Prospective Evaluation of Emgality (Galcanezumab) in Breastmilk in Adult Women With Migraine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Determine average emgality dose to infants through mature breastmilk in a 24-hour period
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Galcanezumab
Postpartum women both nursing and receiving treatment for migraine with galcanezumab.
干预措施: Galcanezumab (Drug)
结局指标
主要结局
Determine average emgality dose to infants through mature breastmilk in a 24-hour period
时间窗: 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 concentration in mature breastmilk
时间窗: 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 maximum emgality dose to infants through mature breastmilk in a 24-hour period
时间窗: 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 emgality concentration in mature breastmilk
时间窗: 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 maximum relative infant dose of emgality in mature breastmilk
时间窗: 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%).
Determine average emgality concentration in mature breastmilk
时间窗: 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 average relative infant dose of emgality in mature breastmilk
时间窗: 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%).
次要结局
- Obtain information on the number of newborn infections until 12 months of life(12 months)
- Obtain information on newborn weight until 12 months of life(12 months)
- Determine the number of days with headaches surrounding the participants' galcanezumab treatments(12 months)
- Obtain information on newborn adjusted length until 12 months of life(12 months)
- Obtain information on newborn developmental milestones at 12 months of life(12 months)
- Obtain information on newborn head circumference until 12 months of life(12 months)
- Determine what acute migraine medications were used by participants surrounding their galcanezumab treatments(12 months)
- Obtain information on newborn developmental milestones at 6 months of life(6 months)
- Determine headache severity surrounding the participants' galcanezumab treatments(12 months)
- Obtain information on number of instances of newborn constipation including medications or interventions until 12 months of life(12 months)
- Determine time to peak levels of galcanezumab in breastmilk(12 months)