Can a dissolvable film quiet ICU delirium?

NCT ID NCT05313386

Terminated Symptom relief Sponsor: BioXcel Therapeutics Inc Source: ClinicalTrials.gov ↗

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether a dissolvable film containing dexmedetomidine (BXCL501) can safely and effectively reduce agitation in adult ICU patients who have delirium. The study will compare four different starting doses of the drug against a placebo to find the best balance of safety and effectiveness. It aims to see if a single dose can quickly calm patients, as measured by a drop in their agitation score.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: BXCL501 (dexmedetomidine) given as a dissolvable film
What this could lead to: If successful, this could provide a fast, easy-to-administer treatment to calm agitation in ICU patients with delirium, potentially improving their care and recovery.
What could go wrong: This is an early-phase trial, so the optimal dose and safety are still being determined. The drug may not work for all patients, and side effects like changes in heart rate or blood pressure are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

delirium Psychomotor Agitation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AGITATION DELIRIUM

Contacts and locations

Locations

BioXcel Clinical Research Site

Nashville, Tennessee, 37203, United States

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