Trial Outcomes & Findings for A Study to Assess Efficacy and Safety of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia (NCT NCT05145413)
NCT ID: NCT05145413
Last Updated: 2026-05-05
Results Overview
PANSS Total Score is a clinician administered measure of schizophrenia symptom severity used widely in antipsychotic research. It includes 30 items across 3 subscales: * Positive Symptoms (7 items) assessing excesses or distortions such as hallucinations, delusions, or grandiosity * Negative Symptoms (7 items) assessing diminished function such as social withdrawal or reduced motivation and * General Psychopathology (16 items) capturing broader symptoms like anxiety, depression, guilt, or cognitive impairment Each item is scored from 1 (absent) to 7 (extreme), producing a PANSS Total Score ranging from 30 to 210, with higher scores indicating more severe symptoms. Baseline is defined as the last non missing PANSS Total Score before first dose. This endpoint evaluates change from Baseline to Week 6, with negative values indicating improvement.
COMPLETED
PHASE3
396 participants
Baseline to Week 6
2026-05-05
Participant Flow
A total of 396 participants were randomized, with 197 assigned to the KarXT group and 199 assigned to the placebo group. Of these, 392 participants received at least one dose of study treatment, including 194 in the KarXT group and 198 in the placebo group.
Participant milestones
| Measure |
KarXT
Participants received oral KarXT (Xanomeline/Trospium Chloride) capsules twice daily (BID) for a treatment period of up to 6 weeks. During Week 1, participants received KarXT 50/20 mg BID, followed by KarXT 75/20 mg BID in Week 2. In Week 3, dosing became flexible based on individual tolerability and clinical response, with allowable doses of KarXT 75/20 mg or 100/20 mg BID. From Weeks 4 to 6, participants continued flexible dosing according to tolerability and clinical response, with allowable doses of KarXT 75/20 mg, 100/20 mg, or 125/30 mg BID.
|
Placebo
Participants received matching placebo to KarXT orally twice daily (BID) for a treatment period of up to 6 weeks.
|
|---|---|---|
|
Pre-treatment Period
STARTED
|
197
|
199
|
|
Pre-treatment Period
COMPLETED
|
194
|
198
|
|
Pre-treatment Period
NOT COMPLETED
|
3
|
1
|
|
Treatment Period
STARTED
|
194
|
198
|
|
Treatment Period
COMPLETED
|
161
|
180
|
|
Treatment Period
NOT COMPLETED
|
33
|
18
|
Reasons for withdrawal
| Measure |
KarXT
Participants received oral KarXT (Xanomeline/Trospium Chloride) capsules twice daily (BID) for a treatment period of up to 6 weeks. During Week 1, participants received KarXT 50/20 mg BID, followed by KarXT 75/20 mg BID in Week 2. In Week 3, dosing became flexible based on individual tolerability and clinical response, with allowable doses of KarXT 75/20 mg or 100/20 mg BID. From Weeks 4 to 6, participants continued flexible dosing according to tolerability and clinical response, with allowable doses of KarXT 75/20 mg, 100/20 mg, or 125/30 mg BID.
|
Placebo
Participants received matching placebo to KarXT orally twice daily (BID) for a treatment period of up to 6 weeks.
|
|---|---|---|
|
Pre-treatment Period
Lost to Follow-up
|
0
|
1
|
|
Pre-treatment Period
Physician Decision
|
1
|
0
|
|
Pre-treatment Period
Withdrawal by Subject
|
2
|
0
|
|
Treatment Period
Withdrawal by Subject
|
10
|
8
|
|
Treatment Period
Protocol Violation
|
3
|
1
|
|
Treatment Period
Lost to Follow-up
|
5
|
1
|
|
Treatment Period
Physician Decision
|
4
|
2
|
|
Treatment Period
Adverse Event
|
7
|
2
|
|
Treatment Period
Other Reasons
|
4
|
4
|
Baseline Characteristics
A Study to Assess Efficacy and Safety of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
Baseline characteristics by cohort
| Measure |
KarXT
n=197 Participants
Participants received oral KarXT (Xanomeline/Trospium Chloride) capsules twice daily (BID) for a treatment period of up to 6 weeks. During Week 1, participants received KarXT 50/20 mg BID, followed by KarXT 75/20 mg BID in Week 2. In Week 3, dosing became flexible based on individual tolerability and clinical response, with allowable doses of KarXT 75/20 mg or 100/20 mg BID. From Weeks 4 to 6, participants continued flexible dosing according to tolerability and clinical response, with allowable doses of KarXT 75/20 mg, 100/20 mg, or 125/30 mg BID.
