Atogepant + Botox for Chronic Migraine

(ATO-BOTOX Trial)

No longer recruiting at 36 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Must be taking: Botox

Must not be taking: Opioids, mAbs, oral gepants

Disqualifiers: Acupuncture, TENS, 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: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of adding atogepant, an investigational oral drug, to Botox for preventing chronic migraines. The researchers aim to determine if combining these treatments can better reduce migraine attacks and assess any side effects. Individuals who have experienced chronic migraines for at least a year, currently use Botox, and have 8 to 23 migraine days per month might be suitable candidates. Participants will need to visit a hospital or clinic regularly for check-ups, blood tests, and to complete questionnaires. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for chronic migraines.

Will I have to stop taking my current medications?

The trial requires that you continue using Botox for chronic migraine, but you cannot use other migraine prevention treatments besides Botox or topiramate (up to 100mg daily). If you are using oral gepants or certain other treatments, you may need to stop before joining the trial.

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

Research has shown that atogepant is generally safe for people. In earlier studies, the most common side effects included nausea, constipation, and fatigue, reported by at least 4% of participants—more than those who took a placebo. Another study found that after about 496 days of taking atogepant, 79% of participants experienced some side effects, but these were already known and expected. Importantly, no new safety issues emerged. Overall, recent research considers atogepant well-tolerated, with no serious or unexpected side effects. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for migraine?

Unlike the standard treatments for chronic migraine, which often include medications like triptans or preventive drugs such as beta-blockers and anticonvulsants, atogepant targets the condition in a new way. Atogepant is a CGRP receptor antagonist, which means it blocks the effects of a protein called calcitonin gene-related peptide that's involved in migraine attacks. This novel mechanism of action offers a promising alternative for individuals who may not respond well to existing options or experience unpleasant side effects. Additionally, atogepant is taken orally once a day, providing a convenient treatment option for those seeking simplicity in their migraine management routine. Researchers are excited about its potential to offer effective relief with fewer side effects and improved patient adherence.

What evidence suggests that atogepant might be an effective treatment for chronic migraine?

Research has shown that atogepant helps prevent migraines. In one study, 64.1% of participants taking atogepant experienced at least a 50% reduction in migraine days. Over 12 weeks, those who took atogepant had fewer migraine days compared to those who did not. Atogepant, a once-daily pill, is considered both effective and safe for migraine prevention. Overall, these findings suggest that atogepant can significantly reduce migraine frequency. ^{6 7 8 9 10}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Adults with chronic migraine who've been treated with BOTOX for at least two cycles in the past 8 months and have had 8-23 migraine days during a screening period. Participants must not have used certain migraine medications recently, including CGRP pathway blockers or oral gepants, and should not be on other preventive treatments besides BOTOX.

Inclusion Criteria

I have been receiving BOTOX for chronic migraines, with at least 2 treatments in the last 8 months.

I have had chronic migraines for at least a year.

Must have 8 to 23 (inclusive) migraine days in the electronic diary [eDiary] screening/baseline period (eDiary data must have been collected for at least 20 days)

Exclusion Criteria

I've used opioids for headaches more than 4 days a month recently.

I haven't had treatments like acupuncture or TENS on my head/neck muscles in the last 4 weeks.

I have used CGRP-blocking medication in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive atogepant oral tablet once a day in addition to their standard of care Botox during the 24-week treatment period

24 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

Trial Overview The trial is testing the safety and effectiveness of an investigational drug called Atogepant when added to standard BOTOX treatment for preventing migraines. Around 125 participants will take Atogepant daily for 24 weeks while continuing their regular BOTOX injections.

How Is the Trial Designed?

Group I: Atogepant Experimental Treatment 1 Intervention

Participants will receive atogepant once a day (QD) during the 24-week treatment period.

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

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 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]

Olcegepant and telcagepant, both calcitonin-gene-related peptide receptor antagonists, significantly improve pain relief and pain-free rates in migraine patients compared to placebo, with olcegepant showing a notable effect at 2 hours post-treatment.

While olcegepant has a similar incidence of adverse reactions as placebo, telcagepant at higher doses (300 mg) does show a higher rate of adverse effects, indicating a need for monitoring liver transaminases with long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic effects and safety of olcegepant and telcagepant for migraine: A meta-analysis. Yao, G., Yu, T., Han, X., et al.[2021]

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]

In a 40-week study involving 685 participants, atogepant, an oral medication for preventing episodic migraines, demonstrated a long-term safety profile with 74.6% of participants completing the treatment.

While 62.5% of participants experienced treatment-emergent adverse events, most were mild, and serious adverse events were rare (3.4%), indicating that atogepant is well tolerated for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability results of atogepant for the preventive treatment of episodic migraine from a 40-week, open-label multicenter extension of the phase 3 ADVANCE trial. Klein, BC., Miceli, R., Severt, L., et al.[2023]

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 3 trial involving 910 adults with episodic migraine, atogepant (30 mg and 60 mg) significantly improved patient-reported outcomes, including quality of life and daily activity performance, compared to placebo over 12 weeks.

Atogepant demonstrated clinically meaningful improvements in the Migraine-Specific Quality-of-Life Questionnaire and Activity Impairment in Migraine-Diary scores, indicating its efficacy as a preventive treatment for migraines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Atogepant for Preventive Migraine Treatment on Patient-Reported Outcomes in the Randomized, Double-blind, Phase 3 ADVANCE Trial. Lipton, RB., Pozo-Rosich, P., Blumenfeld, AM., et al.[2023]

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. 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 ...

3. 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% ...

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 ... Once daily, oral atogepant resulted in a significant decrease in mean monthly migraine days (MMDs) compared with placebo over 12 weeks (primary end point) in ...

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

Long-term safety, efficacy and functional outcomes of ... In this interim analysis, mean duration of atogepant exposure was 496.5 days. Treatment-emergent adverse events (TEAEs) occurred in 79.0% of ...

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. 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 ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT04961671

Efficacy, Safety, and Tolerability of Atogepant for the ... This study evaluated the efficacy, safety and tolerability of atogepant in participants with chronic migraine. This study included a 12-week treatment period.