SchizophreniaPhase 1NCT05025605
Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
A Phase 1 study testing BXCL501 80 Micrograms, BXCL501 120 Micrograms and BXCL501 60 Micrograms in people with Schizophrenia and Schizo-Affective Disorder, run by BioXcel Therapeutics Inc at 5 sites in United States.
Trial summary
This is a study of the efficacy and safety of BXCL501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Schizophrenia, Schizo-Affective Disorder, Schizophreniform; Schizophrenic
- What is being tested?
- BXCL501 80 Micrograms, BXCL501 120 Micrograms and BXCL501 60 Micrograms
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 5 sitesUnited States
- Study dates
- 27 Aug 2021to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female subjects between the ages of 10-17 years, inclusive, with bipolar disorder (DSM-5 criteria) and 13-17 years, inclusive, in subjects with schizophrenia (DSM-5 criteria).
- Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥14 on the 5 items comprising the PANSS Excited Component (PEC).
- Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline.
- Participants who agree to use a medically acceptable and effective birth control method
Who cannot join
- Patients with agitation caused by acute intoxication, including alcohol or drugs of abuse (with the exception of THC) during urine screening.
- Use of benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotic drugs in the 4 hours before study treatment.
- Patients who are judged to be at significant risk of suicide.
- Patients with serious or unstable medical illnesses.
- Patients who have received an investigational drug within 30 days prior to the current agitation episode.
- Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving the study drug.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 4 recruiting
- Recruiting
BioXcel Clinical Research Site
Anaheim, California, 92805
BioXcel CTM, 475-254-5899, info@bioxceltherapeutics.com
- Completed
BioXcel Clinical Research Site
Atlanta, Georgia, 30331
- Recruiting
Bioxcel Clinical Research Site
Decatur, Georgia, 30030
Bioxcel CTM, 475-254-5899, info@bioxceltherapeutics.com
- Recruiting
BioXcel Clinical Research Site
DeSoto, Texas, 75115
Bioxcel CTM, 475-254-5899, info@bioxceltherapeutics.com
- Recruiting
Bioxcel Clinical Research Site
Hialeah, Florida, 33016
Bioxcel CTM, 475-254-5899, info@bioxceltherapeutics.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Determine Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
This is a study of the efficacy and safety of BXCL501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia.
Read the detailed description
The study will enroll approximately 140 subjects randomized to dose regimens of 80 µg or 120 µg BCXL501 or placebo (Group one), or 60 µg BCXL501 or placebo (Group two; Europe only). Subjects with acute agitation will include male and female children and adolescents who are either newly admitted to a hospital setting or already admitted and experiencing acute agitation. Subjects will be domiciled in a clinical research setting or hospitalized to remain under medical supervision while undergoing screening procedures to assess eligibility. Efficacy and safety assessments will be conducted periodically before and after dosing.
- Conditions
- Schizophrenia, Schizo-Affective Disorder, Schizophreniform; Schizophrenic, Bipolar Disorder I, Bipolar Disorder II
- Being tested
- BXCL501 80 Micrograms, Placebo Film, BXCL501 120 Micrograms, BXCL501 60 Micrograms
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BXCL501 80 MicrogramsDrug
Also called Dexmedetomidine
Sublingual film containing 80 Micrograms BXCL501
Placebo FilmDrug
Also called Placebo
Matching Sublingual Placebo film
BXCL501 120 MicrogramsDrug
Also called Dexmedetomidine
Sublingual film containing 120 Micrograms BXCL501
BXCL501 60 MicrogramsDrug
Also called Dexmedetomidine
Sublingual film containing 60 Micrograms BXCL501 Europe Only
| Study group | Role | What they receive |
|---|---|---|
| 80 Micrograms | Experimental | Sublingual film containing 80 micrograms Dexmedetomidine Receives: Drug: BXCL501 80 Micrograms |
| 120 Micrograms | Experimental | Sublingual film containing 120 micrograms Dexmedetomidine Receives: Drug: BXCL501 120 Micrograms |
| Placebo | Placebo comparator | Sublingual Placebo film Receives: Drug: Placebo Film |
| 60 Micrograms | Experimental | Sublingual film containing 60 micrograms Dexmedetomidine Europe Only Receives: Drug: BXCL501 60 Micrograms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change from baseline in the Positive and Negative Syndrome Scale - Excited Component (PEC) total score
The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)
Measured: 120 minutes - Group one only
Secondary outcomes (1)
Absolute change from baseline in the Positive and Negative Syndrome Scale - Excited Component (PEC) total score
The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)
Measured: 90, 60, 45, 30, 20,10 minutes - Group one only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start27 Aug 2021
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study will randomize subjects in Group one 1:1:1 to receive BXCL501 80 μg, BXCL501 120 μg, or matching placebo film; Group two 2:1 to receive BXCL501 60 μg or matching placebo film
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioXcel Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ProPharma Group
- Responsible party
- Sponsor
- Investigators
- BioXcel MM, MD, Study chair, BioXcel Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025605
- Sponsor's protocol ID
- BXCL501-105
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2021
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Determine Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
- ClinicalTrials.gov ID
- NCT05025605
- Acronym / sponsor ID
- BXCL501-105
- Conditions
- Schizophrenia, Schizo-Affective Disorder, Schizophreniform; Schizophrenic, Bipolar Disorder I, Bipolar Disorder II
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- BioXcel Therapeutics IncIndustry (pharma, biotech, devices)
- Collaborators
- ProPharma Group
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of the efficacy and safety of BXCL501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia.