|
Placebo
n=199 Participants
Participants received matching placebo to KarXT orally twice daily (BID) for a treatment period of up to 6 weeks.
|
Total
n=396 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.6 Years
STANDARD_DEVIATION 11.26 • n=54 Participants
|
41.8 Years
STANDARD_DEVIATION 10.41 • n=60 Participants
|
41.7 Years
STANDARD_DEVIATION 10.83 • n=114 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=54 Participants
|
72 Participants
n=60 Participants
|
142 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
127 Participants
n=54 Participants
|
127 Participants
n=60 Participants
|
254 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
35 Participants
n=54 Participants
|
34 Participants
n=60 Participants
|
69 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
161 Participants
n=54 Participants
|
163 Participants
n=60 Participants
|
324 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
3 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
3 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=54 Participants
|
5 Participants
n=60 Participants
|
12 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
78 Participants
n=54 Participants
|
75 Participants
n=60 Participants
|
153 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
White
|
99 Participants
n=54 Participants
|
112 Participants
n=60 Participants
|
211 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Other
|
10 Participants
n=54 Participants
|
5 Participants
n=60 Participants
|
15 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
1 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 6Population: All randomized participants who received at least one dose of study medication, had a baseline positive and negative syndrome scale (PANSS) assessment, and had at least one post baseline PANSS assessment.
PANSS Total Score is a clinician administered measure of schizophrenia symptom severity used widely in antipsychotic research. It includes 30 items across 3 subscales: * Positive Symptoms (7 items) assessing excesses or distortions such as hallucinations, delusions, or grandiosity * Negative Symptoms (7 items) assessing diminished function such as social withdrawal or reduced motivation and * General Psychopathology (16 items) capturing broader symptoms like anxiety, depression, guilt, or cognitive impairment Each item is scored from 1 (absent) to 7 (extreme), producing a PANSS Total Score ranging from 30 to 210, with higher scores indicating more severe symptoms. Baseline is defined as the last non missing PANSS Total Score before first dose. This endpoint evaluates change from Baseline to Week 6, with negative values indicating improvement.
Outcome measures
| Measure |
KarXT
n=190 Participants
Participants received oral KarXT (Xanomeline/Trospium Chloride) capsules twice daily (BID) for a treatment period of up to 6 weeks. During Week 1, participants received KarXT 50/20 mg BID, followed by KarXT 75/20 mg BID in Week 2. In Week 3, dosing became flexible based on individual tolerability and clinical response, with allowable doses of KarXT 75/20 mg or 100/20 mg BID. From Weeks 4 to 6, participants continued flexible dosing according to tolerability and clinical response, with allowable doses of KarXT 75/20 mg, 100/20 mg, or 125/30 mg BID.
|
Placebo
n=196 Participants
Participants received matching placebo to KarXT orally twice daily (BID) for a treatment period of up to 6 weeks.
|
|---|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
|
-14.3 Score on a Scale
Standard Error 1.01
|
-12.2 Score on a Scale
Standard Error 0.98
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: All randomized participants who received at least one dose of study medication, had a baseline positive and negative syndrome scale (PANSS) assessment, and had at least one post baseline PANSS assessment.
