Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
NCT07686263 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 472
Last updated 2026-07-07
Summary
The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia
Conditions
Interventions
- DRUG
-
Xanomeline/Trospium Chloride
Specified dose on specified days
- DRUG
-
Specified dose on specified days
Sponsors & Collaborators
-
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-03
- Primary Completion
- 2029-03-03
- Completion
- 2029-03-03
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Bulgaria
- Czechia
- Denmark
- Poland
- Romania
- Spain
- United Kingdom
Study Locations
More Related Trials
-
A Study to Assess Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adult Patients With Schizophrenia (EMERGENT-2)
NCT04659161 ·Status: COMPLETED ·Phase: PHASE3
-
An Extension Study to Assess Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-4)
NCT04659174 ·Status: COMPLETED ·Phase: PHASE3
-
An Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-5)
NCT04820309 ·Status: COMPLETED ·Phase: PHASE3
-
An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
NCT05304767 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia
NCT06882785 ·Status: RECRUITING ·Phase: PHASE3
-
A Study to Evaluate the Safety, Tolerability, and PK of an Injectable Form of KarXT
NCT07061288 ·Status: RECRUITING ·Phase: PHASE1
-
A Study to Evaluate the Effect of KarXT on Urological Safety
NCT07221877 ·Status: RECRUITING ·Phase: PHASE4
-
A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)
NCT05511363 ·Status: RECRUITING ·Phase: PHASE3
-
A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia
NCT07615426 ·Status: RECRUITING ·Phase: PHASE1
-
Study to Assess Safety and Effectiveness of Slowly Increasing Dose and Food Effect of KarXT in Participants With Schizophrenia
NCT06572449 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Assess the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Chinese Adult Subjects With DSM-5 Schizophrenia
NCT05919823 ·Status: COMPLETED ·Phase: PHASE3
-
An Open-Label Study to Evaluate the Efficacy and Tolerability of Xanomeline/Trospium In First Episode/Early Phase Schizophrenia Patients
NCT06923891 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
Efficacy of NBI-1117568 in Preventing Relapse in Adults With Schizophrenia
NCT07227818 ·Status: RECRUITING ·Phase: PHASE3
-
A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)
NCT06126224 ·Status: RECRUITING ·Phase: PHASE3
-
A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment
NCT02469155 ·Status: COMPLETED ·Phase: PHASE3
-
Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium
NCT02831231 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia
NCT03817502 ·Status: RECRUITING ·Phase: PHASE3
-
A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia
NCT01412060 ·Status: COMPLETED ·Phase: PHASE3
-
Effects of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia
NCT01376076 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial to Assess the Antipsychotic Efficacy of ITI-007
NCT02282761 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Cariprazine in Schizophrenia
NCT01104779 ·Status: COMPLETED ·Phase: PHASE3
-
Randomized, Double-blind, Placebo Controlled, Multi-center and Tolerability of RBP-7000 in Schizophrenia Patients
NCT02109562 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Cariprazine in Patients With Schizophrenia
NCT01104766 ·Status: COMPLETED ·Phase: PHASE3
-
A Study Evaluating the Efficacy of Xanomeline/Trospium (XT) on Cognitive Impairment After 24 and 52 Weeks of Treatment in Adult Participants With Schizophrenia
NCT07084831 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
An 8-week Open-label Study of an Accelerated and Slower Switching to Xanomeline/Trospium Following Atypical Antipsychotic Treatment in Participants With Schizophrenia
NCT06924255 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4