| NCT ID | NCT06085144 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Migraine |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-02-26 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2024-02-26 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
Riley Bove, MD, MSc
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT06085144 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06085144 currently recruiting?
Yes, NCT06085144 is actively recruiting participants. Contact the research team at ayushi.balan@ucsf.edu for enrollment information.
Where is the NCT06085144 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT06085144 clinical trial?
NCT06085144 is sponsored by University of California, San Francisco. The principal investigator is Riley Bove, MD, MSc at University of California, San Francisco. The trial plans to enroll 30 participants.
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