Emgality in Breastmilk for Migraine
This study is looking at how much Emgality (galcanezumab), a medication for migraine, gets into breastmilk. It also wants to understand how babies are doing (their growth, development, and any issues like constipation or colic) when their mothers are taking Emgality and breastfeeding. You can join if you are a woman between 18 and 45 years old, have migraines, have recently given birth without complications, and are planning to take Emgality while nursing. The study will follow 30 women and their babies. The main goal is to measure the amount of Emgality in your breastmilk at 12 months postpartum.
- Study design
- This is an observational study involving 30 women. It is not specified if it is blinded or randomized.
- What's involved
- You will provide serial milk samples and complete questionnaires about your infant at 6 and 12 months postpartum. You will also sign a release for your infant's health records.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 months postpartum to measure Emgality concentration in breastmilk and infant outcomes.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Emgality for Migraine in Breastmilk
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Riley Bove, MD, MSc · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Determine emgality concentration in mature breastmilk12 months
Levels of galcanezumab (μg/mL) in the breastmilk of women at the selected timepoints before and after each treatment (24H pre, 24H post, 7D post, 28D post). For the third treatment, only 7D post will be collected. This outcome will be measured by breastmilk concentration (μg/mL).
- Determine average emgality concentration in mature breastmilk12 months
Levels of galcanezumab (μg/mL) in the breastmilk of women at the selected timepoints before and after each treatment (24H pre, 24H post, 7D post, 28D post). For the third treatment, only 7D post will be collected. This outcome will be measured by average breastmilk concentration (CAVE, determined using pharmacokinetic methods).
- Determine maximum emgality concentration in mature breastmilk12 months
Levels of galcanezumab (μg/mL) in the breastmilk of women at the selected timepoints before and after each treatment (24H pre, 24H post, 7D post, 28D post). For the third treatment, only 7D post will be collected. This outcome will be measured by maximum concentration of galcanezumab in breastmilk (CMAX).
- Determine average emgality dose to infants through mature breastmilk in a 24-hour period12 months
Levels of galcanezumab (μg/mL) in the breastmilk of women at the selected timepoints before and after each treatment (24H pre, 24H post, 7D post, 28D post). For the third treatment, only 7D post will be collected. This outcome will be measured by absolute average galcanezumab dose to the infant in a 24-hour period.
- Determine maximum emgality dose to infants through mature breastmilk in a 24-hour period12 months
Levels of galcanezumab (μg/mL) in the breastmilk of women at the selected timepoints before and after each treatment (24H pre, 24H post, 7D post, 28D post). For the third treatment, only 7D post will be collected. This outcome will be measured by maximum galcanezumab dose to the infant in a 24-hour period.
- Determine average relative infant dose of emgality in mature breastmilk12 months
Levels of galcanezumab (μg/mL) in the breastmilk of women at the selected timepoints before and after each treatment (24H pre, 24H post, 7D post, 28D post). For the third treatment, only 7D post will be collected. This outcome will be measured by average relative infant dose (RIDAVE). The investigators hypothesize that given that galcanezumab is an IgG mAb, it will similarly show very low concentrations, and acceptable relative infant dose (RID) (\<1%).
- Determine maximum relative infant dose of emgality in mature breastmilk12 months
Levels of galcanezumab (μg/mL) in the breastmilk of women at the selected timepoints before and after each treatment (24H pre, 24H post, 7D post, 28D post). For the third treatment, only 7D post will be collected. This outcome will be measured by maximum relative infant dose (RIDMAX). The investigators hypothesize that given that galcanezumab is an IgG mAb, it will similarly show very low concentrations, and acceptable relative infant dose (RID) (\<1%).