Schizophrenia study: BXCL501
Official title Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
ClinicalTrials.gov ID: NCT05025605
What this study is testing
What is BXCL501 80 µg?
an investigational sublingual film being studied as a potential treatment for schizophrenia in children and adolescents is designed to activate alpha‑2 adrenergic receptors, which can reduce norepinephrine activity and produce calming effects
Also referred to as Dexmedetomidine.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out whether BXCL501 is safe and effective for treating acute agitation in young people with bipolar disorder or schizophrenia.
- Who it's for
- Children and adolescents who are experiencing sudden, severe agitation and have been diagnosed with bipolar disorder or schizophrenia.
- What's involved
- Participants will receive the investigational drug BXCL501 and undergo safety monitoring and assessments during the study.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 17
You may be able to join if
- Male and female people between the ages of 10-17 years, inclusive, with bipolar disorder (DSM-5 criteria) and 13-17 years, inclusive, in people with...
- 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...
- 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
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Anaheim, California, United States
- Hialeah, Florida, United States
- Decatur, Georgia, United States
- DeSoto, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Anaheim, California, United States; Hialeah, Florida, United States; Decatur, Georgia, United States; DeSoto, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.