Emgality for Migraine
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how the migraine treatment galcanezumab affects breastmilk and the health of breastfeeding infants. Researchers aim to determine if the medication passes into breastmilk and its potential impact on babies' growth, development, and overall health. They seek mothers who have migraines, are between 14 days and 9 months postpartum, and are breastfeeding. This study is crucial because many women with migraines are new mothers, yet they often cannot participate in trials for migraine medications while nursing. As a Phase 4 trial, this research helps to understand how the already FDA-approved treatment benefits more patients, offering reassurance to breastfeeding mothers considering this medication.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot use gepants while participating.
What prior data suggests that galcanezumab is safe for postpartum women and their infants?
Research has shown that galcanezumab, the treatment under study, has been tested in over 2,500 patients for migraine relief. These studies found the treatment to be generally well-tolerated. The most common side effects were minor, such as pain or reactions at the injection site.
Specific information about using galcanezumab while breastfeeding is not available. However, as a large protein, it is less likely to pass into breast milk in significant amounts. Caution is advised, especially when nursing newborns or premature babies.
Overall, galcanezumab has not raised major safety concerns in otherwise healthy adults. As with any treatment, it is important to weigh the benefits and risks based on the available safety evidence.12345Why are researchers excited about this trial?
Emgality, with its active ingredient galcanezumab, stands out because it specifically targets a protein called calcitonin gene-related peptide (CGRP), which plays a crucial role in migraine development. Unlike traditional migraine treatments that often involve general pain relief or vasoconstriction, Emgality's mechanism of action directly interferes with the migraine pathway, potentially offering more effective relief. Researchers are particularly excited about its use in postpartum women who are nursing, as there is a need for migraine treatments that are safe for both mother and baby during breastfeeding.
What evidence suggests that galcanezumab might be an effective treatment for migraine?
Research has shown that galcanezumab reduces the frequency and severity of migraines. People using galcanezumab experience fewer migraine days each month compared to those who do not use it. In earlier studies, most participants found galcanezumab easy to tolerate, and many reported fewer headache days. This trial will administer galcanezumab to participants to study how the drug passes into breast milk and its effects on infants. Galcanezumab has already proven effective in managing migraines in adults, which is particularly important because migraines are common in women of childbearing age.6789
Who Is on the Research Team?
Riley Bove, MD, MSc
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants provide milk samples at specific timepoints over up to 2 treatment cycles with galcanezumab
Follow-up
Participants are monitored for infant growth, development, and maternal headache outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Galcanezumab
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Postpartum women both nursing and receiving treatment for migraine with galcanezumab.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
Citations
UCSF Headache Trial → 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, ...
Monitoring Pregnancies Exposed to Galcanezumab for ...
Recent monitoring of patient accrual, including data from 28 September 2018 to 31 January 2023, identified 207 galcanezumab-exposed pregnancies ...
Monitoring Pregnancies Exposed to Galcanezumab for ...
Due to the long half-life of galcanezumab and the prevalence of migraine in women of childbearing age, galcanezumab exposure may occur during pregnancy.
4.
trial.medpath.com
trial.medpath.com/clinical-trial/7c434735a350732f/nct06085144-prospective-evaluation-emgality-breastmilk-migraineEmgality for Migraine in Breastmilk - MedPath
The goal of this project is to evaluate galcanezumab transfer into maternal breastmilk, and to evaluate infant (growth, development, constipation, colic, ...
Galcanezumab (Emgality) use while Breastfeeding
Galcanezumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.
EMGALITY (galcanezumab-gnlm) - accessdata.fda.gov
The safety of EMGALITY has been evaluated in 2586 patients with migraine who received at least one dose of. EMGALITY, representing 1487 patient- ...
Galcanezumab - Drugs and Lactation Database (LactMed®)
No information is available on the clinical use of galcanezumab during breastfeeding. Because galcanezumab is a large protein molecule with ...
Galcanezumab (Emgality) for Migraine and Cluster ...
Safety. In otherwise healthy adults, galcanezumab has not been shown to cause significant safety concerns or drug interactions. · Tolerability.
9.
ema.europa.eu
ema.europa.eu/en/documents/product-information/emgality-epar-product-information_en.pdfEmgality, INN-galcanezumab - European Medicines Agency
The reported adverse drug reactions for 120 mg and 240 mg in the migraine clinical trials were injection site pain (10.1 %/11.6 %), injection site reactions ( ...
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