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These trials anchor their findings in patient-reported outcomes (PROs) that reflect not just how often migraines strike, but how they feel and disrupt daily life. For example, ADVANCE/PROGRESS/ELEVATE (RCTs) prioritized migraine-specific tools like the MSQv2.1 and AIM-D, which track functional limitations (e.g., missed workdays, emotional strain) in structured intervals. ELEVATE, which enrolled patients with multiple prior treatment failures, used AIM-D as a co-primary endpoint to quantify physical impairment and daily activity loss in refractory cases. Meanwhile, CAPTURE, an observational study, extended this lens into real-world settings, pairing PROs like WPAI:Migraine (work productivity) with longitudinal data to map how migraines destabilize routines outside clinical trial controls.
In the following Q&A, a trio of migraine specialists—Karen Carr, Ph.D., Jessica Ailani, MD, FAHS; and Dr. Patricia Pozo-Rosich, MD, Ph.D.—share their expertise on atogepant and its role in migraine prevention, and its potential to and its potential to improve daily functioning and quality of life across the migraine spectrum.

Graphsf found in “Effect of preventive treatment with atogepant on quality of life, daily functioning, and headache impact across the spectrum of migraine: Findings from three double-blind, randomized, phase 3 trials” from Gottschalk et al., 2023
Q&A with Karen Carr
Meet the experts
1. Karen Carr, Ph.D.
- Role: Scientific Director, Migraine, International Medical Affairs at AbbVie
- Focus: Discusses clinical trials (CAPTURE, ELEVATE, PROGRESS, ADVANCE) and the real-world impact of migraine therapies
2. Dr. Jessica Ailani, MD FAHS
- Role: Director, Georgetown Headache Center
- Disclosures:
- Consulting (Honoraria): AbbVie, Aeon, Dr. Reddy, Eli-Lilly, Lundbeck, Linpharma, Ipsen, Merz, Pfizer, Neurolief, Gore, Satsuma, Scilex, Vectura Fertin, Theranica, Tonix
- Clinical Trials (Grant to institution): Parema (2024), Ipsen, Lundbeck, AbbVie, Pfizer
- Clinical Trials (Grants to PI): Mi-Helper
- Editorial Boards/Steering Committee: SELF magazine (medical editor)
3. Dr. Patricia Pozo-Rosich, MD, Ph.D.
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- Role: Neurology Department, Vall d’Hebron University Hospital, Headache & Neurological Pain Research Group, VHIR, Barcelona, Spain
- Focus: Discusses safety data from trials (ELEVATE, PROGRESS) and insights from long-term extension studies
Various Trials (CAPTURE, ELEVATE, PROGRESS, ADVANCE) – Subgroup Variations
Q: In these trials, we see consistent reductions in monthly headache/migraine days (MHDs/MMDs). Could you discuss how those reductions vary by patient subgroup (low-frequency episodic vs. high-frequency episodic vs. chronic), and what clinicians should focus on when interpreting differences across trials?
Karen Carr: Migraine is a dynamic neurological disease. These studies capture a snapshot of migraine at a certain point in a patient’s life. What we don’t know is what will happen to a person’s migraine next year, or what happens when someone with migraine makes a lifestyle change like getting a new job or starting holistic life changes to also improve a comorbid condition. Frequency of monthly migraine and monthly headache days are a way we can quantify migraine, but there are many more ways migraine impacts people which is not measured by just MHD/MMD. For example, understanding the impact on the patient’s ability to function, or improvement in quality of life is necessary to fully understand the impact of a preventive treatment.
AbbVie-Sponsored Migraine Research – Next-Generation Therapies
Q: How do cross-species binding data and real-world findings shape your vision for next-generation migraine therapies?
Karen Carr: Real-world findings are essential to understand effectiveness and tolerability of migraine treatments. We also gain important learnings, like what do patients prefer? How do they like to use their medications? What decisions are driving them to get treatments from their providers? Understanding the migraine patient experience is crucial when designing migraine trials. Cross-species binding data gives us important science behind how our treatments work and often can give us new insights into the pathophysiology underlying migraine.
Clinical Implementation and Shared Decision-Making
Q: How do you foresee clinicians integrating atogepant into everyday practice—especially regarding optimal timing, patient education, and follow-up?
Karen Carr: Atogepant is in a tablet form and is dosed daily with or without food. Atogepant can be taken the same time every day at a time preferred by the patient. Patients should discuss their specific treatment and dosing options with their healthcare provider in order to find out if atogepant is the right medication for their migraine. For more details, please see the full prescribing information for your specific country.
Q: Are there specific decision aids, digital tools, or educational resources that could facilitate shared decision-making and help patients understand treatment goals, adherence strategies, and the expected trajectory of symptom improvement with atogepant?
A (Karen Carr): There are helpful resources on the European Migraine & Headache Alliance (EMHA) website and on the National Headache Foundation (NHF) website.
Tracking all symptoms across all migraine phases is important for understanding a treatment’s impact on migraine.

From the poster titled “Contemporary Prospective Understanding of Migraine Real-world Evidence (CAPTURE): Baseline Clinical Characteristics”
Dr. Jessica Ailani, MD FAHS, Director, Georgetown Headache Center
Disclosures:
- Dr. Jessica Ailani: Consulting (Honoraria): Abbvie, Aeon, Dr. Reddy, Eli-Lilly, Lundbeck, Linpharma, Ipsen, Merz, Pfizer, Neurolief, Gore, Satsuma, Scilex, Vectura Fertin, Theranica, Tonix
Clinical Trials (Grant to institution): Parema (2024), Ipsen, Lundbeck, Abbvie, Pfizer
Clinical Trials (Grants to PI): Mi-Helper
Editorial Boards/Steering Committee: SELF magazine (medical editor)
Gottschalk et al. (Cephalalgia 2024) – HFEM and PROMs
Q: Statistically significant differences in MSQv2.1 and HIT-6 responder rates favoring atogepant over placebo were seen in the overall population and most subgroups, but did not reach significance in HFEM within ADVANCE. Given the authors’ suggestion that LFEM/HFEM analyses may be underpowered, what further research is needed to shed light on efficacy specifically for HFEM patients in terms of patient-reported outcomes—especially given the risk of progression to chronic migraine in this group?
