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Administration of Intranasal Midazolam for Anxiety in Palliative Care

Study acronym: AIM Care
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Site details revised at 1 of 5 sitesv7
  2. Study sites: 4 to 5
    • Primary completion date: Jun 2025 to Sep 2025
    • Study completion date: Jun 2025 to Oct 2025
    • Study description revised
    v6
  3. Start date changed from estimate of Jan 1, 2025 to Dec 20, 2024
    • Site details revised at 1 of 4 sites
    v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 4 of 4 sites
    v4
  5. Start date: Nov 1, 2024 to Jan 1, 2025
    • Collaborators shortened, about 9 words
    v3
  6. Primary and study completion dates: Oct 31, 2024 to Jun 2025v2 Show 6 more changesShow less
    • Start date: Jun 1, 2024 to Nov 1, 2024
    • Primary endpoints: 2 to 1
    • Enrollment target: 30 to 36
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 1 of 11 entries
    • Study description expanded, about 5 words
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT06330584
Lead Sponsor Insel Gruppe AG, University Hospital Bern
Conditions
(from sponsor)		 Anxiety, Acute Anxiety, Palliative Care
Related terms Anxiety Disorders
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov