Emgality for Migraine in Breastmilk
Recruiting · NCT06085144 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of California, San Francisco
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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)
Where it is running
1 location listed across 1 US state.
- University of California, San Francisco - San Francisco, California, United States