Dr. Jessica Ailani, MD, FAHS: This is a great question. In order to study this further, the group may need to consider a separate study specifically looking at HFEM and following these patients. This can be done looking at real world data and seeing how patients with HFEM in clinical practice do when starting Atogepant vs. not starting treatment and following progression over time.
Q: How can findings on PROMs be used for a more personalized approach?
Dr. Jessica Ailani, MD, FAHS: PROMs allow clinicians to see what is important to patients and use that in discussion with their own patients when relaying data- if a study shows that atogepant improved function in patients over placebo, this can be relayed to patient in clinic stating that “in studies, people taking Atogepant felt more functional than those not on Atogepant and this was seen as soon as the first few weeks of starting treatment.” This can be very valuable to patients.
Blumenfeld et al. have suggested real-world addition of atogepant to OnabotA
Q: This retrospective chart review suggests that adding atogepant to onabotulinumtoxinA provides further decreases in monthly migraine days. From a clinical or mechanistic standpoint, what do you find most compelling about this synergy?
Dr. Jessica Ailani, MD, FAHS: Clinically, layering of treatments in patients with chronic migraine is important- as we aim for the greatest reduction of migraine frequency and disability. Having continued evidence that layering treatments with complementary mechanism of action helps prove what we do clinically is scientifically sound and valid. It also aids conversations with patients- allowing us to set expectations in regards to outcomes.
Q: How do these real-world data compare with or supplement insights from prospective trials or long-term extension studies?
Dr. Jessica Ailani, MD, FAHS: We do not have any prospective trials in humans combining OnabotulinumtoxinA and Atogepant, so these real world studies are extremely important to aid in clinical practice and improve our knowledge base. This adds to our knowledge base on combination treatments and shows a potentially higher reduction of migraine days when combining OnabotulinumtoxinA and Atogepant compared to OnabotulinumtoxinA and CGRP mAbs. Further studies are needed to see if this data can be replicated.
Q: Finally, how might these findings shape future research on combination approaches for chronic migraine?
Dr. Jessica Ailani, MD, FAHS: These findings help us understand why complimentary mechanisms of action treatments are effective in improving outcomes in patients who are highly impacted by their disease process and how they can be safely used. It also allows us to understand what expectations can be discussed with patients about disease improvement.
Multiple Trials (AIM-D, MSQv2.1, HIT-6 Data) – QoL and PROMs
Q: Several analyses reveal substantial gains in patient-reported measures like AIM-D, MSQv2.1, and HIT-6. Which of these metrics best captures real-world impact, and have you seen benefits for subpopulations—such as those with multiple prior preventive failures—in terms of daily functioning or emotional well-being?
Dr. Jessica Ailani, MD, FAHS: It is important to realize that QoL and PROMs are generally important measures when evaluating migraine treatment. I feel different clinicians each have their favorites. I personally continue to be impressed with AIM-D, though it has only been used in AbbVie trials and has not been used in clinical practice, I find that it is easy as a clinician to interpret and see change. I also have found MSQ to be very easy to understand and show change in trials and it has quickly become an outcome measure I look at in migraine clinical trials. Both these outcomes can be easily relayed to patients in clinical settings- “when you start treatment A, it can significantly improve physical and emotional functioning and reduce fatigue.” Patients understand this and can better understand the value of preventive treatment when it is discussed beyond the reduction of headache days.
Dr. Patricia Pozo-Rosich MD PhD
Neurology Department, Hospital Universitari Vall d’Hebron
Safety Data (ELEVATE, PROGRESS, Extensions) – AE Profiles
Q: GI-related events appear to be the most common side effects of atogepant mentioned in these studies. Have you observed any differences in adverse-event profiles or discontinuation rates when atogepant is combined with other preventives (onabotA, topiramate)?
Dr. Patricia Pozo-Rosich MD PhD: We have not observed any difference in the adverse-event profiles or discontinuation rates when Atogepant is combined with other preventives (onabotA, topiramate).
Q: What further safety or tolerability evidence do you imagine would help guide clinical decisions?
Dr. Patricia Pozo-Rosich MD PhD: Real-world evidence, can be a valuable resource in helping HCPs make informed clinical decisions for patients. HCPs need data from both randomized and real-world studies to best inform clinical decisions, as real-world data helps HCPs better understand how a treatment will perform in real life, outside of a controlled clinical environment.
Pozo-Rosich et al. (EHC 2024 Poster) – 156-Week Extension Study
Q: These interim analyses show sustained improvements in migraine frequency through Week 48 and beyond. How do you see these long-term data informing clinical practice?
Dr. Patricia Pozo-Rosich MD PhD: Long-term analyses show that patients are willing to continue treatment over time. Extension studies, like this one, provide clinicians with more information on the long-term side effects, helping to inform their decision when prescribing treatments for patients.
Q: Are there timepoints (Week 48 vs. Week 52) or sub-outcomes (e.g., ≥75% or 100% reduction in MMDs) that physicians should focus on when reviewing the trial results?
Dr. Patricia Pozo-Rosich MD PhD: The majority of participants who initially experienced clinically meaningful improvements in migraine frequency with atogepant sustained these benefits over 48 weeks, affirming its long-term efficacy and helping HCPs better inform decisions around long term treatment for patients.
Filed Under: Neurological Disease