Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia (NCT04268303) | Clinical Trial Compass
CompletedPhase 3
Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia
United States380 participantsStarted 2020-01-24
Plain-language summary
This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in schizophrenia. The BXCL501-301 study is designed to characterize the efficacy, safety and tolerability of BXCL501 (sublingual film formulation of DEX, HCl) in agitation associated with schizophrenia, schizoaffective disorder or schizophreniform disorder.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and female patients between the ages of 18 to 75 years, inclusive.
. Patients who have met DSM-5 criteria for schizophrenia, schizoaffective, or schizophreniform disorder.
. Patients who are judged to be clinically agitated at Screening and 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 at Baseline.
. Patients who read, understand, and provide written informed consent.
. Patients who are in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ECG with rhythm strip, blood chemistry profile, hematology, urinalysis, and in the opinion of the Principal Investigator.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used a drug called dexmedetomidine to treat agitation in people with schizophrenia or schizoaffective disorder — since the trial is now completed, has the results data been published, and what did it show about how well it worked and whether it was safe?
2The trial measured something called the PEC score, which tracks excitement and agitation symptoms — based on the completed results, how meaningful were the changes in that score, and would that level of improvement actually matter in my day-to-day life?
3Since this was a Phase 3 trial, it was designed to test whether the treatment works at a larger scale after earlier safety studies — does that mean there's now enough evidence for my doctor to consider dexmedetomidine as a real treatment option, or is it still not approved for this use?
4Agitation episodes in schizophrenia can sometimes require fast-acting treatment — how does dexmedetomidine compare to medications already available for managing acute agitation, and is there a reason to consider it over what I might already be prescribed?
5Are there specific features of my diagnosis or health history — like the type of schizophrenia-related condition I have or any other medications I take — that would make dexmedetomidine more or less appropriate for me to discuss as an option?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in the Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score
. Participants who agree to use a medically acceptable and effective birth control method
Exclusion criteria
. Patients with agitation caused by acute intoxication, including positive identification of alcohol by breathalyzer or drugs of abuse (with the exception of THC) during urine screening.
. Use of benzodiazepines, hypnotics and anti-psychotic drugs in the 4 hours before study treatment.
. Treatment with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin) or other prohibited medications.
. Patients who are judged to be at significant risk of suicide
. Female patients who have a positive pregnancy test at screening or are breastfeeding.
. Patients who have hydrocephalus, seizure disorder, or history of significant head trauma, stroke, transient ischemic attack, subarachnoid bleeding, brain tumor, encephalopathy, meningitis, Parkinson's disease or focal neurological findings.
. History of syncope or other syncopal attacks, current evidence of hypovolemia, orthostatic hypotension.
. Patients with laboratory or ECG abnormalities considered clinically significant by the investigator.