The Personal and Social Performance (PSP) Scale is a clinician administered assessment of personal and social functioning in individuals with schizophrenia. It evaluates functioning across four key dimensions: * Socially useful activities * Personal and social relationships * Self care and * Disturbing and aggressive behaviors The PSP is completed through a structured clinical interview and provides a total score ranging from 1 to 100, using a 6 point severity rating for each domain. Higher PSP scores indicate better personal and social functioning. The endpoint measures change from Baseline to Week 6 in PSP score, with positive values indicating improved personal and social functioning.
Outcome measures
| Measure |
KarXT
n=190 Participants
Participants received oral KarXT (Xanomeline/Trospium Chloride) capsules twice daily (BID) for a treatment period of up to 6 weeks. During Week 1, participants received KarXT 50/20 mg BID, followed by KarXT 75/20 mg BID in Week 2. In Week 3, dosing became flexible based on individual tolerability and clinical response, with allowable doses of KarXT 75/20 mg or 100/20 mg BID. From Weeks 4 to 6, participants continued flexible dosing according to tolerability and clinical response, with allowable doses of KarXT 75/20 mg, 100/20 mg, or 125/30 mg BID.
|
Placebo
n=196 Participants
Participants received matching placebo to KarXT orally twice daily (BID) for a treatment period of up to 6 weeks.
|
|---|---|---|
|
Change From Baseline in Personal and Social Performance Scale (PSP) at Week 6
|
5.3 Score on a Scale
Standard Error 0.75
|
5.9 Score on a Scale
Standard Error 0.73
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: All randomized participants who received at least one dose of study medication, had a baseline positive and negative syndrome scale (PANSS) assessment, and had at least one post baseline PANSS assessment.
Change from baseline in the Clinical Global Impression-Severity (CGI-S) assesses change in overall illness severity over time as rated by the clinician. The CGI-S is a clinician-rated, single-item scale that evaluates the severity of the participant's illness at the time of assessment based on the clinician's total clinical experience with patients with the same diagnosis. Severity is rated on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill), with higher scores indicating greater illness severity (worse outcome). Ratings are based on observed and reported symptoms, behavior, and functioning over the previous 7 days. Change from baseline is calculated as the difference between the CGI-S score at baseline and Week 6, with negative values indicating improvement and positive values indicating worsening.
Outcome measures
| Measure |
KarXT
n=190 Participants
Participants received oral KarXT (Xanomeline/Trospium Chloride) capsules twice daily (BID) for a treatment period of up to 6 weeks. During Week 1, participants received KarXT 50/20 mg BID, followed by KarXT 75/20 mg BID in Week 2. In Week 3, dosing became flexible based on individual tolerability and clinical response, with allowable doses of KarXT 75/20 mg or 100/20 mg BID. From Weeks 4 to 6, participants continued flexible dosing according to tolerability and clinical response, with allowable doses of KarXT 75/20 mg, 100/20 mg, or 125/30 mg BID.
|
Placebo
n=196 Participants
Participants received matching placebo to KarXT orally twice daily (BID) for a treatment period of up to 6 weeks.
|
|---|---|---|
|
Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) at Week 6
|
-0.6 Score on a Scale
Standard Error 0.06
|
-0.5 Score on a Scale
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: All randomized participants who received at least one dose of study medication, had a baseline positive and negative syndrome scale (PANSS) assessment, and had at least one post baseline PANSS assessment.
Change from baseline in PANSS M-Pos Symptom Factor Score assesses change in the severity of positive symptoms of schizophrenia over time as rated by the clinician. The PANSS is a clinician-administered scale that evaluates symptom severity based on observed and reported symptoms. The PANSS Marder Positive Symptom Factor score is derived from the following PANSS items: Delusions (P1), Hallucinations (P3), Grandiosity (P5), Suspiciousness/Persecution (P6), Stereotyped Thinking (N7), Somatic Concern (G1), Unusual Thought Content (G9), and Lack of Judgment and Insight (G12). Each item is rated on a 7-point scale (1 = absent to 7 = extreme). The PANSS M-Pos factor score is calculated by summing the relevant item scores, with higher scores indicating greater positive symptom severity (worse outcome). Change from baseline is calculated as the difference between the PANSS M-Pos score at baseline and Week 6, with negative values indicating improvement and positive values indicating worsening.
