Completed

A Phase Ib Multicenter, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Determine Efficacy, Pharmacokinetics and Safety of BXCL501 in Agitation Associated With Schizophrenia

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What is being tested

Sublingual film containing BXCL501 (Dexmedetomidine)

+ Placebo film

Drug
Who is being recruted

Aberrant Motor Behavior in Dementia+11

+ Behavior

+ Mental Disorders

From 18 to 65 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 1
Interventional
Study Start: May 2019
See protocol details

Summary

Principal SponsorBioXcel Therapeutics Inc
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 22, 2019

Actual date on which the first participant was enrolled.

This is a two-stage adaptive Phase Ib trial design. It is a randomized, double-blind, placebo-controlled, multiple ascending dose study assessing efficacy, pharmacokinetics, safety and tolerability of BXCL501 dosing in adult (18-65 years old) males and females with acute agitation associated with schizophrenia, schizoaffective disorder, or schizophreniform disorder. The first stage will characterize a safe and tolerable dose range that results in a calming effect as measured using the PEC total score. The lowest dose with clear clinical benefit, and the highest safe and well-tolerated dose that demonstrates efficacy in a large proportion of subjects will be selected over the course of testing multiple escalating dose cohorts. The second stage will comprise a total of 40 subjects per dose group in a three-arm placebo-controlled design in order to better characterize the broader range of safety and tolerability as well as better estimate variability (effect size) which may be observed in later phase placebo-controlled trials.

Official TitleA Phase Ib Multicenter, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Determine Efficacy, Pharmacokinetics and Safety of BXCL501 in Agitation Associated With Schizophrenia
NCT04010305
Principal SponsorBioXcel Therapeutics Inc
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

135 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Aberrant Motor Behavior in DementiaBehaviorMental DisordersBehavioral SymptomsNervous System DiseasesNeurologic ManifestationsPsychomotor AgitationPsychomotor DisordersSchizophreniaSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsSchizophrenia Spectrum and Other Psychotic DisordersDyskinesias

Criteria

7 inclusion criteria required to participate
Male and female patients between the ages of 18 to 65 years, inclusive.
Patients who have met Diagnostic and Statistical Manual (DSM) -5 criteria for schizophrenia, schizoaffective, or schizophreniform disorder.
Patients who are judged to be clinically agitated at 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).
Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC.
Show More Criteria
11 exclusion criteria prevent from participating
Patients with agitation caused by acute intoxication, including positive identification of alcohol by breathalyzer or non-prescription drugs (with the exception of THC) during urine screening.
Patients treated within 4 hours prior to study drug administration with benzodiazepines, other hypnotics or oral or short-acting intramuscular antipsychotics.
Treatment with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, and alfuzosin, and prazosin) or other prohibited medications.
Patients with significant risk of suicide or homicide per the investigator's assessment, or any suicidal behavior in last 6 months prior to screening.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

5 intervention groups are designated in this study

20% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
2 Sublingual Films, each containing 60 micrograms BXCL501; single administration of 2 films with the possibility of repeating dose after 1 hour in case of lack of significant efficacy

Group II

Experimental
2 Sublingual Films, each containing 60 micrograms BXCL501.

Group III

Experimental
Sublingual Film containing 20 micrograms BXCL501; single administration with the possibility of repeating dose after 1 hour in case of lack of significant efficacy

Group IV

Experimental
Sublingual Film containing 60 micrograms BXCL501; single administration with the possibility of repeating dose after 1 hour in case of lack of significant efficacy

Group 5

Placebo
Sublingual Film with no active drug; single administration with the possibility of repeating dose after 1 hour in case of lack of significant efficacy

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 12 locations

Suspended

BioXcel Clinical Research Site

Little Rock, United StatesOpen BioXcel Clinical Research Site in Google Maps
Suspended

BioXcel Clinical Research Site

Cerritos, United States
Suspended

BioXcel Clinical Research Site

Lemon Grove, United States
Suspended

BioXcel Clinical Research Site

Long Beach, United States
Completed12 Study Centers
A Phase Ib Multicenter, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Determine Efficacy, Pharmacokinetics and Safety of BXCL501 in Agitation Associated With Schizophrenia | PatLynk