protocolSection identificationModule nctId: NCT06330584, orgStudyIdInfo id: AIM Care Study, briefTitle: Administration of Intranasal Midazolam for Anxiety in Palliative Care, acronym: AIM Care, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Insel Gruppe AG, University Hospital Bern, class: OTHER, collaborators name: University Hospital, Basel, Switzerland, collaborators name: University Hospital, Zürich, collaborators name: Stadtspital Zürich, descriptionModule briefSummary: 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., conditionsModule conditions: Anxiety, conditions: Acute Anxiety, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Double-blind, randomized, placebo-controlled parallel-group multicenter exploratory pilot study with 3 study arms, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: All study personnel except the personnel at the facility preparing the investigational medicinal product (IMP) (Hospital Pharmacy, University Hospital Basel), and all patients will be blinded to the assigned treatment. Allocation will be concealed using sequentially coded drug packs (using consecutive patient identification numbers from 1 to at least 30) containing the IMP that are otherwise identical. Each drug pack will contain two nasal sprays of identical appearance. Patients and all trial personnel involved in recruitment and care of patients, trial assessment, monitoring, and analyses will be blinded to the assigned trial arm. Blinding will be upheld until the last patient (at least 30 patients, i.e., at least 10 per study arm) has completed the pilot study and data entry into the trial database has been completed.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., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Placebo Nasal Spray 0 mg/spray, interventions name: Midazolam Nasal Spray 0.45 mg/spray, interventions name: Midazolam Nasal Spray 0.9 mg/spray, outcomesModule primaryOutcomes measure: Change from baseline in anxiety levels, measured by Visual Analogue Scale (VAS), primaryOutcomes measure: Change from baseline in anxiety levels, measured by Numerical Rating Scale (NRS), secondaryOutcomes measure: Sedation, secondaryOutcomes measure: Oxygen saturation SaO2 (percent %), secondaryOutcomes measure: Heart rate (bpm), secondaryOutcomes measure: Cortisol levels in oral fluid, secondaryOutcomes measure: Time to first requested additional dose, secondaryOutcomes measure: Cumulative number of doses over 24 hours, secondaryOutcomes measure: Number of patients with adverse drug events (ADEs), secondaryOutcomes measure: Peak plasma concentration (Cmax), secondaryOutcomes measure: Time to reach the peak plasma concentration (Tmax), secondaryOutcomes measure: Elimination half-life (t1/2), secondaryOutcomes measure: Area under the curve (AUC0-Τ, AUC0-∞), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Inselspital, Universitätsspital Bern, city: Bern, zip: 3010, country: Switzerland, contacts name: Manuel Haschke, MD, role: CONTACT, phone: +41 (0)31 632 67 93, email: manuel.haschke@insel.ch, contacts name: Manuel Haschke, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.94809, lon: 7.44744, locations facility: Universitäres Zentrum für Palliative Care (UZP), city: Bern, country: Switzerland, contacts name: Steffen Eychmüller, MD, role: CONTACT, phone: +41 (0)31 632 51 07, email: steffen.eychmueller@insel.ch, geoPoint lat: 46.94809, lon: 7.44744, locations facility: Zentrum für Palliative Care, Stadtspital Zürich, city: Zürich, zip: 8037, country: Switzerland, contacts name: Andreas Major, MD, role: CONTACT, phone: +41 (0)44 417 29 26, email: andreas.major@stadtspital.ch, geoPoint lat: 47.36667, lon: 8.54999, locations facility: Kompetenzzentrum Palliative Care, Universitätsspital Zürich, city: Zürich, zip: 8091, country: Switzerland, contacts name: Caroline Hertler, MD, role: CONTACT, phone: +41 (0)44 255 29 34, email: caroline.hertler@usz.ch, geoPoint lat: 47.36667, lon: 8.54999, hasResults: False