NCT04252742: EMBRACE

Erenumab - Comprehensive Assessment of Efficacy in (High-Frequency) Episodic Migraine

Completed Phase 4 Results posted Last updated 31 March 2026

What this trial tests

Phase 4 trial testing Erenumab in Migraine in 512 participants. Completed in 26 October 2023.

Timeline

15 September 2020

Primary endpoint
26 October 2023

26 October 2023

Quick facts

Lead sponsor	Amgen
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	512
Start date	15 September 2020
Primary completion	26 October 2023
Estimated completion	26 October 2023
Sites	91 locations across Italy, Hungary, Poland, Romania, Bulgaria, Portugal, United States, Spain

Drugs / interventions tested

• Erenumab (ERENUMAB) — full drug profile →
• Placebo

Conditions studied

• Migraine — all drugs for Migraine →

Sponsor

Amgen — full company profile →

Who can join

18 and older, any sex, with Migraine. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Mean Monthly Hours of at Least Moderate Headache Pain Intensity Over Months 1, 2, and 3 Primary · Baseline, Month 1, Month 2, and Month 3

At least moderate headache pain intensity was defined as headache pain intensity reported as 'Moderate' or 'Severe' based on the 3-level headache pain intensity scale. Worst or peak pain intensity during a headache was collected using the e-diary in 3-levels (mild, moderate or severe). The duration of headaches with at least moderate pain intensity was collected. A negative change from baseline indicates a reduction in mean monthly hours of at least moderate headache pain intensity. Change from baseline in mean monthly measurement is the arithmetic mean of the monthly change from baseline valu

Group	Value	95% CI
Placebo	-23.38	± 1.26
Erenumab 140 mg SC Q4W	-31.33	± 1.25

Change From Baseline in Mean Monthly Physical Function Domain Score as Measured by the Migraine Functional Impact Questionnaire (MFIQ) Over Months 1, 2, and 3 Secondary · Baseline, Month 1, Month 2, and Month 3

The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning including on Physical Functioning (5 items). Participants responded to items using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. Each domain score was calculated as the sum of the item responses and rescaled to a 0 to 100 scale, with higher scores representing greater burden. The recall period was the past 7 days. A negative change from baseline indicates an improvement in burden. Change from baseline in mean monthly scores is the arithmetic mean of

Group	Value	95% CI
Placebo	-22.92	± 1.25
Erenumab 140 mg SC Q4W	-30.28	± 1.23

Change From Baseline in Mean Monthly Usual Activities Domain Score as Measured by the MFIQ Over Months 1, 2, and 3 Secondary · Baseline, Month 1, Month 2, and Month 3

The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning including Impact on Usual Activities (10 items). Participants responded to items using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. Each domain score was calculated as the sum of the item responses and rescaled to a 0 to 100 scale, with higher scores representing greater burden. The recall period was the previous 7 days. A negative change from baseline indicates an improvement in burden. Change from baseline in mean monthly scores is the arithmetic

Group	Value	95% CI
Placebo	-23.98	± 1.17
Erenumab 140 mg SC Q4W	-31.08	± 1.16

Change From Baseline in Mean Monthly Emotional Functioning Domain Score as Measured by the MFIQ Over Months 1, 2, and 3 Secondary · Baseline, Month 1, Month 2, and Month 3

The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning including Impact on Emotional Functioning (5 items). Participants responded to items using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. Each domain score was calculated as the sum of the item responses and rescaled to a 0 to 100 scale, with higher scores representing greater burden. The recall period was the previous 7 days. A negative change from baseline indicates an improvement in burden. Change from baseline in mean monthly scores is the arithm

Group	Value	95% CI
Placebo	-22.77	± 1.34
Erenumab 140 mg SC Q4W	-29.83	± 1.33

Change From Baseline in Mean Monthly Social Functioning Domain Score as Measured by the MFIQ Over Months 1, 2, and 3 Secondary · Baseline, Month 1, Month 2, and Month 3

