Prospective Evaluation of Emgality (Galcanezumab) in Breastmilk in Adult Women With Migraine

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Ayushi D Balan, BA, BS
ayushi.balan@ucsf.edu
415-514-8330
Backup
Stephanie Hsu, BA
stephanie.hsu@ucsf.edu
415-502-7209
Time Frame
Start Date: 2024-02-26
Estimated Completion Date: 2026-04
Participants
Target number of participants: 30
Treatments
Galcanezumab
Postpartum women both nursing and receiving treatment for migraine with galcanezumab.
Related Therapeutic Areas
Sponsors
Leads: University of California, San Francisco
Collaborators: Eli Lilly and Company

This content was sourced from clinicaltrials.gov