TROSPIUM CHLORIDE; XANOMELINE TARTRATE for Schizophrenia

Inclusion criteria

• {"criterion_text":"- Participants must be 13 to 17 years of age, inclusive, at the time of signing the ICF"}
• {"criterion_text":"- Participants' legally acceptable representative (ie, legal guardian or caregiver) must have signed and dated an IRB/IEC-approved ICF in accordance with regulatory, local, and institutional guidelines"}
• {"criterion_text":"- Participants with diagnosis of schizophrenia as defined by the DSM-5-TR criteria and experiencing symptoms of psychosis during screening"}
• {"criterion_text":"- IOCBP must have a negative highly sensitive serum pregnancy test at screening and a urine test within 24 hours prior to the start of study intervention"}
• {"criterion_text":"- Participants must agree to follow instructions for highly effective method(s) of contraception as described in the protocol and included in the ICF"}
• {"criterion_text":"- Participants in a stable living condition and are expected to remain at the same location for the duration of the trial"}

Exclusion criteria

• {"criterion_text":"- Participants with any primary DSM-5-TR disorder diagnosis other than schizophrenia within 12 months before screening including, but not limited to moderate to severe alcohol use disorder, substance (other than nicotine or caffeine) use disorder, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and post-traumatic stress disorder"}
• {"criterion_text":"- Participants who are showing inability to tolerate oral medication or swallow capsules"}
• {"criterion_text":"- Participants with a history or presence of clinically significant cardiovascular, pulmonary, hepatic impairment, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease"}
• {"criterion_text":"- Participants with any neurological disorder, except for Tourette’s Syndrome"}
• {"criterion_text":"- Participants with uncontrolled diabetes or clinically significant abnormal fasting blood glucose level at screening"}
• {"criterion_text":"- Participants who have been diagnosed with epilepsy, or have a history of seizures, severe head trauma or stroke"}
• {"criterion_text":"- Participants who have a significant risk of committing violent acts, serious self-harm, or attempting suicide"}
• {"criterion_text":"- Participants with prior exposure to KarXT(xanomeline-trospiumchloride)"}
• {"criterion_text":"- Participants who experienced any adverse effects due to xanomeline or trospiumchloride"}
• {"criterion_text":"- Participants with any clinically significant abnormal laboratory test results at Visit 1 (screening) as per investigator discretion"}

Primary endpoints

• {"endpoint_text":"- Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 5","definition_or_measurement_approach":"Change from baseline in PANSS total score at Week 5 (measured using the Positive and Negative Syndrome Scale total score)"}

Secondary endpoints

• {"endpoint_text":"- Change from baseline in Clinical Global Impression -Severity (CGI-S) score at Week 5","definition_or_measurement_approach":"Change from baseline in CGI-S score at Week 5 (measured using the Clinical Global Impression - Severity scale)"}

Methods

• Patient recruitment: duty assigned to Praxis Communications LLC (listed sponsor duty: Patient recruitment) — no channel, target audience, or country-specific approach described in the available documents.

Romania

Earliest CTIS Part Ii Submission Date

26-03-2026

Latest Decision Or Authorization Date

20-04-2026

Processing Time Days

25

Number Of Sites

6

Number Of Participants

28

Primary sponsor

Full Name

Bristol-Myers Squibb Services Unlimited Company

Organisation Type

Pharmaceutical company

Country Of Registered Address

Ireland

Contract research organisations

Name

Syneos Health Inc.

Responsibilities

Patient eligibility

Name

Iqvia Inc.

Responsibilities

site payments

Third parties

• {"country":"United States","full_name":"Praxis Communications LLC","duties_or_roles":"Patient recruitment","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Patient eligibility","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"site payments","organisation_type":"Pharmaceutical company"}
• {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Embarc operations","organisation_type":"Pharmaceutical company"}
• {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"pharmacovigilance duties, medical review and cases data entry","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Provides electronic payments, travel arrangements,electronic study-related comunications to patients","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"Subject Number assignment, Treatment/Arm assignment,Drug (re)supplies assignment, PRO/COA","organisation_type":"Pharmaceutical company"}