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Clinical Trials in the USA / NCT07686263
Recruiting Phase 3

Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia

NCT07686263 · tracked via the Priya Life Science USA tracker
Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Phase
Phase 3
Started
2026-08-20
Last updated
2026-09-14

Condition(s) studied

Schizophrenia

Investigational drug(s) / intervention(s)

Xanomeline/Trospium ChloridePlacebo

Xanomeline/Trospium Chloride: Specified dose on specified days

Placebo: Specified dose on specified days

Study summary

The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria * Participant must have a primary diagnosis of schizophrenia for at least 1 year established by a comprehensive psychiatric evaluation based on the DSM-5-TR (American Psychiatric Association 2022) criteria and confirmed by MINI for Psychotic Disorder Studies version 7.0.2 at screening. * Participant must have experienced hospitalization for schizophrenia within 1 year from the screening date. * Participant must be experiencing residual schizophrenia symptoms and have a PANSS total score ≥70 to ≤ 110 at screening and Day -1. * Participant much have a PANSS Score of ≥ 4 (moderate or greater) on ≥ 2 of the following Positive Scale (P) items at screening and Day -1: 1. Item 1 (P1; delusions) 2. Item 2 (P2; conceptual disorganization) 3. Item 3 (P3; hallucinatory behavior) 4. Item 6 (P6; suspiciousness/persecution) * Participant must have a CGI-S score of ≥ 4 at screening and Day -1 * Participant must have a BMI ≥ 18 and ≤ 40 kg/m2. Exclusion Criteria * Participant must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening * Participants must not have a newly diagnosed or are experiencing their first treated episode of psychosis or schizophrenia. * Participant must not have a risk of suicidal behavior as determined by the Investigator's clinical assessment and/or Columbia-suicide Severity Rating Scale (C-SSRS). * Participant must not have had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 6 months before screening. * Participant must not have a history of treatment resistance to schizophrenia medications * Participant must not have decrease in PANSS total score (floor adjusted) between screening and Day -1 of more than 20%. * Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcome measure(s)

Trial sites (59)

FacilityCityRegionStatus
Pillar Clinical Research - Bentonville Bentonville Arkansas Recruiting
Pillar Clinical Research- Little Rock Little Rock Arkansas Recruiting
Local Institution - 0021 Little Rock Arkansas Not Yet Recruiting
Local Institution - 0153 Rogers Arkansas Not Yet Recruiting
Local Institution - 0190 Anaheim California Not Yet Recruiting
Local Institution - 0040 Bellflower California Not Yet Recruiting
Local Institution - 0188 Chino California Not Yet Recruiting
Local Institution - 0032 Culver City California Not Yet Recruiting
Local Institution - 0037 Garden Grove California Not Yet Recruiting
Local Institution - 0068 La Habra California Not Yet Recruiting
Local Institution - 0128 Lemon Grove California Not Yet Recruiting
Local Institution - 0187 Montclair California Not Yet Recruiting
Local Institution - 0151 Orange California Not Yet Recruiting
Local Institution - 0030 Pico Rivera California Not Yet Recruiting
Local Institution - 0185 Redlands California Not Yet Recruiting
Local Institution - 0186 Riverside California Not Yet Recruiting
Local Institution - 0193 Torrance California Not Yet Recruiting
Research Centers of America ( Hollywood ) Hollywood Florida Recruiting
Local Institution - 0075 Miami Florida Withdrawn
Local Institution - 0054 Miami Lakes Florida Withdrawn
Local Institution - 0134 Miami Springs Florida Withdrawn
Local Institution - 0195 Oakland Park Florida Not Yet Recruiting
Local Institution - 0044 West Palm Beach Florida Not Yet Recruiting
Atlanta Center for Medical Research Atlanta Georgia Recruiting
Local Institution - 0070 Sandy Springs Georgia Not Yet Recruiting
Local Institution - 0189 Savannah Georgia Not Yet Recruiting
Local Institution - 0067 Chicago Illinois Not Yet Recruiting
Local Institution - 0056 Chicago Illinois Not Yet Recruiting
Local Institution - 0192 Gaithersburg Maryland Not Yet Recruiting
Local Institution - 0183 Cincinnati Ohio Not Yet Recruiting
Local Institution - 0047 Oklahoma City Oklahoma Not Yet Recruiting
Local Institution - 0049 Austin Texas Not Yet Recruiting
Local Institution - 0194 Dallas Texas Not Yet Recruiting
Pillar Clinical Research - Richardson Richardson Texas Recruiting
Local Institution - 0175 Río Cuarto Córdoba Province Withdrawn
Local Institution - 0143 Buenos Aires Argentina Not Yet Recruiting
Local Institution - 0002 Córdoba Argentina Not Yet Recruiting
Local Institution - 0144 Santiago del Estero Argentina Not Yet Recruiting
Local Institution - 0191 Novi Iskar Bulgaria Not Yet Recruiting
Local Institution - 0162 Brno Czechia Not Yet Recruiting

+ 19 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07686263 on ClinicalTrials.gov ↗ ← All trials in the USA