Outcome measures
| Measure |
KarXT
n=190 Participants
Participants received oral KarXT (Xanomeline/Trospium Chloride) capsules twice daily (BID) for a treatment period of up to 6 weeks. During Week 1, participants received KarXT 50/20 mg BID, followed by KarXT 75/20 mg BID in Week 2. In Week 3, dosing became flexible based on individual tolerability and clinical response, with allowable doses of KarXT 75/20 mg or 100/20 mg BID. From Weeks 4 to 6, participants continued flexible dosing according to tolerability and clinical response, with allowable doses of KarXT 75/20 mg, 100/20 mg, or 125/30 mg BID.
|
Placebo
n=196 Participants
Participants received matching placebo to KarXT orally twice daily (BID) for a treatment period of up to 6 weeks.
|
|---|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale Marder Positive (PANSS M-Pos) Symptom Factor Score at Week 6
|
-5.0 Score on a Scale
Standard Error 0.36
|
-4.2 Score on a Scale
Standard Error 0.35
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: All randomized participants who received at least one dose of study medication, had a baseline positive and negative syndrome scale (PANSS) assessment, and had at least one post baseline PANSS assessment.
Change from baseline in PANSS M-Neg Symptom Factor Score assesses change in the severity of negative symptoms of schizophrenia over time as rated by the clinician. The PANSS is a clinician-administered scale that evaluates symptom severity based on observed and reported symptoms. The PANSS Marder Negative Symptom Factor score is derived from the following PANSS items: Blunted Affect (N1), Emotional Withdrawal (N2), Poor Rapport (N3), Passive Social Withdrawal (N4), Lack of Spontaneity of Conversation (N6), Motor Retardation (G7), and Active Social Avoidance (G16). Each item is rated on a 7-point scale (1 = absent to 7 = extreme). The PANSS M-Neg factor score is calculated by summing the relevant item scores, with higher scores indicating greater negative symptom severity (worse outcome). Change from baseline is calculated as the difference between the PANSS M-Neg score at baseline and Week 6, with negative values indicating improvement and positive values indicating worsening.
Outcome measures
| Measure |
KarXT
n=190 Participants
Participants received oral KarXT (Xanomeline/Trospium Chloride) capsules twice daily (BID) for a treatment period of up to 6 weeks. During Week 1, participants received KarXT 50/20 mg BID, followed by KarXT 75/20 mg BID in Week 2. In Week 3, dosing became flexible based on individual tolerability and clinical response, with allowable doses of KarXT 75/20 mg or 100/20 mg BID. From Weeks 4 to 6, participants continued flexible dosing according to tolerability and clinical response, with allowable doses of KarXT 75/20 mg, 100/20 mg, or 125/30 mg BID.
|
Placebo
n=196 Participants
Participants received matching placebo to KarXT orally twice daily (BID) for a treatment period of up to 6 weeks.
|
|---|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale Marder Negative (PANSS M-Neg) Symptom Factor Score at Week 6
|
-3.1 Score on a Scale
Standard Error 0.33
|
-3.0 Score on a Scale
Standard Error 0.32
|
SECONDARY outcome
Timeframe: At Week 6Population: All randomized participants who received at least one dose of study medication, had a baseline positive and negative syndrome scale (PANSS) assessment, and had at least one post baseline PANSS assessment.
The Positive and Negative Syndrome Scale (PANSS) is a clinician administered scale that assesses symptom severity in schizophrenia and includes 30 items across three subscales: 7 positive symptoms, 7 negative symptoms, and 16 general psychopathology symptoms. Each item is scored from 1 (absent) to 7 (extreme), generating a PANSS Total Score ranging from 30 to 210, with higher scores indicating more severe symptoms. This endpoint evaluates the percentage of participants whose Week 6 PANSS Total Score decreased by at least 30% from Baseline, reflecting clinically meaningful improvement.
