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A Study to Assess Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adult Patients With Schizophrenia (EMERGENT-2)

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ClinicalTrials.gov Identifier: NCT04659161
Recruitment Status : Completed
First Posted : December 9, 2020
Results First Posted : December 12, 2023
Last Update Posted : December 12, 2023
Sponsor:
Information provided by (Responsible Party):
Karuna Therapeutics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Schizophrenia
Schizophrenia; Psychosis
Interventions Drug: Xanomeline and Trospium Chloride Capsules
Drug: Placebo
Enrollment 252
Recruitment Details The study was conducted in 21 study centers in the United States.
Pre-assignment Details A total of 407 participants were screened, 252 were randomized, and 251 participants were treated.
Arm/Group Title KarXT Placebo
Hide Arm/Group Description Participants received oral capsule KarXT (xanomeline/trospium chloride BID) in a treatment period of 5 weeks. Participants were started on a lead in dose of xanomeline 50 mg/trospium chloride 20 mg twice a day (BID) for the first 2 days followed by xanomeline 100 mg/trospium chloride 20 mg BID for the remainder of Week 1 (Days 3 to 7). On Day 8, dosing was titrated upwards to xanomeline 125 mg/trospium chloride 30 mg BID unless the Participant was continuing to experience adverse events from the previous dose increase of xanomeline 100 mg/trospium chloride 20 mg BID. All Participants who were increased to xanomeline 125 mg/trospium chloride 30 mg BID, depending on clinical response and tolerability, had the option to return to xanomeline 100 mg/trospium chloride 20 mg BID for the remainder of the treatment period. Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
Period Title: Overall Study
Started 126 126
Completed 94 100
Not Completed 32 26
Reason Not Completed
Adverse Event             10             6
Withdrawal by Subject             13             12
Other             9             8
Arm/Group Title KarXT Placebo Total
Hide Arm/Group Description Participants received oral capsule KarXT (xanomeline/trospium chloride BID) in a treatment period of 5 weeks. Participants were started on a lead in dose of xanomeline 50 mg/trospium chloride 20 mg twice a day (BID) for the first 2 days followed by xanomeline 100 mg/trospium chloride 20 mg BID for the remainder of Week 1 (Days 3 to 7). On Day 8, dosing was titrated upwards to xanomeline 125 mg/trospium chloride 30 mg BID unless the Participant was continuing to experience adverse events from the previous dose increase of xanomeline 100 mg/trospium chloride 20 mg BID. All Participants who were increased to xanomeline 125 mg/trospium chloride 30 mg BID, depending on clinical response and tolerability, had the option to return to xanomeline 100 mg/trospium chloride 20 mg BID for the remainder of the treatment period. Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks. Total of all reporting groups
Overall Number of Baseline Participants 126 126 252
Hide Baseline Analysis Population Description
The Intent-to-Treat (ITT) population included all participants who were randomized to the study. Participants were analyzed according to randomized treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 126 participants 126 participants 252 participants
45.6  (10.42) 46.2  (10.78) 45.9  (10.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants 126 participants 252 participants
Female
31
  24.6%
31
  24.6%
62
  24.6%
Male
95
  75.4%
95
  75.4%
190
  75.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants 126 participants 252 participants
Hispanic or Latino
14
  11.1%
11
   8.7%
25
   9.9%
Not Hispanic or Latino
111
  88.1%
114
  90.5%
225
  89.3%
Unknown or Not Reported
1
   0.8%
1
   0.8%
2
   0.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants 126 participants 252 participants
Black or African American
97
  77.0%
92
  73.0%
189
  75.0%
White
26
  20.6%
31
  24.6%
57
  22.6%
Asian
2
   1.6%
1
   0.8%
3
   1.2%
Other
1
   0.8%
2
   1.6%
3
   1.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 126 participants 126 participants 252 participants
126 126 252
Baseline PANSS Total Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 126 participants 125 participants 251 participants
98.3  (8.93) 97.9  (9.71) 98.1  (9.31)
[1]
Measure Description: The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of participants with schizophrenia. 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. It takes approximately 45 to 50 minutes to administer. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
[2]
Measure Analysis Population Description: Measure Analysis Population Description: A total of 252 subjects were randomized (126 subjects in each group) at 21 sites, and a total of 251 subjects were treated (126 [100.0%] in the KarXT group and 125 [99.2%] in the placebo group) during the study.
