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

> **NIH NIH R21** · NORTHWESTERN UNIVERSITY · 2022 · $240,000

## Abstract

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.

## Key facts

- **NIH application ID:** 10390898
- **Project number:** 1R21HD105101-01A1
- **Recipient organization:** NORTHWESTERN UNIVERSITY
- **Principal Investigator:** KATHERINE L WISNER
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $240,000
- **Award type:** 1
- **Project period:** 2022-06-13 → 2024-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10390898

## Citation

> US National Institutes of Health, RePORTER application 10390898, ENDEAVOR TO STOP NAUSEA/VOMITING ASSOCIATED WITH PREGNANCY (E-SNAP) (1R21HD105101-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10390898. Licensed CC0.

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