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Can a dissolvable film quiet ICU delirium?

NCT ID NCT05313386

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Started

Feb 2021

Expected to finish

Feb 2022

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Inclusion Criteria for Enrollment (Informed Consent): 1. ICU admitted male and female patients, ≥ 18 years, COVID 19 (+) and (-) 2. Subject or legally appointed representative (LAR) able to read, understand and provide informed consent, or to provide assent Inclusion Criteria for Randomization: 3. Positive CAM-ICU 4. RASS score ≥ +1 5. Subject judged to be likely capable of self-administration Exclusion Criteria: 1. Clinically significant ECG changes, brady- and tachyarrhythmias, QTc prolongation 2. Hepatic dysfunction 3. Pregnancy 4. Known allergy to Dexmedetomidine or Haloperidol.

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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

More trials for these conditions

Other studies related to the condition(s) this trial covers.