Neurology ·
Three-year open-label study reports sustained atogepant outcomes in migraine
A 156-week open-label extension followed adults with chronic or episodic migraine who had previously responded inadequately to two to four classes of conventional preventive treatments. Among 595 treated participants, safety findings were consistent with the known profile of atogepant, and improvements in migraine and functional outcomes were maintained.
- 595 participants received atogepant for up to 156 weeks
- 63.2% completed the open-label treatment period
- No serious adverse events were judged related to atogepant
- Migraine and functional improvements were maintained
This phase 3, open-label extension study assessed atogepant 60 mg once daily for 156 weeks in adults with chronic or episodic migraine who completed the PROGRESS or ELEVATE lead-in trials. Participants had a prior inadequate response to two to four classes of conventional oral, non-migraine-specific preventive treatments. Safety and tolerability were the primary outcomes; efficacy and functional measures were exploratory. Of 596 enrolled participants, 595 received treatment and 529 were included in the modified intention-to-treat population. Mean exposure was 808.1 days, and 63.2% completed the three-year treatment period.
Treatment-emergent adverse events occurred in 83.2%; the most common were COVID-19 (33.6%) and nasopharyngitis (15.5%). Serious adverse events occurred in 8.7%, with none considered related to atogepant. One death, attributed to asphyxia in a house fire, was reported. Adverse events led to treatment discontinuation in 6.7%. Three participants had alanine or aspartate aminotransferase levels at least three times the upper limit of normal; none met Hy’s Law criteria. Improvements in migraine and functional outcomes from the lead-in studies were maintained through week 156.
The findings provide long-term safety and outcome data in a population with prior treatment failures, but the extension was open-label and lacked a concurrent control group. Efficacy analyses were exploratory, and 36.8% did not complete the treatment period. Weight changes of at least 7% were reported in both directions, underscoring the need to interpret these outcomes in the context of the study design.
In practice
For adults with chronic or episodic migraine and prior inadequate response to two to four classes of conventional oral preventives, this extension adds long-term information on atogepant 60 mg once daily: improvements from the lead-in studies were maintained through 156 weeks, and no serious adverse events were considered treatment-related. These findings do not establish comparative effectiveness or prove sustained benefit versus control, because the extension was open-label and efficacy outcomes were exploratory. Attrition and reported weight changes also warrant consideration; the results alone do not justify a change in treatment practice.
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Cephalalgia: Three-year safety, tolerability, clinical efficacy, and functional outcomes of atogepant for the preventive treatment of migraine: Final results from a phase 3, open-label extension study ↗This is an automated AI-condensed summary that has not yet been reviewed by an editor. Always consult the full item at the original source.