants reporting nausea as a migraine symptom	Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.
Number of Participants With Phonophobia	The number of participants reporting phonophobia as a migraine symptom	Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.
Number of Participants With Photophobia	The number of participants reporting photophobia as a migraine symptom	Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.
Number of Participants With Vomiting	The number of participants reporting vomiting as a migraine symptom	Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours after study drug administration.
Number of Participants With Sustained 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. 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.	24 and 48 hours after study drug administration

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (ACTUAL): May 1, 2009
• Study Completion (ACTUAL): May 1, 2009

Study Registration Dates

• First Submitted: December 5, 2008
• First Submitted That Met QC Criteria: December 5, 2008
• First Posted (ESTIMATE): December 9, 2008

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 5, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Migraine; Headache
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Vasoconstrictor Agents; Sumatriptan
• Other Study ID Numbers: 12258; I2W-MC-DMAB (OTHER: Eli Lilly)