Migraine Preventive Medications for Migraine

Recruiting at 9 trial locations

Overseen By Dani C Smith, M.S.

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Must not be taking: CGRP-targeting, Beta-blockers, Opioids, Butalbital

Disqualifiers: Epilepsy, Severe hepatic impairment, others

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

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

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

1335 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which of the three migraine preventive medications—atogepant, topiramate, or propranolol—works best and is easiest to tolerate for preventing migraines. Participants will receive one of these medications at random and will track their migraine patterns using a headache diary. Suitable candidates have experienced migraines for over a year, have at least four days of moderate to severe headaches each month, and are open to trying a new preventive medication. As a Phase 4 trial, this research helps to understand how these FDA-approved treatments benefit a broader patient population.

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

If you are already taking a migraine preventive treatment, you can continue with it without changing the dose during the first 16 weeks of the study. However, you cannot currently be taking atogepant, propranolol, or topiramate, or any CGRP-targeting preventive medication or beta-blocker.

What is the safety track record for these treatments?

Research has shown that atogepant is generally safe and effective for preventing migraines, significantly reducing the number of migraine days. Common side effects, such as nausea and tiredness, are mild for most people.

Propranolol, another common medication for migraine prevention, has been used safely for many years. Some individuals might experience tiredness or dizziness, but these effects are usually manageable.

Topiramate is also a well-known option with a good safety record. It is typically well-tolerated, though some individuals might experience tingling in their hands and feet or notice changes in taste. These side effects are generally mild.

Extensive studies have confirmed the safety of all three medications for most people. However, side effects can vary, so discussing these options with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because they offer unique approaches to migraine prevention. Atogepant is a CGRP receptor antagonist, which works differently from typical migraine drugs by blocking a protein involved in migraine attacks, potentially offering fewer side effects and better tolerance. Propranolol, although a long-standing treatment, is being re-evaluated for its effectiveness and safety in higher doses for migraine prevention, which could optimize its use. Topiramate, another established option, is being tested to refine dosing strategies, aiming to minimize side effects while maintaining its preventive benefits. Each of these treatments brings a distinct approach, potentially broadening the options for individuals seeking relief from migraines.

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

Research shows that atogepant, one of the treatments in this trial, reduces the number of migraine days. Studies find it lowers migraine frequency more than a placebo and is generally well tolerated. Propranolol, another treatment option in this trial, also has strong evidence supporting its use in preventing migraines. A review of 58 trials showed that propranolol significantly reduced migraine frequency compared to a placebo. Topiramate, the third treatment in this trial, is another option, with many studies showing it effectively reduces headache frequency. It is generally considered safe and effective for many patients. Each of these medications has been shown to prevent migraines, though they may work differently for different people. ^{2 4 6 7 8}

Who Is on the Research Team?

Todd J Schwedt, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals who frequently experience migraines. Participants will be randomly assigned to one of three medications and must track their migraine patterns daily. Specific eligibility details are not provided, but typically participants should meet certain health criteria.

Inclusion Criteria

Not pregnant or breastfeeding

Women of childbearing potential must use effective contraception

Ability to provide informed consent

Exclusion Criteria

I cannot take atogepant, propranolol, or topiramate due to health reasons.

I am currently taking atogepant, propranolol, or topiramate.

I have taken atogepant, propranolol, or topiramate before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Randomization

Participants are randomized to one of the three medications after the initial screening period

1 week

1 visit (in-person)

Treatment

Participants receive the assigned study medication for 12 weeks

12 weeks

4 visits (in-person) at weeks 4, 8, 12, and 24

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

2 visits (in-person) at weeks 24 and 48

What Are the Treatments Tested in This Trial?

Interventions

• Atogepant
• Propranolol
• Topiramate

Trial Overview The study compares the effectiveness and tolerability of three migraine preventive medications: Atogepant (60 mg), Propranolol (160 mg), and Topiramate (100 mg). Patients will be placed into groups by chance to receive one medication.

How Is the Trial Designed?

Group I: Topiramate Active Control 1 Intervention

Participants randomized to this arm will take up to 100 mg daily for 12 weeks .

Group II: Atogepant Active Control 1 Intervention

Participants who are randomized to this arm will take up to 60mg daily for 12 weeks.

Group III: Propranolol Active Control 1 Intervention

Participants randomized to this arm will take up to 160 mg daily for 12 weeks.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

University of Iowa

Collaborator

Trials

486

Recruited

934,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

AbbVie

Industry 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

Citations

1. 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 ...

2. 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 ...

3. thelancet.com thelancet.com/journals/laneur/article/PIIS1474-4422(24)00025-5/abstract

Safety and efficacy of atogepant for the preventive ... Atogepant 60 mg once a day was safe, well tolerated, and showed significant and clinically relevant reductions in mean monthly migraine days ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2793155

Rates of Response to Atogepant for Migraine Prophylaxis ... Atogepant appears to be effective and well tolerated for the preventive treatment of migraine as measured by 4 levels of the clinically meaningful end point of ...

5. neurology.org neurology.org/doi/10.1212/WNL.0000000000208366

a Systematic Review with Meta-Analysis and Trial ... This meta-analysis indicates that atogepant effectively reduces migraine frequency and acute medication use while improving quality of life.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40831083/

Long-term safety, efficacy and functional outcomes of ... Here, we report the long-term safety, tolerability, efficacy and functional outcomes of one-year preventive treatment of EM or CM with atogepant ...

7. 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 ... The overall long-term safety results were consistent with the known safety profile of atogepant in chronic and episodic migraine, and no new ...

8. bmcneurol.biomedcentral.com bmcneurol.biomedcentral.com/articles/10.1186/s12883-025-04350-x

“The efficacy and safety of Atogepant for migraine prophylaxis ... Atogepant is an effective and safe option for migraine prophylaxis, showing significant reductions in MMDs. Further extensive trials are ...