Recruiting

Emgality

Sponsor:

UCLA

Code:

NCT06085144

Conditions

Migraine

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Galcanezumab

Study Details

Brief 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.

Conditions

Migraine

Study ID

NCT06085144

Start date

Feb 26, 2024

Status verified date

Aug, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Galcanezumab

Postpartum women both nursing and receiving treatment for migraine with galcanezumab.

Interventions

Galcanezumab

Receiving either 120mg or 300mg injections.

Primary outcome measure

  • Determine emgality concentration in mature breastmilk [ Time Frame: 12 months ]
  • Determine average emgality concentration in mature breastmilk [ Time Frame: 12 months ]
  • Determine maximum emgality concentration in mature breastmilk [ Time Frame: 12 months ]
  • Determine average emgality dose to infants through mature breastmilk in a 24-hour period [ Time Frame: 12 months ]
  • Determine maximum emgality dose to infants through mature breastmilk in a 24-hour period [ Time Frame: 12 months ]
  • Determine average relative infant dose of emgality in mature breastmilk [ Time Frame: 12 months ]
  • Determine maximum relative infant dose of emgality in mature breastmilk [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Ayushi D Balan, BA, BS

415-514-8330ayushi.balan@ucsf.edu

Stephanie Hsu, BA

415-502-7209stephanie.hsu@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

Ayushi D Balan, BA, BS

415-514-8330ayushi.balan@ucsf.edu

Stephanie Hsu, BA

415-502-7209stephanie.hsu@ucsf.edu

Principal Investigator:

Riley Bove, MD, MSc

More Information

Sponsor

University of California, San Francisco

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

  • Emgality
  • Galcanezumab
  • Migraine
  • Breastmilk
  • Milk
  • Breastfeeding
  • Pregnancy
  • Postpartum
  • Monoclonal Antibodies

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-08-11.