Topics

Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia

2020-02-17 18:20:50 | BioPortfolio

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.

Description

The study will enroll approximately 375 subjects randomized 1:1:1 to dose regimens of 180µg, 120µg BXCL501, or placebo. Male and female adults with acute agitation associated with schizophrenia, schizoaffective disorder, or schizophreniform disorder will be enrolled. Eligible subjects may be identified in outpatient clinics, mental health, psychiatric or medical emergency services including medical/psychiatric observation units, or as newly admitted to a hospital setting for acute agitation or already in hospital for chronic underlying conditions. Subjects will be domiciled in a clinical research setting or hospitalized to remain under medical supervision while undergoing screening procedures to assess eligibility. Efficacy and safety assessments will be conducted periodically before and after dosing.

Study Design

Conditions

Agitation

Intervention

Sublingual film containing dexmedetomidine (BXCL501), Placebo Film

Location

BioXcel Clinical Research Site
Little Rock
Arkansas
United States
72211

Status

Recruiting

Source

BioXcel Therapeutics Inc

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-02-17T18:20:50-0500

Clinical Trials [1125 Associated Clinical Trials listed on BioPortfolio]

Sub-Lingual Dexmedetomidine in Agitation Associated With Schizophrenia

This is a two-stage adaptive Phase Ib trial design, that will identify two doses (lowest dose with clinical benefit and highest safe dose) in a first stage and better evaluate safety, tole...

Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia

This is an adaptive Phase 1b trial design. It is randomized, double-blind, placebo-controlled, multiple ascending dose study assessing efficacy, pharmacokinetics, safety and tolerability o...

Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers

The primary objective of this study is to compare the bioavailability of a test formulation of Buprenorphine Naloxone Sublingual (SL) spray to that of a single dose of Suboxone® (buprenor...

Evaluating Peanut Immunotherapy Dissolving Film in Healthy Subjects

Open label, cross-over, local pharmacokinetics study of a sublingual film with peanut extract in healthy adults and children

A Study of the Safety and Acceptability of a Placebo Vaginal Film: FAME 101

This is a phase I randomized trial assessing the safety of a single vaginal placebo film application. In order to develop a vaginal film which can provide extended release of an Antiretrov...

PubMed Articles [2090 Associated PubMed Articles listed on BioPortfolio]

Characterization of bioactive film from pectin incorporated with gamma-aminobutyric acid.

Gamma-aminobutyric acid (GABA) is a nutritious bioactive compound that is also an antioxidant. The effect of GABA contents (5-15%) on pectin film properties were investigated and compared to those obt...

Dexmedetomidine to facilitate non-invasive ventilation after blunt chest trauma: a randomised, double-blind, crossover, placebo-controlled pilot study.

Although non-invasive ventilation (NIV) is recommended in patients with chest trauma, this procedure may expose to discomfort and even failure due to agitation or excessive pain. We tested the impact ...

Highly sensitive thermoelectric touch sensor based on p-type SnOx thin film.

Here, the ability of using p-type tin oxide (SnOx) thin films as a thermal sensor has been investigated. Firstly, the thermoelectric performance was optimized by controlling the thickness of the SnOx ...

Study on the changes of ultrasonic parameters over supercritical Ni-Co electroplating process.

This work discusses the influence of changes to ultrasound (US) parameters over the nickel cobalt (Ni-Co) metal thin film properties produced by supercritical CO (SC-CO) electroplating. Additionally, ...

Developing a simultaneously antioxidant and pH-responsive κ-carrageenan/hydroxypropyl methylcellulose film blended with Prunus maackii extract.

к-Carrageenan and hydroxypropyl methylcellulose were used as matrix materials in which the extract of Prunus maackii pomace (EPm) was added to prepare a simultaneously antioxidant and pH-responsive f...

Medical and Biotech [MESH] Definitions

Use of a device (film badge) for measuring exposure of individuals to radiation. It is usually made of metal, plastic, or paper and loaded with one or more pieces of x-ray film.

A film base coated with an emulsion designed for use with x-rays.

The measurement of radiation by photography, as in x-ray film and film badge, by Geiger-Mueller tube, and by SCINTILLATION COUNTING.

Technique involving the passage of X-rays through oral structures to create a film record while a central tab or wing of dental X-ray film is being held between upper and lower teeth.

Screens which absorb the energy in the x-ray beam that has penetrated the patient and convert this energy into a light pattern which has as nearly as possible the same information as the original x-ray beam. The more light a screen produces for a given input of x-radiation, the less x-ray exposure and thus shorter exposure time are needed to expose the film. In most film-screen systems, the film is sandwiched between two screens in a cassette so that the emulsion on each side is exposed to the light from its contiguous screen.

More From BioPortfolio on "Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia"

Quick Search

Relevant Topics

Psychiatry
Psychiatry is the study of mental disorders and their diagnosis, management and prevention.  Conditions include schizophrenia, severe depression and panic disorders among others. There are pharmaceutical treatments as well as other therapies to help...

Mental Health
Adhd Anorexia Depression Dyslexia Mental Health Psychiatry Schizophrenia Stress Mental health, although not being as obvious as physical health, is very important, causing great unhappiness to those affected, causing add...


Searches Linking to this Trial