drugset / Trial / NCT05452174
Endeavor to Stop Nausea/Vomiting Associated With Pregnancy (E-SNAP)
Phase 1/2
Withdrawn
Northwestern University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab
NaSingle-groupOpen-labelTreatment
Summary
The primary objective of this proposal is to conduct an early Phase 2 clinical trial to determine the acceptability, dosing, tolerability and safety of mirtazapine for severe nausea and vomiting of pregnancy (sNVP) that is not adequately responsive to current standard treatments. This plan mirrors clinical practice since commonly prescribed antiemetic/ antinauseant drugs will be tested for efficacy before treating with mirtazapine.
Timeline
- Start
- 2022-06-13
- Primary completion
- 2023-10-29
- Completion
- 2023-10-29
Publications
- Background Abramowitz A, Miller ES, Wisner KL. Treatment options for hyperemesis gravidarum. Arch Womens Ment Health. 2017 Jun;20(3):363-372. doi: 10.1007/s00737-016-0707-4. Epub 2017 Jan 9.
- Background Fejzo MS, MacGibbon KW, Wisner KL. Pregnant, miserable, and starving in 21st century America. AJOG Glob Rep. 2022 Dec 5;3(1):100141. doi: 10.1016/j.xagr.2022.100141. eCollection 2023 Feb.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mirtazapine | Other / unclassified | 45 mg | — |