Emgality for Migraine in Breastmilk

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06085144
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Galcanezumab — DRUG
    Receiving either 120mg or 300mg injections.

Study Details

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.

Key Dates

Start date
Feb 26, 2024
Status verified
Apr 2025
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Galcanezumab
    Postpartum women both nursing and receiving treatment for migraine with galcanezumab.

Primary Outcome Measure

Determine emgality concentration in mature breastmilk [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94158
Ayushi D Balan, BA, BS
[email protected]
415-514-8330
Stephanie Hsu, BA
[email protected]
415-502-7209
Riley Bove, MD, MSc (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
Migraine
By specialty
Neurology
By research site
University of California, San Francisco· San Francisco, CA

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