Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY2951742 · 3 trials · 3 indications
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.
A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section
Clinically significant effects were defined as serious and other non-serious adverse events (AEs). A summary of serious and all other non-serious AEs is located in the Reported Adverse Events module.
| 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. |
| 5 mg LY2951742 Single Dose | EXPERIMENTAL | 5 mg LY2951742 given subcutaneously once |
| 50 mg LY2951742 Single Dose | EXPERIMENTAL | 50 mg LY2951742 given subcutaneously once |
| 120 mg LY2951742 Single Dose | EXPERIMENTAL | 120 mg LY2951742 given subcutaneously once |
| 300 mg LY2951742 Single Dose | EXPERIMENTAL | 300 mg LY2951742 given subcutaneously once |
| 300 mg LY2951742 Multiple Dose | EXPERIMENTAL | 300 mg LY2951742 given subcutaneously once every 4 weeks (Q4W) |
| Placebo Single Dose | PLACEBO_COMPARATOR | Placebo given subcutaneously once |
| Placebo Multiple Dose | PLACEBO_COMPARATOR | Placebo given subcutaneously once every 4 weeks (Q4W) |
| Single dose 1 milligram (mg) LY2951742 | EXPERIMENTAL | Administered single subcutaneous injection |
| Single dose 5 mg LY2951742 | EXPERIMENTAL | Administered single subcutaneous injection |
| Single dose 25 mg LY2951742 | EXPERIMENTAL | Administered single subcutaneous injection |
| Single dose 75 mg LY2951742 | EXPERIMENTAL | Administered single subcutaneous injection |
| Single dose 200 mg LY2951742 | EXPERIMENTAL | Administered single subcutaneous injection |
| Single dose 600 mg LY2951742 | EXPERIMENTAL | Administered single subcutaneous injection |
| Single dose placebo | PLACEBO_COMPARATOR | Administered single subcutaneous injection |
| Multiple dose placebo | PLACEBO_COMPARATOR | Administered subcutaneously every 2 weeks for 6 weeks (4 doses) |
| 150 mg LY2951742 | EXPERIMENTAL | Administered subcutaneously every 2 weeks for 6 weeks (4 doses) |
| 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...
LY2951742 is an investigational small molecule being developed for the treatment of migraines, including migraine headache and migraine disorders. It is in clinical development for these neurological conditions, though it is not yet approved by regulatory authorities.
LY2951742 is being developed by Eli Lilly and Company, a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in migraine patients.
LY2951742 has completed Phase 1 and Phase 2 clinical trials. The most advanced completed trial was a Phase 2 study in participants with migraine headache. The drug is investigational and still in clinical development, with no approved status.
LY2951742 has been studied in three completed clinical trials: NCT01337596, a Phase 1 study in healthy volunteers in Belgium; NCT01625988, a Phase 2 study in participants with migraine headache in the United States; and NCT02104765, a Phase 1 study in healthy Japanese and Caucasian participants in the United States.
LY2951742 is also known as galcanezumab, a monoclonal antibody targeting calcitonin gene-related peptide (CGRP) for migraine prevention. It is being developed by Eli Lilly and Company and has been studied in clinical trials for migraine disorders.