RecruitingPhase 2NCT06330584

Administration of Intranasal Midazolam for Anxiety in Palliative Care

Administration of Intranasal Midazolam for Anxiety in Palliative Care - a Double-blind, Randomized, Placebo-controlled Multicenter Exploratory Pilot Study With a Nested Pharmacokinetic Analysis


Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

36 participants

Start Date

Dec 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this double-blind, randomized, placebo-controlled parallel-group multicenter exploratory pilot study (three study arms) is to describe effects and safety of different doses of intranasal midazolam to treat acute anxiety in palliative care patients, while providing pharmacokinetic and pharmacodynamic data.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the use of midazolam (a sedative medication) delivered through a nasal spray to quickly relieve sudden episodes of severe anxiety in palliative care patients — people receiving end-of-life or comfort-focused care. Intranasal delivery is fast, non-invasive, and may be easier than injections for patients in this situation. Researchers want to confirm how well it works, how safe it is, and how it is absorbed by the body. **You may be eligible if:** - You are an adult (18+) receiving palliative care at one of the participating hospitals - You have a sudden episode of acute anxiety, and your doctor has decided intranasal midazolam is appropriate for you - You are able and willing to give written consent and complete anxiety assessments **You may NOT be eligible if:** - Midazolam is being prescribed for seizures or continuous sedation - You have an allergy or known sensitivity to midazolam or benzodiazepines - You have had a paradoxical reaction to midazolam (meaning it made you more agitated instead of calmer) - You have acute narrow-angle glaucoma (a specific eye condition) - You have nasal obstructions (such as nasal tubes, polyps, or blockages) that would prevent absorption - You are taking certain medications that strongly interact with midazolam - You were recently started on strong opioid pain medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPlacebo Nasal Spray 0 mg/spray

A unit-dose nasal spray will be used for the intervention. 1 spray (= 0.1 μl = 0 mg midazolam/spray) in each nostril, i.e., no active compound

DRUGMidazolam Nasal Spray 0.45 mg/spray

A unit-dose nasal spray will be used for the intervention. 1 spray (= 0.1 μl = 0.45 mg midazolam/spray) in each nostril, i.e., total dose of midazolam 0.9 mg

DRUGMidazolam Nasal Spray 0.9 mg/spray

A unit-dose nasal spray will be used for the intervention. 1 spray (= 0.1 μl = 0.9 mg midazolam/spray) in each nostril, i.e., total dose of midazolam 1.8 mg


Locations(5)

Palliativzentrum Bethesda Spital

Basel, Canton of Basel-City, Switzerland

Inselspital, Universitätsspital Bern

Bern, Switzerland

Universitäres Zentrum für Palliative Care (UZP)

Bern, Switzerland

Zentrum für Palliative Care, Stadtspital Zürich

Zurich, Switzerland

Kompetenzzentrum Palliative Care, Universitätsspital Zürich

Zurich, Switzerland

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NCT06330584


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