Baseline PANSS Positive Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 126 participants 125 participants 251 participants
26.8  (3.74) 26.7  (3.97) 26.7  (3.85)
[1]
Measure Analysis Population Description: Measure Analysis Population Description: A total of 252 subjects were randomized (126 subjects in each group) at 21 sites, and a total of 251 subjects were treated (126 [100.0%] in the KarXT group and 125 [99.2%] in the placebo group) during the study.
Baseline PANSS Negative Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 126 participants 125 participants 251 participants
22.9  (4.00) 22.9  (3.82) 22.9  (3.90)
[1]
Measure Analysis Population Description: Measure Analysis Population Description: A total of 252 subjects were randomized (126 subjects in each group) at 21 sites, and a total of 251 subjects were treated (126 [100.0%] in the KarXT group and 125 [99.2%] in the placebo group) during the study.
Baseline PANSS General Psychopathology Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 126 participants 125 participants 251 participants
48.6  (5.79) 48.4  (5.99) 48.5  (5.88)
[1]
Measure Description: The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of participants with schizophrenia. 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. It takes approximately 45 to 50 minutes to administer. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
[2]
Measure Analysis Population Description: Measure Analysis Population Description: A total of 252 subjects were randomized (126 subjects in each group) at 21 sites, and a total of 251 subjects were treated (126 [100.0%] in the KarXT group and 125 [99.2%] in the placebo group) during the study.
Baseline PANSS Marder Factor Negative Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 126 participants 125 participants 251 participants
22.9  (4.97) 22.5  (4.73) 22.7  (4.85)
[1]
Measure Description: The Marder Factor Negative Score is derived from the Positive and Negative Syndrome Scale (PANSS) and consists of the sum of 5 negative scales (N) and 2 general scales (G) (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), with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
[2]
Measure Analysis Population Description: Measure Analysis Population Description: A total of 252 subjects were randomized (126 subjects in each group) at 21 sites, and a total of 251 subjects were treated (126 [100.0%] in the KarXT group and 125 [99.2%] in the placebo group) during the study.
1.Primary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5
Hide Description The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. 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. It takes approximately 45 to 50 minutes to administer. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
Time Frame Baseline and Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
The Modified Intent-to-Treat (MITT) population included all participants who were randomized, received at least one dose of study medication, and had a baseline and at least one post-baseline PANSS assessment. Here, the number of participants analyzed indicates participants who were evaluable for this measure at given time points for each group.
Arm/Group Title KarXT Placebo
Hide Arm/Group Description:
Participants received oral capsule KarXT (xanomeline/trospium chloride BID) in a treatment period of 5 weeks. Participants were started on a lead in dose of xanomeline 50 mg/trospium chloride 20 mg twice a day (BID) for the first 2 days followed by xanomeline 100 mg/trospium chloride 20 mg BID for the remainder of Week 1 (Days 3 to 7). On Day 8, dosing was titrated upwards to xanomeline 125 mg/trospium chloride 30 mg BID unless the Participant was continuing to experience adverse events from the previous dose increase of xanomeline 100 mg/trospium chloride 20 mg BID. All Participants who were increased to xanomeline 125 mg/trospium chloride 30 mg BID, depending on clinical response and tolerability, had the option to return to xanomeline 100 mg/trospium chloride 20 mg BID for the remainder of the treatment period.
Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
Overall Number of Participants Analyzed 117 119
Least Squares Mean (Standard Deviation)
Unit of Measure: score on a scale
-21.2  (1.652) -11.6  (1.600)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection KarXT, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Model for Repeated Measures
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -9.6
Confidence Interval (2-Sided) 95%
-13.9 to -5.2
Estimation Comments [Not Specified]
Other Statistical Analysis Statistics are from a mixed model for repeated measures (MMRM). The model includes the treatment group (KarXT or placebo), visit, and the interaction between the treatment group and visit as fixed factors, and baseline PANSS total score, site, age, and gender as covariates. An unstructured covariance matrix is used to model the correlation among repeated measurements and the denominator degrees of freedom are computed using the Kenward-Roger method.
