Emgality for Migraine in Breastmilk (NCT06085144)
Prospective Evaluation of Emgality (Galcanezumab) in Breastmilk in Adult Women With Migraine
🩺 Plain-English Summary (8th-Grade Level)
The goal of this project is to evaluate galcanezumab transfer into maternal breastmilk, and to evaluate infant (growth, development, constipation, colic, infections) and maternal (headache) outcomes for dyads in which the mother was treated with galcanezumab and to compare outcomes for infants who were or were not breastfed after maternal treatment. In this prospective observational study, the study team proposes to prospectively collect serial milk samples from 30 adult women who are treated with galcanezumab for migraine. Mothers who are interested in participating will be connected with us, the main clinical site, by neurologists across the USA. Mothers must carry a diagnosis of migraine, be aged 18-45 years, and be between 14 days and 9 months postpartum, and still nursing, at the time of enrollment. This study will fill a significant unmet need as women of childbearing potential are over-represented in the migraine population, and yet they are excluded from clinical trials of migraine treatments during pregnancy and lactation.
Who can join: Review the eligibility criteria below.
Location: University of California, San Francisco — San Francisco, California
Age range: 18 Years to 45 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- University of California, San Francisco — San Francisco, California
📞 Contact the Study Coordinator
Phone: (415) 514-8330
Email: ayushi.balan@ucsf.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Migraine
- A Study of Wearable Devices to Predict Migraines — Rochester, Minnesota
- Treatment for Migraine and Mood — The Bronx, New York
- Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine — Birmingham, Alabama
- A Study to Evaluate White Matter Hyperintensities in Migraine — Phoenix, Arizona
- Migraine Manager (R01) — Cincinnati, Ohio
- Nerivio Efficacy Under High-Frequency Use — Bridgewater, New Jersey
Explore by condition: All Migraine clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.