Evaluation of Atogepant for Preventive Treatment of Chronic Migraine in Pediatric Patients Aged 12-17: A Phase 3, Double-Blind, Placebo-Controlled Study

The primary objective of this study is to evaluate the **safety** and **efficacy** of atogepant when administered daily for the preventive treatment of **chronic migraine** in pediatric subjects aged 12 to 17 years. This is clinically relevant as chronic migraine significantly impacts the quality of life in adolescents, and effective preventive treatments are essential to reduce the frequency and severity of migraine episodes.

The secondary objective is to assess the efficacy of preventive treatment with atogepant compared to placebo concerning secondary endpoints in the same pediatric population. This evaluation will provide additional insights into the therapeutic potential of atogepant in managing chronic migraine in adolescents.

The clinical trial involves a total of **306 participants** who are pediatric subjects aged 12 to 17 years, both male and female, with a focus on evaluating the safety and efficacy of atogepant for the preventive treatment of **chronic migraine**. The study population was selected based on specific criteria, including a weight range of ≥ 20 kg (44 pounds) and < 135 kg (298 pounds), and a history of migraine with or without aura consistent with the International Classification of Headache Disorders, 3rd Edition (ICHD-3) for at least 6 months. Participants may have current or past use of at least one oral medication for migraine treatment. The trial includes a vulnerable population, and lifestyle factors such as diet and physical activity are not specified in the available data.

The clinical trial is a **Phase 3**, multicenter, 12-week, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of **atogepant** for the preventive treatment of **chronic migraine** in pediatric subjects aged 12 to 17 years. The trial employs a randomized methodology to ensure unbiased results, with participants receiving either the active drug, atogepant, or a placebo. The primary objective is to assess the change from baseline in mean monthly migraine days across the 12-week treatment period. Secondary endpoints include changes in mean monthly headache days, acute medication use days, and quality of life scores, among others.

Participants will be involved in the study for a total duration of approximately 12 weeks. The sequence of study visits begins with an inclusion (screening) visit, where eligibility is confirmed based on criteria such as weight and a history of migraine consistent with the International Classification of Headache Disorders, 3rd Edition (ICHD-3). Following successful screening, participants will be randomized and commence the treatment phase. Regular follow-up visits will be conducted to monitor safety, efficacy, and adherence to the study protocol. The end-of-study visit will conclude the participant's involvement, during which final assessments will be made.

Conditions that may lead to early termination from the study include non-compliance with the study protocol, adverse events that compromise participant safety, or withdrawal of consent. The trial is expected to start recruitment in July 2025, with an estimated end date in March 2031. The study is not classified as low intervention, reflecting its comprehensive design and rigorous assessment of the investigational product's impact on chronic migraine in the specified pediatric population.

The clinical trial involves the administration of **Atogepant**, a chemical compound developed by Allergan Sales, LLC, a subsidiary of AbbVie Inc. Atogepant is provided in the form of a **tablet** and is intended for oral administration. The trial is designed to evaluate the safety and efficacy of Atogepant for the preventive treatment of chronic migraine in pediatric subjects aged 12 to 17 years. Participants will receive Atogepant daily over a 12-week period. The specific dosage in milligrams is not detailed in the provided data, but the administration is consistent with the standard oral route for tablet formulations.

In addition to the experimental treatment, a **placebo** is utilized as a comparator in this double-blind, placebo-controlled study. The placebo is designed to match the Atogepant tablet in appearance but does not contain any active pharmaceutical ingredients. The placebo serves to ensure that any observed effects can be attributed to the active treatment rather than psychological or other non-specific effects. The placebo is administered following the same schedule as the Atogepant, maintaining the study's blinding integrity.

The efficacy of Atogepant in the preventive treatment of chronic migraine in pediatric subjects aged 12 to 17 years will be assessed through a series of primary and secondary endpoints over a 12-week treatment period. The primary endpoint is the change from baseline in mean monthly migraine days across the 12-week treatment period. Secondary endpoints include the change from baseline in mean monthly headache days, mean monthly acute medication use days, and the percentage of participants achieving at least a 50% reduction in the 3-month average of monthly migraine days. Additionally, changes from baseline in the Pediatric Quality of Life Inventory (PedsQL) total score and the Pediatric Migraine Disability Assessment (PedMIDAS) total score at week 12 will be evaluated.

Data collection will occur at specified intervals throughout the trial, with efficacy parameters being measured using validated scales and patient-reported outcomes. The analysis will focus on comparing the changes from baseline to the end of the treatment period, providing insights into the effectiveness of Atogepant in reducing migraine frequency and improving quality of life in the target population. The trial is designed as a double-blind, placebo-controlled study to ensure the reliability and validity of the results.