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New dissolving film could calm agitation in schizophrenia without needles

NCT ID NCT04268303

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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times

Summary

This Phase 3 trial tested a sublingual film containing dexmedetomidine (BXCL501) to quickly reduce agitation in 380 adults with schizophrenia or related disorders. Participants received either the drug or a placebo film, and researchers measured changes in agitation symptoms over time. The goal is to offer a needle-free, fast-acting option for acute agitation episodes.

What this could mean

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

Active substance
dexmedetomidine (BXCL501) sublingual film
What this could lead to
If successful, this could provide a fast-acting, non-injectable option to calm agitation in people with schizophrenia, potentially reducing the need for emergency sedation.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The effect may be modest, and side effects like low blood pressure or drowsiness 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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

380 people

The number who actually took part.

Started

Jan 2020

Finished

May 2020

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 to 75 years

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: A subject will be eligible for inclusion in the study if he or she meets the following criteria: 1. Male and female patients between the ages of 18 to 75 years, inclusive. 2. Patients who have met DSM-5 criteria for schizophrenia, schizoaffective, or schizophreniform disorder. 3. Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥ 14 on the 5 items (poor impulse control, tension, hostility, uncooperativeness, and excitement) comprising the PANSS Excited Component (PEC). 4. Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline. 5. Patients who read, understand, and provide written informed consent. 6. Patients who are in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ECG with rhythm strip, blood chemistry profile, hematology, urinalysis, and in the opinion of the Principal Investigator. 7. Participants who agree to use a medically acceptable and effective birth control method Exclusion Criteria: A subject will be excluded from the study if he or she meets the following criteria: 1. Patients with agitation caused by acute intoxication, including positive identification of alcohol by breathalyzer or drugs of abuse (with the exception of THC) during urine screening. 2. Use of benzodiazepines, hypnotics and anti-psychotic drugs in the 4 hours before study treatment. 3. Treatment with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin) or other prohibited medications. 4. Patients who are judged to be at significant risk of suicide 5. Female patients who have a positive pregnancy test at screening or are breastfeeding. 6. Patients who have hydrocephalus, seizure disorder, or history of significant head trauma, stroke, transient ischemic attack, subarachnoid bleeding, brain tumor, encephalopathy, meningitis, Parkinson's disease or focal neurological findings. 7. History of syncope or other syncopal attacks, current evidence of hypovolemia, orthostatic hypotension. 8. Patients with laboratory or ECG abnormalities considered clinically significant by the investigator. 9. Patients with serious or unstable medical illnesses. 10. Patients who have received an investigational drug within 30 days prior to the current agitation episode. 11. Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving DEX.

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Conditions

The condition(s) this trial relates to.

Psychomotor Agitation Psychotic Disorders schizoaffective disorder schizophrenia schizophreniform disorder

As listed by the trial registrant

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

Agitation Schizo affective disorder Schizoaffective disorder Schizophrenia Schizophreniform disorders

Contacts and locations

Locations

  • BioXcel Clinical Research Site

    Little Rock, Arkansas, 72211, United States

  • BioXcel Clinical Research Site

    Cerritos, California, 78754, United States

  • BioXcel Clinical Research Site

    Culver City, California, 90230, United States

  • BioXcel Clinical Research Site

    Long Beach, California, 90806, United States

  • BioXcel Clinical Research Site

    Orange, California, 92868, United States

  • BioXcel Clinical Research Site

    Miami Lakes, Florida, 33016, United States

  • BioXcel Clinical Research Site

    Chicago, Illinois, 60640, United States

  • BioXcel Clinical Research Site

    Gaithersburg, Maryland, 20877, United States

  • BioXcel Clinical Research Site

    Las Vegas, Nevada, 89102, United States

  • BioXcel Clinical Research Site

    Berlin, New Jersey, 08009, United States

  • BioXcel Clinical Research Site

    Marlton, New Jersey, 08053, United States

  • BioXcel Clinical Research Site

    Charleston, South Carolina, 29407, United States

  • BioXcel Clinical Research Site

    Austin, Texas, 78754, United States

  • BioXcel Clinical Research Site

    DeSoto, Texas, 75115, United States

  • BioXcel Clinical Research Site

    Richardson, Texas, 75080, United States

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