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NCT06085144 · ClinicalTrials.gov registry record
Emgality for Migraine in Breastmilk
A clinical trial of Migraine, sponsored by University of California, San Francisco.
- Recruiting
- Registry status
- 30
- Enrollment target
- 1
- Study location
NCT06085144: Recruiting study of Migraine, sponsored by University of California, San Francisco.
NCT06085144 is a study of Migraine that is actively recruiting participants, run by University of California, San Francisco. The registered enrollment target is 30 participants, below the 358-participant average among 102 other Migraine trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06085144, a study of Migraine, is actively recruiting participants, sponsored by University of California, San Francisco.
- RECRUITING
- Registry status
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- DRUG Galcanezumab
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-02-26 |
| Est. Completion | 2026-04 |
What NCT06085144 shows while recruiting
NCT06085144 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 358-participant average among 102 other Migraine trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Migraine appearing as the primary indexed condition, and to 1 intervention - of which Galcanezumab is the first listed.
NCT06085144 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06085144 about?
NCT06085144 is a clinical study titled "Emgality for Migraine in Breastmilk". 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 w...
What is the current status of trial NCT06085144?
This trial is currently recruiting. The enrollment target is 30 participants. The study started on 2024-02-26. Estimated completion is 2026-04.
What conditions does trial NCT06085144 study?
This clinical trial studies the following conditions: Migraine.
What interventions are being tested in trial NCT06085144?
The interventions under investigation include: Galcanezumab (DRUG).
Who is sponsoring clinical trial NCT06085144?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06085144 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Migraine
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06085144's enrollment target sits among peer trials
30 92nd of 102 higher than 8 of 102 other Migraine trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Migraine trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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