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

Anxiety Palliative Care Acute Anxiety

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

Inclusion Criteria6

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 Criteria12

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)

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