Evaluation of Long-Term Safety and Tolerability of Lasmiditan for Acute Migraine Treatment in Pediatric Patients: A 12-Month Open-Label Study

The primary objective of this study is to evaluate the **safety** and tolerability of long-term intermittent use of **lasmiditan** for the acute treatment of **migraine** in pediatric participants. This is clinically relevant as it addresses the need for effective and safe treatment options for children aged 6 to 17 suffering from migraines, a condition that can significantly impact quality of life and daily functioning. The study aims to provide insights into the long-term effects of lasmiditan, which could inform treatment guidelines and improve patient outcomes in this population.

The clinical trial involves a total of **825 participants** who are being evaluated for the safety and tolerability of long-term intermittent use of lasmiditan for the acute treatment of **migraine**. The study population includes both male and female pediatric participants, with an age range starting from 2 years old. Participants were selected based on their completion of either study H8H-MC-LAHX (NCT03988088) or study H8H-MC-LAHV, and they must weigh at least 15 kilograms. The trial includes a vulnerable population, indicating special considerations for the participants' health and safety. The study does not specify any particular lifestyle considerations such as diet or physical activity. The selection criteria ensure that the participants are suitable for the objectives of the trial, focusing on a specific pediatric demographic affected by migraine.

The clinical trial is designed to evaluate the **safety** and tolerability of long-term intermittent use of **lasmiditan** for the acute treatment of **migraine** in pediatric participants. This is a Phase III, open-label study with a duration of 12 months. The trial involves pediatric patients who have completed a previous study and meet specific inclusion criteria, such as a minimum weight of 15 kilograms. The study is structured as a controlled trial, although it is not double-blind, given its open-label nature.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on the inclusion criteria. Throughout the trial, there will be regular follow-up visits to monitor the participants' response to the treatment and to assess any adverse events. The primary endpoints include the percentage of treatment-emergent adverse events by treated migraine attack and the percentage of participants with discontinuations due to adverse events. The trial will conclude with an end-of-study visit, where final assessments will be conducted to evaluate the overall safety and tolerability of the treatment.

The expected length of participant involvement is 12 months, aligning with the overall trial duration. Conditions that may lead to early termination from the study include the occurrence of significant adverse events or the participant's inability to comply with the study protocol. The trial is set to end by January 31, 2031, with recruitment having started on July 27, 2020. The study involves the administration of **lasmiditan** in the form of oral tablets, with the maximum treatment period being one day per migraine attack, as per the study protocol.

The clinical trial involves the administration of **Lasmiditan**, a chemical compound used for the acute treatment of migraine. The experimental medication is provided in the form of a **film-coated tablet** and is administered orally. The dosage is specified in milligrams, although the exact daily and total dose amounts are not detailed in the provided data. The maximum treatment period for the trial is set at one day. The product is identified by the sponsor product code LY573144 and is not a pediatric formulation. The trial aims to evaluate the safety and tolerability of long-term intermittent use of Lasmiditan in pediatric patients.

In addition to the experimental medication, the trial may involve the use of **analgesics** as non-experimental treatments. These are standard-of-care therapies that may be used to manage pain associated with migraine. The specific analgesics used are not detailed, but they are administered in tablet form, similar to the experimental medication. The trial does not specify the use of a placebo or comparator treatment. Participant compliance with the dosing schedule is monitored, although specific methods for compliance monitoring are not provided in the data.

The efficacy of **lasmiditan** in the clinical trial will be assessed through the evaluation of primary endpoints, which include the percentage of Treatment Emergent Adverse Events (TEAEs) by treated migraine attack and the percentage of participants with discontinuations due to adverse events (AEs). These endpoints are designed to measure the safety and tolerability of long-term intermittent use of **lasmiditan** for the acute treatment of migraine in pediatric participants. The trial is structured as a Phase 3, 12-month, open-label study, focusing on pediatric patients with migraine. The data collection will occur throughout the trial duration, with specific attention to the occurrence of adverse events and any resulting discontinuations. The analysis will involve calculating the percentage of TEAEs and discontinuations, providing insights into the drug's efficacy in managing migraine symptoms while monitoring safety concerns.