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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 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.

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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.

Conditions Studied

Interventions

  • DRUG Galcanezumab

Study Locations (1)

California

  • University of California, San Francisco - San Francisco

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2024-02-26
Est. Completion 2026-04

What the Registry Record Tells You About NCT06085144

The ClinicalTrials.gov registry entry for NCT06085144 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 358-participant average among 102 other Migraine trials with a reported enrollment target (92% lower). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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