BXCL501 for Schizophrenia and Bipolar Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, BXCL501, to evaluate its effectiveness for individuals with schizophrenia, bipolar disorder, and similar conditions. The primary focus is on episodes of psychomotor agitation, characterized by restlessness or an inability to sit still. Researchers aim to compare assessments of these episodes by patients, their close contacts, and doctors. Individuals who have experienced an agitation episode requiring treatment in the last 30 days and are on stable medication for their condition might be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications to join the trial?
You need to be on stable psychotropic treatment for 30 days before the trial and continue it during the study. However, you cannot take certain medications like alpha-1 noradrenergic blockers or alpha-2 adrenergic agonists.
Is there any evidence suggesting that BXCL501 is likely to be safe for humans?
Research has shown that BXCL501, a small film placed under the tongue containing dexmedetomidine, is generally well-tolerated by patients. Earlier studies tested various doses, including 120 micrograms, for safety and effectiveness. Participants handled the treatment well, and it helped manage sudden agitation in people with bipolar disorder and schizophrenia.
Some studies included a large number of patients, providing strong support for these findings. Although mild side effects like drowsiness were reported, the treatment is considered safe for these conditions. The current phase of research indicates that BXCL501 has shown enough promise in earlier studies to warrant continued testing.12345Why do researchers think this study treatment might be promising for schizophrenia and bipolar disorder?
Unlike the standard treatments for schizophrenia and bipolar disorder, which often involve antipsychotics and mood stabilizers, BXCL501 introduces an innovative approach with its sublingual film delivery of dexmedetomidine. This treatment is unique because it targets the alpha-2 adrenergic receptors, a different mechanism of action compared to traditional options that primarily focus on dopamine and serotonin pathways. The sublingual film allows for rapid absorption and onset of action, potentially offering quicker relief from symptoms. Researchers are excited about BXCL501 because it promises a new pathway for managing these conditions, potentially with fewer side effects and faster results.
What evidence suggests that BXCL501 might be an effective treatment for Schizophrenia and Bipolar Disorder?
Research has shown that BXCL501, a small film placed under the tongue, holds promise for treating restlessness and agitation. In earlier studies, patients felt much calmer just two hours after taking BXCL501 compared to those who took a placebo, which contains no active medicine. This treatment has effectively managed episodes in conditions like bipolar disorder. The FDA recognized its potential by granting it special status for treating agitation related to dementia. These findings suggest that BXCL501 could be a helpful option for managing agitation in schizophrenia and similar disorders. Participants in this trial will receive BXCL501 as a sublingual film to evaluate its effectiveness in these conditions.13567
Who Is on the Research Team?
Matt Mandel, MD
Principal Investigator
BioXcel Therapeutics
Are You a Good Fit for This Trial?
This trial is for individuals with conditions like schizophrenia, bipolar disorder, schizoaffective disorder, and schizophreniform disorder who experience severe restlessness or agitation (psychomotor agitation). Specific eligibility criteria are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BXCL501 Sublingual film and are assessed for psychomotor agitation measures
Follow-up
Participants are monitored for safety and effectiveness after treatment
Informant and Patient Training
Assessment of content validity of training materials for informants and patients
What Are the Treatments Tested in This Trial?
Interventions
- BXCL501
Find a Clinic Near You
Who Is Running the Clinical Trial?
BioXcel Therapeutics Inc
Lead Sponsor
Premier Research Group plc
Industry Sponsor
John Ratliff
Premier Research Group plc
Chief Executive Officer since 2024
MBA
Dr. Milena Kanova-Petrova
Premier Research Group plc
Chief Medical Officer since 2024
MD
Premier Research Group plc
Collaborator
Premier Research
Collaborator