2025-523711-11-00招募中3 期
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (13 to 17 years of age)
Bristol-Myers Squibb Services Unlimited Company6 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2026年5月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 28
- 试验地点
- 6
- 主要终点
- Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 5
研究概览
简要总结
To determine if KarXT is better than placebo (“dummy drug” with no medicine) in reducing the symptoms of schizophrenia in teenagers (13-17 years old)
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 who are showing inability to tolerate oral medication or swallow capsules
- •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
研究组 & 干预措施
KarXT, KarXT, KarXT
Test
干预措施: KarXT (Drug)
KarXT Matching Placebo
Placebo
干预措施: KarXT Matching Placebo (Drug)
结局指标
主要结局
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 5
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 5
次要结局
- Change from baseline in Clinical Global Impression -Severity (CGI-S) score at Week 5
研究者
GSM-CT
Scientific
Bristol-Myers Squibb Services Unlimited Company
研究点 (6)
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