RecruitingNCT06085144

Emgality for Migraine in Breastmilk

Prospective Evaluation of Emgality (Galcanezumab) in Breastmilk in Adult Women With Migraine


Sponsor

University of California, San Francisco

Enrollment

30 participants

Start Date

Feb 26, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Galcanezumab for people with migraine. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGalcanezumab

Receiving either 120mg or 300mg injections.


Locations(1)

University of California, San Francisco

San Francisco, California, United States

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NCT06085144


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