Detailed description
The study will enroll approximately 140 subjects randomized to dose regimens of 80 µg or 120 µg BCXL501 or placebo (Group one), or 60 µg BCXL501 or placebo (Group two; Europe only). Subjects with acute agitation will include male and female children and adolescents who are either newly admitted to a hospital setting or already admitted and experiencing acute agitation. Subjects will be domiciled in a clinical research setting or hospitalized to remain under medical supervision while undergoing screening procedures to assess eligibility. Efficacy and safety assessments will be conducted periodically before and after dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Study will randomize subjects in Group one 1:1:1 to receive BXCL501 80 μg, BXCL501 120 μg, or matching placebo film; Group two 2:1 to receive BXCL501 60 μg or matching placebo film
| Arm | Type | Receives |
|---|---|---|
| 80 Micrograms | Experimental | Drug: BXCL501 80 MicrogramsSublingual film containing 80 micrograms Dexmedetomidine |
| 120 Micrograms | Experimental | Drug: BXCL501 120 MicrogramsSublingual film containing 120 micrograms Dexmedetomidine |
| Placebo | Placebo comparator | Drug: Placebo FilmSublingual Placebo film |
| 60 Micrograms | Experimental | Drug: BXCL501 60 MicrogramsSublingual film containing 60 micrograms Dexmedetomidine Europe Only |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male and female subjects between the ages of 10-17 years, inclusive, with bipolar disorder (DSM-5 criteria) and 13-17 years, inclusive, in subjects with schizophrenia (DSM-5 criteria).
- Patients who are judged to be clinically agitated at Screening and Baseline with a total score of ≥14 on the 5 items comprising the PANSS Excited Component (PEC).
- Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline.
- Participants who agree to use a medically acceptable and effective birth control method
Key exclusion criteria (6 listed)
- Patients with agitation caused by acute intoxication, including alcohol or drugs of abuse (with the exception of THC) during urine screening.
- Use of benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotic drugs in the 4 hours before study treatment.
- Patients who are judged to be at significant risk of suicide.
- Patients with serious or unstable medical illnesses.
- Patients who have received an investigational drug within 30 days prior to the current agitation episode.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BXCL501 80 MicrogramsAlso: DexmedetomidineSublingual film containing 80 Micrograms BXCL501 | Drug | 80 Micrograms |
| Placebo FilmAlso: PlaceboMatching Sublingual Placebo film | Drug | Placebo |
| BXCL501 120 MicrogramsAlso: DexmedetomidineSublingual film containing 120 Micrograms BXCL501 | Drug | 120 Micrograms |
| BXCL501 60 MicrogramsAlso: DexmedetomidineSublingual film containing 60 Micrograms BXCL501 Europe Only | Drug | 60 Micrograms |
Primary outcome
Absolute change from baseline in the Positive and Negative Syndrome Scale - Excited Component (PEC) total score
Time frame: 120 minutes - Group one only
The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)
1 secondary outcome
Absolute change from baseline in the Positive and Negative Syndrome Scale - Excited Component (PEC) total score
Time frame: 90, 60, 45, 30, 20,10 minutes - Group one only
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BioXcel MM, MD study chair
BioXcel Therapeutics
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BXCL501 80 Micrograms, BXCL501 120 Micrograms and BXCL501 60 Micrograms in people with Schizophrenia and Schizo-Affective Disorder, run by BioXcel Therapeutics Inc at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BioXcel CTM (475-238-6837, info@bioxceltherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change from baseline in the Positive and Negative Syndrome Scale - Excited Component (PEC) total score (time frame: 120 minutes - Group one only). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.