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Nasal spray could quickly calm anxiety in End-of-Life patients

NCT ID NCT06330584

Symptom relief Sponsor: Insel Gruppe AG, University Hospital Bern Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests whether a midazolam nasal spray can quickly reduce acute anxiety in adults receiving palliative care. Participants will receive one of two doses of midazolam or a placebo spray. The main goal is to see if anxiety levels drop within 30 minutes, while also checking safety and how the drug moves through the body.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
midazolam nasal spray
What this could lead to
If it works, this could offer a fast, needle-free way to calm severe anxiety in people receiving end-of-life care.
What could go wrong
This is a very small early pilot study with only 36 participants, so results may not apply broadly. Midazolam can cause drowsiness or breathing problems, especially in frail patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Oct 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult palliative care patients (≥ 18 years) hospitalized at one of the study sites * Self-reported acute anxiety with clinical indication for intranasal midazolam administration according to attending physician * Patient willing and able to provide written informed consent * Informed consent as documented by signature * Patient willing and able to complete anxiety assessment * Additionally for nested pharmacokinetic analysis: Patients with available central or peripheral venous access, i.e., peripheral venous catheter (PVC), central venous catheter (CVC), peripherally inserted central venous catheter (PICC) line, midline catheter, or PORT-A-CATH® (PAC), and patient willing and able to provide blood samples Exclusion Criteria: * Intranasal midazolam prescribed for seizures * Midazolam (any route of administration) prescribed and administered for continuous sedation * History of allergy or hypersensitivity to midazolam * History of benzodiazepine-related paradoxical reaction to midazolam * Acute narrow-angle glaucoma * Impaired nasal absorption (e.g., nasogastric tube, nasal obstruction, nasal polyps, etc.) * Intranasal midazolam within 24 h before study enrollment * Time between informed general consent for study participation through investigators and planned midazolam administration \< 24 h * Co-medication with strong CYP3A4 inducers or inhibitors according to pre-defined list (FDA) * Recently initiated therapy with strong opioids (i.e., within past 5 days) * Co-medication with other CNS depressants causing clinically relevant degree of sedation * Inability to follow the procedures of the study (i.e., provision of Informed Consent, completion of assessment tool, e.g., due to language problems or dementia)

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute anxiety Anxiety Palliative care

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Inselspital, Universitätsspital Bern

    NOT_YET_RECRUITING

    Bern, 3010, Switzerland

  • Kompetenzzentrum Palliative Care, Universitätsspital Zürich

    RECRUITING

    Zurich, 8091, Switzerland

  • Palliativzentrum Bethesda Spital

    RECRUITING

    Basel, Canton of Basel-City, 4052, Switzerland

  • Universitäres Zentrum für Palliative Care (UZP)

    RECRUITING

    Bern, Switzerland

  • Zentrum für Palliative Care, Stadtspital Zürich

    RECRUITING

    Zurich, 8037, Switzerland

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