Protocol H8H-MC-LAHWA Phase 3, 12-Month, Open-Label Study of Lasmiditan in Pediatric Patients with Migraine - PIONEER-PEDS2

Protocol H8H-MC-LAHW, titled PIONEER-PEDS2, is described as a Phase 3, 12-month, open-label clinical study of lasmiditan in pediatric patients with migraine. The record identifies the protocol and study title but provides no additional protocol-specific details in the supplied excerpt. Based on the available information, this study represents a late-phase clinical investigation intended to evaluate lasmiditan when administered to a pediatric population diagnosed with migraine over a one-year period. As a Phase 3 study, PIONEER-PEDS2 would typically be positioned to assess the drug's safety profile, tolerability, and clinical effectiveness in a larger patient cohort compared with earlier-phase trials.

The open-label designation indicates that both investigators and participants are aware of the treatment being administered, which often reflects an emphasis on long-term safety monitoring, real-world tolerability and collection of data on adverse events and patient-reported outcomes over an extended follow-up period. The use of lasmiditan in pediatric patients with migraine is the central focus as identified by the protocol title; lasmiditan is named as the investigational therapy under evaluation in this study context.