Administration of Intranasal Midazolam for Anxiety in Palliative Care
Recruiting · NCT06330584 · Interventional (participants receive a specific treatment) · Lead sponsor: Insel Gruppe AG, University Hospital Bern
View the official record on ClinicalTrials.gov →Interventions studied
Midazolam Nasal Spray 0.45 mg/sprayMidazolam Nasal Spray 0.9 mg/sprayPlacebo Nasal Spray 0 mg/spray
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
5 locations listed.
- 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
- Palliativzentrum Bethesda Spital - Basel, Canton of Basel-City, Switzerland