Atogepant vs Topiramate for Migraine

(ATO-TOPIRAMATE Trial)

Not currently recruiting at 144 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Disqualifiers: Cardiovascular, Cerebrovascular, Endocrine, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments, atogepant and topiramate, to evaluate their effectiveness and safety in preventing migraines. Atogepant is already used for occasional migraine prevention, while topiramate is another approved migraine prevention medication. Participants will initially use either atogepant or topiramate for 24 weeks and, if eligible, will receive atogepant for an additional 52 weeks. The trial seeks individuals who have experienced migraines for at least a year and have at least four migraine days each month. As a Phase 3 trial, this study is the final step before FDA approval, allowing participants to contribute to the availability of new migraine treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. However, since the study involves taking either atogepant or topiramate, it's possible that changes to your current migraine treatment may be required. Please consult with the trial coordinators for specific guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both atogepant and topiramate have undergone studies for safety and tolerability in treating migraines.

For atogepant, studies indicate it is generally well-tolerated. Common side effects include nausea, constipation, and fatigue. Importantly, no major differences in side effects appeared between atogepant and a placebo, suggesting safety. Long-term studies found no new safety issues, and most participants experienced fewer migraine days.

Topiramate is also considered generally safe for adults. The most common side effects are tingling sensations and changes in taste. However, topiramate should not be used during pregnancy unless effective birth control is in place, as it can harm the unborn baby.

Both medications have approval for preventing migraines, further supporting their safety for this purpose. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about atogepant for migraines because it offers a novel approach by targeting the CGRP (calcitonin gene-related peptide) pathway, which plays a key role in migraine development. Most traditional migraine treatments, like triptans and beta-blockers, work by constricting blood vessels or altering neurotransmitter activity. Atogepant, on the other hand, prevents migraines by blocking CGRP receptors, potentially offering better tolerance and fewer side effects. Meanwhile, topiramate, an existing option used for migraine prevention, is being compared to see how atogepant stacks up in terms of effectiveness and safety. This exploration could lead to more personalized and effective migraine management strategies.

What evidence suggests that this trial's treatments could be effective for migraine?

Research shows that atogepant, which participants in this trial may receive, reduces the number of migraine days. In one study, 64.1% of people taking atogepant experienced a reduction of migraine days by half or more. Another study found that people taking atogepant had fewer migraine days each month, with benefits observed at different doses. Similarly, topiramate, another treatment option in this trial, effectively prevents migraines. Studies have shown that it significantly reduces headache frequency and is generally well-tolerated. Both treatments have strong evidence supporting their effectiveness in preventing migraines. ^{2 6 7 8 9}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-blind Treatment

Participants receive either atogepant or topiramate for 24 weeks

24 weeks

Regular visits at a hospital or clinic

Open-label Extension

Eligible participants receive atogepant for 52 weeks

52 weeks

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Atogepant
• Topiramate

Trial Overview 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.

How Is the Trial Designed?

Group I: Atogepant Experimental Treatment 2 Interventions

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

Group II: Topiramate Active Control 3 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:

• Preventive treatment of migraine in adults

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

Atogepant (Qulipta™) is an oral medication that works as a CGRP receptor antagonist, specifically designed for preventing episodic migraines, and was approved in the USA in September 2021.

The drug is currently undergoing phase 3 clinical trials in other countries, indicating ongoing research and potential for broader use in migraine prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atogepant: First Approval. Deeks, ED.[2022]

Citations

1. quliptahcp.com quliptahcp.com/powerful-reductions

Powerful Migraine Day Reductions Effect of atogepant for preventive migraine treatment on patient-reported outcomes in the randomized, double-blind phase 3 ADVANCE trial. Neurology. 2023 ...

2. news.abbvie.com news.abbvie.com/2025-06-18-AbbVie-Announces-New-Data-Demonstrating-Atogepant-QULIPTA-R-AQUIPTA-R-Achieves-Superiority-Across-All-Endpoints-in-Phase-3-Head-to-Head-Study-Compared-to-Topiramate-for-Migraine-Prevention

AbbVie Announces New Data Demonstrating Atogepant ... The study also met all six secondary endpoints, including a key measure of clinical efficacy: 64.1% of patients on atogepant achieved a ≥50% ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12335800/

The efficacy and safety of Atogepant for migraine prophylaxis Atogepant significantly reduces mean monthly migraine days compared to placebo across multiple dosage levels. Significant improvements were ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2035908

Atogepant for the Preventive Treatment of Migraine Oral atogepant once daily was effective in reducing the number of migraine days and headache days over a period of 12 weeks. Adverse events included ...

5. neurology.org neurology.org/doi/10.1212/WNL.0000000000209584

Efficacy of Atogepant in Chronic Migraine With and Without ... There was a 52.1%–61.9% reduction in the proportion of atogepant-treated participants meeting acute medication overuse criteria over 12 weeks.

6. quliptahcp.com quliptahcp.com/safety

Safety Studies - QULIPTA® (atogepant) HCP The most common adverse reactions (at least 4% and greater than placebo) are nausea, constipation, and fatigue/somnolence.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2025/215206s011lbl.pdf

QULIPTA® (atogepant) tablets, for oral use - accessdata.fda.gov The estimated rate of major birth defects (2.2%-2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women ...

8. news.abbvie.com news.abbvie.com/2024-04-12-AbbVie-Announces-Late-Breaking-Data-at-AAN-Supporting-Long-Term-Safety-and-Efficacy-of-Atogepant-QULIPTA-R-for-Preventive-Treatment-of-Migraine

AbbVie Announces Late-Breaking Data at AAN Supporting ... Overall safety results were consistent with the known safety profile of atogepant 60 mg, and no new safety signals were identified.

9. thejournalofheadacheandpain.biomedcentral.com thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/s10194-024-01736-z

Safety and tolerability of atogepant for the preventive ... Moreover, in an open-label trial, 84% of atogepant participants achieved ≥ 50% reduction in monthly migraine days across 52 weeks of treatment [ ...