2.Secondary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Score at Week 5
Hide Description The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. 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. For positive symptoms in schizophrenia, participants are rated from 1 to 7 on each symptom scale, with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
Time Frame Baseline and Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
The Modified Intent-to-Treat (MITT) population included all participants who were randomized, received at least one dose of study medication, and had a baseline and at least one post-baseline PANSS assessment. Here, the number of participants analyzed indicates participants who were evaluable for this measure at given time points for each group.
Arm/Group Title KarXT Placebo
Hide Arm/Group Description:
Participants received oral capsule KarXT (xanomeline/trospium chloride BID) in a treatment period of 5 weeks. Participants were started on a lead in dose of xanomeline 50 mg/trospium chloride 20 mg twice a day (BID) for the first 2 days followed by xanomeline 100 mg/trospium chloride 20 mg BID for the remainder of Week 1 (Days 3 to 7). On Day 8, dosing was titrated upwards to xanomeline 125 mg/trospium chloride 30 mg BID unless the Participant was continuing to experience adverse events from the previous dose increase of xanomeline 100 mg/trospium chloride 20 mg BID. All Participants who were increased to xanomeline 125 mg/trospium chloride 30 mg BID, depending on clinical response and tolerability, had the option to return to xanomeline 100 mg/trospium chloride 20 mg BID for the remainder of the treatment period.
Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
Overall Number of Participants Analyzed 117 119
Least Squares Mean (Standard Deviation)
Unit of Measure: score on a scale
-6.8  (0.526) -3.9  (0.512)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection KarXT, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Model for Repeated Measures
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Score at Week 5
Hide Description The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. For negative symptoms in schizophrenia, participants are rated from 1 to 7 on each symptom scale, with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
Time Frame Baseline and Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
The Modified Intent-to-Treat (MITT) population included all participants who were randomized, received at least one dose of study medication, and had a baseline and at least one post-baseline PANSS assessment. Here, the number of participants analyzed indicates participants who were evaluable for this measure at given time points for each group.
Arm/Group Title KarXT Placebo
Hide Arm/Group Description:
Participants received oral capsule KarXT (xanomeline/trospium chloride BID) in a treatment period of 5 weeks. Participants were started on a lead in dose of xanomeline 50 mg/trospium chloride 20 mg twice a day (BID) for the first 2 days followed by xanomeline 100 mg/trospium chloride 20 mg BID for the remainder of Week 1 (Days 3 to 7). On Day 8, dosing was titrated upwards to xanomeline 125 mg/trospium chloride 30 mg BID unless the Participant was continuing to experience adverse events from the previous dose increase of xanomeline 100 mg/trospium chloride 20 mg BID. All Participants who were increased to xanomeline 125 mg/trospium chloride 30 mg BID, depending on clinical response and tolerability, had the option to return to xanomeline 100 mg/trospium chloride 20 mg BID for the remainder of the treatment period.
Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
Overall Number of Participants Analyzed 117 119
Least Squares Mean (Standard Deviation)
Unit of Measure: score on a scale
-3.4  (0.479) -1.6  (0.466)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection KarXT, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0055
Comments [Not Specified]
Method Mixed Model Repeated Measures
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Factor Negative Score
Hide Description The Marder Factor Negative Score is derived from the Positive and Negative Syndrome Scale (PANSS) and consists of the sum of 5 negative scales (N) and 2 general scales (G) (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), with a minimum score of 7 and a maximum score of 49. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
Time Frame Baseline and Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
The Modified Intent-to-Treat (MITT) population included all participants who were randomized, received at least one dose of study medication, and had a baseline and at least one post-baseline PANSS assessment. Here, the number of participants analyzed indicates participants who were evaluable for this measure at given time points for each group.
Arm/Group Title KarXT Placebo
Hide Arm/Group Description:
Participants received oral capsule KarXT (xanomeline/trospium chloride BID) in a treatment period of 5 weeks. Participants were started on a lead in dose of xanomeline 50 mg/trospium chloride 20 mg twice a day (BID) for the first 2 days followed by xanomeline 100 mg/trospium chloride 20 mg BID for the remainder of Week 1 (Days 3 to 7). On Day 8, dosing was titrated upwards to xanomeline 125 mg/trospium chloride 30 mg BID unless the Participant was continuing to experience adverse events from the previous dose increase of xanomeline 100 mg/trospium chloride 20 mg BID. All Participants who were increased to xanomeline 125 mg/trospium chloride 30 mg BID, depending on clinical response and tolerability, had the option to return to xanomeline 100 mg/trospium chloride 20 mg BID for the remainder of the treatment period.
Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
Overall Number of Participants Analyzed 117 119
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-4.2  (0.530) -2.0  (0.517)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection KarXT, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0022
Comments [Not Specified]
Method Mixed Model for Repeated Measures
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline Clinical Global Impression - Severity (CGI-S) Score at Week 5
Hide Description The CGI-S modified asked the clinician 1 question: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician's answer rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants.
Time Frame Baseline and Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
The Modified Intent-to-Treat (MITT) population included all participants who were randomized, received at least one dose of study medication, and had a baseline and at least one post-baseline PANSS assessment. Here, the number of participants analyzed indicates participants who were evaluable for this measure at given time points for each group.
Arm/Group Title KarXT Placebo
Hide Arm/Group Description:
Participants received oral capsule KarXT (xanomeline/trospium chloride BID) in a treatment period of 5 weeks. Participants were started on a lead in dose of xanomeline 50 mg/trospium chloride 20 mg twice a day (BID) for the first 2 days followed by xanomeline 100 mg/trospium chloride 20 mg BID for the remainder of Week 1 (Days 3 to 7). On Day 8, dosing was titrated upwards to xanomeline 125 mg/trospium chloride 30 mg BID unless the Participant was continuing to experience adverse events from the previous dose increase of xanomeline 100 mg/trospium chloride 20 mg BID. All Participants who were increased to xanomeline 125 mg/trospium chloride 30 mg BID, depending on clinical response and tolerability, had the option to return to xanomeline 100 mg/trospium chloride 20 mg BID for the remainder of the treatment period.
Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
Overall Number of Participants Analyzed 117 119
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-1.2  (0.103) -0.7  (0.099)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection KarXT, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Model for Repeated Measures
Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Positive and Negative Syndrome Scale (PANSS) Responders (>=30% Change in PANSS Total Score) at Week 5
Hide Description The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. 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 total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A PANSS responder is defined as a participant with at least a 30% change in PANSS total score compared to baseline at Week 5.
Time Frame Baseline and Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
The Modified Intent-to-Treat (MITT) population included all participants who were randomized, received at least one dose of study medication, and had a baseline and at least one post-baseline PANSS assessment. Here, the number of participants analyzed indicates participants who were evaluable for this measure at given time points for each group. The overall number of participants was analyzed (N) = number of subjects with Week 5 score.
Arm/Group Title KarXT Placebo
Hide Arm/Group Description:
Participants received oral capsule KarXT (xanomeline/trospium chloride BID) in a treatment period of 5 weeks. Participants were started on a lead in dose of xanomeline 50 mg/trospium chloride 20 mg twice a day (BID) for the first 2 days followed by xanomeline 100 mg/trospium chloride 20 mg BID for the remainder of Week 1 (Days 3 to 7). On Day 8, dosing was titrated upwards to xanomeline 125 mg/trospium chloride 30 mg BID unless the Participant was continuing to experience adverse events from the previous dose increase of xanomeline 100 mg/trospium chloride 20 mg BID. All Participants who were increased to xanomeline 125 mg/trospium chloride 30 mg BID, depending on clinical response and tolerability, had the option to return to xanomeline 100 mg/trospium chloride 20 mg BID for the remainder of the treatment period.
Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
Overall Number of Participants Analyzed 93 99
Measure Type: Count of Participants
Unit of Measure: Participants
51
  54.8%
28
  28.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection KarXT, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Model for Repeated Measures
Comments [Not Specified]
Time Frame From the start of study drug administration up to Week 5.
Adverse Event Reporting Description The Safety population included all participants who received at least one dose of study medication.
