Endeavor to Stop Nausea/Vomiting Associated With Pregnancy (E-SNAP) (NCT05452174) | Clinical Trial Compass
WithdrawnPhase 1/2
Endeavor to Stop Nausea/Vomiting Associated With Pregnancy (E-SNAP)
Stopped: transfer of PI to new organization
United States0Started 2022-06-13
Plain-language 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.
Who can participate
Age range
18 Years – 49 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* singleton pregnancy
* inpatient or outpatient status
* English speaking
* obstetrician's evaluation and diagnosis of sNVP or HG
* tolerance of oral disintegrating tablet at bedtime
* PUQE score of 10-15; moderate/high or severe
* refractory sNVP
* blood pressure range 70-200 / 45-120
* normal ECG
Exclusion Criteria:
* allergic or adverse reaction to mirtazapine
* patient has bipolar disorder
* subjects with active depression, or history of or current active suicidal ideation or attempt
* subjects with renal or hepatic impairment
* substance about in last 6 months
* use of medicinal or recreational cannabis-derived products in the last 6 months
* taking MAOIs, strong CYP3A inducers or inhibitors, and SSRIs
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
change in Pregnancy Unique Quality of Emesis (PUQE) score