A study to evaluate the effectiveness and safety of trospium chloride and xanomeline tartrate for treating schizophrenia in adolescents aged 13 to 17 years.
- Trial ID
- 2025-523711-11-00
- Protocol
- CN0120020
Trial statistics
Diseases & Conditions
Objectives
The primary objective is to evaluate the efficacy and safety of KarXT in the treatment of schizophrenia among adolescents aged 13 to 17 years. This investigation seeks to determine the therapeutic superiority of the investigational product compared to placebo in reducing clinical symptoms. The secondary objective includes:
- Assessment of the reduction in overall disease severity.
Participants
This study involves 138 participants diagnosed with schizophrenia. The study population consists of adolescents aged 13 to 17 years, including both males and females. Selection is based on a diagnosis meeting DSM-5-TR criteria and the presence of psychosis during the screening period. Eligible individuals must maintain a stable living condition throughout the duration of the trial. Requirements for participation include a negative serum pregnancy test and adherence to highly effective contraception methods. Participation requires the written consent of a legally acceptable representative.
Plans and Procedures
This Phase 3, multicenter, randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of KarXT in adolescents aged 13 to 17 years diagnosed with schizophrenia. The primary objective is to assess the change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 5. Participants will undergo a screening visit to confirm eligibility based on DSM-5-TR criteria, presence of psychosis, and negative pregnancy testing. Following screening, subjects will be assigned to receive either KarXT or a matching placebo administered as an oral capsule. The study involves monitoring clinical outcomes, including secondary endpoints such as the Clinical Global Impression - Severity (CGI-S) score. The duration of participant involvement is not explicitly specified beyond the assessment at Week 5, though the total trial recruitment and completion period is estimated to span from May 2026 to October 2029.
Treatment
The experimental medication, KarXT, is an oral capsule containing the active substances xanomeline tartrate and trospium chloride. The administration involves specific dosages of 9999 mg or 99999 mg per dose.
The control group receives a KarXT Matching Placebo, which is an inactive substance used for comparison.
Efficacy
The efficacy of KarXT in the treatment of schizophrenia will be evaluated using specific primary and secondary endpoints. The primary endpoint is the change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 5.
Secondary efficacy assessment includes the change from baseline in the Clinical Global Impression-Severity (CGI-S) score at Week 5.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Participants must be 13 to 17 years of age, inclusive, at the time of signing the ICF
- 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
- Participants with diagnosis of schizophrenia as defined by the DSM-5-TR criteria and experiencing symptoms of psychosis during screening
- 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
- Participants must agree to follow instructions for highly effective method(s) of contraception as described in the protocol and included in the ICF
- Participants in a stable living condition and are expected to remain at the same location for the duration of the trial
Exclusion Criteria
- 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
- Participants with a history or presence of clinically significant cardiovascular, pulmonary, hepatic impairment, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease
- Participants with any neurological disorder, except for Tourette’s Syndrome
- Participants with uncontrolled diabetes or clinically significant abnormal fasting blood glucose level at screening
- Participants who have been diagnosed with epilepsy, or have a history of seizures, severe head trauma or stroke
- Participants who have a significant risk of committing violent acts, serious self-harm, or attempting suicide
- Participants with prior exposure to KarXT(xanomeline-trospiumchloride)
- Participants who experienced any adverse effects due to xanomeline or trospiumchloride
- Participants with any clinically significant abnormal laboratory test results at Visit 1 (screening) as per investigator discretion
- Participants who are showing inability to tolerate oral medication or swallow capsules
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Romania | Recruiting | 18 May 2026 | 28 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
KarXT | Test | CAPSULE | ORAL | 9999 | 9999 | PRD12327569 |
KarXT Matching Placebo | Placebo | N/A | — | — | — | N/A |
KarXT | Test | CAPSULE | ORAL | 9999 | 9999 | PRD12327577 |
KarXT | Test | CAPSULE | ORAL | 99999 | 99999 | PRD12327546 |