Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05658510
Other study ID # BXCL501-401
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date November 21, 2022
Est. completion date March 30, 2025

Study information

Verified date December 2023
Source BioXcel Therapeutics Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, an investigational medication named BXCL501 is being tested for the treatment of episodes of agitation associated with bipolar I and bipolar II disorder, schizophrenia, schizoaffective and schizophreniform disorder. This study compares the study drug to a placebo.


Description:

This is a randomized, double-blind, placebo-controlled, 2-Part, Phase III study to assess the efficacy, safety, and tolerability of a 60 mcg dose of BXCL501 in adult (18-75 years old) males and females with agitation episodes associated with a primary diagnosis of bipolar I disorder, bipolar II disorder, schizophrenia, schizoaffective disorder, or schizophreniform disorder. Part 1 of the study is a one-day, in-clinic treatment, and post-treatment observation period with patients experiencing an acute episode of agitation. Part 2 of the study is a 12-week study to determine the safety of BXCL501 when used as needed for episodes of agitation at home.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 450
Est. completion date March 30, 2025
Est. primary completion date March 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility A patient may enroll in only one part of the study; either Part 1 or Part 2. Inclusion Criteria: - Male and female patients between the ages of 18 to 75 years, inclusive - Patients who can read, understand and provide written informed consent. - Patients who have met Diagnostic and Statistical Manual5/5-Text Revision criteria for bipolar I or bipolar II disorder, schizophrenia, schizoaffective or schizophreniform disorder. - Patients who, in the opinion of the Principal Investigator, are in good general health before study participation based on a detailed medical history, a physical examination, a 12-lead ECG, a blood chemistry profile, hematology, and urinalysis. - Participants who agree to use a medically acceptable and effective birth control method Part 1 only - 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 PEC. - Patients with a score of =4 on at least 1 of the 5 items on the PEC at Baseline. Part 2 only - Patients have had at least three clinical presentations of agitation requiring an intervention in the past three months prior to Screening - Patients who are receiving stable treatment for the last 3 months prior to Screening for the underlying primary diagnosis and who are expected to remain on stable treatment for the duration of the study - Patients who manage agitation episodes with as needed (PRN) medication - The patient has an Informant who can read, understand, and provide written informed consent and understand and follow the study procedures Exclusion Criteria: - Patients with serious or unstable medical illnesses. - A history of agitation episodes due to substance use. - A diagnosis of antisocial personality disorder, borderline personality disorder, or narcissistic personality disorder that predated the diagnosis of schizophrenia or bipolar disorder - Patients who are judged to be at significant risk of suicide - Female patients who have a positive pregnancy test at Screening or Baseline, or are breastfeeding. - Patients currently treated with alpha-1 noradrenergic blockers (terazosin, doxazosin, tamsulosin, alfuzosin, or prazosin), alpha-2 adrenergic agonists, or other prohibited medications. - Patients with 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. - History of syncope or other syncopal attacks, current evidence of hypovolemia, or orthostatic hypotension - Patients with laboratory or ECG abnormalities considered clinically significant by the Investigator - Patients who have received an investigational drug within 30 days before the study start - Patients who have previously received BXCL501 via prescription (under the trade name IGALMIā„¢) or received BXCL501 in an open-label clinical trial - Patients considered by the Investigator to be unsuitable candidates for receiving dexmedetomidine or considered to be unsuitable for participating in the study for any reason. Part 1 only - Patients with agitation caused by acute intoxication, including identification of alcohol by breathalyzer or drugs of abuse (except for THC) during urine screening. - Use of benzodiazepines or other hypnotics or antipsychotic drugs in the 4 hours before study treatment. - Patients who have previously received BXCL501 in a clinical trial

