MigraineNCT06085144
Emgality for Migraine in Breastmilk
An observational study of Migraine, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Migraine
- What is being tested?
- Galcanezumab
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2024to Apr 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94158
Ayushi D Balan, BA, BS, 415-514-8330, ayushi.balan@ucsf.edu
Stephanie Hsu, BA, 415-502-7209, stephanie.hsu@ucsf.edu
About this study
Official title: Prospective Evaluation of Emgality (Galcanezumab) in Breastmilk in Adult Women With Migraine
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.
Read the detailed description
Galcanezumab will be prescribed clinically by the treating clinician, i.e., no drug will be provided by the study. This treatment may be prescribed in several clinical scenarios:
- Patient with established migraine history, treated with galcanezumab prior to pregnancy, who plans to resume the medication post partum
- Patient with established migraine history, who experiences migraines postpartum and who has previously been "failed by", or intolerant to, other first-line prophylactic medications
- Patient with established migraine history, who warrants said treatment trial otherwise, at the discretion of the prescribing clinician
Interested participants will be contacted by our UCSF coordinator, sign an informed consent form, and receive instructions for milk collection. A pamphlet on effective birth control will be provided to all enrollees (https://owh-wh-d9-dev.s3.amazonaws.com/s3fs-public/documents/fact-sheet-birth-control-methods.pdf), as well as OCT-available at-home pregnancy tests.
Mothers will complete questionnaires relating to their infants, at 6M and 12M postpartum (Ages and Stages, colic, etc.) and will sign a release form for us to obtain and review infant health records up to 12 months post-delivery to calculate: growth, infections, incidence of constipation or infant colic.
Milk collection:
Participants will pump and provide up to 8 samples (15mL volume each), at specific timepoints over up to 2 treatment cycles (before treatment 1; 24hours, 7d, 28d post treatment 1; 24hours, 7d, 28d post treatment 2 and 7d post treatment 3). Samples will be shipped in an insulated container with gel packs to maintain temperature via FedEx priority overnight shipping to our Laboratory at UCSF and stored in a -80 °C degrees freezer.
Sample assays:
Samples will be batch analyzed using enzyme immunoassay at (1) interim report after 15 sets received and (2) final report after all 30 sets received. The study team has worked with MarinBio who are experts in measuring biologics.
- Conditions
- Migraine
- Being tested
- Galcanezumab
- Keywords
- Emgality, Galcanezumab, Migraine, Breastmilk, Milk, Breastfeeding, Pregnancy, Postpartum, Monoclonal Antibodies
- Medical subject headings
- Migraine Disorders, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GalcanezumabDrug
Also called Emgality
Receiving either 120mg or 300mg injections.
| Study group | Role | What they receive |
|---|---|---|
| Galcanezumab | Postpartum women both nursing and receiving treatment for migraine with galcanezumab. Receives: Drug: Galcanezumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
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).
Measured: 12 months
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).
Measured: 12 months
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.
Measured: 12 months
Determine maximum 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 maximum galcanezumab dose to the infant in a 24-hour period.
Measured: 12 months
Determine average relative infant dose of emgality 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 relative infant dose (RIDAVE).
The investigators hypothesize that given that galcanezumab is an IgG mAb, it will similarly show very low concentrations, and acceptable relative infant dose (RID) (<1%).
Measured: 12 months
Determine maximum relative infant dose of emgality 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 relative infant dose (RIDMAX).
The investigators hypothesize that given that galcanezumab is an IgG mAb, it will similarly show very low concentrations, and acceptable relative infant dose (RID) (<1%).
Measured: 12 months
Secondary outcomes (11)
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).
Measured: 6 months
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).
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Obtain information on newborn head circumference until 12 months of life
Newborn head circumference (in cm) will be collected by manual review of infant medical records at all visits occurring in the first 12 months of life.
Measured: 12 months
Obtain information on the number of newborn infections until 12 months of life
The number of and nature of each newborn infections will be collected by manual review of infant medical records at all visits occurring in the first 12 months of life.
