BXCL501 films may be divided in half if needed to deliver half-dose strengths. 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 Negative Syndrome Scale, Excitatory Component (PEC). Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. This volume collects the invited lectures and some selected contributions presented at the 5th International Meeting on Clinical Pharmacology in Psychiatry, which was held 26-30 June 1988 at the University of Troms0, Norway. The study will enroll approximately 375 subjects randomized 1:1:1 to dose regimens of 180µg, 120µg BXCL501, or placebo stratified by age < 65 and age ≥ 65. 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 . BioXcel Therapeutics's investigational BXCL501 (dexmedetomidine sublingual film) may reduce agitation in adult patients with schizophrenia or bipolar disorder, two phase 3 trials suggest. ClinicalTrials.gov Identifier: NCT04251910, Interventional
This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in bipolar disorder. 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. Adverse Events (AEs), clinical laboratory tests, ECG, and vital signs will be monitored, and all observed. For general information, Learn About Clinical Studies. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Listing a study does not mean it has been evaluated by the U.S. Federal Government. * BIOXCEL THERAPEUTICS ANNOUNCES COMPLETION OF PATIENT ENROLLMENT IN PHASE 3 SERENITY TRIALS WITH BXCL501 Source text for Eikon: Further company coverage: BXCL501 was well tolerated in both SERENITY trials. Patients who have received an investigational drug within 30 days prior to the current agitation episode. BioXcel Therapeutics announced that BXCL501, a proprietary sublingual thin film of dexmedetomidine, met the primary and secondary endpoints in the phase 3 SERENITY I and SERENITY II trials. 3. 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 are judged to be at significant risk of suicide. The NDA filing for BXCL501 is based in part on the positive results from the Phase 3 SERENITY I and SERENITY II clinical trials, which the company disclosed in July 2020. First published in 1987. Routledge is an imprint of Taylor & Francis, an informa company. Choosing to participate in a study is an important personal decision. 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. Bloomberg the Company & Its Products The Company & its Products Bloomberg Terminal Demo Request Bloomberg Anywhere Remote Login Bloomberg Anywhere Login Bloomberg Customer Support Customer Support Found insideTopics covered in this new volume include DELT, Oligos: ASO, siRNA, CRISPR, Micro-fluidic chemistry, High throughput screening, Kinase-centric computational drug development, Virtual Screening, Phenotypic screening, PROTACS, Chemical ... NEW HAVEN, Conn., March 19, 2020 (GLOBE NEWSWIRE) -- BioXcel . Due to the nature of the drug, the pharmacist and the drug administrator will both be aware of the treatment. You have reached the maximum number of saved studies (100). Positive Results in Phase 3 SERENITY Trials. 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. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251910. Why Should I Register and Submit Results? Male and female patients between the ages of 18 to 75 years, inclusive. Read our, ClinicalTrials.gov Identifier: NCT04276883, Interventional
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 Maximum score value 16. higher scores mean a worse outcome). BXCL501 is an investigational, proprietary, orally dissolving, thin film formulation of dexmedetomidine, a selective alpha-2a receptor agonist for the treatment of agitation and opioid withdrawal symptoms. 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. You have reached the maximum number of saved studies (100). 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. At least 30 subjects (10 per cohort) will be enrolled at up to 3 study sites in the United States. The SERENITY I trial was a . BioXcel Therapeutics announced that BXCL501, a proprietary sublingual thin film of dexmedetomidine, met the primary and secondary endpoints in the phase 3 SERENITY I and SERENITY II trials. BXCL501 films may be divided in half if needed to deliver half-dose strengths. Male and female adults with acute agitation associated with bipolar disorder will be enrolled. The overall objective of the proposed study is to determine if Dexmedetomidine HCl (BXCL501) is safe for treatment of alcohol use disorder (AUD) with comorbid posttraumatic stress disorder (PTSD) and also shows potential signals of efficacy thereby supporting the conduct of later phase clinical trials. 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. 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. Evaluation of 3 doses are planned. Patients at significant risk of harm to themselves or others, Patients considered medically unstable or in recovery. 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). The SERENITY studies were randomized, double-blinded, placebo-controlled parallel group adaptive . 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. The SERENITY studies are randomized, double-blinded, placebo-controlled, adaptive trials of up to 750 patients, 18 to 75 years of age. Patients who have a score of ≥ 4 on at least 1 of the 5 items on the PEC at Baseline. (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 Schizophrenia, 18 Years to 75 Years (Adult, Older Adult), Little Rock, Arkansas, United States, 72211, Cerritos, California, United States, 78754, 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. You have reached the maximum number of saved studies (100). Listing a study does not mean it has been evaluated by the U.S. Federal Government. 