Plain-English translation of NCT05431595 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This trial is testing whether three medications—, , and —can help calm severe agitation and restlessness in cancer patients who develop delirium (confusion and agitation) while in the hospital. You would receive one of these medications or a placebo (inactive treatment) by IV every 12 hours, along with comfort-focused care. The goal is to find out which approach works best to reduce distressing agitation over a 72-hour period.
Delirium with severe agitation is very distressing for patients and their families, and doctors need better, safer ways to manage it. This medication approach aims to reduce the need for higher doses of single drugs while keeping patients more comfortable.
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You would stay in the hospital for 72 hours while receiving one of the four treatment options by IV every 12 hours (and more often if needed for breakthrough agitation). A research team would monitor your comfort, any side effects, how severe your agitation is, and how well the treatment works. Your family member would also be asked about their experience and how distressed they feel. The study focuses on measuring restlessness and other symptoms over this three-day period.
AI-generated summary from trial data · Jun 1, 2026 · Not medical advice
United States