Measured: 12 months
Obtain information on number of instances of newborn constipation including medications or interventions until 12 months of life
The number of instances of newborn constipation along with any relevant evidence will be collected by manual review of infant medical records at all visits occurring in the first 12 months of life.
Measured: 12 months
Determine time to peak levels of galcanezumab in 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. The average peak level of galcanezumab concentration will be determined from this.
Measured: 12 months
Determine headache severity surrounding the participants' galcanezumab treatments
The maternal migraine diary will be completed by participating mothers in the months surrounding their galcanezumab treatments. It tracks headache severity by asking participants to self-report their percieved headache severity on a scale of 0-10 daily.
Measured: 12 months
Determine the number of days with headaches surrounding the participants' galcanezumab treatments
The maternal migraine diary will be completed by participating mothers in the months surrounding their galcanezumab treatments. It tracks headache dats by asking participants to self-report whether or not they experienced at least one migraine daily.
Measured: 12 months
Determine what acute migraine medications were used by participants surrounding their galcanezumab treatments
The maternal migraine diary will be completed by participating mothers in the months surrounding their galcanezumab treatments. It tracks acute medication use by asking participants to self-report what acute medications they use to manage their migraines and when.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start26 Feb 2024
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Riley Bove, MD, MSc, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085144
- Sponsor's protocol ID
- Emgality in breast milk
- Status last verified
- Aug 2026
- First submitted
- 4 Oct 2023
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
LaHue SC, Gelfand AA, Bove RM. Navigating monoclonal antibody use in breastfeeding women: Do no harm or do little good? Neurology. 2019 Oct 8;93(15):668-672. doi: 10.1212/WNL.0000000000008213. Epub 2019 Sep 6.
PubMed 31492717Krysko KM, LaHue SC, Anderson A, Rutatangwa A, Rowles W, Schubert RD, Marcus J, Riley CS, Bevan C, Hale TW, Bove R. Minimal breast milk transfer of rituximab, a monoclonal antibody used in neurological conditions. Neurol Neuroimmunol Neuroinflamm. 2019 Nov 12;7(1):e637. doi: 10.1212/NXI.0000000000000637. Print 2020 Jan.
PubMed 31719115Proschmann U, Haase R, Inojosa H, Akgun K, Ziemssen T. Drug and Neurofilament Levels in Serum and Breastmilk of Women With Multiple Sclerosis Exposed to Natalizumab During Pregnancy and Lactation. Front Immunol. 2021 Aug 26;12:715195. doi: 10.3389/fimmu.2021.715195. eCollection 2021.
PubMed 34512637
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Emgality (Galcanezumab) in Breastmilk in Adult Women With Migraine
- ClinicalTrials.gov ID
- NCT06085144
- Acronym / sponsor ID
- Emgality in breast milk
- Conditions
- Migraine
- Keywords
- Emgality, Galcanezumab, Migraine, Breastmilk, Milk, Breastfeeding, Pregnancy, Postpartum
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Galcanezumab will be prescribed clinically by the treating clinician, i.e., no drug will be provided by the study. This treatment may be prescribed in several clinical scenarios:
- Patient with established migraine history, treated with galcanezumab prior to pregnancy, who plans to resume the medication post partum
- Patient with established migraine history, who experiences migraines postpartum and who has previously been "failed by", or intolerant to, other first-line prophylactic medications
- Patient with established migraine history, who warrants said treatment trial otherwise, at the discretion of the prescribing clinician
Interested participants will be contacted by our UCSF coordinator, sign an informed consent form, and receive instructions for milk collection. A pamphlet on effective birth control will be provided to all enrollees (https://owh-wh-d9-dev.s3.amazonaws.com/s3fs-public/documents/fact-sheet-birth-control-methods.pdf), as well as OCT-available at-home pregnancy tests.
Mothers will complete questionnaires relating to their infants, at 6M and 12M postpartum (Ages and Stages, colic, etc.) and will sign a release form for us to obtain and review infant health records up to 12 months post-delivery to calculate: growth, infections, incidence of constipation or infant colic.
