Study in Subjects With Acute Migraines Headaches.

This study has been terminated.
(Due to efficacy results of interim analysis)
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00804973
First received: December 5, 2008
Last updated: April 16, 2010
Last verified: April 2010
  Purpose

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


Condition Intervention Phase
Migraine Headache
Drug: LY2590443
Drug: Placebo injection
Drug: Sumatriptan
Drug: Placebo capsule
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Safety, Tolerability, and Efficacy Study of LY2590443 in the Treatment of Acute Migraine Headache

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Headache pain free response. [ Time Frame: 2 hour after study drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain free response [ Time Frame: 30 minutes, 1 hour, 1.5 hours, 3 hours and 4 hours after study drug administration. ] [ Designated as safety issue: No ]
  • Pain relief response. [ Time Frame: 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours and 4 hours after study drug administration. ] [ Designated as safety issue: No ]
  • Sustained pain relief response. [ Time Frame: 24 hours, 48 hours ] [ Designated as safety issue: No ]
  • Time to headache recurrence. [ Time Frame: Up to 48 hours after study drug administration. ] [ Designated as safety issue: No ]
  • Change in nausea. [ Time Frame: Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours and 4 hours after study drug administration. ] [ Designated as safety issue: No ]
  • Change in phonophobia. [ Time Frame: Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours and 4 hours after study drug administration. ] [ Designated as safety issue: No ]
  • Change in photophobia. [ Time Frame: Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours and 4 hours after study drug administration. ] [ Designated as safety issue: No ]
  • Change in vomiting. [ Time Frame: Pre-dose, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours and 4 hours after study drug administration. ] [ Designated as safety issue: No ]
  • Sustained pain free response [ Time Frame: 24 hours, 48 hours ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: November 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: LY2590443
200mg as 4-50 mg capsules, oral, once
Drug: Placebo injection
saline solution, injection, once
Placebo Comparator: 2 Drug: Placebo injection
saline solution, injection, once
Drug: Placebo capsule
4 capsules, once
Active Comparator: 3 Drug: Sumatriptan
6mg injection (0.5mL of 12mg/mL solution), once
Drug: Placebo capsule
4 capsules, once

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female subjects between the ages of 18 and 65 years, inclusive.
  • Subjects who have migraine headaches, with or without aura (diagnosis according the International Classification of Headache Disorders-II), for at least 1 year.
  • Subjects who have had 2-8 migraine attacks on average per month for the last 3 months (but less than 15 headache days per month).
  • Subjects who are willing and able to comply with the study schedule and requirements.
  • Subjects who speak, read and understand English sufficiently well and are willing to provide written informed consent.
  • Subjects 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:

  • Subjects who do not or may not tolerate 5HT1 agonist treatments, with known hypersensitivity to sumatriptan (as discussed with the investigator).
  • Female subjects 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.
  • Subjects 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 500mL 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 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 subject.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00804973

Locations
United States, California
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
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
United States, Florida
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.
West Palm Beach, Florida, United States, 33407
United States, Illinois
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.
Chicago, Illinois, United States, 60625
United States, Massachusetts
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.
Wellesley Hills, Massachusetts, United States, 02481
United States, Michigan
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.
Ann Arbor, Michigan, United States, 48104
United States, New York
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.
Mount Vernon, New York, United States, 10550
United States, Ohio
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.
West Chester, Ohio, United States, 45069
United States, Pennsylvania
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.
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
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.
Memphis, Tennessee, United States, 38119
United States, Texas
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.
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
United States, Virginia
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, 23502
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00804973     History of Changes
Other Study ID Numbers: 12258, I2W-MC-DMAB
Study First Received: December 5, 2008
Last Updated: April 16, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Migraine
Headache

Additional relevant MeSH terms:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Sumatriptan
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014