140 Participants Needed

BXCL501 for Pediatric Schizophrenia and Bipolar Agitation

Recruiting at 5 trial locations
LH
CB
RD
CG
Overseen ByCarl Gommoll
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a study of the efficacy and safety of BXCL501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia.

Will I have to stop taking my current medications?

The trial requires that you do not use benzodiazepines or other hypnotics, or certain antipsychotic drugs in the 4 hours before the study treatment. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Is BXCL501 (Dexmedetomidine) safe for treating agitation in schizophrenia and bipolar disorder?

In studies, sublingual dexmedetomidine (BXCL501) was found to be safe for treating agitation in adults with schizophrenia and bipolar disorder, with the most common side effect being mild sleepiness.12345

How is the drug BXCL501 different from other treatments for pediatric schizophrenia and bipolar agitation?

BXCL501 is unique because it is a sublingual (under the tongue) film formulation of dexmedetomidine, which is typically used as a sedative in intensive care settings. This method of administration allows for rapid absorption and onset of action, which can be particularly beneficial in managing acute agitation in pediatric patients.678910

What data supports the effectiveness of the drug BXCL501 for treating agitation in pediatric patients with schizophrenia and bipolar disorder?

Research shows that sublingual dexmedetomidine, a component of BXCL501, is effective in reducing agitation in adults with schizophrenia and bipolar disorder. In clinical trials, it significantly improved agitation symptoms without serious side effects, suggesting it could be a promising option for similar conditions in pediatric patients.134511

Who Is on the Research Team?

RR

Robert Risinger, MD

Principal Investigator

BioXcel Therapeutics

Are You a Good Fit for This Trial?

This trial is for children and teens aged 10-17 with bipolar disorder, and those aged 13-17 with schizophrenia who are experiencing significant agitation. They must have a specific level of agitation on the PANSS Excited Component scale and agree to use effective birth control. It's not for those who've used certain sedatives recently, are at suicide risk, have serious health issues, or have taken experimental drugs within the last month.

Inclusion 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)
I am between 10-17 years old and have been diagnosed with bipolar disorder.
I am a teenager aged 13-17 with schizophrenia.
See 2 more

Exclusion Criteria

Patients with serious or unstable medical illnesses
Patients with agitation caused by acute intoxication, including alcohol or drugs of abuse (with the exception of THC) during urine screening
I haven't taken any sleep or antipsychotic medication in the last 4 hours.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive sublingual film containing Dexmedetomidine or placebo

1-2 weeks
Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • BXCL501
Trial Overview The study tests BXCL501 at different doses (60, 80, and 120 micrograms) against a placebo to see if it helps calm down kids and teens with bipolar disorder or schizophrenia during acute agitation episodes. The effectiveness and safety of these treatments are being compared.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Placebo Group
Group I: 80 MicrogramsExperimental Treatment1 Intervention
Group II: 60 MicrogramsExperimental Treatment1 Intervention
Group III: 120 MicrogramsExperimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

BXCL501 is already approved in United States for the following indications:

🇺🇸
Approved in United States as IGALMI for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

BioXcel Therapeutics Inc

Lead Sponsor

Trials
20
Recruited
2,400+

Cognitive Research Corporation

Industry Sponsor

Trials
25
Recruited
2,400+

Published Research Related to This Trial

Dexmedetomidine sublingual film has been shown to be effective in reducing acute agitation in patients with schizophrenia and bipolar disorder, with significant improvements observed as early as 20 minutes after administration in pivotal trials involving these conditions.
The most common side effect was somnolence, while cardiovascular effects were generally mild and temporary, making dexmedetomidine a promising non-invasive alternative to traditional antipsychotics and benzodiazepines for managing agitation.
Dexmedetomidine Sublingual Film: A New Treatment to Reduce Agitation in Schizophrenia and Bipolar Disorders.Karlin, DM., Nelson, LA., Campbell, AR.[2023]
Sublingual dexmedetomidine (Igalmi) is a safe and effective treatment for acute agitation in adults with schizophrenia or bipolar disorder, as demonstrated in two phase 3 trials involving different dose strengths (180 μg and 120 μg).
Both doses significantly improved agitation scores compared to placebo within two hours, with mild somnolence being the most common side effect, indicating a favorable safety profile without serious adverse events.
Sublingual Dexmedetomidine for the Treatment of Agitation in Patients with Schizophrenia and Bipolar Disorder.Smith, CM., Santalucia, M., Bunn, H., et al.[2023]
Sublingual dexmedetomidine has a favorable efficacy profile for treating agitation in adults with schizophrenia or bipolar disorder, with a number needed to treat of 3 for significant response at 2 hours post-dose in both conditions.
The treatment's safety profile is also acceptable, as the number needed to harm for adverse events is generally greater than 10, except for somnolence, which has a number needed to harm of 7, indicating that the benefits outweigh the risks.
Sublingual Dexmedetomidine for Agitation Associated with Schizophrenia or Bipolar Disorder: A Post Hoc Analysis of Number Needed to Treat, Number Needed to Harm, and Likelihood to be Helped or Harmed.Citrome, L., Risinger, R., Rajachandran, L., et al.[2023]

Citations

Dexmedetomidine Sublingual Film: A New Treatment to Reduce Agitation in Schizophrenia and Bipolar Disorders. [2023]
Sublingual Dexmedetomidine for the Treatment of Agitation in Patients with Schizophrenia and Bipolar Disorder. [2023]
Sublingual Dexmedetomidine for Agitation Associated with Schizophrenia or Bipolar Disorder: A Post Hoc Analysis of Number Needed to Treat, Number Needed to Harm, and Likelihood to be Helped or Harmed. [2023]
Sublingual dexmedetomidine: repurposing an anesthetic as an anti-agitation agent. [2023]
Sublingual Dexmedetomidine for the Treatment of Acute Agitation in Adults With Schizophrenia or Schizoaffective Disorder: A Randomized Placebo-Controlled Trial. [2022]
The treatment of acute agitation associated with schizophrenia or bipolar disorder: investigational drugs in early stages of their clinical development, and their clinical context and potential place in therapy. [2020]
Ionotropic glutamate receptors as therapeutic targets in schizophrenia. [2022]
Directly and Indirectly Targeting the Glycine Modulatory Site to Modulate NMDA Receptor Function to Address Unmet Medical Needs of Patients With Schizophrenia. [2021]
The NMDA receptor glycine modulatory site: a therapeutic target for improving cognition and reducing negative symptoms in schizophrenia. [2018]
A review of aripiprazole in the treatment of patients with schizophrenia or bipolar I disorder. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Clozapine: its impact on aggressive behavior among children and adolescents with schizophrenia. [2013]
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