Long-Term Safety and Tolerability of Atogepant for Migraine Prevention in Chronic or Episodic Migraine: A Phase 3, 156-Week Extension Study

The primary objective of this Phase 3, multicenter, open-label extension study is to evaluate the **safety** and **tolerability** of oral atogepant, administered at a dose of 60 mg once daily over a period of 156 weeks, for the prevention of **migraine** in participants with either chronic or episodic migraine. This objective is clinically relevant as it aims to assess the long-term effects of atogepant, a calcitonin gene-related peptide receptor antagonist, which could provide a sustained preventive treatment option for individuals suffering from migraine, a condition characterized by recurrent headaches that can significantly impact quality of life.

The clinical trial involves a total of **214 participants** who are being evaluated for the safety and tolerability of atogepant 60 mg administered once daily over 156 weeks for the prevention of **migraine**, including both chronic and episodic forms. The study population comprises both male and female subjects, with an age range that includes adults and adolescents. Participants were selected based on their completion of specific visits in prior studies without significant protocol deviations and without experiencing adverse events that could indicate an unacceptable safety risk. The trial includes a vulnerable population, suggesting careful consideration of ethical standards. Lifestyle factors such as diet, physical activity, and habits were not specified in the available data.

The clinical trial is a **Phase 3**, multicenter, open-label extension study designed to evaluate the long-term safety and tolerability of **atogepant** for the prevention of **migraine** in participants with chronic or episodic migraine. The trial will span a duration of 156 weeks, during which participants will receive a daily oral dose of 60 mg of atogepant. The primary objective is to assess the safety and tolerability of the treatment, with the primary endpoint being the percentage of participants experiencing at least one treatment-emergent adverse event. Secondary endpoints include the percentage of participants with clinically significant laboratory values, electrocardiogram findings, and vital sign measurements, as well as results from the Columbia-Suicide Severity Rating Scale (CSSRS).

Participants eligible for this study are those who have completed specific visits in prior studies (3101-303-002 or 3101-304-002) without significant protocol deviations and have not experienced adverse events indicating an unacceptable safety risk. The study involves a sequence of visits, beginning with an inclusion (screening) visit to confirm eligibility. Follow-up visits will be conducted periodically to monitor safety and efficacy, with assessments including laboratory tests, ECGs, and vital signs. The end-of-study visit will conclude the participant's involvement, summarizing the overall safety and tolerability outcomes.

The expected length of participant involvement is up to 156 weeks, aligning with the trial's duration. Conditions that may lead to early termination from the study include the occurrence of adverse events that pose a significant safety risk or failure to adhere to the study protocol. The trial is not categorized as low intervention, and it is not an orphan drug study. The study is conducted under the sponsorship of Allergan Sales, LLC, a subsidiary of AbbVie Inc., and the investigational product is administered in tablet form via the oral route.

The clinical trial involves the administration of **Atogepant**, an experimental medication developed by Allergan Sales, LLC, a subsidiary of AbbVie Inc. Atogepant is formulated as a **tablet** and is intended for oral administration. The dosage regimen for this study is 60 mg once daily, with a maximum daily dose of 60 mg. The treatment period extends up to 156 weeks, allowing for the evaluation of long-term safety and tolerability in participants with chronic or episodic migraine. The active substance, Atogepant, is of chemical origin, and the study aims to assess its efficacy in the prevention of migraine.

In this trial, no non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatments are specified. The focus is solely on the administration of Atogepant to evaluate its safety profile over the extended treatment period. Participant compliance with the dosing schedule will be monitored throughout the study to ensure adherence to the prescribed regimen. The trial does not include any pediatric formulations, and Atogepant is not classified as an orphan drug for this study.

Efficacy in this clinical trial will be assessed through the evaluation of several primary and secondary endpoints. The primary endpoint focuses on the safety profile, specifically the **percentage of participants with at least one treatment-emergent adverse event**. Secondary endpoints include the percentage of participants with clinically significant laboratory values, electrocardiogram (ECG) findings, and vital sign measurements, as assessed by the investigator. Additionally, the trial will evaluate the percentage of participants with clinically significant laboratory values, ECG findings, or vital sign measures, along with results from the Columbia-Suicide Severity Rating Scale (CSSRS).

The trial is designed as a Phase 3, multicenter, open-label extension study, with a duration of 156 weeks, to evaluate the long-term safety and tolerability of oral Atogepant for the prevention of migraine in participants with chronic or episodic migraine. The efficacy parameters will be collected and analyzed at various timepoints throughout the study, ensuring a comprehensive assessment of the treatment's impact on the participants. The data collection will involve validated laboratory tests and clinical assessments conducted by qualified investigators to ensure accuracy and reliability in the evaluation of the treatment's efficacy.