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ENDEAVOR TO STOP NAUSEA/VOMITING ASSOCIATED WITH PREGNANCY (E-SNAP)

努力停止与怀孕相关的恶心/呕吐 (E-SNAP)

基本信息

批准号：
10643818
负责人：
KATHERINE L WISNER
金额：
$ 20万
依托单位：
NORTHWESTERN UNIVERSITY AT CHICAGO
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-06-13 至 2024-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10643818
关键词：
Advisory Committees Affect Antidepressive Agents Antiemetics Area Body Weight decreased Brain Case Series Chemotherapy-Oncologic Procedure Clinical Trials Cognitive Congenital Abnormality Data Dehydration Development Discipline of obstetrics Dose Drug Kinetics Drug Prescriptions Electrolytes Enrollment Exhibits Formulation Frequencies Gastroparesis General Population Grant Hospitalization Hyperemesis Gravidarum Impairment Lactation Marketing Mental Depression Mirtazapine Monitor Morning Sickness Mothers National Institute of Child Health and Human Development Nausea Nausea and Vomiting Neurodevelopmental Deficit New Agents Newborn Infant Norepinephrine Ondansetron Oral Paper Parenteral Nutrition Pathway interactions Pharmaceutical Preparations Pharmacogenetics Pharmacotherapy Phase Phase II Clinical Trials Physiological Placebos Plasma Pregnancy Pregnancy Outcome Pregnant Women Premature Birth Property Quality of life Randomized, Controlled Trials Regimen Reporting Research Research Support Resolution Resources Risk Safety Sample Size Serotonin Small for Gestational Age Infant Structure Symptoms Therapeutic Third Pregnancy Trimester Time Translational Research Vomiting Woman clinical practice daily functioning depressive symptoms design drug repurposing drug standard effective therapy efficacy evaluation experience improved inhibitor multidisciplinary neonatal outcome novel novel therapeutics offspring patient population pediatric pharmacology phase 2 study prevent receptor reduce symptoms reproductive outcome reuptake serotonin receptor side effect standard care systematic review treatment duration treatment research trial planning week trial

项目摘要

PROJECT SUMMARY/ABSTRACT ENDEAVOR TO STOP NAUSEA/VOMITING ASSOCIATED WITH PREGNANCY (E-SNAP) Up to 85% of pregnant women experience nausea and vomiting of pregnancy (NVP), which impairs daily function and reduces quality of life. A severe form, hyperemesis gravidarum (HG), affects 0.3-3% of pregnant women and is the most common reason for hospitalization in the first half of pregnancy. Although NVP and HEG usually resolve by mid-pregnancy, symptoms persist into the third trimester in 15--20% of women. HG is associated with preterm birth and small-for gestational age infants as well as termination of desired pregnancies in 14.4% of affected women. Recent studies show that women with severe NVP (sNVP), defined by weight loss or continuation of symptoms beyond 20 weeks gestation, have offspring at risk for structural brain changes and cognitive developmental problems. Despite the frequency and complications of sNVP, only low-quality evidence is available to direct treatment. The NICHD report from the Task Force on Research Specific to Pregnant Women and Lactating Women stated that the drug pipeline for conditions specific to pregnancy is “minimal at best” and listed hyperemesis as an area of need for treatment research. This exploratory/developmental Clinical Trial Planning Grant is a Phase 2 study that will provide data on the acceptability, dose regimen, tolerability and safety of mirtazapine (Remeron®) for the treatment of sNVP that has not responded to at least two standard medications. We will to determine whether a larger randomized controlled trial to evaluate mirtazapine’s efficacy for sNVP is warranted. An FDA application for an IND will be submitted and a DSMB will be constituted. Mirtazapine is prescribed for nausea and vomiting during cancer chemotherapy. Rapid reduction of NVP during mirtazapine treatment has been reported in case series of pregnant women who have not responded to other medications. Mirtazapine impacts the serotonin receptor (similar to ondansetron) as well as three additional receptors involved in the physiologic cascade that results in nausea and emesis. It is a compelling candidate to consider for repurposing to expand therapeutic options for sNVP. Reproductive outcome data for mirtazapine do not indicate an increased risk for birth defects, although the number of women studied is relatively small (≈500). Additionally, pharmacogenetic factors that affect mirtazapine plasma concentrations and thereby affect its tolerability and safety will be considered in the proposed project.

项目总结/文摘