Add-on atogepant 60 mg daily reduced monthly migraine days in chronic migraine patients on stable onabotulinumtoxinAAdding atogepant to botulinum toxin reduced migraine days in a small study

Cephalalgia : an international journal of headache Published April 18, 2026 Study authors: Rothrock John, Najib Umer, Ailani Jessica, Ashina Sait, Bao Jia, Smith Jonathan H, Adams Aubrey M, D… PubMed ↗ NCT05216263 ↗ DOI ↗ Editorial oversight: Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development

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Key Takeaway

Consider add-on atogepant 60 mg daily for chronic

This Phase 3, multicenter, 24-week, open-label, single arm study enrolled 75 participants with chronic migraine who were on a stable dose of onabotulinumtoxinA (155-200U) with baseline mean monthly migraine days (MMDs) of 8-23. The intervention was add-on atogepant 60 mg once daily, with no comparator group reported. The study assessed changes in MMDs, mean monthly headache days (MHDs), and responder rates over 24 weeks.

Regarding efficacy, the least squares mean change from baseline of MMDs was -6.45 MMDs at Weeks 1-4 (95% CI: -7.7, -5.1), -6.89 MMDs across Weeks 1-12 (95% CI: -8.1, -5.6), and -7.20 MMDs across Weeks 13-24 (95% CI: -8.4, -5.9). For MHDs, the reductions were -6.57 MHDs at Weeks 1-4 (95% CI: -7.8, -5.3), -7.33 MHDs across Weeks 1-12 (95% CI: -8.6, -6.0), and -8.15 MHDs across Weeks 13-24 (95% CI: -9.4, -6.8). Responder rates for ≥50% reduction in MMD were 54.2% at Weeks 1-12 and 61.9% at Weeks 13-24. For ≥75% reduction, rates were 30.6% at Weeks 1-12 and 38.1% at Weeks 13-24.

Safety and tolerability showed treatment-emergent adverse events (TEAEs) in 65.3% of participants (n=75). TEAEs occurring in ≥5% included constipation (n=12, 16.0%), nausea (n=10, 13.3%), and urinary tract infection (n=6, 8.0%). Two participants (2.7%) discontinued due to an adverse event, and two participants experienced treatment-emergent serious adverse events (TESAEs), neither considered treatment-related. The study notes that combining treatments with distinct and complementary mechanisms may benefit suppression of chronic migraine. Limitations include the open-label design and lack of a control group, which precludes definitive causal conclusions regarding efficacy.

Researchers conducted a 24-week study involving 75 people who had chronic migraine and were already taking botulinum toxin injections. These participants added atogepant, taken once daily, to their existing treatment plan. The goal was to see if combining these two different types of medicines would further reduce the number of migraine and headache days.

During the study, participants experienced an average reduction in monthly migraine days. By the end of the 24 weeks, about 62% of people saw at least a 50% reduction in their migraine days. Headache days also decreased steadily over the course of the trial. Most participants reported that the treatment was safe and generally well-tolerated.

Some side effects were noted, with constipation, nausea, and urinary tract infections occurring in about 8% to 16% of people. Only two participants stopped the drug because of side effects. However, because this was a small study with only one group of patients, the results should be viewed as promising but not yet definitive. More research is needed to confirm these findings in larger groups.

What this means for you:

Adding atogepant to botulinum toxin reduced migraine days in a small 24-week study, though larger trials are needed.

Study Details

Study typePhase3

Sample sizen = 75

EvidenceLevel 2

Follow-up5.5 mo

PublishedJun 2026

PMID41944477

TrialNCT05216263

View Original Abstract ↓

Status: COMPLETED | Phase: PHASE3 Condition(s): Chronic Migraine Intervention(s): Atogepant (DRUG) Migraine is characterized by attacks of throbbing, moderate or severe headache, often associated with nausea, vomiting, and/or sensitivity to light and/or sound. The study will assess safety and tolerability of atogepant when added to BOTOX, as well as prospectively evaluate the efficacy of add-on atogepant for migraine prevention. Adverse events and change in disease activity will be monitored. Atogepant is an investigational drug being developed to prevent chronic migraine. Approximately 75 adult participants will be enrolled at approximately 30 sites in the United States. All participants will receive atogepant oral tablet once a day (QD) during the 24-week treatment period, in addition to their standard of care Botox. 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 effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Primary Outcome(s): Number of Participants With Adverse Events (AEs); Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator; Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Enrollment: 75 (ACTUAL) Lead Sponsor: AbbVie Start: 2022-03-22 | Primary Completion: 2025-05-02 Results posted: 2026-06-16

Add-on atogepant 60 mg daily reduced monthly migraine days in chronic migraine patients on stable onabotulinumtoxinAAdding atogepant to botulinum toxin reduced migraine days in a small study

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Add-on atogepant 60 mg daily reduced monthly migraine days in chronic migraine patients on stable onabotulinumtoxinAAdding atogepant to botulinum toxin reduced migraine days in a small study

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