Randomized, Double-Blind, Placebo-Controlled Trial of Galcanezumab for Preventive Treatment of Episodic Migraine in Pediatric Patients Aged 6-17 Years

The primary objective of this study is to evaluate the **efficacy** and **safety** of **galcanezumab** in participants aged 6 to 17 years for the preventive treatment of **episodic migraine**. The study aims to demonstrate the superiority of galcanezumab over placebo in reducing the number of monthly migraine headache days during a 3-month double-blind treatment period. This is clinically relevant as it addresses the need for effective preventive treatments in the pediatric population suffering from episodic migraine, potentially improving their quality of life and reducing the burden of migraine-related disability.

The clinical trial involves a total of **236 participants** aged between **6 to 17 years**, both male and female, who are being evaluated for the preventive treatment of **episodic migraine**. The study population was selected based on a diagnosis of migraine with or without aura, as defined by the IHS ICHD-3 guidelines, with a history of migraine headaches for at least six months prior to screening. Participants include a vulnerable population, given the age range. The trial does not specify any particular lifestyle considerations such as diet or physical activity. The selection criteria ensure that the participants have a consistent history of migraine, which is crucial for assessing the efficacy and safety of galcanezumab in reducing monthly migraine headache days over a three-month double-blind treatment period.

The clinical trial is designed to evaluate the **efficacy** and safety of **galcanezumab** in participants aged 6 to 17 years for the preventive treatment of **episodic migraine**. This study is a randomized, double-blind, placebo-controlled trial, which aims to demonstrate the superiority of galcanezumab over placebo in reducing the number of monthly migraine headache days over a 3-month double-blind treatment period. The trial is expected to run from March 26, 2021, to November 30, 2026, with participant involvement lasting approximately 3 months. The study includes a screening visit to confirm eligibility based on the diagnosis of migraine with or without aura, as defined by the IHS ICHD-3 guidelines. Following the screening, participants will be randomly assigned to receive either galcanezumab or a placebo, both administered as a **solution for injection**. Study visits will occur at regular intervals to monitor the participants' response to treatment and to ensure safety. The primary endpoint is the change from baseline in the number of monthly migraine headache days. Participants may be withdrawn from the study if they experience significant adverse effects or if they do not adhere to the study protocol. The end-of-study visit will assess the overall outcomes and gather final data on the efficacy and safety of the treatment. The trial is categorized as a Phase III study, confirming the safety and efficacy of the investigational medicinal product for a new indication in this age group.

The clinical trial involves the administration of **Galcanezumab**, a monoclonal antibody used for the preventive treatment of **episodic migraine** in participants aged 6 to 17 years. Galcanezumab is provided as a **solution for injection** and is administered subcutaneously. The pharmaceutical form is a solution for injection, and the product is identified by the sponsor product code LY2951742. The active substance, galcanezumab, is a protein of other origin, specifically designed to target and inhibit the activity of calcitonin gene-related peptide (CGRP), which is implicated in migraine pathophysiology. The administration schedule and dosage are determined by the study protocol, with a focus on maintaining participant compliance through regular monitoring.

In addition to the experimental treatment, a **placebo** is used as a comparator in this double-blind, placebo-controlled study. The placebo is designed to match the appearance and administration route of the galcanezumab solution for injection, ensuring blinding of both participants and investigators. The placebo does not contain any active substance and serves to evaluate the efficacy and safety of galcanezumab by providing a baseline for comparison. The placebo is administered following the same schedule as the active treatment to maintain consistency across the study arms.

The efficacy of **Galcanezumab** in the clinical trial will be assessed by evaluating its impact on reducing the number of monthly migraine headache days in participants aged 6 to 17 years with episodic migraine. The primary endpoint for efficacy is the change from baseline in the number of monthly migraine headache days. This assessment will be conducted over a 3-month double-blind treatment period, comparing the results between the **Galcanezumab** group and the placebo group. The trial is designed to demonstrate the superiority of **Galcanezumab** over placebo in this regard. Data collection will occur at specified intervals throughout the treatment period to ensure accurate and reliable measurement of the primary endpoint.