Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00387881 | TREXIMET (Formerly Known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1) | PHASE3 | COMPLETED | 679 | — | — | Sep 1, 2006 | Feb 1, 2008 | Dec 16, 2016 | 70 | United States |
Pain-free was defined as a headache severity of no pain (grade 0) at 2 hours post-treatment in subjects who have not used rescue medication prior to or at the time of the assessment. Sustained pain-free response was defined as pain-free at 2 hours post-treatment through 24 hours post-treatment without rescue medicine.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| Treximet | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| sumatriptan succinate / naproxen sodium | DRUG | sumatriptan 85mg / naproxen sodium 500mg |
| Placebo | DRUG | Placebo to match Treximet tablets |
Inclusion Criteria: * At least a 6 month history of probably migraine (6 migraine attacks per month) * Males and women of childbearing potential on a adequate contraception. Exclusion Criteria: * Physician diagnosis of migraine; history of triptan or ergot use; history of headache prophylaxis use...