Status:
RECRUITING
Emgality for Migraine in Breastmilk
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Migraine
Eligibility:
FEMALE
18-45 years
Brief 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 f...
Detailed Description
Galcanezumab will be prescribed clinically by the treating clinician, i.e., no drug will be provided by the study. This treatment may be prescribed in several clinical scenarios: * Patient with estab...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 26 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06085144
Start Date
February 26 2024
End Date
April 1 2026
Last Update
April 7 2025
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94158