Bioxcel Therapeutics ((BTAI)) announced an update on their ongoing clinical study.
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Study Overview: Bioxcel Therapeutics is conducting a clinical study titled A Randomized, Double-blind, Placebo-controlled Study to Determine Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder. The study aims to evaluate the efficacy and safety of BXCL501 in managing acute agitation in children and adolescents with schizophrenia and bipolar disorder, highlighting its potential significance in addressing unmet needs in pediatric mental health.
Intervention/Treatment: The study tests BXCL501, a sublingual film containing Dexmedetomidine, in doses of 60, 80, and 120 micrograms. It is designed to calm agitation quickly and safely in pediatric patients.
Study Design: This interventional study uses a randomized, parallel assignment model with double-blind masking involving both participants and investigators. The primary purpose is treatment, with participants allocated to receive either BXCL501 or a placebo.
Study Timeline: The study began on August 24, 2021, with the last update submitted on November 11, 2024. These dates are crucial for tracking the study’s progress and ensuring timely updates for stakeholders.
Market Implications: The ongoing study could significantly impact Bioxcel Therapeutics’ stock performance and investor sentiment, especially if BXCL501 proves effective. Success in this trial could position Bioxcel favorably against competitors in the pediatric mental health treatment market, potentially leading to increased market share.
The study is currently recruiting, with further details available on the ClinicalTrials portal.