Randomized, Double-Blind, Placebo-Controlled Trial of Lasmiditan for Acute Migraine Treatment in Pediatric Patients Aged 6 to 17 Years

The primary objective of this study is to evaluate the **safety** and **efficacy** of **lasmiditan** in children aged 6 to 17 years with **migraine**. This is clinically relevant as it aims to provide a potential therapeutic option for pediatric patients suffering from acute migraine attacks, a condition that can significantly impact quality of life and daily functioning in this age group. The study is designed to assess whether lasmiditan can offer a safe and effective treatment alternative, potentially improving management strategies for pediatric migraine.

The clinical trial involves a total of **1133 participants** who are children aged **6 to 17 years** diagnosed with **migraine**. The study population includes both **male and female** subjects. Participants were selected based on specific criteria, including a history of migraine with or without aura as defined by the International Headache Society's International Classification of Headache Disorders, 3rd edition. The trial population is characterized by a history of migraine attacks for more than six months, with a frequency of 2 to 8 moderate-to-severe attacks per month in the two months prior to the screening visit. Participants must be able to swallow a tablet and, if on preventive medication, must have a stable treatment regimen for at least three months before screening. Additionally, participants must weigh at least 15 kilograms. The study does not specify any particular lifestyle considerations such as diet or physical activity. The trial includes a vulnerable population, as it involves children. The objective of the study is to evaluate the safety and efficacy of lasmiditan in this demographic over a period of up to 20 weeks, potentially involving up to four visits.

The clinical trial is designed to evaluate the safety and efficacy of **lasmiditan** in children aged 6 to 17 with **migraine**. This study is a randomized, double-blind, placebo-controlled trial, which will last up to 20 weeks and may include up to four visits. Participants will be randomly assigned to receive either lasmiditan or a placebo, with the primary endpoint being the percentage of participants achieving pain freedom with a high dose of lasmiditan. The trial will involve oral administration of the investigational product, with lasmiditan being provided in tablet form.

The sequence of study visits begins with an inclusion (screening) visit, where eligibility is assessed based on criteria such as a history of migraine attacks, the ability to swallow a tablet, and a stable preventive medication regimen if applicable. Participants must weigh at least 15 kilograms. Following the screening, participants will attend follow-up visits to monitor their response to the treatment and any adverse effects. The end-of-study visit will conclude the trial, where final assessments will be conducted to evaluate the outcomes.

Participant involvement is expected to last for the entire duration of the trial, approximately 20 weeks. However, conditions that may lead to early termination from the study include non-compliance with the study protocol, withdrawal of consent, or the occurrence of adverse events that, in the opinion of the investigator, warrant discontinuation. The trial is conducted in accordance with ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.

The clinical trial involves the administration of **Lasmiditan**, a pharmaceutical product developed by Eli Lilly and Company. Lasmiditan is provided in the form of a **tablet** and is intended for **oral use**. The active substance in Lasmiditan is chemically derived and identified as lasmiditan. The product is not a paediatric formulation and is not classified as an orphan drug. The maximum treatment period for Lasmiditan is one day, with no specified maximum daily or total dose amount. The product is categorized under analgesics, and its administration is monitored to ensure compliance with the dosing schedule.

In addition to Lasmiditan, the study includes the use of a **placebo** to match various dosages of Lasmiditan tablets. The placebo is designed to mimic the appearance and administration route of the active medication, ensuring the study remains double-blind. The placebo is available in forms to match 25mg, 50mg, and 100mg tablets, as well as 50mg and 100mg film-coated tablets. These placebos are also intended for oral use and are utilized to maintain the integrity of the control group within the trial. The placebo does not contain any active substances and is not a paediatric formulation.

The efficacy of **Lasmiditan** in the treatment of migraine in children aged 6 to 17 will be assessed in this clinical trial. The primary endpoint for evaluating efficacy is the percentage of participants achieving pain freedom with a high dose of the investigational product. This endpoint will be measured at specified time points throughout the study duration, which lasts up to 20 weeks and may include up to four visits. The trial is designed as a randomized, double-blind, placebo-controlled study, ensuring that the assessment of efficacy is conducted under rigorous conditions to minimize bias.