Evaluating Emgality's effects on breastfeeding mothers with migraines
Prospective Evaluation of Emgality (Galcanezumab) in Breastmilk in Adult Women With Migraine
This study is testing how a migraine medication called Emgality affects breast milk in nursing mothers and how it impacts their health and their babies' growth over the first year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of California, San Francisco Academic / other |
| Drugs / interventions | galcanezumab |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06085144 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the transfer of galcanezumab, a medication for migraines, into the breastmilk of nursing mothers. It will involve collecting milk samples from 30 women aged 18-45 who are postpartum and experiencing migraines. The study will also evaluate the health outcomes of both mothers and their infants, including growth and development, over a period of up to 12 months. Participants will complete questionnaires and provide health records to help analyze the effects of the medication on breastfeeding.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-45 with a diagnosis of migraine who are between 14 days and 9 months postpartum and still nursing.
Not a fit: Patients who are not breastfeeding or have contraindications to breastfeeding or galcanezumab will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety and effects of migraine treatment in breastfeeding mothers, potentially improving their quality of life.
How similar studies have performed: While studies on migraine treatments exist, this specific focus on breastfeeding and galcanezumab is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Riley Bove, MD, MSc — University of California, San Francisco
- Study coordinator: Ayushi D Balan, BA, BS
- Email: ayushi.balan@ucsf.edu
- Phone: 415-514-8330
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.