Atogepant vs Topiramate for Migraine
(ATO-TOPIRAMATE Trial)

Recruiting in Palo Alto (17 mi)

+122 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AbbVie

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults with a history of migraines for at least 12 months, experiencing 4 or more migraine days per month and needing preventive treatment. Participants should not have used Atogepant or Topiramate before and must be free from significant health issues in major body systems like the heart, brain, blood, hormones, lungs, kidneys, liver, stomach or nerves.

Inclusion Criteria

I have had migraines for at least 12 months.

I experience 4 or more migraine days per month and need preventive treatment.

Exclusion Criteria

I have taken topiramate or atogepant before.

I have a serious heart, blood, hormone, lung, kidney, liver, stomach, brain or nerve condition.

Participant Groups

The trial is testing the tolerability and safety of Atogepant compared to Topiramate for preventing migraines. Initially participants are randomly assigned to receive either Atogepant with placebo for Topiramate or vice versa for 24 weeks; afterwards all eligible participants will take Atogepant for an additional 52 weeks.

2Treatment groups

Experimental Treatment

Active Control

Group I: AtogepantExperimental Treatment2 Interventions

Participants will receive atogepant in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.

Group II: TopiramateActive Control3 Interventions

Participants will receive topiramate in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.

Atogepant is already approved in United States for the following indications:

🇺🇸 Approved in United States as Qulipta for: