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Effectiveness and Tolerability of Atogepant (Qulipta) in the Prevention of Migraine

Posted on April 23 2025, By: Cerebral Torque

Effectiveness and Tolerability of Atogepant in the Prevention of Migraine

The STAR study: A real-life, prospective, multicentric evaluation of atogepant for migraine prevention in clinical practice
Published in Cephalalgia | April 2025

Study Overview

The STAR study (Effectiveness and Tolerability of Atogepant in the Prevention of Migraine: A Real Life, Prospective, Multicentric Study) evaluated the effectiveness, safety, and tolerability of atogepant 60 mg daily as a preventive treatment for both episodic migraine (EM) and chronic migraine (CM) in real-world clinical practice across 10 Italian centers.

106
Study Participants
106 patients completed the 12-week observation, with 87.7% female participants and an average age of 50.6 years.
52.8%
Chronic Migraine
56 of 106 patients (52.8%) had chronic migraine, while the remaining 47.2% had episodic migraine.
60 mg
Atogepant Dosage
All patients received atogepant 60 mg once daily, the standard therapeutic dose.

Key Findings

  • Significant reduction in monthly migraine days across both EM and CM patients
  • Over half of patients (56.6%) achieved ≥50% reduction in monthly migraine days
  • Effectiveness observed even in patients who had previously failed anti-CGRP monoclonal antibodies
  • Low discontinuation rate (6.6%) indicating good tolerability
  • First real-world evidence for atogepant's effectiveness in a clinical practice setting

Study Design & Patient Characteristics

The STAR study was designed as a real-world, prospective, multicenter trial evaluating atogepant in patients with a clinical indication for migraine prevention. Participants were enrolled regardless of the number of prior ineffective or non-tolerated preventive treatments, reflecting actual clinical practice conditions.

Patient Baseline Characteristics
Female Participants 87.7%
Mean Age 50.6 years
Monthly Migraine Days (baseline) 17.6 days
Medication Overuse 57.5%
Previous Anti-CGRP mAb Treatment 52.8%
Previous OnabotulinumtoxinA 40.6%
Prior Treatment History

Many participants had previously received multiple migraine preventive treatments without adequate response:

Median Prior Preventive Failures 4 treatments
Prior Erenumab Use 39.6%
Prior Galcanezumab Use 21.7%
Prior Fremanezumab Use 9.4%
Concomitant Preventive Treatments 34.9%
"This resistant (in some cases, refractory) population nevertheless benefitted from atogepant treatment, at least in the short term."

Primary Outcomes & Efficacy Results

The study evaluated two co-primary endpoints: (1) changes in monthly migraine days (MMDs) after 12 weeks of treatment compared to baseline, and (2) the percentage of Responders - patients who achieved a ≥50% reduction in MMDs.

Monthly Migraine Day Reduction
Overall Reduction -6.9 days
Episodic Migraine -4.9 days
Chronic Migraine -8.6 days
56.6%
≥50% Response Rate
Overall, 60 of 106 patients (56.6%) achieved at least a 50% reduction in monthly migraine days.
31.1%
≥75% Response Rate
Nearly one-third of patients achieved a 75% or greater reduction in monthly migraine days.
6.6%
100% Response Rate
Some patients experienced complete freedom from migraine during the treatment period.

Response by Migraine Type

  • Episodic Migraine: 60.0% achieved ≥50% reduction
  • Chronic Migraine: 46.4% achieved ≥50% reduction
  • 58.9% of patients with chronic migraine at baseline reverted to episodic migraine
  • The proportion of patients with chronic migraine decreased from 52.8% to 31.1%
"The MMD reductions from baseline to week 12 were slightly larger than those observed in the atogepant RCTs... These findings should be evaluated in light of the previous failure of anti-CGRP mAbs beyond a mean of four SOC treatment failures in 52.8% of patients."

Secondary Outcomes

Beyond the primary endpoints, the study evaluated multiple secondary outcomes including medication use, disability measures, and patient-reported quality of life.

Medication Use
Monthly Acute Medications (baseline) 16.3
Monthly Acute Medications (12 weeks) 8.8
Medication Overuse (baseline) 57.5%
Medication Overuse (12 weeks) 31.1%
Disability & Quality of Life
MIDAS Score (baseline) 69.1
MIDAS Score (12 weeks) 28.4
ASC-12 Score (baseline) 6.2
ASC-12 Score (12 weeks) 3.8
MSQ Score (baseline) 41.8
MSQ Score (12 weeks) 66.6

Patient Global Impression of Change

The PGIC questionnaire assessed patients' perception of their improvement after 12 weeks:

  • 50.9% reported feeling "much better" or "very much better"
  • 66.0% reported at least a noteworthy improvement
  • Only 13.2% reported no change or worsening of their condition

Safety & Tolerability

Atogepant demonstrated a favorable safety and tolerability profile in this real-world setting, with a low discontinuation rate despite the inclusion of patients with prior treatment failures.

Adverse Events
Patients Reporting AEs 44.3%
Constipation 25.5%
Decreased Appetite 16.0%
Nausea 15.0%
Fatigue 6.6%
Treatment Discontinuation 6.6%

Weight Change

An interesting finding was the impact on body weight:

  • Mean reduction of 1 kg from baseline (p < 0.001)
  • Consistent with previous clinical trial observations
  • Potentially related to atogepant's action on CGRP receptors in adipose tissue
"The very low discontinuation rate (6.6%) was equally high for those patients who stopped the therapy due to a lack of effectiveness. This point is of pivotal importance because the low discontinuation rate makes a substantial difference from oral SOC preventive therapies."

Conclusions & Clinical Implications

The STAR study provides the first real-world evidence of atogepant's effectiveness in preventing episodic and chronic migraine in clinical practice. Its results largely confirm or even exceed those observed in randomized controlled trials.

Key Conclusions

  • Atogepant 60 mg daily is effective for both episodic and chronic migraine prevention in real-world settings
  • Benefits are observed even in patients who previously failed other preventive treatments, including anti-CGRP monoclonal antibodies
  • The medication is well-tolerated with a low discontinuation rate
  • Significant improvements were observed in disability scores and quality of life measures
  • The reduction in medication overuse represents an important clinical benefit
"The STAR study demonstrates atogepant effectiveness in real life, observing migraine frequency reduction and patients' reported outcome measures improvement. Moreover, we point out that 43% of hard-to-treat patients resistant to previous anti-CGRP mAbs treatment benefitted from atogepant after only 12 weeks."

These findings suggest that atogepant represents a valuable addition to the migraine prevention armamentarium, offering an effective option for patients who have not responded adequately to other treatments, including anti-CGRP monoclonal antibodies. The oral administration, good tolerability profile, and effectiveness across both episodic and chronic migraine make it a potentially important therapeutic approach in clinical practice.

Vernieri, F., Iannone, L.F., Lo Castro, F., Sebastianelli, G., De Santis, F., Corrado, M., Marcosano, M., Ornello, R., Grazzi, L., Montisano, D.A., De Cesaris, F., Munafò, A., Fofi, L., Doretti, A., Vaghi, G., Pistoia, F., Ferrandi, D., Battistini, S., Sacco, S., Guerzoni, S., Altamura, C. (2025). Effectiveness and tolerability of atogepant in the prevention of migraine: A real life, prospective, multicentric study (the STAR study). Cephalalgia, 45(4), 1-14. https://doi.org/10.1177/03331024251335927

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