Trial Outcomes & Findings for An Extension Study to Assess Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-4) (NCT NCT04659174)
NCT ID: NCT04659174
Last Updated: 2024-10-28
Results Overview
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.
COMPLETED
PHASE3
152 participants
From first dose to end of study (Up to approximately 53 weeks)
2024-10-28
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
84
|
|
Overall Study
COMPLETED
|
19
|
16
|
|
Overall Study
NOT COMPLETED
|
49
|
68
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Sponsor decision to discontinue study
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
9
|
11
|
|
Overall Study
Adverse Event
|
8
|
5
|
|
Overall Study
Withdrawal by Subject
|
17
|
33
|
|
Overall Study
Progressive disease
|
0
|
2
|
|
Overall Study
Other reasons
|
0
|
2
|
|
Overall Study
Participant fails to adhere to the protocol requirements
|
14
|
9
|
|
Overall Study
Alcohol or illegal drug use
|
0
|
3
|
|
Overall Study
Violation of entry criteria
|
1
|
0
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
An Extension Study to Assess Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-4)
Baseline characteristics by cohort
| Measure |
KarXT Arm A
n=68 Participants
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.
|
KarXT Arm B
n=84 Participants
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.
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.8 Years
STANDARD_DEVIATION 10.94 • n=5 Participants
|
43.3 Years
STANDARD_DEVIATION 12.07 • n=7 Participants
|
44.9 Years
STANDARD_DEVIATION 11.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
64 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
46 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose to end of study (Up to approximately 53 weeks)Population: All treated participants
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.
Outcome measures
| Measure |
KarXT Arm B
n=84 Participants
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.
|
KarXT Arm A
n=68 Participants
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.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
45 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: From first dose to end of study (Up to approximately 53 weeks)Population: All treated participants
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.
Outcome measures
| Measure |
KarXT Arm B
n=84 Participants
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.
|
KarXT Arm A
n=68 Participants
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.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From first dose to end of study (Up to approximately 53 weeks)Population: All treated participants
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.
Outcome measures
| Measure |
KarXT Arm B
n=84 Participants
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.
|
KarXT Arm A
n=68 Participants
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.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAE) Leading to Study Drug Discontinuation
|
7 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Open-label extension baseline, week 52Population: All participants who received at least 1 dose of KarXT and have a valid post-baseline PANSS assessment
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.
Outcome measures
| Measure |
KarXT Arm B
n=16 Participants
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.
|
KarXT Arm A
n=19 Participants
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.
|
|---|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 52
|
-23.9 score on a scale
Standard Deviation 22.06
|
-9.0 score on a scale
Standard Deviation 17.33
|
SECONDARY outcome
Timeframe: Open-labe extension baseline, week 52Population: All participants who received at least 1 dose of KarXT and have a valid post-baseline PANSS assessment
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.
Outcome measures
| Measure |
KarXT Arm B
n=16 Participants
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.
|
KarXT Arm A
n=19 Participants
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.
|
|---|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Score at Week 52
|
-7.8 score on a scale
Standard Deviation 6.38
|
-3.2 score on a scale
Standard Deviation 5.85
|
SECONDARY outcome
Timeframe: Open-label extension baseline, week 52Population: All participants who received at least 1 dose of KarXT and have a valid post-baseline PANSS assessment
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.
Outcome measures
| Measure |
KarXT Arm B
n=16 Participants
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.
|
KarXT Arm A
n=19 Participants
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.
|
|---|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Score at Week 52
|
-4.6 score on a scale
Standard Deviation 5.06
|
-2.1 score on a scale
Standard Deviation 4.01
|
SECONDARY outcome
Timeframe: Open-label extension baseline, week 52Population: All participants who received at least 1 dose of KarXT and have a valid post-baseline PANSS assessment
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.
Outcome measures
| Measure |
KarXT Arm B
n=16 Participants
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.
|
KarXT Arm A
n=19 Participants
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.
|
|---|---|---|
|
Change From Baseline in PANSS Negative Marder Factor Score at Week 52
|
-5.1 score on a scale
Standard Deviation 5.67
|
-2.4 score on a scale
Standard Deviation 4.22
|
SECONDARY outcome
Timeframe: Open-label extension baseline, week 52Population: All participants who received at least 1 dose of KarXT and have a valid post-baseline CGI-S assessment
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.
Outcome measures
| Measure |
KarXT Arm B
n=16 Participants
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.
|
KarXT Arm A
n=19 Participants
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.
|
|---|---|---|
|
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 52
|
-1.2 score on a scale
Standard Deviation 1.60
|
-0.5 score on a scale
Standard Deviation 1.12
|
SECONDARY outcome
Timeframe: At week 52Population: All participants who received at least 1 dose of KarXT and have a valid post-baseline PANSS assessment
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.
Outcome measures
| Measure |
KarXT Arm B
n=16 Participants
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.
|
KarXT Arm A
n=19 Participants
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.
|
|---|---|---|
|
Percentage of PANSS Responders With >=30% Reduction in PANSS Total Score at Week 52
|
56.3 Percentage of participants
|
42.1 Percentage of participants
|
Adverse Events
KarXT Arm A
KarXT Arm B
Serious adverse events
| Measure |
KarXT Arm A
n=68 participants at risk
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.
|
KarXT Arm B
n=84 participants at risk
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.
|
|---|---|---|
|
General disorders
Death
|
0.00%
0/68 • 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.
|
1.2%
1/84 • 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.
|
|
Infections and infestations
Influenza
|
0.00%
0/68 • 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.
|
1.2%
1/84 • 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.
|
|
Injury, poisoning and procedural complications
Fall
|
1.5%
1/68 • 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.
|
0.00%
0/84 • 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.
|
|
Psychiatric disorders
Anxiety
|
1.5%
1/68 • 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.
|
0.00%
0/84 • 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.
|
|
Psychiatric disorders
Hallucination
|
1.5%
1/68 • 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.
|
0.00%
0/84 • 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.
|
|
Psychiatric disorders
Schizophrenia
|
2.9%
2/68 • 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.
|
1.2%
1/84 • 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.
|
Other adverse events
| Measure |
KarXT Arm A
n=68 participants at risk
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.
|
KarXT Arm B
n=84 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
5.9%
4/68 • 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.
|
3.6%
3/84 • 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.
|
|
Gastrointestinal disorders
Dry mouth
|
4.4%
3/68 • 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.
|
6.0%
5/84 • 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.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.4%
5/68 • 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.
|
9.5%
8/84 • 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.
|
|
Gastrointestinal disorders
Nausea
|
8.8%
6/68 • 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.
|
9.5%
8/84 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
2/68 • 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.
|
13.1%
11/84 • 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.
|
|
Investigations
Weight increased
|
4.4%
3/68 • 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.
|
7.1%
6/84 • 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.
|
|
Vascular disorders
Hypertension
|
4.4%
3/68 • 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.
|
6.0%
5/84 • 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.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER