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The mean change from baseline in the PEC total score at 2 hours (primary endpoint) was -8.5 and -10.3 with BXCL501 120 mcg and 180 mcg, respectively, versus -4.8 for placebo (P < .0001 vs placebo). Information provided by (Responsible Party): This is an adaptive Phase 1b/2 trial design. Patients in both trials received either BXCL501 (120 mcg or 180 mcg) or placebo while they were experiencing agitation as measured via the Positive and . This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in bipolar disorder. Patients who have a score of 4 on at least 1 of the 5 items on the PEC at Baseline. U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. BXCL501 is a potential first-in-class, proprietary sublingual thin film of dexmedetomidine, a selective alpha-2a receptor agonist for the treatment of acute agitation. Participants who agree to use a medically acceptable and effective birth control method. Patients with history of clinically significant syncope or syncopal attacks, orthostatic hypotension within the past 2 years, current evidence of hypovolemia, orthostatic hypotension. It is randomized, double-blind, placebo-controlled, multiple ascending dose study assessing efficacy, pharmacokinetics, safety and tolerability of BXCL-501 dosing in adult (65 years and older) males and females with acute agitation associated with dementia. Evaluation of 3 doses are planned. This detailed volume examines computer-aided drug discovery (CADD), a crucial component of modern drug discovery programs that is widely utilized to identity and optimize bioactive compounds for the development of new drugs. You have reached the maximum number of saved studies (100). Current FDA approval status, regulatory history, and clinical trial results for BXCL501 (dexmedetomidine), an investigational treatment for agitation associated with schizophrenia and bipolar disorder from the development pipeline at BioXcel Therapeutics, Inc. The increase was primarily attributable to increased personnel, clinical trial and professional research costs primarily related to our BXCL501 studies. Overall, the most commonly reported adverse events from both trials were somnolence, dry mouth, and dizziness. Listing a study does not mean it has been evaluated by the U.S. Federal Government. NEW HAVEN, Conn., April 26, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. ("BioXcel" or the "Company") (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that data from its two pivotal Phase 3 trials (SERENITY I & II) of BXCL501 for the acute . On track to report topline data from both studies in mid-2020. Research and development expenses were $58.0 million for the full year 2020, as compared to $25.8 million for the same period in 2019. A subject will be eligible for inclusion in the study if he or she meets the following criteria: A subject will be excluded from the study if he or she meets the following criteria: To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. BTI's two most advanced clinical development programs are BXCL501, an investigational sublingual thin film formulation in development for acute treatment of agitation resulting from neuropsychiatric disorders, and BXCL701, an investigational orally administered systemic innate immunity activator in development for treatment of a rare form of . Published: Mar 19, 2020. BXCL501 has been studied in two Phase 3 trials (SERENITY I and II) for the acute treatment of schizophrenia related agitation and bipolar disorder related agitation, respectively, and in a Phase 1b/2 trial (TRANQUILITY) for the acute treatment of dementia related agitation. We are optimistic that enrollment rates will continue to stay consistent with previous weeks and are looking forward to sharing topline results in . Garden Grove, CA 92845. Research and Development Expenses: Research and development expenses were $13.5 million during the second quarter of 2021, as compared to $17.9 million for the same period in 2020.The decreased expenses were primarily attributable to a reduction in our SERENITY clinical trial costs offset in-part by an increase in personnel and related costs necessary to enlarge our development and medical teams. Patients with laboratory or ECG abnormalities considered clinically significant by the investigator. Patients who have met DSM-5 criteria for bipolar I or II disorder. Efficacy and safety assessments will be conducted periodically before and after dosing. Male and female patients 65 years and older. Participants who agree to use a medically acceptable and effective birth control method. BXCL501 was well tolerated in both SERENITY trials. BTI believes that BXCL501 directly targets a causal agitation mechanism and the Company has observed anti-agitation effects in multiple clinical studies across multiple . In Part B a total of 46 subjects will receive BXCL501 40 g or matching placebo film. BioXcel Therapeutics, Inc., a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, announced full enrollment of its pivotal Phase 3 SERENITY trials evaluating BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorder. Any other anti-hypertensives should be maintained in the course of the study. Patients who have received an investigational drug within 30 days prior to the current agitation episode must be excluded. The effects of BXCL 501 on