Adults 18 to 65, any sex, with Schizophrenia or Schizophrenia; Psychosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5Primary· Baseline and Week 5
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.
Group
Value
95% CI
KarXT
-21.2
± 1.652
Placebo
-11.6
± 1.600
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Score at Week 5Secondary· Baseline and Week 5
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.
Group
Value
95% CI
KarXT
-6.8
± 0.526
Placebo
-3.9
± 0.512
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Score at Week 5Secondary· Baseline and Week 5
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.
Group
Value
95% CI
KarXT
-3.4
± 0.479
Placebo
-1.6
± 0.466
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Factor Negative ScoreSecondary· Baseline and Week 5
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.
Group
Value
95% CI
KarXT
-4.2
± 0.530
Placebo
-2.0
± 0.517
Change From Baseline Clinical Global Impression - Severity (CGI-S) Score at Week 5Secondary· Baseline and Week 5
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.
Group
Value
95% CI
KarXT
-1.2
± 0.103
Placebo
-0.7
± 0.099
Percentage of Positive and Negative Syndrome Scale (PANSS) Responders (>=30% Change in PANSS Total Score) at Week 5Secondary· Baseline and Week 5
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.
Group
Value
95% CI
KarXT
51
Placebo
28
Adverse events — posted to ClinicalTrials.gov
Time frame: From the start of study drug administration up to Week 5..
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a Phase 3, randomized, double-blind, parallel-group, placebo-controlled, multicenter inpatient study to examine the efficacy and safety of KarXT in adult subjects who are acutely psychotic with a Diagnostic and Statistical Manual Fifth Edition (DSM-5) diagnosis of schizophrenia. The primary objective of the study is to assess the efficacy of KarXT (a fixed combination of xanomeline 125 mg and trospium chloride 30 mg twice daily \[BID\]) versus placebo in reducing Positive and Negative Syndrome Scale (PANSS) total scores in adult inpatients with a DSM-5 diagnosis of schizophrenia. The secondary objectives of the study are to evaluate improvement in disease severity and symptoms, safety and tolerability, and pharmacokinetics in adult inpatients with a DSM-5 diagnosis of schizophrenia.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Other trials of Xanomeline and Trospium Chloride Capsules
Trials testing the same drug.
NCT05919823 — A Study to Assess the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Chinese Adult Subjects With DSM-5 S
· Phase 3
· completed
NCT05643170 — An Open-label Study to Assess the Long-term Safety, Tolerability, Effectiveness, and Durability of Effect of KarXT in Pa
· Phase 3
· terminated
NCT05304767 — An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Control
· Phase 3
· recruiting
NCT05145413 — A Study to Assess Efficacy and Safety of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophr
· Phase 3
· completed
NCT04820309 — An Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophr
· Phase 3
· completed
Other recruiting trials for Schizophrenia
Currently open trials in the same condition.
NCT07424404 — A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Au
· Phase 3
· recruiting
NCT07467993 — Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia
· Phase 2
· recruiting
NCT07379827 — Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT)
· recruiting
NCT06758414 — CBT-CP for Veterans With SMI
· NA
· recruiting
NCT07395206 — Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Dis
· NA
· recruiting
Other Karuna Therapeutics, Inc., a Bristol Myers Squibb company trials
Trials by the same sponsor.
NCT07424404 — A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Au
· Phase 3
· recruiting
NCT07257120 — KarXT Concentrations in the Breast Milk and Plasma of Lactating Females
· Phase 4
· recruiting
NCT07204418 — A Study to Evaluate the Effects of CYP2D6 Phenotypes on the Pharmacokinetics of Xanomeline Following KarXT Administratio
· Phase 1
· recruiting
NCT07118215 — A Study to Evaluate the Effects of KarXT on the Drug Levels of Midazolam, Fexofenadine, and Digoxin
· Phase 1
· recruiting
NCT06729970 — A Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Pharmacokinetics of KarXT and Effects
· Phase 1
· completed
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Last refreshed: 12 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04659161.