BXCL501 for Agitation in Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-09

Study Completion Date

2023-05-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Agitation is characterized by excessive motor or verbal activity, irritability, uncooperativeness, threatening gestures, and, in some cases, aggressive or violent behavior. While agitation may have various underlying causes, patients with schizophrenia are especially vulnerable to acute episodes of agitation, especially during exacerbation of disease, and clinicians do not always diagnose these episodes early enough. Agitation associated with psychosis is a frequent reason for emergency department visits, and unless it is recognized early and managed effectively, it can rapidly escalate to potentially dangerous behaviors, including physical violence. Educating psychiatric professionals about the timely and accurate diagnosis of agitation among patients with schizophrenia or bipolar disorder and developing a well-tolerated easily administered medication will contribute to the prompt and effective management of this condition and could help reduce the risk of violent behavior and other undesirable outcomes. This study is designed to identify the ideal dose range and tolerability of sublingual Dexmedetomidine in patients with schizophrenia.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia

NCT04268303

Agitation Schizophrenia Schizo Affective Disorder +2 more

COMPLETED PHASE3

Sub-Lingual Dexmedetomidine in Agitation Associated With Schizophrenia

NCT04010305

Agitation Schizophrenia

COMPLETED PHASE1

A Study to Assess Adverse Events, Change in Disease Activity, and How Oral Emraclidine Moves Through the Body in Adult Participants With Schizophrenia

NCT07145918

Schizophrenia

RECRUITING PHASE2

Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia

NCT05184335

Schizophrenia

RECRUITING PHASE3

Safety and Efficacy of Study Drug Versus Placebo for Negative Symptoms of Schizophrenia

NCT00063297

Schizophrenia

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia Schizoaffective Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The subjects will be randomized and will get either a sublingual formulation of dexmedetomidine or placebo.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Order 1

Subjects will be given a sublingual formulation of BXCL501 (dexmedetomidine)

Group Type ACTIVE_COMPARATOR

Dexmedetomidine Hydrochloride

Intervention Type DRUG

Dexmedetomidine Hydrochloride

Order 2

Subjects will be given a sublingual film of placebo.

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexmedetomidine Hydrochloride

Intervention Type DRUG

Placebos

Placebo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Precedex

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Ability to give informed consent.
2. Male or female between 18 and 65 years of age, inclusive
3. According to DSM-V meet criteria for Schizophrenia or Schizoaffective disorder.