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Can migraine meds be safe while breastfeeding? a new study investigates

NCT ID NCT06085144

Knowledge-focused Sponsor: University of California, San Francisco Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This study looks at how much of the migraine drug galcanezumab (Emgality) appears in breastmilk after a mother receives her usual injections. Researchers will measure drug levels in milk samples from 30 women with migraine who are breastfeeding, and also track infant growth, development, and any side effects like colic or infections. The goal is to fill a gap in knowledge about whether this treatment is safe for nursing mothers and their babies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
galcanezumab (Emgality) injections
What this could lead to
If successful, this could provide crucial safety data on using galcanezumab while breastfeeding, potentially expanding treatment options for new mothers with migraine.
What could go wrong
This is a small observational study, so results may not apply to all women. It does not test effectiveness, and there is a possibility that drug levels in milk could be higher than expected, though the hypothesis suggests they will be low.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

Breast Feeding migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Migraine

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of California, San Francisco

    RECRUITING

    San Francisco, California, 94158, United States

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