Milk collection:
Participants will pump and provide up to 8 samples (15mL volume each), at specific timepoints over up to 2 treatment cycles (before treatment 1; 24hours, 7d, 28d post treatment 1; 24hours, 7d, 28d post treatment 2 and 7d post treatment 3). Samples will be shipped in an insulated container with gel packs to maintain temperature via FedEx priority overnight shipping to our Laboratory at UCSF and stored in a -80 °C degrees freezer.
Sample assays:
Samples will be batch analyzed using enzyme immunoassay at (1) interim report after 15 sets received and (2) final report after all 30 sets received. The study team has worked with MarinBio who are experts in measuring biologics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Galcanezumab | – | Drug: GalcanezumabPostpartum women both nursing and receiving treatment for migraine with galcanezumab. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GalcanezumabAlso: EmgalityReceiving either 120mg or 300mg injections. | Drug | Galcanezumab |
Primary outcome
Determine emgality concentration in mature breastmilk
Time frame: 12 months
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).
Determine average emgality concentration in mature breastmilk
Time frame: 12 months
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).
Determine maximum emgality concentration in mature breastmilk
Time frame: 12 months
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).
Determine average emgality dose to infants through mature breastmilk in a 24-hour period
Time frame: 12 months
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.
Determine maximum emgality dose to infants through mature breastmilk in a 24-hour period
Time frame: 12 months
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 galcanezumab dose to the infant in a 24-hour period.
Determine average relative infant dose of emgality in mature breastmilk
Time frame: 12 months
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 relative infant dose (RIDAVE). The investigators hypothesize that given that galcanezumab is an IgG mAb, it will similarly show very low concentrations, and acceptable relative infant dose (RID) (<1%).
Determine maximum relative infant dose of emgality in mature breastmilk
Time frame: 12 months
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 relative infant dose (RIDMAX). The investigators hypothesize that given that galcanezumab is an IgG mAb, it will similarly show very low concentrations, and acceptable relative infant dose (RID) (<1%).
11 secondary outcomes
Obtain information on newborn developmental milestones at 6 months of life
Time frame: 6 months
Obtain information on newborn developmental milestones at 12 months of life
Time frame: 12 months
Obtain information on newborn adjusted length until 12 months of life
Time frame: 12 months
Obtain information on newborn weight until 12 months of life
Time frame: 12 months
Obtain information on newborn head circumference until 12 months of life
Time frame: 12 months
Obtain information on the number of newborn infections until 12 months of life
Time frame: 12 months
Obtain information on number of instances of newborn constipation including medications or interventions until 12 months of life
Time frame: 12 months
Determine time to peak levels of galcanezumab in breastmilk
Time frame: 12 months
Determine headache severity surrounding the participants' galcanezumab treatments
Time frame: 12 months
Determine the number of days with headaches surrounding the participants' galcanezumab treatments
Time frame: 12 months
Determine what acute migraine medications were used by participants surrounding their galcanezumab treatments
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Background: PubMed 31492717LaHue SC, Gelfand AA, Bove RM. Navigating monoclonal antibody use in breastfeeding women: Do no harm or do little good? Neurology. 2019 Oct 8;93(15):668-672. doi: 10.1212/WNL.0000000000008213. Epub 2019 Sep 6.
- Background: PubMed 31719115Krysko KM, LaHue SC, Anderson A, Rutatangwa A, Rowles W, Schubert RD, Marcus J, Riley CS, Bevan C, Hale TW, Bove R. Minimal breast milk transfer of rituximab, a monoclonal antibody used in neurological conditions. Neurol Neuroimmunol Neuroinflamm. 2019 Nov 12;7(1):e637. doi: 10.1212/NXI.0000000000000637. Print 2020 Jan.
- Background: PubMed 34512637Proschmann U, Haase R, Inojosa H, Akgun K, Ziemssen T. Drug and Neurofilament Levels in Serum and Breastmilk of Women With Multiple Sclerosis Exposed to Natalizumab During Pregnancy and Lactation. Front Immunol. 2021 Aug 26;12:715195. doi: 10.3389/fimmu.2021.715195. eCollection 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Riley Bove, MD, MSc principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayushi D Balan, BA, BS (415-514-8330, ayushi.balan@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine emgality concentration in mature breastmilk (time frame: 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06085144, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.