The EMBRACE Phase 4 trial showed erenumab 140 mg reduced monthly hours of moderate-to-severe headache pain by nearly 8 hours and significantly improved physical, social, and emotional functioning in 512 high-frequency migraine patients who had failed prior preventive treatments.
-7.95 hours moderate+ headache pain/monthErenumab reduced monthly hours of at least moderate headache pain by nearly 8 hours versus placebo, while also making breakthrough migraines shorter (-1.07 hours) and less intense (-0.48 on pain scale).
What the researchers found
In 512 randomized patients (erenumab 140 mg n=254, placebo n=256) over 3 months:
- Primary endpoint: Monthly hours of moderate-severe headache pain reduced by 7.95 hours vs. placebo (95% CI: -11.45 to -4.46, p<0.001)
- Functional impact (MFIQ): All four domains significantly improved vs. placebo (all p<0.001): physical functioning (-7.36), usual activities (-7.10), social functioning (-6.82), emotional functioning (-7.05)
- Breakthrough migraine attacks: Shorter duration at moderate+ pain intensity (-1.07 hours, p=0.013) and lower peak pain intensity (-0.48, p=0.011)
- Safety: Grade 3 adverse events 1.6% vs 1.2% placebo; no grade 4 or fatal events
- Study conducted at 61 sites across North America and Europe (2020-2023)
Why it matters
This study fundamentally shifts how we measure migraine treatment success. Rather than just counting headache days (which treats all migraines equally), EMBRACE measured what matters most to patients: how long they suffer, how bad it gets, and whether they can function at work, socially, and emotionally. The results show erenumab doesn't just prevent some migraines — it also makes the ones that break through shorter and less severe, providing a more complete picture of treatment benefit. This approach could change how future migraine drugs are evaluated.
How the study worked
EMBRACE was a Phase 4, interventional, double-blind, randomized, placebo-controlled, multicenter global study conducted at 61 sites in North America and Europe from September 2020 to October 2023. Adults with high-frequency episodic migraine (8-14 monthly migraine days) and at least one failed prior preventive treatment were randomized to erenumab 140 mg or placebo subcutaneously once monthly for 4 months. The primary endpoint was change in monthly hours of moderate-to-severe headache pain (months 1-3). Secondary endpoints included functional impact (MFIQ four domains), breakthrough migraine duration and intensity. Only patients with at least one qualifying triptan-treated attack at baseline were included.
What this study cannot tell us
The 4-month treatment period is relatively short for a chronic condition; longer studies would assess durability. Only erenumab 140 mg was tested (not the 70 mg dose). The study enrolled only patients with high-frequency episodic migraine (8-14 days/month), so results may not apply to chronic migraine (≥15 days/month) or lower-frequency patients. The requirement for a qualifying triptan-treated attack at baseline may have selected for patients with a specific migraine profile. The study was conducted during the COVID-19 pandemic (2020-2023), which may have affected patient behavior and reporting.
How to read the evidence
This is a Phase 4 (post-approval) randomized, double-blind, placebo-controlled trial with 512 patients across 61 international sites — representing high-quality clinical evidence. The large sample, rigorous design, and novel endpoints provide robust evidence for erenumab's holistic benefit in treatment-resistant migraine.
When this study was published
Published in 2026 (study conducted 2020-2023), this is a very current Phase 4 study adding to the post-market evidence base for erenumab (Aimovig), which has been approved since 2018.
The bigger picture
Erenumab was the first FDA-approved anti-CGRP monoclonal antibody for migraine prevention (2018), and the CGRP-targeting drug class has transformed migraine care. This Phase 4 study addresses a gap that remained even after approval: understanding the full scope of benefit beyond simple headache day counts. The EMBRACE results are particularly relevant for the treatment-resistant population — patients who have failed other preventives often feel marginalized, and this study validates that CGRP-targeted therapy provides meaningful, measurable improvement in their quality of life.
Questions still open
- Should regulatory agencies adopt pain duration and functional impact as co-primary endpoints for migraine drug approval?
- How does erenumab's holistic benefit compare to other anti-CGRP drugs (fremanezumab, galcanezumab) using these same measures?
- Does the improvement in breakthrough migraine characteristics translate to reduced need for acute migraine medications?
Common questions
What is erenumab and how does it prevent migraines?
How is this study different from earlier erenumab trials?
Read the original research
Comprehensive assessment of erenumab efficacy in participants with high-frequency episodic migraine with at least one previously failed preventive treatment: The EMBRACE study.
Headache, 66(3), 658-671
Citation
Paiva da Silva Lima, Gabriel; Rao, Renata; Szabó, Gyöngyi; Szklener, Sebastian; Tassorelli, Cristina; Nastaj, Marcin; Chou, Denise E; Khodavirdi, Ani C; Chehrenama, Mahan; Zhu, Yineng; Bhatia, Ajay K; Dodick, David W. (2026). Comprehensive assessment of erenumab efficacy in participants with high-frequency episodic migraine with at least one previously failed preventive treatment: The EMBRACE study.. Headache, 66(3), 658-671. https://doi.org/10.1111/head.15071