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, the potential commercialization of . Patients who read, understand, and provide written informed consent. Synthesizing theoretical and methodological developments in affective science and highlighting their potential application to psychopathology, this edited volume illustrates the importance of transferring basic research into the clinical ... Female patients who have a positive pregnancy test at screening or are breastfeeding. Male and female adults with acute agitation associated with schizophrenia, schizoaffective disorder, or schizophreniform disorder will be enrolled. But there are times - more frequent than most would guess - that this common wisdom runs counter to […] Overall, the most commonly reported adverse events from both trials were somnolence, dry mouth, and dizziness. The NDA filing for BXCL501 is based in part on the positive results from the Phase 3 SERENITY I and SERENITY II clinical trials, which the company disclosed in July 2020. 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 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, a Phase 1b/2 trial (TRANQUILITY) for the acute treatment of dementia related agitation, as well as a Phase 1b/2 trial (RELEASE) for the treatment of opioid withdrawal . 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). Study record managers: refer to the Data Element Definitions if submitting registration or results information. Subjects will be domiciled in a clinical research setting or hospitalized to remain under medical supervision while undergoing screening procedures to assess eligibility. Information provided by (Responsible Party): This is an adaptive Phase 1b/2 trial design. 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. This product candidate is also currently being evaluated in a Phase 1b . Patients who have a score of ≥ 2 on at least 1 of the 4 items on the Pittsburgh Agitation Scale (PAS). 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. Subjects assigned to Cohort 3 will participate in a 1-week safety observation before being enrolled. 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 and the potential for BXCL501 to be used as a sub-chronic treatment. Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Incidence of abnormal laboratory test results [ Time Frame: 7 days ], Incidence of abnormal vital signs [ Time Frame: 7 days ], Incidence of abnormal ECG findings [ Time Frame: 7 days ], Magnitude of calming effects [ Time Frame: 24 hours ]. Based on these results the company plans to file a New Drug Application with the U.S. FDA in Q1 of 2021. Patients with serious or unstable medical illnesses. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04268303. Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Primary End Point [ Time Frame: 120 minutes ], Key Secondary Endpoint [ Time Frame: 120 minutes ]. 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. 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 . The NDA filing for BXCL501 is based in part on the positive results from the Phase 3 SERENITY I and SERENITY II clinical trials, which the company disclosed in July 2020. BioXcel is planning to conduct two pivotal Phase 3 trials for BXCL501 in the treatment of agitation associated with schizophrenia and bipolar disorder. BXCL501 - BioXcel Therapeutics (NASDAQ: BTAI) BXCL501 is a thin film version of dexmedetomidine that is dissolved under the tongue, which allows the drug to work quickly in the body. 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. The study will enroll approximately 375 subjects randomized 1:1:1 to dose regimens of 180µg, 120µg BXCL501, or placebo. Evaluation of three (3) doses of sublingual BXCL 501 are planned. Female patients who have a positive pregnancy test at screening or are breastfeeding. Patients with agitation caused by acute intoxication. Cohort 2 consists of 10 patients out of whom 8 patients receive 60 Micrograms film and the remaining 2 patients receive a placebo. BXCL501. Treatment with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin) or other prohibited medications. 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 . Patients with serious or unstable medical illnesses. 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. Patients with history of clinically significant syncope or syncopal attacks, orthostatic hypotension within the past 2 years, current evidence of hypovolemia, orthostatic hypotension. Drug: Sublingual film containing Dexmedetomidine. Sublingual film containing 120 Micrograms Dexmedetomidine, Sublingual film containing Dexmedetomidine (BXCL501), Sublingual film containing 180 Micrograms Dexmedetomidine, Absolute change from baseline in the PEC score at 2 hours, Earliest time where an effect on agitation is apparent as measured by change from baseline PEC total score in contrast with placebo, Agitation Associated With Bipolar Disorder, Drug: Sublingual film containing Dexmedetomidine (BXCL501). Observation before being enrolled BXCL501 or placebo by ( Responsible Party ): NCT04268303 tests, ECG, and.... Association ( IPA ) diagnostic criterion for agitation, a common symptom of psychiatric and neurologic disorders family members friends! The 5 items on the PEC at Baseline 60µg and 90µg dose respectively BXCL501! To be an unsuitable candidate for receiving DEX topline Data from both trials were somnolence, mouth... 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