Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events in Adult Participants With Migraine

Study Overview
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Brief Summary
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A migraine is a moderate to severe headache on one side of the head that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. The main goal of the study is to evaluate the tolerability (how patients handle the study treatment) and safety of atogepant compared to topiramate in participants with migraine. Atogepant is a medicine currently approved for the preventive treatment of adult patients with episodic migraine (0 to 14 migraine days per month) and is being studied for the preventative treatment of migraine globally. Topiramate is an approved medication for migraine prevention. This study is conducted in 2 periods. In Period 1, participants will be randomly put into 1 of 2 groups at the start of the study to receive atogepant or topiramate. In Period 2, eligible participants will receive atogepant. Approximately 520 participants aged 18 and older will be enrolled in this study in approximately 85 sites across the world. Participants will receive atogepant (and placebo for topiramate) or topiramate (and placebo for atogepant) for 24 weeks in Period 1. Both atogepant and placebo for atogepant are given as a tablet to take by mouth while topiramate and placebo for topiramate are given as a capsule to take by mouth. After 24 weeks, all eligible participants will receive atogepant for 52 weeks in Period 2. Participants are monitored for safety for 4 weeks after their last study treatment. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.

Official Title
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A Randomized, Double-Blind, Parallel-Group, Active Controlled Trial With Open-Label Safety Extension to Evaluate the Tolerability, Safety, and Efficacy of Atogepant Versus Topiramate in Subjects Requiring Preventive Treatment of Migraine (TEMPLE)

Conditions
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Migraine

Intervention / Treatment
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* Drug: Atogepant
* Drug: Placebo for Atogepant
* Drug: Topiramate
* Drug: Placebo for Topiramate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented history of migraine (with or without aura) for >= 12 months prior to screening (Visit 1). History of >= 4 migraine days per month who require preventive treatment of migraine and are eligible for conventional migraine prophylaxis. Exclusion Criteria: Have used topiramate or atogepant in the past. Have clinically significant cardiovascular, cerebrovascular, hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atogepant<br>Participants will receive atogepant in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period. | Drug: Atogepant<br>* Oral Tablet<br>* Other names: QULIPTA;Drug: Placebo for Topiramate<br>* Oral Capsule<br>|
| Active Comparator: Topiramate<br>Participants will receive topiramate in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period. | Drug: Atogepant<br>* Oral Tablet<br>* Other names: QULIPTA;Drug: Placebo for Atogepant<br>* Oral Tablet<br>Drug: Topiramate<br>* Oral Capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Discontinued Treatment due to Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to Week 24 (Double-blind treatment period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving >= 50% Improvement (Reduction) in Mean Monthly Migraine Days Based on mITT Population. | Improvement in mean monthly migraine days will be assessed. | Month 4 to Month 6 (Double-blind treatment period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, Episodic migraine, Chronic migraine, Atogepant, Topiramine, QULIPTA, Migraine prophylaxis