Study Design


Intervention

Drug:
BXCL501
Sublingual Film
Matching Placebo
Sublingual Placebo Film

Locations

Country Name City State
United States Bioxcel Clinical Research Site 106 Atlanta Georgia
United States BioXcel Clinical Research Site 122 Beachwood Ohio
United States BioXcel Clinical Research Site 113 Bellflower California
United States BioXcel Clinical Research Site 105 Berlin New Jersey
United States BioXcel Clinical Research Site 128 Cerritos California
United States BioXcel Clinical Research Site 109 Chicago Illinois
United States BioXcel Clinical Research Site 110 Culver City California
United States BioXcel Clinical Research Site 107 Decatur Georgia
United States BioXcel Clinical Research Site 129 Denver Colorado
United States BioXcel Clinical Research Site 102 DeSoto Texas
United States BioXcel Clinical Research Site 130 Elgin Illinois
United States BioXcel Clinical Research Site 126 Everett Washington
United States BioXcel Clinical Research Site 103 Gaithersburg Maryland
United States BioXcel Clinical Research Site 108 Garden Grove California
United States BioXcel Clinical Research Site 125 Irving Texas
United States BioXcel Clinical Research Site 118 Las Vegas Nevada
United States BioXcel Clinical Research Site 117 Lemon Grove California
United States BioXcel Clinical Research Site 112 Little Rock Arkansas
United States BioXcel Clinical Research Site 119 Little Rock Arkansas
United States BioXcel Clinical Research Site 121 Los Angeles California
United States BioXcel Clinical Research Site 101 Marlton New Jersey
United States BioXcel Clinical Research Site 124 Miami Florida
United States BioXcel Clinical Research Site 131 Miami Florida
United States BioXcel Clinical Research Site 120 Murray Utah
United States BioXcel Clinical Research Site 134 Oakland Park Florida
United States BioXcel Clinical Research Site 123 Oceanside California
United States BioXcel Clinical Research Site 104 Orange California
United States BioXcel Clinical Research Site 127 Plano Texas
United States BioXcel Clinical Research Site 133 Rancho Cucamonga California
United States BioXcel Clinical Research Site 114 Riverside California
United States BioXcel Clinical Research Site 132 Rutland Vermont

Sponsors (2)

