Clinical trial NCT06085144: Emgality for Migraine in Breastmilk
Official title: Prospective Evaluation of Emgality (Galcanezumab) in Breastmilk in Adult Women With Migraine
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Migraine
Keywords: Emgality
Galcanezumab
Migraine
Breastmilk
Milk
Breastfeeding
Pregnancy
Postpartum
Monoclonal Antibodies
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2023-10-16
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Galcanezumab will be prescribed clinically by the treating clinician, i.e., no drug will be provided by the study. This treatment may be prescribed in several clinical scenarios:

* Patient with established migraine history, treated with galcanezumab prior to pregnancy, who plans to resume the medication post partum
* Patient with established migraine history, who experiences migraines postpartum and who has previously been "failed by", or intolerant to, other first-line prophylactic medications
* Patient with established migraine history, who warrants said treatment trial otherwise, at the discretion of the prescribing clinician

Interested participants will be contacted by our UCSF coordinator, sign an informed consent form, and receive instructions for milk collection. A pamphlet on effective birth control will be provided to all enrollees (https://owh-wh-d9-dev.s3.amazonaws.com/s3fs-public/documents/fact-sheet-birth-control-methods.pdf), as well as OCT-available at-home pregnancy tests.

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.

Milk collection:

Participants will pump and provide up to 8 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.

Sample assays:

Samples will be batch analyzed using enzyme immunoassay at (1) interim report after 15 sets received and (2) final report after all 30 sets received. The study team has worked with MarinBio who are experts in measuring biologics.

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)

Primary outcomes:
measure: Determine emgality concentration in mature breastmilk
timeFrame: 12 months
measure: Determine average emgality concentration in mature breastmilk
timeFrame: 12 months
measure: Determine maximum emgality concentration in mature breastmilk
timeFrame: 12 months
measure: Determine average emgality dose to infants through mature breastmilk in a 24-hour period
timeFrame: 12 months
measure: Determine maximum emgality dose to infants through mature breastmilk in a 24-hour period
timeFrame: 12 months
measure: Determine average relative infant dose of emgality in mature breastmilk
timeFrame: 12 months
measure: Determine maximum relative infant dose of emgality in mature breastmilk
timeFrame: 12 months
Secondary outcomes:
measure: Obtain information on newborn developmental milestones at 6 months of life
timeFrame: 6 months
measure: Obtain information on newborn developmental milestones at 12 months of life
timeFrame: 12 months
measure: Obtain information on newborn adjusted length until 12 months of life
timeFrame: 12 months
measure: Obtain information on newborn weight until 12 months of life
timeFrame: 12 months
measure: Obtain information on newborn head circumference until 12 months of life
timeFrame: 12 months
measure: Obtain information on the number of newborn infections until 12 months of life
timeFrame: 12 months
measure: Obtain information on number of instances of newborn constipation including medications or interventions until 12 months of life
timeFrame: 12 months
measure: Determine time to peak levels of galcanezumab in breastmilk
timeFrame: 12 months
measure: Determine headache severity surrounding the participants' galcanezumab treatments
timeFrame: 12 months
measure: Determine the number of days with headaches surrounding the participants' galcanezumab treatments
timeFrame: 12 months
measure: Determine what acute migraine medications were used by participants surrounding their galcanezumab treatments
timeFrame: 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Riley Bove, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.