Trial Outcomes & Findings for A Study to Assess Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adult Patients With Schizophrenia (EMERGENT-2) (NCT NCT04659161)
NCT ID: NCT04659161
Last Updated: 2023-12-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
252 participants
Primary outcome timeframe
Baseline and Week 5
Results posted on
2023-12-12
Participant Flow
The study was conducted in 21 study centers in the United States.
A total of 407 participants were screened, 252 were randomized, and 251 participants were treated.
Participant milestones
| Measure |
KarXT
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.
|
Placebo
Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
126
|
126
|
|
Overall Study
COMPLETED
|
94
|
100
|
|
Overall Study
NOT COMPLETED
|
32
|
26
|
Reasons for withdrawal
| Measure |
KarXT
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.
|
Placebo
Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
6
|
|
Overall Study
Withdrawal by Subject
|
13
|
12
|
|
Overall Study
Other
|
9
|
8
|
Baseline Characteristics
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 characteristics by cohort
| Measure |
KarXT
n=126 Participants
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.
|
Placebo
n=126 Participants
Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.6 years
STANDARD_DEVIATION 10.42 • n=126 Participants
|
46.2 years
STANDARD_DEVIATION 10.78 • n=126 Participants
|
45.9 years
STANDARD_DEVIATION 10.58 • n=252 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=126 Participants
|
31 Participants
n=126 Participants
|
62 Participants
n=252 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=126 Participants
|
95 Participants
n=126 Participants
|
190 Participants
n=252 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=126 Participants
|
11 Participants
n=126 Participants
|
25 Participants
n=252 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
111 Participants
n=126 Participants
|
114 Participants
n=126 Participants
|
225 Participants
n=252 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=126 Participants
|
1 Participants
n=126 Participants
|
2 Participants
n=252 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
97 Participants
n=126 Participants
|
92 Participants
n=126 Participants
|
189 Participants
n=252 Participants
|
|
Race/Ethnicity, Customized
White
|
26 Participants
n=126 Participants
|
31 Participants
n=126 Participants
|
57 Participants
n=252 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=126 Participants
|
1 Participants
n=126 Participants
|
3 Participants
n=252 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=126 Participants
|
2 Participants
n=126 Participants
|
3 Participants
n=252 Participants
|
|
Region of Enrollment
United States
|
126 participants
n=126 Participants
|
126 participants
n=126 Participants
|
252 participants
n=252 Participants
|
|
Baseline PANSS Total Score
|
98.3 units on a scale
STANDARD_DEVIATION 8.93 • n=126 Participants • 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.
|
97.9 units on a scale
STANDARD_DEVIATION 9.71 • n=125 Participants • 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.
|
98.1 units on a scale
STANDARD_DEVIATION 9.31 • n=251 Participants • 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
|
26.8 units on a scale
STANDARD_DEVIATION 3.74 • n=126 Participants • 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.
|
26.7 units on a scale
STANDARD_DEVIATION 3.97 • n=125 Participants • 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.
|
26.7 units on a scale
STANDARD_DEVIATION 3.85 • n=251 Participants • 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
|
22.9 units on a scale
STANDARD_DEVIATION 4.00 • n=126 Participants • 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.
|
22.9 units on a scale
STANDARD_DEVIATION 3.82 • n=125 Participants • 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.
|
22.9 units on a scale
STANDARD_DEVIATION 3.90 • n=251 Participants • 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
|
48.6 units on a scale
STANDARD_DEVIATION 5.79 • n=126 Participants • 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.
|
48.4 units on a scale
STANDARD_DEVIATION 5.99 • n=125 Participants • 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.
|
48.5 units on a scale
STANDARD_DEVIATION 5.88 • n=251 Participants • 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
|
22.9 units on a scale
STANDARD_DEVIATION 4.97 • n=126 Participants • 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.
|
22.5 units on a scale
STANDARD_DEVIATION 4.73 • n=125 Participants • 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.
|
22.7 units on a scale
STANDARD_DEVIATION 4.85 • n=251 Participants • 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.
|
PRIMARY outcome
Timeframe: Baseline and Week 5Population: 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 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.
Outcome measures
| Measure |
KarXT
n=117 Participants
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.
|
Placebo
n=119 Participants
Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
|
|---|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5
|
-21.2 score on a scale
Standard Deviation 1.652
|
-11.6 score on a scale
Standard Deviation 1.600
|
SECONDARY outcome
Timeframe: Baseline and Week 5Population: 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 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.
