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This is a Phase 3, multicenter, 53-week, outpatient, open-label extension (OLE) study to evaluate the long-term safety, tolerability, and efficacy of KarXT in subjects with Diagnostic and Statistical Manual-Fifth Edition (DSM-5) schizophrenia who previously completed the treatment period of one of the two Phase 3 double-blind studies, KAR-007 or KAR-009. In this OLE study, all subjects will receive KarXT (a fixed combination of xanomeline 125 mg and trospium chloride 30 mg twice daily [BID]) for up to 52 weeks regardless of treatment assignment in the preceding Phase 3 acute study. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with a DSM-5 diagnosis of schizophrenia. The secondary objective of this study is to assess the long-term efficacy and monitor trough concentrations of xanomeline and trospium after administration of KarXT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KarXT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xanomeline and Trospium Chloride Capsules | Drug | Oral xanomeline 50 mg/trospium chloride 20 mg BID on days 1-2 followed by xanomeline 100 mg/trospium chloride 20 mg BID on days 3-7. The dosage is increased to xanomeline 125 mg/trospium chloride 30 mg BID on days 8-364 unless the subject is experiencing adverse events from the xanomeline 100 mg/ trospium chloride 20 mg dose. Subjects who were increased to xanomeline 125 mg/trospium chloride 30 mg will have the option to return to xanomeline 100 mg/ trospium chloride 20 mg depending on clinical response and tolerability. Re-escalation to 125/30 BID or re-titration in cases in which the subject has been off KarXT for a longer period of time (at least a week) is allowed and will require a discussion between the principal investigator and the medical monitor. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAEs are defined as events with an onset date on or after the first dose of KarXT. An Adverse Event is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at baseline, worsens during the study, regardless of the suspected cause of the event using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. | From first dose to end of study (Up to approximately 53 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) | An SAE is any untoward medical occurrence, in the view of either the investigator or sponsor, that results in death; is life-threatening; results in inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity, and/or; is a congenital anomaly/birth defect using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. |
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Inclusion Criteria:
Subject is aged 18 to 65 years, at time of enrollment into the preceding acute study (KAR-007/009).
Subject is capable of providing informed consent.
Subject has completed the treatment period on study drug (through Day 35 -2 days) of Studies KAR-007 or KAR-009.
Subject resides in a stable living situation, in the opinion of the investigator.
Subject has an identified, reliable informant/caregiver willing to be able to address some questions related to certain study visits, if needed. An informant/caregiver may not be necessary if the subject has been the patient of the investigator for ≥1 year.
Women of childbearing potential or men with sexual partners of childbearing potential must be sexually abstinent (in line with their preferred and usual lifestyle) or willing and able to use at least 1 highly effective method of contraception during the study and for at least 7 days after the last dose of KarXT. Sperm donation is not allowed for 7 days after the final dose of KarXT.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pillar Clinical Research | Bentonville | Arkansas | 72712 | United States | ||
| Woodland International Research Group |
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| ID | Title | Description |
|---|---|---|
| FG000 | KarXT Arm A | Lead-in doses of KarXT (KarXT 50/20 BID). Dosing will be titrated to 100/20 BID on Days 3 to 7 and further titrated to 125/30 BID on Day 8, unless the participant continues to experience AE(s) from the previous dose increase of KarXT. All participants will have the option to return to KarXT 100/20 BID for the remainder of the treatment period. Participants received KarXT previously from KAR-007 and KAR-009. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 11, 2022 |
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|
| From first dose to end of study (Up to approximately 53 weeks) |
| Number of Participants With Treatment-Emergent Adverse Events (TEAE) Leading to Study Drug Discontinuation | TEAEs are defined as events with an onset date on or after the first dose of KarXT. An Adverse Event is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at baseline, worsens during the study, regardless of the suspected cause of the event using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. | From first dose to end of study (Up to approximately 53 weeks) |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 52 | The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. The positive symptoms in schizophrenia are the excess or distortion of normal function and the negative symptoms are the diminution or loss of normal functions. PANSS total score is the sum of all 30 items with a minimum score of 30 and a maximum score of 210. Higher scores indicate more severe symptoms. Open-label Extension Baseline (OLEB) is defined as the most recent measurement prior to the first administration of study drug in KAR-008. The assessments performed on Visit 10 (Day 35) of studies KAR-007 or KAR-009 will be considered for OLEB baseline along with any additional procedures that will be performed on Day 0 of