Emgality for Migraine in Breastmilk
ConditionMigraine
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female
Childbearing age (18-45)
Established diagnosis of migraine
Status post uncomplicated delivery (no long-term maternal complications)
Disqualifiers
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)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Galcanezumab
DrugReceiving either 120mg or 300mg injections.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Galcanezumab1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
12 months2
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).
Time frame
12 months3
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).
Time frame
12 months4
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.
Time frame
12 monthsSecondary outcomes
1
Obtain information on newborn developmental milestones at 6 months of life
The Ages and Stages Questionnaire, third edition, (ASQ-3) will be completed by participating mothers at the following timepoints postpartum, to determine the developmental age of infants at 6 months. The questionnaire scores 5 areas of development: Communication, Gross Motor, Fine Motor, Problem Solving and Personal-Social. Cumulative scores range from 0 to 60. Higher scores indicate more positive outcomes. Each version of the ASQ-3 has different cutoff scores that indicate whether the child's development appears to be on schedule, requires monitoring or requires further assessment. (Above and Monitoring Ranges indicate on schedule infant development for age).
Time frame
6 months2
Obtain information on newborn developmental milestones at 12 months of life
The Ages and Stages Questionnaire, third edition, (ASQ-3) will be completed by participating mothers at the following timepoints postpartum, to determine the developmental age of infants at 12 months. The questionnaire scores 5 areas of development: Communication, Gross Motor, Fine Motor, Problem Solving and Personal-Social. Cumulative scores range from 0 to 60. Higher scores indicate more positive outcomes. Each version of the ASQ-3 has different cutoff scores that indicate whether the child's development appears to be on schedule, requires monitoring or requires further assessment. (Above and Monitoring Ranges indicate on schedule infant development for age).
Time frame
12 months3
Obtain information on newborn adjusted length until 12 months of life
Newborn adjusted length (in cm) will be collected by manual review of infant medical records at all visits occurring in the first 12 months of life.
Time frame
12 months4
Obtain information on newborn weight until 12 months of life
Newborn weight (in kg) will be collected by manual review of infant medical records at all visits occurring in the first 12 months of life.
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
Eli Lilly and Company
Collaborator
Source ClinicalTrials.gov