Clinical trial

Endeavor to Stop Nausea/Vomiting Associated With Pregnancy (E-SNAP)

Name

STU00215676

Description

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.

Trial arms

Trial start

2022-06-13

Estimated PCD

2023-10-29

Trial end

2023-10-29

Status

Terminated

Phase

Early phase I

Treatment

Mirtazapine

Mirtazapine, sold under the brand name Remeron, is an atypical antidepressant, and as such is used primarily to treat depression.

Arms:

Mirtazapine Treatment Arm

Other names:

Remeron

Size

Primary endpoint

change in Pregnancy Unique Quality of Emesis (PUQE) score

daily for three weeks

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 2, 'type': 'ACTUAL'}}

Updated at

2024-04-24

1 organization

1 product

3 indications

Organization

Northwestern University

Product

Mirtazapine

Indication

Pregnancy

Indication

Severe Nausea and Vomiting

Indication

Hyperemesis Gravidarum