Emgality for Migraine in Breastmilk (NCT06085144) | Clinical Trial Compass
RecruitingNot Applicable
Emgality for Migraine in Breastmilk
United States30 participantsStarted 2024-02-26
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine emgality concentration in mature breastmilk
Timeframe: 12 months
2
Determine average emgality concentration in mature breastmilk
Timeframe: 12 months
3
Determine maximum emgality concentration in mature breastmilk
Timeframe: 12 months
4
Determine average emgality dose to infants through mature breastmilk in a 24-hour period
Timeframe: 12 months
5
Determine maximum emgality dose to infants through mature breastmilk in a 24-hour period
Timeframe: 12 months
6
Determine average relative infant dose of emgality in mature breastmilk
Timeframe: 12 months
7
Determine maximum relative infant dose of emgality in mature breastmilk