Lead Sponsor Collaborator
BioXcel Therapeutics Inc Worldwide Clinical Trials

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Part 1: Change from baseline in Positive and Negative Syndrome Scale - Excited (PEC) total score The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe) 2 hours
Primary Part 2: Incidence of treatment-emergent adverse events (TEAEs) To assess the safety of BXCL501 when used in an at-home environment based on treatment-emergent adverse events (TEAEs) Through study completion, an average of 12 weeks
Primary Part 2: Incidence of serious adverse events (SAEs) To assess the safety of BXCL501 when used in an at-home environment based on serious adverse events (SAEs) Through study completion, an average of 12 weeks
Secondary Part 1: Clinical Global Impression - Improvement (CGI-I) The Clinical Global Impression - Improvement (CGI-I) for agitation in response to treatment measures the current level of agitation relative to the level of agitation prior to administration of study intervention. The CGI-I scores range from 1 to 7 with a score of 1 indicating very much improved, and a score of 7 indicating very much worse. 2 hours
Secondary Part 1: Change in Modified Clinical Global Impression - Severity (mCGI-S) scores from Baseline The Modified Clinical Global Impression - Severity (mCGI-S) measures the current level of agitation. For this study, the mCGI-S is a 4-point scale where a score of 0 represents no agitation, and scores of 1-3 describe increasing severities of agitation (mild, moderate, severe). 2 hours
Secondary Part 1:The number of responders based on the Modified Clinical Global Impression - Severity (mCGI-S) score The Modified Clinical Global Impression - Severity (mCGI-S) measures the current level of agitation. A responder is characterized as a participant with a score of 0 (represents no agitation) or 1 (mild agitation) 2 hours
Secondary Part 1:Change from baseline in Agitation-Calmness Evaluation Scale (ACES) The Agitation-Calmness Evaluation Scale (ACES) is a single item scale that measures overall agitation and sedation, where a score of 1 indicates marked agitation; 2 - moderate agitation; 3 - mild agitation; 4 - normal behavior; 5 - mild calmness; 6 - moderate calmness; 7 - marked calmness; 8 - deep sleep; and 9 - unarousable. 2 hours
Secondary Part 1: Incidence of treatment-emergent adverse events (TEAEs) To assess the safety of BXCL501 based on treatment-emergent adverse events (TEAEs) Through study completion, an average of 8 hours
Secondary Part 1: Change from baseline in heart rate (HR) at rest The effect of BXCL501 on heart rate at rest Baseline, and 2, 4, 6, and 8 hours postdose
Secondary Part 1: Change from baseline in heart rate (HR) under orthostatic stress The effect of BXCL501 on heart rate under orthostatic stress Baseline, and 2, 4, 6, and 8 hours postdose
Secondary Part 1: Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at rest The effect of BXCL501 on systolic and diastolic blood pressure at rest Baseline, and 2, 4, 6, and 8 hours postdose
Secondary Part 1: Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) under orthostatic stress The effect of BXCL501 on systolic and diastolic blood pressure under orthostatic stress Baseline, and 2, 4, 6, and 8 hours postdose
Secondary Part 1: Incidence of abnormal electrocardiograms (ECG) reported as an adverse event (AE) Any abnormal ECG value that is reported as an adverse event (AE) Through study completion, an average of 8 hours
Secondary Part 1: Incidence of abnormal clinical laboratory values reported as an adverse event (AE) Any abnormal clinical laboratory value that is reported as an adverse event (AE) Through study completion, an average of 8 hours
Secondary Part 2: Incidence of interactions with emergency services related to agitation Evaluate the impact of BXCL501 on the use of healthcare and emergency service resources because of agitation episodes Through study completion, an average of 12 weeks
Secondary Part 2: Incidence of overall adverse events and AEs leading to discontinuation To evaluate the safety and tolerability profile of BXCL501 Through study completion, an average of 12 weeks
Secondary Part 2: Proportion of patients who report somnolence (ACES score =8 reported by Informant) pre-dose to post-dose To evaluate the safety and tolerability profile of BXCL501 2 hours after each treatment for an episode of agitation
Secondary Part 2: Proportion of patients who report somnolence (KSS score =8 reported by patient) pre-dose to post-dose To evaluate the safety and tolerability profile of BXCL501 2 hours after each treatment for an episode of agitation
Secondary Part 2: Evaluate the effect of BXCL501 on the signs and symptoms of agitation following study drug administration in patients with schizophrenia and bipolar disorder Proportion of patients with an improvement in agitation (Yes/No) post-dose for the first treated episode compared with placebo 2 hours after treatment for the first episode of agitation
Secondary Part 2: Evaluate the effect of BXCL501 on the signs and symptoms of agitation following study drug administration in patients with schizophrenia and bipolar disorder Proportion of mCGI-S responders (patients who achieve a mCGI-S score of 0 or 1) following drug administration for the first treated episode 2 hours after treatment for the first episode of agitation
Secondary Part 2: Evaluate the effect of BXCL501 on the signs and symptoms of agitation following study drug administration in patients with schizophrenia and bipolar disorder Proportion of patients with a 1-point improvement in mCGI-S score following drug administration for the first treated episode 2 hours after treatment for the first episode of agitation
