Phase 3 ECLIPSE Trial: Atogepant in Acute Migraine Treatment

The phase 3 ECLIPSE trial showed that atogepant produced significantly higher rates of pain freedom at two hours versus placebo for the acute treatment of the first migraine attack, meeting its primary and multiple key secondary endpoints.

In this randomized, double‑blind, placebo‑controlled phase 3 study evaluating acute treatment across multiple qualifying attacks, atogepant’s proportion of patients achieving two‑hour pain freedom exceeded placebo—confirming the prespecified efficacy signal and supporting its potential role as an oral acute migraine option.

Key secondary outcomes—including sustained pain freedom and freedom from the most bothersome symptom at two hours, assessed across prespecified attacks—were met.

Safety findings aligned with prior atogepant experience; no new safety signals emerged in this acute‑treatment readout. Tolerability and adverse‑event profiles were consistent with earlier preventive‑treatment studies.

AbbVie has initiated engagement with the European Medicines Agency and is preparing a submission based on the ECLIPSE findings.

Key Takeaways:

• The ECLIPSE trial confirms atogepant’s superiority over placebo for two‑hour pain freedom.
• Adults with migraine seeking an effective oral acute therapy may gain an additional option.
• What changes next? AbbVie’s European submission will prompt regulator review and could lead to integration into clinical practice pending approval.