KAR-008. | Open-label extension baseline, week 52 |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Score at Week 52 | PANSS positive score is the sum of all PANSS 7 positive symptom scales with a minimum score of 7 and a maximum score of 49. Higher scores indicate more severe symptoms. Participants are rated from 1 to 7 on each symptom scale. The positive symptoms in schizophrenia are the excess or distortion of normal function such as hallucinations, delusions, grandiosity, and hostility. Open-label Extension Baseline (OLEB) is defined as the most recent measurement prior to the first administration of study drug in KAR-008. The assessments performed on Visit 10 (Day 35) of studies KAR-007 or KAR-009 will be considered for OLEB baseline along with any additional procedures that will be performed on Day 0 of KAR-008. | Open-labe extension baseline, week 52 |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Score at Week 52 | PANSS negative score is the sum of all PANSS 7 negative symptom scales with a minimum score of 7 and a maximum score of 49. Higher scores indicate more severe symptoms. Participants are rated from 1 to 7 on each symptom scale. The negative symptoms in schizophrenia are the diminution or loss of normal functions. Open-label Extension Baseline (OLEB) is defined as the most recent measurement prior to the first administration of study drug in KAR-008. The assessments performed on Visit 10 (Day 35) of studies KAR-007 or KAR-009 will be considered for OLEB baseline along with any additional procedures that will be performed on Day 0 of KAR-008. | Open-label extension baseline, week 52 |
| Change From Baseline in PANSS Negative Marder Factor Score at Week 52 | PANSS Negative Marder Factor Score is the sum of 5 negative scales and 2 general scales (N1. Blunted affect; N2. Emotional withdrawal; N3. Poor rapport; N4. Passive/apathetic social withdrawal; N6. Lack of spontaneity; G7. Motor retardation; and G16. Active social avoidance). Participants are rated from 1 to 7 on each symptom scale. Higher score indicates more severe symptoms. The negative symptoms in schizophrenia are the diminution or loss of normal functions. Open-label Extension Baseline (OLEB) is defined as the most recent measurement prior to the first administration of study drug in KAR-008. The assessments performed on Visit 10 (Day 35) of studies KAR-007 or KAR-009 will be considered for OLEB baseline along with any additional procedures that will be performed on Day 0 of KAR-008. | Open-label extension baseline, week 52 |
| Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 52 | Completed independently by a clinician, the CGI-S categorizes the severity of the illness as: 1 = Normal, not at all ill; 2 = Borderline mentally ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; and 7 = Among the most extremely ill patients, by asking the clinical 1 question and providing a rating based upon observed and reported symptoms, behavior, and function in the past 7 days to reflect the average severity level across the 7 days. Higher score indicates more severe illness. Open-label Extension Baseline (OLEB) is defined as the most recent measurement prior to the first administration of study drug in KAR-008. The assessments performed on Visit 10 (Day 35) of studies KAR-007 or KAR-009 will be considered for OLEB baseline along with any additional procedures that will be performed on Day 0 of KAR-008. | Open-label extension baseline, week 52 |
| Percentage of PANSS Responders With >=30% Reduction in PANSS Total Score at Week 52 | A PANSS responder is defined as a participant with reduction from open-label extension baseline (OLEB) of at least a 30% improvement at Week 52 in the PANSS total score. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. PANSS total score is the sum of all 30 items with a minimum score of 30 and a maximum score of 210. Higher scores indicate more severe symptoms. OLEB is defined as the most recent measurement prior to the first administration of study drug in KAR-008. The assessments performed on Visit 10 (Day 35) of studies KAR-007 or KAR-009 will be considered for OLEB baseline along with any additional procedures that will be performed on Day 0 of KAR-008. | At week 52 |
| Little Rock |
| Arkansas |
| 72211 |
| United States |
| Advanced Research Center, Inc. | Anaheim | California | 92805 | United States |
| Advanced Research Center Inc | Bellflower | California | 90706 | United States |
| CITrials | Bellflower | California | 90706 | United States |
| Proscience Research Group | Culver City | California | 90230 | United States |
| Collaborative NeuroScience Research, LLC | Garden Grove | California | 92845 | United States |
| California Clinical Trial Medical Group | Glendale | California | 91206 | United States |
| Synergy San Diego | Lemon Grove | California | 91945 | United States |
| CNS Network | Long Beach | California | 90806 | United States |
| Catalina Research Institute, LLC | Montclair | California | 91763 | United States |
| NRC Research Institute | Orange | California | 92868 | United States |
| California Neuropsychopharmacology Clinical Research Institute | Pico Rivera | California | 90660 | United States |
| California Neuropsychopharmacology Clinical Research Institute | San Diego | California | 92102 | United States |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | United States |
| Schuster Medical Research Institute | Sherman Oaks | California | 91403 | United States |
| Collaborative Neuroscience Research, LLC. | Torrance | California | 90502 | United States |
| Behavioral Clinical Research, Inc. | Hollywood | Florida | 33021 | United States |
| Research Centers of America | Hollywood | Florida | 33024 | United States |
