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Study in Subjects With Acute Migraines Headaches.
This study has been terminated.
( Due to efficacy results of interim analysis )
Study NCT00804973   Information provided by Eli Lilly and Company
First Received: December 5, 2008   Last Updated: November 24, 2009   History of Changes

December 5, 2008
November 24, 2009
November 2008
May 2009   (final data collection date for primary outcome measure)
Headache pain free response. [ Time Frame: 2 hour after study drug administration ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00804973 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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: Yes ]
  • 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: Yes ]
  • Sustained pain relief response. [ Time Frame: 24 hours, 48 hours ] [ Designated as safety issue: Yes ]
  • Time to headache recurrence. [ Time Frame: Up to 48 hours after study drug administration. ] [ Designated as safety issue: Yes ]
  • 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: Yes ]
  • 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: Yes ]
  • 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: Yes ]
  • 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: Yes ]
  • Sustained pain free response [ Time Frame: 24 hours, 48 hours ] [ Designated as safety issue: Yes ]
 
Study in Subjects 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 subjects with migraines.

 
Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Migraine Headache
  • Drug: LY2590443
  • Drug: Placebo injection
  • Drug: Sumatriptan
  • Drug: Placebo capsule
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
120
May 2009
May 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00804973
Chief Medical Officer, Eli Lilly
12258, I2W-MC-DMAB
Eli Lilly and Company
 
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
Eli Lilly and Company
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP