Actively Recruiting
Emgality for Migraine in Breastmilk
Led by University of California, San Francisco · Updated on 2025-04-07
30
Participants Needed
1
Research Sites
109 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Emgality for Migraine in Breastmilk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- Aged between 18 and 45 years
- Established diagnosis of migraine
- Uncomplicated delivery with no long-term maternal complications
- Infant did not have a prolonged NICU stay longer than 3 nights
- Between 14 days and 9 months postpartum and still nursing at enrollment
- Planning to receive galcanezumab postpartum
- Suitable candidate for galcanezumab treatment postpartum as determined by a clinician
You will not qualify if you...
- Contraindications to breastfeeding, such as prior surgery or infant contraindications
- Contraindications to galcanezumab or lack of insurance coverage
- Use of gepants medications
- Moderately severe or severe depression with PHQ9 score of 15 or above
- Currently pregnant or planning pregnancy within the next 6 months
- Severe mastitis during the study
- Infants with severe medical issues including developmental problems, delivery complications, or on other medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
Research Team
A
Ayushi D Balan, BA, BS
CONTACT
S
Stephanie Hsu, BA
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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