The MFIQ is a self-administered 26-item instrument measuring the impact of migraine on broader functioning including Impact on Social Functioning (5 items). Participants responded to items using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. Each domain score was calculated as the sum of the item responses and rescaled to a 0 to 100 scale, with higher scores representing greater burden. The recall period was the previous 7 days. A negative change from baseline indicates an improvement in burden. Change from baseline in mean monthly scores is the arithmeti

Group	Value	95% CI
Placebo	-25.05	± 1.28
Erenumab 140 mg SC Q4W	-31.87	± 1.27

Change From Baseline in Mean Monthly Average Duration of at Least Moderate Headache Pain Intensity in Migraine Attacks Occurring Over Months 1, 2, and 3 Secondary · Baseline, Month 1, Month 2, and Month 3

At least moderate headache pain intensity was defined as headache pain intensity reported as 'Moderate' or 'Severe' based on the 3-level headache pain intensity scale. Worst or peak pain intensity during a headache was collected using the e-diary in 3-levels (mild, moderate or severe). The duration of headaches with at least moderate pain intensity during a migraine attack was collected. A negative change from baseline indicates a reduction in mean monthly average duration of at least moderate headache pain intensity during a migraine attack. Change from baseline in mean monthly measurement is

Group	Value	95% CI
Placebo	-2.78	± 0.31
Erenumab 140 mg SC Q4W	-3.86	± 0.30

Change From Baseline in Mean Monthly Average Peak Migraine Pain Intensity as Assessed by the 11-point Numeric Rating Scale (NRS) Over Months 1, 2, and 3 Secondary · Baseline, Month 1, Month 2, and Month 3

The NRS assesses headache pain intensity ranging from 0 to 10 with a higher score indicating more severe pain. Participants recorded the pain intensity using the e-diary at the headache end-time or in an evening diary entry on a daily basis for an ongoing headache. A negative change from baseline indicates an improvement in pain intensity. Change from baseline in mean monthly scores is the arithmetic mean of the monthly change from baseline values for the months considered with observed data, if there was at least one observed monthly value. The LSM estimates utilized a linear mixed model whi

Group	Value	95% CI
Placebo	-1.48	± 0.13
Erenumab 140 mg SC Q4W	-1.96	± 0.13

Adverse events — posted to ClinicalTrials.gov

Time frame: Day 1 to end of the DBTP (up to 16 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 2/256 (1%)

Deaths: 0/256

Erenumab 140 mg SC Q4W

Serious: 0/254 (0%)

Deaths: 0/256

Serious adverse events (2 terms)

Reaction	System	Placebo	Erenumab 140 mg SC Q4W
COVID-19 pneumonia	Infections and infestations	—	—
Psychogenic tremor	Psychiatric disorders	—	—

Most-reported serious reactions: COVID-19 pneumonia, Psychogenic tremor.

Data from ClinicalTrials.gov NCT04252742 adverse events section.

Sponsor's own description

The primary objective of this study is to evaluate the treatment benefit of erenumab on headache duration of at least moderate pain intensity.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Migraine Prevention with Erenumab: Focus on Patient Selection, Perspectives and Outcomes.
   De Matteis E, Sacco S, Ornello R. · · 2022 · cited 5× · PMID 35411146 · DOI 10.2147/tcrm.s263825
2. Neuro-Immune Crosstalk: Molecular Mechanisms, Biological Functions, Diseases, and Therapeutic Targets.
   Guo X, Liu H, Song YJ, Wang JH, et al · · 2026 · cited 2× · PMID 41583906 · DOI 10.1002/mco2.70497
3. Comprehensive assessment of erenumab efficacy in participants with high-frequency episodic migraine with at least one previously failed preventive treatment: The EMBRACE study.
   Paiva da Silva Lima G, Rao R, Szabó G, Szklener S, et al · · 2026 · PMID 41084999 · DOI 10.1111/head.15071