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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.
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.
Sublingual film containing dexmedetomidine (BXCL501), Placebo Film
BioXcel Clinical Research Site
BioXcel Therapeutics Inc
Published on BioPortfolio: 2020-02-17T18:20:50-0500
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...
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...
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...
Open label, cross-over, local pharmacokinetics study of a sublingual film with peanut extract in healthy adults and children
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...
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...
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 ...
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 ...
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, ...
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...
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.
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...
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...