Clinical Trials in Spain / NCT07424404
Recruiting
Phase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
NCT07424404 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
SchizophreniaAutism-Related Irritability
Investigational drug(s) / intervention(s)
KarXT: Specified dose on specified days
KarX-EC: Specified dose on specified days
Study summary
The purpose of this study is to evaluate the long-term safety and tolerability of Xanomeline and Trospium Chloride for the treatment of psychiatric disorders in children and adolescents
Eligibility
Inclusion Criteria
* Participants must have completed the double-blind treatment period (ie, Visit 8) of Study CN0120020 or the double-blind treatment period (ie, Week 8) of Study CN0120044 or CN0120045 without an adverse event (AE) that, in the opinion of the investigator, may indicate an unacceptable safety risk.
* De-novo participants must have confirmed diagnosis of ASD with symptoms of irritability, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL).
Exclusion Criteria
* Participants must not have a significant risk of committing violent acts, serious self-harm, or attempting suicide based on history or routine psychiatric status examination, or those who are homicidal or are considered to be a high risk to others, or who have an answer of "Yes" on Questions 4 or 5 on the suicidal ideation section of the "Since Last Visit" version of the C-SSRS at baseline (Visit 1). Nonsuicidal, self-injurious behavior is not exclusionary.
* Participants must not have any clinically significant abnormality including any finding(s) from the physical examination, vital signs, or ECG at the end of treatment visit of Study CN0120020, CN0120044 or CN00120045 that the investigator, in consultation with the Sponsor Medical Monitor, would jeopardize the safety of the participant.
* Participants must not have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 hypertension (HTN), regardless of the presence or absence of symptoms.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Primary outcome measure(s)
- Number of participants with treatment emergent adverse events (TEAEs) — Up to 56 weeks
- Number of participants with adverse events of special interest (AESIs) — Up to 56 weeks
- Number of participants with serious adverse events (SAEs) — Up to 56 weeks
Trial sites (94)
| Facility | City | Region | Status |
|---|---|---|---|
| Local Institution - 0054 | Dothan | Alabama | Not Yet Recruiting |
| Local Institution - 0163 | Phoenix | Arizona | Not Yet Recruiting |
| Advanced Research Center Inc. | Anaheim | California | Recruiting |
| Local Institution - 0159 | Anaheim | California | Not Yet Recruiting |
| Inland Psychiatric Medical Group. | Chino | California | Recruiting |
| Proscience Research Group | Culver City | California | Recruiting |
| Local Institution - 0162 | Glendale | California | Not Yet Recruiting |
| Local Institution - 0153 | Los Angeles | California | Not Yet Recruiting |
| Local Institution - 0158 | Orange | California | Not Yet Recruiting |
| Local Institution - 0174 | San Diego | California | Not Yet Recruiting |
| UCSF Neurosciences Clinical Research Unit (NCRU) | San Francisco | California | Recruiting |
| Local Institution - 0157 | San Rafael | California | Not Yet Recruiting |
| Local Institution - 0161 | Colorado Springs | Colorado | Not Yet Recruiting |
| Local Institution - 0154 | New Haven | Connecticut | Not Yet Recruiting |
| Local Institution - 0145 | Boca Raton | Florida | Not Yet Recruiting |
| Local Institution - 0160 | Gainesville | Florida | Not Yet Recruiting |
| Local Institution - 0164 | Gainesville | Florida | Not Yet Recruiting |
| Local Institution - 0168 | Hollywood | Florida | Not Yet Recruiting |
| Apg Research, Llc | Orlando | Florida | Recruiting |
| Atlanta Center for Medical Research | Atlanta | Georgia | Recruiting |
| Salveo Integrative Health - Lawrenceville | Lawrenceville | Georgia | Recruiting |
| Denali Health Atlanta, LLC | Stone Mountain | Georgia | Recruiting |
| Local Institution - 0175 | Chicago | Illinois | Not Yet Recruiting |
| EmVenio Research Center - Prime Healthcare | Chicago | Illinois | Recruiting |
| Boston Children's Hospital | Boston | Massachusetts | Recruiting |
| Local Institution - 0132 | Lexington | Massachusetts | Not Yet Recruiting |
| Local Institution - 0059 | Worcester | Massachusetts | Not Yet Recruiting |
| Local Institution - 0152 | Bloomfield Hills | Michigan | Not Yet Recruiting |
| Local Institution - 0142 | Columbia | Missouri | Not Yet Recruiting |
| Local Institution - 0147 | Lincoln | Nebraska | Not Yet Recruiting |
| Local Institution - 0144 | Las Vegas | Nevada | Not Yet Recruiting |
| Local Institution - 0146 | Neptune City | New Jersey | Not Yet Recruiting |
| Local Institution - 0061 | Great Neck | New York | Not Yet Recruiting |
| Local Institution - 0156 | Staten Island | New York | Not Yet Recruiting |
| Local Institution - 0151 | The Bronx | New York | Not Yet Recruiting |
| University of Cincinnati Cancer Institute | Cincinnati | Ohio | Recruiting |
| Local Institution - 0148 | Cincinnati | Ohio | Not Yet Recruiting |
| Local Institution - 0139 | West Chester | Ohio | Withdrawn |
| Local Institution - 0143 | Danville | Pennsylvania | Not Yet Recruiting |
| Local Institution - 0150 | Pittsburgh | Pennsylvania | Not Yet Recruiting |
+ 54 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 NCT07424404 on ClinicalTrials.gov ↗ ← All trials in Spain