acute agitation will be assessed by the following scales: Pittsburgh Agitation Scale (PAS), the PANSS-EC (PEC), Cohen-Mansfield Agitation Inventory (CMAI), CGI-Severity for Agitation and CGI Improvement for Agitation. Forward-looking statements in this press release include but are not limited to the timing and data from clinical development initiatives and trials for BXCL501 in patients suffering from . In this book, experts in statistics and psychometrics describe classes of linkages, the history of score linkings, data collection designs, and methods used to achieve sound score linkages. This volume of the Handbook of Experimental Pharmacology will explore sodium channels from the perspectives of their biophysical behavior, their structure, the drugs and toxins with which they are known to interact, acquired and inherited BXCL501 is our most advanced neuroscience clinical program, currently being developed for the treatment of agitation associated . Learn how to become a millionaire on an average salary. Get a simple strategy to eliminate debt. Understand the secret to saving. Invest like the best. Discover wealth building secrets of the rich, in this book. Patients who have received an investigational drug within 30 days prior to the current agitation episode. BXCL501 has been studied in two Phase 3 trials (SERENITY I and II) for the acute treatment of schizophrenia related agitation and bipolar disorder related agitation, respectively, and in a Phase 1b/2 trial (TRANQUILITY) for the acute treatment of dementia related agitation. BXCL501 was well tolerated in both SERENITY trials. Overall, the most commonly reported adverse events from both trials were somnolence (22% for 180 mcg dose arms, 21% for 120 mcg dose arms and 6% for placebo arms; >75% of these events were classified as mild), dry mouth (4.4%, 7.5% and 1.2%, respectively), and dizziness (6.0%, 3.9%, and 0.8% . About Schizophrenia and Bipolar Disorder Related Agitation BXCL501 is versatile in that it is being investigated to treat agitation associated with a variety of diseases such as schizophrenia/bipolar disorders . You have reached the maximum number of saved studies (100). 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). BXCL501 Program Update: BTI has completed dosing subjects in a Phase 1 placebo-controlled, single dose, dose-escalation study of BXCL501. Provides state-of-the-art information about cognition in schizophrenia with a wide ranging focus on measuring and treating cognitive deficits. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04268303. BXCL501 films may be divided in half if needed to deliver half-dose strengths. At least 30 subjects (10 per cohort) will be enrolled at up to 3 study sites in the United States. Female patients who have a positive pregnancy test at screening or are breastfeeding. BXCL501 has been studied in two Phase 3 trials (SERENITY I and II) for the acute treatment of schizophrenia related agitation and bipolar disorder related agitation, respectively, and in a Phase . About Schizophrenia and Bipolar Disorder Related Agitation BioXcel is planning to conduct two pivotal Phase 3 trials for BXCL501 in the treatment of agitation associated with schizophrenia and bipolar disorder. More than one-third of the SERENITY I & II patients have been dosed, including over 100 bipolar patients. Patients who meet International Psychogeriatric Association (IPA) diagnostic criterion for agitation. Study record managers: refer to the Data Element Definitions if submitting registration or results information. 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. Patients who have a score of 2 on at least 1 of the 4 items on the Pittsburgh Agitation Scale (PAS). 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. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Patients with laboratory or ECG abnormalities considered clinically significant by the investigator. With contributions from the major international names in the field, this book reviews research on the impairment of cognitive functioning in schizophrenia, covering: what it is, what the clinical implications are, and how it can be treated. For general information, Learn About Clinical Studies. Patients experiencing clinically significant pain, per Investigator. Read our, ClinicalTrials.gov Identifier: NCT04276883, Interventional Male and female adults with acute agitation associated with schizophrenia, schizoaffective disorder, or schizophreniform disorder will be enrolled. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. 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. BXCL501 has been studied in two Phase 3 trials (SERENITY I and II) for the acute treatment of schizophrenia related agitation and bipolar disorder related agitation, respectively, and in a Phase 1b/2 trial (TRANQUILITY) for the acute treatment of dementia related agitation. History of syncope or other syncopal attacks, current evidence of hypovolemia, orthostatic hypotension. BioXcel's two most advanced clinical development programs are BXCL501, an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine for the treatment of agitation and opioid withdrawal symptoms, and BXCL701, an investigational, orally administered, systemic innate immunity activator in development for the . The FDA accepted the company's new drug application based on the results of two phase 3 clinical