Secondary Part 2: Evaluate the effect of BXCL501 on the signs and symptoms of agitation following study drug administration in patients with schizophrenia and bipolar disorder Proportion of CGI-C responders (patients who achieve a CGI-C score of 1 or 2) following drug administration for the first treated episode 2 hours after treatment for the first episode of agitation
Secondary Part 2: Evaluate the effect of BXCL501 on the signs and symptoms of agitation following study drug administration in patients with schizophrenia and bipolar disorder Change in mCGI-S scores from pre-dose to post dose for the first treated episode 2 hours after treatment for the first episode of agitation
Secondary Part 2: Evaluate the effect of BXCL501 on the signs and symptoms of agitation following study drug administration in patients with schizophrenia and bipolar disorder CGI-C scores following drug administration for the first treated episode 2 hours after treatment for the first episode of agitation
Secondary Part 2: Evaluate the effect of BXCL501 on the signs and symptoms of agitation following study drug administration in patients with schizophrenia and bipolar disorder Time to end of an agitation episode from dosing for the first treated episode Up to 24 hours after treatment for the first episode of agitation
Secondary Part 2: Assess the continued efficacy of BXCL501 in the treatment of episodes of agitation Proportion of patients with an improvement in agitation (Yes/No) post-dose for all treated episodes compared with placebo 2 hours after treatment for all episodes of agitation, up to 12 weeks
Secondary Part 2: Assess the continued efficacy of BXCL501 in the treatment of episodes of agitation Proportion of mCGI-S responders following drug administration for the last treated episode and all treated episodes 2 hours after treatment for all episodes of agitation, up to 12 weeks
Secondary Part 2: Assess the continued efficacy of BXCL501 in the treatment of episodes of agitation Proportion of patients with a 1-point improvement in mCGI-S score following drug administration for the last treated episode and all treated episodes 2 hours after treatment for all episodes of agitation, up to 12 weeks
Secondary Part 2: Assess the continued efficacy of BXCL501 in the treatment of episodes of agitation Proportion of CGI-C responders following drug administration for the last treated episode and all treated episodes 2 hours after treatment for all episodes of agitation, up to 12 weeks
Secondary Part 2: Assess the continued efficacy of BXCL501 in the treatment of episodes of agitation Change in mCGI-S scores from pre dose to post dose following drug administration for the last treated episode and all treated episodes 2 hours after treatment for all episodes of agitation, up to 12 weeks
Secondary Part 2: Assess the continued efficacy of BXCL501 in the treatment of episodes of agitation CGI-C scores following drug administration for the last treated episode and all treated episodes 2 hours after treatment for all episodes of agitation, up to 12 weeks
Secondary Part 2: Assess the continued efficacy of BXCL501 in the treatment of episodes of agitation The frequency of treated agitation episodes compared with placebo Through study completion, an average of 12 weeks
Secondary Part 2: Assess the continued efficacy of BXCL501 in the treatment of episodes of agitation Time to end of an agitation episode from dosing for the last treated episode and across all treated episodes Up to 24 hours after treatment for all episodes of agitation, up to 12 weeks
Secondary Part 2: Assess the continued efficacy of BXCL501 in the treatment of episodes of agitation Change in agitation behaviors scale following drug administration 2 hours after treatment for all episodes of agitation, up to 12 weeks
Secondary Part 2: Determine the overall clinical improvement after drug administration as measured by the use of rescue medications Proportion of patients who receive rescue medication compared with placebo Through study completion, an average of 12 weeks
Secondary Part 2: Determine the overall clinical improvement after drug administration as measured by the use of rescue medications Time to use of rescue medication for patients receiving BXCL501 compared with placebo Through study completion, an average of 12 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05039489 - A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia N/A
Completed NCT05111548 - Brain Stimulation and Cognitive Training - Efficacy N/A
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Completed NCT04503954 - Efficacy of Chronic Disease Self-management Program in People With Schizophrenia N/A
Completed NCT02831231 - Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium Phase 1
Completed NCT05517460 - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center N/A
Completed NCT03652974 - Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy Phase 4
Recruiting NCT04012684 - rTMS on Mismatch Negativity of Schizophrenia N/A
Recruiting NCT04481217 - Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia N/A
Completed NCT00212784 - Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935) Phase 3
Completed NCT04092686 - A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia Phase 3
Completed NCT01914393 - Pediatric Open-Label Extension Study Phase 3
Recruiting NCT03790345 - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics Phase 2/Phase 3
Recruiting NCT05956327 - Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training N/A
Terminated NCT03261817 - A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders N/A
Terminated NCT03209778 - Involuntary Memories Investigation in Schizophrenia N/A
Completed NCT02905604 - Magnetic Stimulation of the Brain in Schizophrenia or Depression N/A
Recruiting NCT05542212 - Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia N/A
Completed NCT04411979 - Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia N/A
Terminated NCT03220438 - TMS Enhancement of Visual Plasticity in Schizophrenia N/A