Evaluating Emgality's effects on breastfeeding mothers with migraines
Official title: Prospective Evaluation of Emgality (Galcanezumab) in Breastmilk in Adult Women With Migraine
Run by University of California, San Francisco · NCT06085144 · Data updated 2026-11-12
This study is testing how a migraine medication called Emgality affects breast milk in nursing mothers and how it impacts their health and their babies' growth over the first year.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 30 (estimated) |
| Sponsor | University of California, San Francisco Academic / other |
| Drugs / interventions | galcanezumab |
| Locations | 1 site (San Francisco, California) |
| Status | Recruiting |
| Started | February 26, 2024 |
| Main results expected | April 2028 |
| Study ends | April 2028 |
| Registry record updated | August 11, 2026 |
| Trial ID | NCT06085144 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18-45 with a diagnosis of migraine who are between 14 days and 9 months postpartum and still nursing.
✕Probably not a fit
Patients who are not breastfeeding or have contraindications to breastfeeding or galcanezumab will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the transfer of galcanezumab, a medication for migraines, into the breastmilk of nursing mothers. It will involve collecting milk samples from 30 women aged 18-45 who are postpartum and experiencing migraines. The study will also evaluate the health outcomes of both mothers and their infants, including growth and development, over a period of up to 12 months. Participants will complete questionnaires and provide health records to help analyze the effects of the medication on breastfeeding.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety and effects of migraine treatment in breastfeeding mothers, potentially improving their quality of life.
How similar studies have gone: While studies on migraine treatments exist, this specific focus on breastfeeding and galcanezumab is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female * Childbearing age (18-45) * Established diagnosis of migraine * Status post uncomplicated delivery (no long-term maternal complications) * No prolonged (\>3 night) NICU stay for infant * Between 14 days and 9 months postpartum, and still nursing, at the time of enrollment * Planning to receive galcanezumab postpartum * Suitable candidate to receive galcanezumab postpartum, at discretion of prescribing clinician Exclusion Criteria: * Contraindications to breastfeeding, such as prior surgery or infant contraindications * Contraindications to galcanezumab or insurance coverage * Use of gepants * Moderately Severe or Severe Depression as established by the PHQ9 screen (i.e. score 15 or above) * Pregnant or planning pregnancy in the coming 6M * Patients with severe mastitis will not be enrolled; should mastitis occur during the study, this will be included as a covariate and results analyzed accordingly * Patients of infants with severe medical issues identified in the health record (developmental issues, delivery issues, concomitant medications)
Where it's running
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University of California, San Francisco
San Francisco, California, United States Recruiting
Study contacts
- Principal investigator: Riley Bove, MD, MSc — University of California, San Francisco
- Study coordinator: Ayushi D Balan, BA, BS
- Email: ayushi.balan@ucsf.edu
- Phone: 415-514-8330
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.