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Emgality for Migraine in Breastmilk

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 45 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Mothers will complete questionnaires relating to their infants, at 6M and 12M postpartum (Ages and Stages, colic, etc.) and will sign a release form for us to obtain and review infant health records up to 12 months post-delivery to calculate: growth, infections, incidence of constipation or infant colic."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how much galcanezumab (Emgality), a migraine medicine, passes into breast milk. It also tracks mothers’ headaches and babies’ health, comparing babies who were and were not breastfed after treatment. It is for breastfeeding women ages 18–45 with migraines who plan to receive this medicine after giving birth.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are female and age 18–45.
  • You have been diagnosed with migraine.
  • You had a birth without complications and have no long-term health problems from delivery.
  • Your baby did not stay more than 3 nights in the NICU, a special care unit for newborns.
  • You gave birth 14 days to 9 months ago and are still breastfeeding when you join.
  • You plan to receive galcanezumab after giving birth.
  • Your prescribing clinician thinks galcanezumab is suitable for you after giving birth.

Who can't join

  • You or your baby have a medical reason to avoid breastfeeding, such as certain past surgeries.
  • You have a medical reason to avoid galcanezumab or an insurance coverage issue.
  • You use gepants, a type of migraine medicine.
  • You have moderately severe or severe depression, shown by a score of 15 or higher on the PHQ-9 depression screening test.
  • You are pregnant or plan to become pregnant in the next 6 months.
  • You have severe mastitis, which is swelling and pain in the breast.
  • Your baby’s health record shows serious medical issues, including problems with development, birth, or medicines they take.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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)

Study sites (1)

CA