| 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
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| |
| |
| |
| 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 |