trials. Male and female patients between the ages of 18 to 75 years, inclusive. BXCL501 has been studied in two Phase 3 trials (SERENITY I and II) for the acute treatment of schizophrenia related agitation and bipolar disorder related agitation, respectively, and in a Phase 1b/2 trial (TRANQUILITY) for the acute treatment of dementia related agitation. Eligible subjects (acutely agitated subjects with bipolar disorder, generally hypomanic, manic or mixed episodes) 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. BXCL501 Program Update: BTI has completed dosing subjects in a Phase 1 placebo-controlled, single dose, dose-escalation study of BXCL501. The SERENITY studies are randomized, double-blinded, placebo-controlled, adaptive trials of up to 750 patients, 18 to 75 years of age. U.S. Department of Health and Human Services. Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Incidence of abnormal laboratory test results [TimeFrame:7 days], Incidence of abnormal vital signs [TimeFrame:7 days], Incidence of abnormal ECG findings [TimeFrame:7 days], Magnitude of calming effects [TimeFrame:24 hours]. Female patients who have a positive pregnancy test at screening or are breastfeeding. Evaluation of three (3) doses of sublingual BXCL 501 are planned. But there are times - more frequent than most would guess - that this common wisdom runs counter to [] Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Primary End Point [TimeFrame:120 minutes], key Secondary Endpoint [TimeFrame:120 minutes]. BXCL501 has been studied in two Phase 3 trials (SERENITY I and II) for the acute treatment of schizophrenia related agitation and bipolar disorder related agitation, respectively, and in a Phase . The clinical trial data is currently undergoing analyses with topline results expected to be announced shortly. Found insideThis volume presents the results of a unique collaboration between psychiatrists, computational and theoretical neuroscientists, and reveals the synergistic ideas, surprising results, and novel open questions that emerged. The SERENITY studies were randomized, double-blinded, placebo-controlled parallel group adaptive . ClinicalTrials.gov Identifier: NCT04251910, Interventional Found insideThe book encompasses the effects on appetite, sleep, substance abuse, cognition, and anxiety. Additionally, it examines new therapeutic approaches utilizing orexins, including utilization of orexin receptors for drug development. The SERENITY I trial was a randomized, double blind, placebo controlled parallel group adaptive trial in patients with schizophrenia or schizoaffective disorder (n=381) that . BXCL501 is a potential first-in-class, proprietary sublingual thin film of dexmedetomidine, a selective alpha-2a receptor agonist for the treatment of acute agitation. In both trials, BXCL501 was well-tolerated and met the primary and secondary endpoints at the 120 mcg and 180 mcg doses, demonstrating statistically significant, rapid and durable improvements from baseline versus placebo across multiple agitation scales. With the positive results from the Phase 3 SERENITY trials we have increased our probability of approval, the potential peak market share for BXCL501 in agitated patients with schizophrenia or . The BXCL501-302 study is designed to characterize the efficacy, safety and tolerability of BXCL501 (sublingual film formulation of DEX, HCl) in agitation associated with bipolar disorder. 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. This book is divided into two parts. The first eight chapters of the book explain attention and its relationship to vision and visual stimuli. The core topics discussed here include Autism, ADHD, Dyslexia, Executive Function, and Memory. Found insideA practical guide to the origins and treatment options for agitation, a common symptom of psychiatric and neurologic disorders. Patients who have a score of 4 on at least 1 of the 5 items on the PEC at Baseline. Patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving DEX. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. This product candidate is also currently being evaluated in a Phase 1b . Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276883. Serving as a valuable resource, this volume will interest not only graduate students, scientists, and engineers but also newcomers to the field of cybernics. BXCL501 has been studied in two Phase 3 trials (SERENITY I and II) for the acute treatment of schizophrenia related agitation and bipolar disorder related agitation, respectively, and in a Phase 1b/2 trial (TRANQUILITY) for the acute treatment of dementia related agitation. NEW HAVEN, Conn., May 14, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. ("BTI" or "Company") (NASDAQ:BTAI), a clinical-stage biopharmaceutical company utilizing. --BioXcel Therapeutics, Inc., a clinical-stage biopharmaceutical company utilizing artificial intelligence to identify improved therapies in neuroscience and immuno-oncology, today announced full . (Clinical Trial), phase III, randomized, double-blind, placebo-controlled, Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor), A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine Efficacy and Safety of BXCL501 In Agitation Associated With Bipolar Disorder, 18 Years to 75 Years (Adult, Older Adult), Little Rock, Arkansas, United States, 72211, Cerritos, California, United