Outcome measures
| Measure |
KarXT
n=117 Participants
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.
|
Placebo
n=119 Participants
Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
|
|---|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Score at Week 5
|
-6.8 score on a scale
Standard Deviation 0.526
|
-3.9 score on a scale
Standard Deviation 0.512
|
SECONDARY outcome
Timeframe: Baseline and Week 5Population: 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 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.
Outcome measures
| Measure |
KarXT
n=117 Participants
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.
|
Placebo
n=119 Participants
Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
|
|---|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Score at Week 5
|
-3.4 score on a scale
Standard Deviation 0.479
|
-1.6 score on a scale
Standard Deviation 0.466
|
SECONDARY outcome
Timeframe: Baseline and Week 5Population: 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 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.
Outcome measures
| Measure |
KarXT
n=117 Participants
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.
|
Placebo
n=119 Participants
Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
|
|---|---|---|
|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Factor Negative Score
|
-4.2 score on a scale
Standard Error 0.530
|
-2.0 score on a scale
Standard Error 0.517
|
SECONDARY outcome
Timeframe: Baseline and Week 5Population: 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 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.
Outcome measures
| Measure |
KarXT
n=117 Participants
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.
|
Placebo
n=119 Participants
Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
|
|---|---|---|
|
Change From Baseline Clinical Global Impression - Severity (CGI-S) Score at Week 5
|
-1.2 score on a scale
Standard Error 0.103
|
-0.7 score on a scale
Standard Error 0.099
|
SECONDARY outcome
Timeframe: Baseline and Week 5Population: 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.
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.
Outcome measures
| Measure |
KarXT
n=93 Participants
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.
|
Placebo
n=99 Participants
Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
|
|---|---|---|
|
Percentage of Positive and Negative Syndrome Scale (PANSS) Responders (>=30% Change in PANSS Total Score) at Week 5
|
51 Participants
|
28 Participants
|
Adverse Events
KarXT
Serious events: 2 serious events
Other events: 95 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 73 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
KarXT
n=126 participants at risk
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.
|
Placebo
n=125 participants at risk
Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/126 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
0.80%
1/125 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Suicidal ideation
|
1.6%
2/126 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
0.00%
0/125 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/126 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
0.80%
1/125 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
Other adverse events
| Measure |
KarXT
n=126 participants at risk
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.
|
Placebo
n=125 participants at risk
Participants received the matching placebo to KarXT orally twice daily for a treatment period of 5 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
21.4%
27/126 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
10.4%
13/125 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
19.0%
24/126 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
8.0%
10/125 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
19.0%
24/126 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
5.6%
7/125 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
18/126 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
0.80%
1/125 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.6%
7/126 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
3.2%
4/125 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
7/126 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
3.2%
4/125 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Dry mouth
|
4.8%
6/126 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
1.6%
2/125 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.3%
8/126 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
0.00%
0/125 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.2%
4/126 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
1.6%
2/125 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Toothache
|
0.79%
1/126 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
4.0%
5/125 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
13.5%
17/126 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
12.0%
15/125 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
8.7%
11/126 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
3.2%
4/125 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Somnolence
|
4.8%
6/126 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
4.0%
5/125 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
4.8%
6/126 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
4.0%
5/125 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Agitation
|
1.6%
2/126 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
6.4%
8/125 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
2.4%
3/126 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
4.8%
6/125 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Psychotic disorder
|
0.79%
1/126 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
4.8%
6/125 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
|
Vascular disorders
Hypertension
|
9.5%
12/126 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
0.80%
1/125 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
|
Vascular disorders
Orthostatic hypotension
|
2.4%
3/126 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
0.80%
1/125 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
|
Investigations
Heart rate increased
|
3.2%
4/126 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
0.80%
1/125 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/126 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
4.0%
5/125 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
2/126 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
2.4%
3/125 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
|
Eye disorders
Vision blurred
|
4.8%
6/126 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
0.00%
0/125 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
2.4%
3/126 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
0.00%
0/125 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/126 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
2.4%
3/125 • From the start of study drug administration up to Week 5.
The Safety population included all participants who received at least one dose of study medication.
|
Additional Information
Inder Kaul, VP Clinical Development
Karuna Therapeutics, Inc.
Phone: 1-888-783-0380
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60