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Emgality for Migraine in Breastmilk

NCT06085144 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-04-07

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Galcanezumab

Receiving either 120mg or 300mg injections.

Sponsors & Collaborators

Principal Investigators

  • Riley Bove, MD, MSc · University of California, San Francisco

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-26
Primary Completion
2026-04-30
Completion
2026-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06085144 on ClinicalTrials.gov