Not yet recruiting NCT07686263
Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Xanomeline/Trospium Chloride, Placebo.
- Who it may be relevant to
- Registry conditions: Schizophrenia. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Bulgaria, Czechia, Denmark +4
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3 Double-blind, Placebo-controlled Randomized Withdrawal Maintenance Trial of KarXT Treatment in Participants With Schizophrenia
Overview
The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia
Interventions
- Drug Xanomeline/Trospium Chloride
Specified dose on specified days - Drug Placebo
Specified dose on specified days
Primary outcome measures
- Time From Randomization to the First Relapse Event [Time frame: Up to approximately Week 43]
Secondary outcome measures (6)
- Time to Discontinuation During Double-blind Treatment Period [Time frame: Approximately From Week 18 to 43]
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Time frame: Up to approximately Week 45]
- Number of Participants With Adverse Events of Special Interest (AESIs) [Time frame: Up to approximately Week 45]
- Number of Participants With Procholinergic Symptoms [Time frame: Up to approximately Week 45]
- Number of Participants With Anticholinergic Symptoms [Time frame: Up to approximately Week 45]
- Number of Participants With Serious Adverse Events (SAEs) [Time frame: Up to approximately Week 45]
Eligibility criteria
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:
- Item 1 (P1; delusions)
- Item 2 (P2; conceptual disorganization)
- Item 3 (P3; hallucinatory behavior)
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 33 centers
- Local Institution - 0133 — Bentonville
- Local Institution - 0154 — Bentonville
- Local Institution - 0139 — Little Rock
- Local Institution - 0021 — Little Rock
- Local Institution - 0153 — Rogers
- Local Institution - 0190 — Anaheim
- Local Institution - 0040 — Bellflower
- Local Institution - 0188 — Chino
- … and 25 more centers
Romania · 8 centers
- Local Institution - 0103 — Bucharest
- Local Institution - 0105 — Bucharest
- Local Institution - 0107 — Bucharest
- Local Institution - 0110 — Bucharest
- Local Institution - 0174 — Bucharest
- Local Institution - 0106 — Bucharest
- Local Institution - 0109 — Bucharest
- Local Institution - 0055 — Iași
Argentina · 4 centers
- Local Institution - 0175 — Río Cuarto
- Local Institution - 0143 — Buenos Aires
- Local Institution - 0002 — Córdoba
- Local Institution - 0144 — Santiago del Estero
Denmark · 4 centers
- Local Institution - 0159 — Aarhus
- Local Institution - 0182 — Hovedvejen 19
- Local Institution - 0157 — Glostrup
- Local Institution - 0158 — Aalborg
Poland · 4 centers
- Local Institution - 0123 — Warsaw
- Local Institution - 0122 — Bialystok
- Local Institution - 0120 — Gdansk
- Local Institution - 0001 — Poznan
Spain · 4 centers
- Local Institution - 0112 — Barcelona
- Local Institution - 0101 — Barcelona
- Local Institution - 0167 — Valladolid
- Local Institution - 0181 — Zamora
Czechia · 2 centers
- Local Institution - 0162 — Brno
- Local Institution - 0014 — Klecany
Bulgaria · 1 center
- Local Institution - 0191 — Novi Iskar
United Kingdom · 1 center
- Local Institution - 0177 — Oxford
Identifiers
NCT: NCT07686263 · CN012-0006 · 2025-523664-20 · U1111-1327-7599