Clinical Trials in Spain / NCT07686263
Recruiting
Phase 3
Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
NCT07686263 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Schizophrenia
Investigational drug(s) / intervention(s)
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
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)
- Time From Randomization to the First Relapse Event — Up to approximately Week 43
Trial sites (59)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
| Health Synergy Clinical Research | West Palm Beach | Florida | 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 |
| Pillar Clinical Research -Chicago | Chicago | Illinois | 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 | Withdrawn |
| 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.
More Karuna Therapeutics, Inc., a Bristol Myers Squibb company trials in Spain
Other trials for the same condition
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 Spain