Prospective Evaluation of Emgality (Galcanezumab) in Breastmilk in Adult Women With Migraine
University of California, San Francisco
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.
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 established migraine history, treated with galcanezumab prior to pregnancy, who plans to resume the medication post partum * Patient with established migraine history, who experiences migraines postpartum and who has previously been "failed by", or intolerant to, other first-line prophylactic medications * Patient with established migraine history, who warrants said treatment trial otherwise, at the di…
Eligibility
- Age range
- 18–45 years
- Sex
- Female
- Healthy volunteers
- No
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 insur…
Interventions
- DrugGalcanezumab
Receiving either 120mg or 300mg injections.
Location
- University of California, San FranciscoSan Francisco, California