States, 90703, Culver City, California, United States, 90230, Long Beach, California, United States, 90806, Miami Lakes, Florida, United States, 33016, Gaithersburg, Maryland, United States, 20877, Marlton, New Jersey, United States, 08053, Charleston, South Carolina, United States, 29407. They have no other responsibility in the trial, A Phase Ib/II, Multicenter, Randomized, Double Blind, Placebo Controlled, Ascending Dose Finding, Efficacy, Pharmacokinetic and Safety Study of BXCL501 In Agitation Associated With Dementia, Active Comparator: Cohort 1- 30 Micrograms, Active Comparator: Cohort 2- 60 Micrograms, Active Comparator: Cohort 3- 90 Micrograms, Miami Lakes, Florida, United States, 33016, Springfield, Massachusetts, United States, 01103, Toms River, New Jersey, United States, 08755. Patients with agitation caused by acute intoxication. The clinical trial data is currently undergoing analyses . Overall, the most commonly reported adverse events from both trials were somnolence (22% for 180 mcg dose arms, 21% for 120 mcg dose arms and 6% for placebo arms; >75% of these events were classified as mild), dry mouth (4.4%, 7.5% and 1.2%, respectively), and dizziness (6.0%, 3.9%, and 0.8% . On July 20, 2020, BioXcel announced positive results from the SERENITY (S ub-Lingual D E xmedetomidine in Agitation Associated With Schizoph RENI a and Bipolar Disorder S T ud Y) trials of BXCL501 for treating agitation in patients with schizophrenia and bipolar disorder. Cohort 3 only: Patients who are taking nitrates or beta blockers shall be excluded. Cohort 1 consists of 10 patients out of whom 8 patients receive 30 Micrograms film and the remaining 2 patients receive a placebo, Sublingual film containing Dexmedetomidine, Sublingual placebo film that matches BXCL501, Cohort 3 consists of 10 patients out of whom 8 patients receive 90 Micrograms film and the remaining 2 patients receive a placebo, Part B cohort consists 46 subjects receiving 40 Micrograms or placebo, Incidence of abnormal laboratory test results, Incidence of abnormal vital sign (systolic and diastolic blood pressures, heart rate measured as pulse, respiratory rate, and temperature). ICH GCP. Study record managers: refer to the Data Element Definitions if submitting registration or results information. The SERENITY I trial was a randomized, double blind, placebo controlled parallel group adaptive trial in patients with schizophrenia or schizoaffective disorder (n=381) that . Patients treated within 4 hours prior to study drug administration with benzodiazepines, other sedatives, hypnotics or oral or short-acting intramuscular antipsychotics must be excluded. Magnitude of calming effects of different doses of BXCL501 on symptoms of acute agitation associated with dementia as measured by the Pittsburgh Agitation Scale (PAS) (Minimum Score value: 0. Adverse Events (AEs), clinical laboratory tests, ECG, and vital signs will be monitored, and all observed. For general information, Learn About Clinical Studies. BXCL501 films may be divided in half if needed to deliver half-dose strengths. Talk with your doctor and family members or friends about deciding to join a study. 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. Based on these results the company plans to file a New Drug Application with the U.S. FDA in Q1 of 2021. The SERENITY I trial was a randomized, double blind, placebo controlled parallel group adaptive trial in patients with schizophrenia or schizoaffective disorder (n=381) that . Why Should I Register and Submit Results? Topics discussed include: Obstructive airway diseases, etiology, pathophysiology, and existing therapeutic options What constitutes a lipid and how it is broken down to generate biologically active mediators The role of enzymes in the BioXcel Therapeutics Announces Completion of Patient Enrollment in Phase 3 SERENITY Trials with BXCL501 Topline results, expected in July of 2020, are intended to support a New Drug Application filing Information provided by (Responsible Party): This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in schizophrenia. Subjects will be domiciled in a clinical research setting or hospitalized to remain under medical supervision while undergoing screening procedures to assess eligibility. No new chronic medications initiated in the past 14 days prior to screening excluding over-the-counter products taken sporadically. The study will enroll approximately 375 subjects randomized 1:1:1 to dose regimens of 180g, 120g BXCL501, or placebo stratified by age < 65 and age 65. Positive Results in Phase 3 SERENITY Trials. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. BioXcel Therapeutics's investigational BXCL501 (dexmedetomidine sublingual film) may reduce agitation in adult patients with schizophrenia or bipolar disorder, two phase 3 trials suggest. Patients with serious or unstable medical illnesses. BioXcel Therapeutics Provides an Update on its Ongoing Phase 3 SERENITY Trials. After all, rock bottom prices usually happen for a reason, and those reasons are usually not good for the stock's prospects. BTI believes that BXCL501 directly targets a causal agitation mechanism and the Company has observed anti-agitation effects in multiple clinical studies across multiple . SERENITY I is evaluating patients with agitation associated . 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