Outcome measures
| Measure |
KarXT
n=161 Participants
Participants received oral KarXT (Xanomeline/Trospium Chloride) capsules twice daily (BID) for a treatment period of up to 6 weeks. During Week 1, participants received KarXT 50/20 mg BID, followed by KarXT 75/20 mg BID in Week 2. In Week 3, dosing became flexible based on individual tolerability and clinical response, with allowable doses of KarXT 75/20 mg or 100/20 mg BID. From Weeks 4 to 6, participants continued flexible dosing according to tolerability and clinical response, with allowable doses of KarXT 75/20 mg, 100/20 mg, or 125/30 mg BID.
|
Placebo
n=180 Participants
Participants received matching placebo to KarXT orally twice daily (BID) for a treatment period of up to 6 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving a ≥ 30% Improvement in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
|
37.9 Percentage of Participants
|
35.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: At Week 6Population: All randomized participants who received at least one dose of study medication, had a baseline positive and negative syndrome scale (PANSS) assessment, and had at least one post baseline PANSS assessment.
The Preference of Medication (POM) is a two item questionnaire assessing the participant's and informant's preference for the current antipsychotic compared with the most recent pre study antipsychotic. It evaluates perceived benefit or worsening relative to prior treatment. The POM uses a 5 point scale: 1 = "much better, I prefer this medication," 2 = "slightly better," 3 = "about the same," 4 = "slightly worse," 5 = "much worse, I much prefer my previous medication." Based on this scale, responses are categorized as Better (scores 1-2) or Same or Worse (scores 3-5) for both participant and informant assessments.
Outcome measures
| Measure |
KarXT
n=159 Participants
Participants received oral KarXT (Xanomeline/Trospium Chloride) capsules twice daily (BID) for a treatment period of up to 6 weeks. During Week 1, participants received KarXT 50/20 mg BID, followed by KarXT 75/20 mg BID in Week 2. In Week 3, dosing became flexible based on individual tolerability and clinical response, with allowable doses of KarXT 75/20 mg or 100/20 mg BID. From Weeks 4 to 6, participants continued flexible dosing according to tolerability and clinical response, with allowable doses of KarXT 75/20 mg, 100/20 mg, or 125/30 mg BID.
|
Placebo
n=180 Participants
Participants received matching placebo to KarXT orally twice daily (BID) for a treatment period of up to 6 weeks.
|
|---|---|---|
|
Percentage of Participants With Preference of Medication (POM) at Week 6
Informant Preference: Better (Scores 1-2)
|
64.3 Percentage of Participants
|
52.2 Percentage of Participants
|
|
Percentage of Participants With Preference of Medication (POM) at Week 6
Participant Preference: Better (Scores 1-2)
|
58.5 Percentage of Participants
|
50.0 Percentage of Participants
|
|
Percentage of Participants With Preference of Medication (POM) at Week 6
Participant Preference: Same or Worse (Scores 3-5)
|
41.5 Percentage of Participants
|
50.0 Percentage of Participants
|
|
Percentage of Participants With Preference of Medication (POM) at Week 6
Informant Preference: Same or Worse (Scores 3-5)
|
35.7 Percentage of Participants
|
47.8 Percentage of Participants
|
Adverse Events
KarXT
Placebo
Serious adverse events
| Measure |
KarXT
n=194 participants at risk
Participants received oral KarXT (Xanomeline/Trospium Chloride) capsules twice daily (BID) for a treatment period of up to 6 weeks. During Week 1, participants received KarXT 50/20 mg BID, followed by KarXT 75/20 mg BID in Week 2. In Week 3, dosing became flexible based on individual tolerability and clinical response, with allowable doses of KarXT 75/20 mg or 100/20 mg BID. From Weeks 4 to 6, participants continued flexible dosing according to tolerability and clinical response, with allowable doses of KarXT 75/20 mg, 100/20 mg, or 125/30 mg BID.
|
Placebo
n=198 participants at risk
Participants received matching placebo to KarXT orally twice daily (BID) for a treatment period of up to 6 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/194 • Participants were assessed for All-Cause Mortality, SAEs and Other AEs from first dose of study medication until study completion (assessed up to approximately 175 weeks).
