Randomized, Double-Blind, Placebo-Controlled Trial of Galcanezumab in Adolescents Aged 12-17 with Chronic Migraine: REBUILD-2 Study

The primary objective of this study is to demonstrate the superiority of **galcanezumab** versus placebo in the prevention of migraine in an adolescent population aged 12 to 17 years with **chronic migraine**. This objective is clinically relevant as it aims to provide evidence for an effective preventive treatment option for adolescents suffering from chronic migraine, a condition that can significantly impact quality of life and daily functioning. The study does not list any secondary objectives.

The clinical trial involves a total of **209 participants** diagnosed with **chronic migraine**, as defined by the IHS ICHD-3 guidelines. The study population consists of adolescents aged 12 to 17 years, including both male and female subjects. Participants were selected based on their diagnosis of chronic migraine, characterized by headaches occurring on 15 or more days per month for at least the last three months, with migraine features on at least eight days per month. The trial includes a vulnerable population, given the adolescent age range. Lifestyle considerations such as diet, physical activity, or habits are not specified in the available data. The primary objective of the trial is to assess the efficacy of galcanezumab compared to a placebo in preventing migraines within this demographic. Key inclusion criteria focus on the chronic nature and frequency of migraine episodes, ensuring participants meet the defined clinical parameters for the study.

The clinical trial is designed to evaluate the efficacy of **galcanezumab** in preventing migraine in adolescents aged 12 to 17 years with **chronic migraine**. This study is a randomized, double-blind, placebo-controlled trial, ensuring that neither the participants nor the investigators know which treatment the participants are receiving, thereby minimizing bias. The trial is expected to run from March 31, 2021, to March 30, 2026, with the primary endpoint being the change from baseline in the number of monthly migraine headache days over a three-month period.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on the diagnosis of chronic migraine as per the IHS ICHD-3 guidelines. Following successful screening, participants will be randomized to receive either galcanezumab or a placebo, both administered as a **solution for injection**. The study will include regular follow-up visits to monitor the participants' 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 primary and any secondary endpoints.

The expected length of participant involvement in the study is approximately three months, corresponding to the primary endpoint time frame. Participants may be withdrawn from the study early if they experience significant adverse effects, fail to comply with the study protocol, or withdraw consent. The trial aims to provide robust data on the safety and efficacy of galcanezumab in this specific patient population, contributing to the understanding of its potential as a preventive treatment for chronic migraine in adolescents.

The clinical trial involves the administration of **Galcanezumab**, a monoclonal antibody, as the experimental medication. Galcanezumab is provided in the form of a **solution for injection**. The pharmaceutical formulation is designed for subcutaneous administration. The dosing regimen is specified as a single administration, with the maximum treatment period being one month. The product is manufactured by Eli Lilly and Company, and it is identified by the sponsor product code LY2951742. The active substance, Galcanezumab, is classified as a protein of other origin. The trial includes a pediatric formulation to accommodate adolescent participants aged 12 to 17 years with chronic migraine.

A **placebo** is utilized as the comparator treatment in this study. The placebo is designed to match the experimental medication, LY2951742, in appearance and administration method, ensuring the double-blind nature of the trial. The placebo does not contain any active pharmaceutical ingredients and is administered in the same manner as the experimental drug, as a solution for injection. The use of a placebo allows for the assessment of the efficacy of Galcanezumab in preventing migraines in the adolescent population by providing a control for comparison.

Efficacy in this clinical trial will be assessed by evaluating the primary endpoint, which is the change from baseline in the number of monthly **migraine headache days**. This assessment will be conducted over a time frame from baseline to 3 months. The trial is designed to demonstrate the superiority of **galcanezumab** versus placebo in preventing migraines in adolescents aged 12 to 17 years with chronic migraine. The primary endpoint will be measured and collected at specified time points, including baseline and at the end of the 3-month treatment period. The data collected will be analyzed to determine the efficacy of **galcanezumab** in reducing the frequency of migraine headache days compared to placebo. The trial is a randomized, double-blind, placebo-controlled study, ensuring that the efficacy assessments are conducted in a rigorous and unbiased manner.