Emgality for Migraine in Breastmilk

NCT06085144 | Recruiting FDA Drug

• 1 other identifier: Emgality in breast milk
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (7)

• Determine emgality concentration in mature breastmilk

  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).

  12 months

• Determine average emgality concentration in mature breastmilk

  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).

  12 months

• Determine maximum emgality concentration in mature breastmilk

  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).

  12 months

• Determine average emgality dose to infants through mature breastmilk in a 24-hour period

  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.

  12 months

• Determine maximum emgality dose to infants through mature breastmilk in a 24-hour period

  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.

  12 months

• Determine average relative infant dose of emgality in mature breastmilk

  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%).

  12 months

• Determine maximum relative infant dose of emgality in mature breastmilk

  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%).

  12 months

Secondary Outcomes (11)

• Obtain information on newborn developmental milestones at 6 months of life

  6 months

• Obtain information on newborn developmental milestones at 12 months of life

  12 months

• Obtain information on newborn adjusted length until 12 months of life

  12 months

• Obtain information on newborn weight until 12 months of life

  12 months

• Obtain information on newborn head circumference until 12 months of life

  12 months

Study Arms (1)

Galcanezumab

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

Drug: Galcanezumab

Interventions

Galcanezumab DRUG

Receiving either 120mg or 300mg injections.

Also known as: Emgality

Galcanezumab

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

RECRUITING

Related Publications (3)

• LaHue SC, Gelfand AA, Bove RM. Navigating monoclonal antibody use in breastfeeding women: Do no harm or do little good? Neurology. 2019 Oct 8;93(15):668-672. doi: 10.1212/WNL.0000000000008213. Epub 2019 Sep 6.

  PMID: 31492717 BACKGROUND

• Krysko KM, LaHue SC, Anderson A, Rutatangwa A, Rowles W, Schubert RD, Marcus J, Riley CS, Bevan C, Hale TW, Bove R. Minimal breast milk transfer of rituximab, a monoclonal antibody used in neurological conditions. Neurol Neuroimmunol Neuroinflamm. 2019 Nov 12;7(1):e637. doi: 10.1212/NXI.0000000000000637. Print 2020 Jan.

  PMID: 31719115 BACKGROUND

• Proschmann U, Haase R, Inojosa H, Akgun K, Ziemssen T. Drug and Neurofilament Levels in Serum and Breastmilk of Women With Multiple Sclerosis Exposed to Natalizumab During Pregnancy and Lactation. Front Immunol. 2021 Aug 26;12:715195. doi: 10.3389/fimmu.2021.715195. eCollection 2021.

  PMID: 34512637 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Participants will pump and provide up to 8 breastmilk samples (15mL volume each), at specific timepoints over up to 2 treatment cycles (before treatment 1; 24hours, 7d, 28d post treatment 1; 24hours, 7d, 28d post treatment 2 and 7d post treatment 3). Samples will be shipped in an insulated container with gel packs to maintain temperature via FedEx priority overnight shipping to our Laboratory at UCSF and stored in a -80 °C degrees freezer.

MeSH Terms

Conditions

Migraine Disorders; Breast Feeding

Interventions

galcanezumab; erenumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Feeding Behavior; Behavior

Study Officials

• Riley Bove, MD, MSc

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayushi D Balan, BA, BS

CONTACT

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

Stephanie Hsu, BA

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 16, 2023
• Study Start: February 26, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 7, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)