The number at Risk for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.51%
1/198 • Participants were assessed for All-Cause Mortality, SAEs and Other AEs from first dose of study medication until study completion (assessed up to approximately 175 weeks).
The number at Risk for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/194 • Participants were assessed for All-Cause Mortality, SAEs and Other AEs from first dose of study medication until study completion (assessed up to approximately 175 weeks).
The number at Risk for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.51%
1/198 • Participants were assessed for All-Cause Mortality, SAEs and Other AEs from first dose of study medication until study completion (assessed up to approximately 175 weeks).
The number at Risk for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Psychotic disorder
|
0.52%
1/194 • Participants were assessed for All-Cause Mortality, SAEs and Other AEs from first dose of study medication until study completion (assessed up to approximately 175 weeks).
The number at Risk for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.51%
1/198 • Participants were assessed for All-Cause Mortality, SAEs and Other AEs from first dose of study medication until study completion (assessed up to approximately 175 weeks).
The number at Risk for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Schizophrenia
|
0.52%
1/194 • Participants were assessed for All-Cause Mortality, SAEs and Other AEs from first dose of study medication until study completion (assessed up to approximately 175 weeks).
The number at Risk for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/198 • Participants were assessed for All-Cause Mortality, SAEs and Other AEs from first dose of study medication until study completion (assessed up to approximately 175 weeks).
The number at Risk for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
Other adverse events
| Measure |
KarXT
n=194 participants at risk
Participants received oral KarXT (Xanomeline/Trospium Chloride) capsules twice daily (BID) for a treatment period of up to 6 weeks. During Week 1, participants received KarXT 50/20 mg BID, followed by KarXT 75/20 mg BID in Week 2. In Week 3, dosing became flexible based on individual tolerability and clinical response, with allowable doses of KarXT 75/20 mg or 100/20 mg BID. From Weeks 4 to 6, participants continued flexible dosing according to tolerability and clinical response, with allowable doses of KarXT 75/20 mg, 100/20 mg, or 125/30 mg BID.
|
Placebo
n=198 participants at risk
Participants received matching placebo to KarXT orally twice daily (BID) for a treatment period of up to 6 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
8.8%
17/194 • Participants were assessed for All-Cause Mortality, SAEs and Other AEs from first dose of study medication until study completion (assessed up to approximately 175 weeks).
The number at Risk for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.5%
3/198 • Participants were assessed for All-Cause Mortality, SAEs and Other AEs from first dose of study medication until study completion (assessed up to approximately 175 weeks).
The number at Risk for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
15.5%
30/194 • Participants were assessed for All-Cause Mortality, SAEs and Other AEs from first dose of study medication until study completion (assessed up to approximately 175 weeks).
The number at Risk for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.0%
6/198 • Participants were assessed for All-Cause Mortality, SAEs and Other AEs from first dose of study medication until study completion (assessed up to approximately 175 weeks).
The number at Risk for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
11.3%
22/194 • Participants were assessed for All-Cause Mortality, SAEs and Other AEs from first dose of study medication until study completion (assessed up to approximately 175 weeks).
The number at Risk for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.0%
2/198 • Participants were assessed for All-Cause Mortality, SAEs and Other AEs from first dose of study medication until study completion (assessed up to approximately 175 weeks).
The number at Risk for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Somnolence
|
6.2%
12/194 • Participants were assessed for All-Cause Mortality, SAEs and Other AEs from first dose of study medication until study completion (assessed up to approximately 175 weeks).
The number at Risk for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.5%
7/198 • Participants were assessed for All-Cause Mortality, SAEs and Other AEs from first dose of study medication until study completion (assessed up to approximately 175 weeks).
The number at Risk for All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
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