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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
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
* I…
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)
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.