Administration of Intranasal Midazolam for Anxiety in Palliative Care
NCT ID: NCT06330584
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
36 participants
INTERVENTIONAL
2024-12-20
2025-10-31
Brief Summary
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Detailed Description
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In a nested analysis, pharmacokinetic properties of all three doses will be analyzed in participants with available venous access.
The primary outcome is the change in patient-reported levels of anxiety from baseline. Secondary outcomes include time until first requested additional dose, cumulative number of doses including time points of administration after the first application, oxygen saturation, heart rate, cortisol levels in oral fluid, levels of sedation on the Richmond Agitation Sedation Scale Palliative Version (RASS-PAL), and occurrence of (serious) adverse events.
The primary and secondary outcomes will be assessed at baseline, i.e., immediately before the intervention (0 minutes) and 30 minutes after the intervention. The secondary outcomes 'Time to first requested additional dose' and 'Cumulative number of doses over 24 hours' as well as (serious) adverse events will be assessed starting 30 minutes after the intervention up to 24 hours after the intervention.
In patients included in the nested pharmacokinetic analysis, basic pharmacokinetic parameters will additionally be assessed at 10 time points, starting at baseline (0 minutes) up to 240 minutes after the intervention.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
To safeguard blinding, placebo formulation will be produced with the same pH as the active study drug formulations to mimic nasal irritation induced by verum sprays.
Study Groups
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Placebo
Total dose of midazolam = 0 mg (no active compound)
Placebo 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
Standard of Care (SOC)
Total dose of midazolam = 0.9 mg
Midazolam 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
Double Dose of Standard of Care (2xSOC)
Total dose of midazolam = 1.8 mg
Midazolam 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
Interventions
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Placebo 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
Midazolam 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
Midazolam 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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Carla Meyer-Massetti, PhD
Role: STUDY_CHAIR
Inselspital, Universitätsspital Bern
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-00873
Identifier Type: -
Identifier Source: org_study_id
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