| Innovative Clinical Research, Inc. | Miami Lakes | Florida | 33016 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | United States |
| iResearch Atlanta, LLC | Decatur | Georgia | 30030 | United States |
| Mitchell L. Glaser | Chicago | Illinois | 60622 | United States |
| Uptown Research Institute | Chicago | Illinois | 60640 | United States |
| AMITA Health Center for Psychiatric Research | Hoffman Estates | Illinois | 60169 | United States |
| Pillar Clinical Research | Lincolnwood | Illinois | 60712 | United States |
| Arch Clinical Trials | St Louis | Missouri | 63125 | United States |
| Altea Research Institute | Las Vegas | Nevada | 89102 | United States |
| Hassman Research Institute | Berlin | New Jersey | 08009 | United States |
| Hassman Research Institute | Marlton | New Jersey | 08053 | United States |
| Neuro-Behavioral Clinical Research, Inc. | North Canton | Ohio | 44720 | United States |
| Community Clinical Research | Austin | Texas | 78754 | United States |
| InSite Clinical Research | DeSoto | Texas | 75115 | United States |
| Pillar Clinical Research, LLC | Richardson | Texas | 75080 | United States |
| Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council, Female Department #11, Male Department #12 | Smila | Cherkasy Oblast | 20708 | Ukraine |
| Dnipropetrovsk Regional Clinical Hospital named after I.I. Mechnikov | Dnipro | 49005 | Ukraine |
| Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine | Kharkiv | 61068 | Ukraine |
| Regional Clinical Psychiatric Hospital No. 3, Adult Psychiatric Department No. 3 | Kharkiv | Ukraine |
| Kherson Regional Insititution of Mental Care of Kherson Regional Council Male Psychiatric Department #3, Femail Psychiatric Department #10 | Kherson | 73488 | Ukraine |
| Kyiv Regional Medical Incorporation "Psychiatry", Center for Novel Treatment and Rehabilitation of Psychotic Disorders | Kyiv | 04080 | Ukraine |
| Lviv Regional Clinical Psychiatric Hospital, Department #20 | Lviv | 79021 | Ukraine |
| Lviv Regional Clinical Psychiatric Hospital, Department #25 | Lviv | 79021 | Ukraine |
| Regional Facility for Psychiatric Care of Poltava Regional Council, 2-A acute general psychiatric male ward, 5-B acute, quiet, general psychiatric female ward, Poltava State Medical University, Academic Department of Psychiatry, Addictology and Medical | Poltava | 36013 | Ukraine |
| M.I. Pyrogov Vinnytsya National Medical University | Vinnytsia | 21037 | Ukraine |
| FG001 | KarXT Arm B | Lead-in doses of KarXT (KarXT 50/20 BID). Dosing will be titrated to 100/20 BID on Days 3 to 7 and further titrated to 125/30 BID on Day 8, unless the participant continues to experience AE(s) from the previous dose increase of KarXT. All participants will have the option to return to KarXT 100/20 BID for the remainder of the treatment period. Participants received Placebo previously from KAR-007 and KAR-009. |
|
| COMPLETED | Completed treatment |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | KarXT Arm A | Lead-in doses of KarXT (KarXT 50/20 BID). Dosing will be titrated to 100/20 BID on Days 3 to 7 and further titrated to 125/30 BID on Day 8, unless the participant continues to experience AE(s) from the previous dose increase of KarXT. All participants will have the option to return to KarXT 100/20 BID for the remainder of the treatment period. Participants received KarXT previously from KAR-007 and KAR-009. |
| BG001 | KarXT Arm B | Lead-in doses of KarXT (KarXT 50/20 BID). Dosing will be titrated to 100/20 BID on Days 3 to 7 and further titrated to 125/30 BID on Day 8, unless the participant continues to experience AE(s) from the previous dose increase of KarXT. All participants will have the option to return to KarXT 100/20 BID for the remainder of the treatment period. Participants received Placebo previously from KAR-007 and KAR-009. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAEs are defined as events with an onset date on or after the first dose of KarXT. An Adverse Event is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at baseline, worsens during the study, regardless of the suspected cause of the event using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. | All treated participants | Posted | Count of Participants | Participants | From first dose to end of study (Up to approximately 53 weeks) |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Adverse Events (SAEs) | An SAE is any untoward medical occurrence, in the view of either the investigator or sponsor, that results in death; is life-threatening; results in inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity, and/or; is a congenital anomaly/birth defect using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. | All treated participants | Posted | Count of Participants | Participants | From first dose to end of study (Up to approximately 53 weeks) |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAE) Leading to Study Drug Discontinuation | TEAEs are defined as events with an onset date on or after the first dose of KarXT. An Adverse Event is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at baseline, worsens during the study, regardless of the suspected cause of the event using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. | All treated participants | Posted | Count of Participants | Participants | From first dose to end of study (Up to approximately 53 weeks) |
