Atogepant for Migraine Prevention

No longer recruiting at 438 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Disqualifiers: Hypertension, Suicidal ideation, ECG abnormalities, 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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 156 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called Atogepant (also known as Qulipta) to determine its safety and effectiveness in preventing migraines over time for frequent sufferers. It focuses on individuals who participated in a previous study with this medication and did not experience major issues. Participants should have frequent migraines but not serious health conditions like high blood pressure or other significant diseases. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new migraine prevention treatment.

Will I have to stop taking my current medications?

You may need to stop taking some of your current medications if they are on the list of prohibited treatments for this trial. If your medication is not on the list, you might be able to continue or switch to an allowed alternative.

Is there any evidence suggesting that Atogepant is likely to be safe for humans?

Research has shown that atogepant is generally safe for people. In earlier studies, the most common side effects were mild, including nausea and constipation, affecting about 4% to 7.7% of those taking the medication. Some participants also reported feeling very tired.

Long-term studies have found that atogepant remains safe over time, with no new safety issues. This indicates it is well-tolerated for long-term use in preventing migraines. While some individuals experienced side effects, they were mostly manageable and not serious. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for migraine?

Atogepant is unique because it targets the CGRP receptor, which plays a key role in migraine development. Unlike traditional migraine prevention treatments, such as beta-blockers or anticonvulsants, Atogepant is taken orally as a once-daily pill, offering convenience and ease of use. Researchers are excited about Atogepant because it has the potential to provide effective migraine prevention with fewer side effects compared to existing options.

What evidence suggests that Atogepant might be an effective treatment for migraine prevention?

Research has shown that atogepant, which participants in this trial will receive, effectively prevents migraines. Studies have found that about 80% of people taking it long-term experienced a 50% reduction in migraine days. In one study, 64.1% of patients experienced a significant drop in migraine days. Another study demonstrated a decrease in both migraine and headache days over 12 weeks. Overall, this evidence suggests that atogepant can be a strong option for preventing migraines. ^{3 6 7 8 9}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for people who have chronic or episodic migraines and were part of earlier studies without major issues or serious side effects. They shouldn't need any off-limits treatments, have significant heart problems, uncontrolled high blood pressure, a risk of self-harm, or other serious health conditions.

Inclusion Criteria

I completed previous study visits without major issues or unsafe side effects.

- Eligible participants who completed Visit 7, and Visit 8 if applicable, of Study 3101-303-002 or Study 3101-304-002 without significant protocol deviations and who did not experience an Adverse Event that may indicate an unacceptable safety risk.

Exclusion Criteria

Your first ECG shows important irregularities.

Participants with a significant risk of self-harm, or of harm to others; participants who report suicidal ideation with intent, with or without a plan, since the last visit, must be excluded.

I have high blood pressure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Atogepant 60 mg daily for the prevention of migraine

156 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Atogepant

Trial Overview The study tests the long-term safety and tolerability of Atogepant 60 mg taken daily to prevent migraines. It's an extension study for participants from previous trials on this medication.

How Is the Trial Designed?

Group I: Atogepant 60 mg Experimental Treatment 1 Intervention

Taken once daily

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

Allergan

Lead Sponsor

Trials

782

Recruited

277,000+

Brent Saunders

Allergan

Chief Executive Officer since 2015

JD and MBA from Temple University

Dr. David Nicholson

Allergan

Chief Medical Officer since 2015

MD from Harvard Medical School

Published Research Related to This Trial

In a 52-week trial involving 744 adults with migraine, daily oral atogepant 60 mg was found to be safe and well-tolerated, with 67% of participants experiencing treatment-emergent adverse events, mostly mild to moderate.

Atogepant significantly reduced the mean monthly migraine days, with 84.2% of participants achieving at least a 50% reduction in migraine frequency by the end of the study, demonstrating its efficacy as a preventive treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Once-daily oral atogepant for the long-term preventive treatment of migraine: Findings from a multicenter, randomized, open-label, phase 3 trial. Ashina, M., Tepper, SJ., Reuter, U., et al.[2023]

Atogepant is an effective oral medication for preventing migraines, significantly reducing mean monthly migraine days in patients with episodic migraine over a 12-week period in placebo-controlled trials.

While atogepant offers a new alternative to injectable migraine treatments, it has potential side effects like nausea and constipation, and its high cost may limit its use to patients who prefer oral therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atogepant for the prevention of episodic migraine in adults. Switzer, MP., Robinson, JE., Joyner, KR., et al.[2023]

Atogepant, an oral CGRP antagonist approved for migraine prevention, demonstrated significant efficacy in reducing monthly migraine days and was well tolerated in two randomized, double-blind trials involving 1,727 participants.

The most common side effects reported were nausea, constipation, and upper respiratory infections, indicating that while atogepant is effective, it does have some mild adverse effects that patients should be aware of.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atogepant for Migraine Prevention: A Systematic Review of Efficacy and Safety. Singh, A., Balasundaram, MK.[2022]

Atogepant, a calcitonin gene-related peptide receptor antagonist, significantly reduced the number of monthly migraine days in participants compared to placebo, with reductions ranging from -3.1 to -4.4 days across different treatment periods over 12 weeks.

The treatment effects of atogepant were evident as early as the first day after starting the medication, with a lower percentage of participants experiencing migraines on the first post-dose day compared to those on placebo (10.8% to 14.1% vs. 25.2%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time course of efficacy of atogepant for the preventive treatment of migraine: Results from the randomized, double-blind ADVANCE trial. Schwedt, TJ., Lipton, RB., Ailani, J., et al.[2022]

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]

In a phase 3 trial involving 910 adults, atogepant significantly reduced the number of migraine days per month compared to placebo, with reductions of 3.7 to 4.2 days depending on the dosage over 12 weeks.

Common side effects of atogepant included constipation and nausea, but serious adverse events were rare, indicating a generally favorable safety profile; however, further long-term studies are needed to fully assess its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atogepant for the Preventive Treatment of Migraine. Ailani, J., Lipton, RB., Goadsby, PJ., et al.[2021]

In a phase 2b/3 trial involving 834 adults with a history of migraines, all doses of atogepant significantly reduced the number of monthly migraine days compared to placebo over a 12-week period, indicating its efficacy as a preventive treatment for migraines.

Atogepant was found to be safe and well tolerated, with the most common side effects being nausea and fatigue, and serious adverse events were not related to the treatment, supporting its further development for migraine prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, tolerability, and efficacy of orally administered atogepant for the prevention of episodic migraine in adults: a double-blind, randomised phase 2b/3 trial. Goadsby, PJ., Dodick, DW., Ailani, J., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40874574/

Effectiveness and tolerability of atogepant as preventive ... Primary outcomes included change in monthly migraine days (MMDs) and greater than 50% responder rate at 12 and 24 weeks. ... Treatment-emergent ...

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. 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 ...

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

“The efficacy and safety of Atogepant for migraine prophylaxis ... Emerging evidence from randomized controlled trials (RCT) has demonstrated that approximately 80% of long-term users of Atogepant achieve a ≥ 50 ...

5. 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 ...

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

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 ...

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

9. 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 ...