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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01625988 | A Study of LY2951742 in Participants With Migraine | PHASE2 | COMPLETED | 218 | — | — | Jun 28, 2012 | Sep 18, 2013 | Jan 9, 2020 | 37 | United States |
The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2004). The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-II definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. Least square (LS) means were calculated using mixed model repeated measures (MMRM) with baseline value, treatment, month, and treatment-by-month interaction as fixed effects and participant as random effect.
| Arm | Type | Description |
|---|---|---|
| LY2951742 | EXPERIMENTAL | LY2951742: 150 milligrams (mg), subcutaneous (SC) injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period. |
| Placebo | PLACEBO_COMPARATOR | Placebo: 0.9% Sodium Chloride, Untied States Pharmacopoeia (USP), subcutaneous (SC) injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period. |
| Name | Type | Description |
|---|---|---|
| LY2951742 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Have a history of migraine as defined by the International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2004) of at least 1 year prior to enrollment, migraine onset prior to age 50, and a moderate frequ...