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 52 | The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. The positive symptoms in schizophrenia are the excess or distortion of normal function and the negative symptoms are the diminution or loss of normal functions. PANSS total score is the sum of all 30 items with a minimum score of 30 and a maximum score of 210. Higher scores indicate more severe symptoms. Open-label Extension Baseline (OLEB) is defined as the most recent measurement prior to the first administration of study drug in KAR-008. The assessments performed on Visit 10 (Day 35) of studies KAR-007 or KAR-009 will be considered for OLEB baseline along with any additional procedures that will be performed on Day 0 of KAR-008. | All participants who received at least 1 dose of KarXT and have a valid post-baseline PANSS assessment | Posted | Mean | Standard Deviation | score on a scale | Open-label extension baseline, week 52 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Score at Week 52 | PANSS positive score is the sum of all PANSS 7 positive symptom scales with a minimum score of 7 and a maximum score of 49. Higher scores indicate more severe symptoms. Participants are rated from 1 to 7 on each symptom scale. The positive symptoms in schizophrenia are the excess or distortion of normal function such as hallucinations, delusions, grandiosity, and hostility. Open-label Extension Baseline (OLEB) is defined as the most recent measurement prior to the first administration of study drug in KAR-008. The assessments performed on Visit 10 (Day 35) of studies KAR-007 or KAR-009 will be considered for OLEB baseline along with any additional procedures that will be performed on Day 0 of KAR-008. | All participants who received at least 1 dose of KarXT and have a valid post-baseline PANSS assessment | Posted | Mean | Standard Deviation | score on a scale | Open-labe extension baseline, week 52 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Score at Week 52 | PANSS negative score is the sum of all PANSS 7 negative symptom scales with a minimum score of 7 and a maximum score of 49. Higher scores indicate more severe symptoms. Participants are rated from 1 to 7 on each symptom scale. The negative symptoms in schizophrenia are the diminution or loss of normal functions. Open-label Extension Baseline (OLEB) is defined as the most recent measurement prior to the first administration of study drug in KAR-008. The assessments performed on Visit 10 (Day 35) of studies KAR-007 or KAR-009 will be considered for OLEB baseline along with any additional procedures that will be performed on Day 0 of KAR-008. | All participants who received at least 1 dose of KarXT and have a valid post-baseline PANSS assessment | Posted | Mean | Standard Deviation | score on a scale | Open-label extension baseline, week 52 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in PANSS Negative Marder Factor Score at Week 52 | PANSS Negative Marder Factor Score is the sum of 5 negative scales and 2 general scales (N1. Blunted affect; N2. Emotional withdrawal; N3. Poor rapport; N4. Passive/apathetic social withdrawal; N6. Lack of spontaneity; G7. Motor retardation; and G16. Active social avoidance). Participants are rated from 1 to 7 on each symptom scale. Higher score indicates more severe symptoms. The negative symptoms in schizophrenia are the diminution or loss of normal functions. Open-label Extension Baseline (OLEB) is defined as the most recent measurement prior to the first administration of study drug in KAR-008. The assessments performed on Visit 10 (Day 35) of studies KAR-007 or KAR-009 will be considered for OLEB baseline along with any additional procedures that will be performed on Day 0 of KAR-008. | All participants who received at least 1 dose of KarXT and have a valid post-baseline PANSS assessment | Posted | Mean | Standard Deviation | score on a scale | Open-label extension baseline, week 52 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 52 | Completed independently by a clinician, the CGI-S categorizes the severity of the illness as: 1 = Normal, not at all ill; 2 = Borderline mentally ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; and 7 = Among the most extremely ill patients, by asking the clinical 1 question and providing a rating based upon observed and reported symptoms, behavior, and function in the past 7 days to reflect the average severity level across the 7 days. Higher score indicates more severe illness. Open-label Extension Baseline (OLEB) is defined as the most recent measurement prior to the first administration of study drug in KAR-008. The assessments performed on Visit 10 (Day 35) of studies KAR-007 or KAR-009 will be considered for OLEB baseline along with any additional procedures that will be performed on Day 0 of KAR-008. | All participants who received at least 1 dose of KarXT and have a valid post-baseline CGI-S assessment | Posted | Mean | Standard Deviation | score on a scale | Open-label extension baseline, week 52 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of PANSS Responders With >=30% Reduction in PANSS Total Score at Week 52 | A PANSS responder is defined as a participant with reduction from open-label extension baseline (OLEB) of at least a 30% improvement at Week 52 in the PANSS total score. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. PANSS total score is the sum of all 30 items with a minimum score of 30 and a maximum score of 210. Higher scores indicate more severe symptoms. OLEB is defined as the most recent measurement prior to the first administration of study drug in KAR-008. The assessments performed on Visit 10 (Day 35) of studies KAR-007 or KAR-009 will be considered for OLEB baseline along with any additional procedures that will be performed on Day 0 of KAR-008. | All participants who received at least 1 dose of KarXT and have a valid post-baseline PANSS assessment | Posted | Number | Percentage of participants | At week 52 |
|
Participants were assessed for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events from the date of first dose until study completion (Up to approximately 53 weeks).