 
Arm/Group Title KarXT Placebo
Hide Arm/Group Description Participants received oral capsule KarXT (xanomeline/trospium chloride BID) in a treatment period of 5 weeks. Participants were started on a lead in dose of xanomeline 50 mg/trospium chloride 20 mg twice a day (BID) for the first 2 days followed by xanomeline 100 mg/trospium chloride 20 mg BID for the remainder of Week 1 (Days 3 to 7). On Day 8, dosing was titrated upwards to xanomeline 125 mg/trospium chloride 30 mg BID unless the Participant was continuing to experience adverse events from the previous dose increase of xanomeline 100 mg/trospium chloride 20 mg BID. All Participants who were increased to xanomeline 125 mg/trospium chloride 30 mg BID, depending on clinical response and tolerability, had the option to return to xanomeline 100 mg/trospium chloride 20 mg BID for the remainder of the treatment period. Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
All-Cause Mortality
KarXT Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/126 (0.00%)   0/125 (0.00%) 
Hide Serious Adverse Events
KarXT Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/126 (1.59%)   2/125 (1.60%) 
Infections and infestations     
Appendicitis * 1  0/126 (0.00%)  1/125 (0.80%) 
Psychiatric disorders     
Suicidal ideation * 1 [1]  2/126 (1.59%)  0/125 (0.00%) 
Schizophrenia * 1  0/126 (0.00%)  1/125 (0.80%) 
1
Term from vocabulary, MedDRA version 23.1
*
Indicates events were collected by non-systematic assessment
[1]
Suicidal ideation
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
KarXT Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   95/126 (75.40%)   73/125 (58.40%) 
Cardiac disorders     
Tachycardia * 1  0/126 (0.00%)  3/125 (2.40%) 
Eye disorders     
Vision blurred * 1  6/126 (4.76%)  0/125 (0.00%) 
Gastrointestinal disorders     
Constipation * 1  27/126 (21.43%)  13/125 (10.40%) 
Dyspepsia * 1  24/126 (19.05%)  10/125 (8.00%) 
Nausea * 1  24/126 (19.05%)  7/125 (5.60%) 
Vomiting * 1  18/126 (14.29%)  1/125 (0.80%) 
Abdominal discomfort * 1  7/126 (5.56%)  4/125 (3.20%) 
Diarrhoea * 1  7/126 (5.56%)  4/125 (3.20%) 
Dry mouth * 1  6/126 (4.76%)  2/125 (1.60%) 
Gastrooesophageal reflux disease * 1  8/126 (6.35%)  0/125 (0.00%) 
Abdominal pain * 1  4/126 (3.17%)  2/125 (1.60%) 
Toothache * 1  1/126 (0.79%)  5/125 (4.00%) 
Salivary hypersecretion * 1  3/126 (2.38%)  0/125 (0.00%) 
Investigations     
Heart rate increased * 1  4/126 (3.17%)  1/125 (0.80%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  0/126 (0.00%)  5/125 (4.00%) 
Back pain * 1  2/126 (1.59%)  3/125 (2.40%) 
Nervous system disorders     
Headache * 1  17/126 (13.49%)  15/125 (12.00%) 
Dizziness * 1  11/126 (8.73%)  4/125 (3.20%) 
Somnolence * 1  6/126 (4.76%)  5/125 (4.00%) 
Psychiatric disorders     
Anxiety * 1  6/126 (4.76%)  5/125 (4.00%) 
Agitation * 1  2/126 (1.59%)  8/125 (6.40%) 
Insomnia * 1  3/126 (2.38%)  6/125 (4.80%) 
Psychotic disorder * 1  1/126 (0.79%)  6/125 (4.80%) 
Vascular disorders     
Hypertension * 1  12/126 (9.52%)  1/125 (0.80%) 
Orthostatic hypotension * 1  3/126 (2.38%)  1/125 (0.80%) 
1
Term from vocabulary, MedDRA version 23.1
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Inder Kaul, VP Clinical Development
Organization: Karuna Therapeutics, Inc.
Phone: 1-888-783-0380
EMail: medinfo@karunatx.com
Layout table for additonal information
Responsible Party: Karuna Therapeutics
ClinicalTrials.gov Identifier: NCT04659161    
Other Study ID Numbers: KAR-007
First Submitted: December 2, 2020
First Posted: December 9, 2020
Results First Submitted: October 27, 2023
Results First Posted: December 12, 2023
Last Update Posted: December 12, 2023