All participants who received at least one dose of study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | KarXT Arm A | Lead-in doses of KarXT (KarXT 50/20 BID). Dosing will be titrated to 100/20 BID on Days 3 to 7 and further titrated to 125/30 BID on Day 8, unless the participant continues to experience AE(s) from the previous dose increase of KarXT. All participants will have the option to return to KarXT 100/20 BID for the remainder of the treatment period. Participants received KarXT previously from KAR-007 and KAR-009. | 0 | 68 | 5 | 68 | 19 | 68 |
| EG001 | KarXT Arm B | Lead-in doses of KarXT (KarXT 50/20 BID). Dosing will be titrated to 100/20 BID on Days 3 to 7 and further titrated to 125/30 BID on Day 8, unless the participant continues to experience AE(s) from the previous dose increase of KarXT. All participants will have the option to return to KarXT 100/20 BID for the remainder of the treatment period. Participants received Placebo previously from KAR-007 and KAR-009. | 1 | 84 | 3 | 84 | 31 | 84 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
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Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please Email | Clinical.Trials@bms.com |
| Oct 2, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C075257 | xanomeline |
| C003330 | trospium chloride |
Not provided
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| Other |
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| Unknown or Not Reported |
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| KarXT Arm B |
Lead-in doses of KarXT (KarXT 50/20 BID). Dosing will be titrated to 100/20 BID on Days 3 to 7 and further titrated to 125/30 BID on Day 8, unless the participant continues to experience AE(s) from the previous dose increase of KarXT. All participants will have the option to return to KarXT 100/20 BID for the remainder of the treatment period. Participants received Placebo previously from KAR-007 and KAR-009. |
|
|
Lead-in doses of KarXT (KarXT 50/20 BID). Dosing will be titrated to 100/20 BID on Days 3 to 7 and further titrated to 125/30 BID on Day 8, unless the participant continues to experience AE(s) from the previous dose increase of KarXT. All participants will have the option to return to KarXT 100/20 BID for the remainder of the treatment period. Participants received Placebo previously from KAR-007 and KAR-009.
|
|
|
|
Lead-in doses of KarXT (KarXT 50/20 BID). Dosing will be titrated to 100/20 BID on Days 3 to 7 and further titrated to 125/30 BID on Day 8, unless the participant continues to experience AE(s) from the previous dose increase of KarXT. All participants will have the option to return to KarXT 100/20 BID for the remainder of the treatment period. Participants received Placebo previously from KAR-007 and KAR-009. |
|
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| KarXT Arm B |
Lead-in doses of KarXT (KarXT 50/20 BID). Dosing will be titrated to 100/20 BID on Days 3 to 7 and further titrated to 125/30 BID on Day 8, unless the participant continues to experience AE(s) from the previous dose increase of KarXT. All participants will have the option to return to KarXT 100/20 BID for the remainder of the treatment period. Participants received Placebo previously from KAR-007 and KAR-009. |
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Lead-in doses of KarXT (KarXT 50/20 BID). Dosing will be titrated to 100/20 BID on Days 3 to 7 and further titrated to 125/30 BID on Day 8, unless the participant continues to experience AE(s) from the previous dose increase of KarXT. All participants will have the option to return to KarXT 100/20 BID for the remainder of the treatment period. Participants received Placebo previously from KAR-007 and KAR-009. |
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