2025-523060-20-00撤回3 期
A prospective, open-label, single-arm, multicenter study evaluating the efficacy of Xanomeline/Trospium (XT) on cognitive impairment after 24 and 52 weeks of treatment in adult participants with schizophrenia.
European Group for Research in Schizophrenia Stichting15 个研究点 分布在 8 个国家目标入组 160 人开始时间: 2026年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 160
- 试验地点
- 15
- 主要终点
- Change from baseline to week 24 in the BACS composite cognitive score.
研究概览
简要总结
To assess efficacy of XT on cognitive impairment.
研究设计
- 分配方式
- Na
- 主要目的
- Xt Medication Use
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Be between 18 and 55 years of age.
- •Be willing and able to provide informed consent, after the nature of the study has been fully explained. This includes being able to understand the locally approved informed consent (and information letter) in the local language.
- •Have a current DSM-5 diagnosis of schizophrenia, , which needs to be confirmed by MINI.
- •Have all PANSS positive items + G8 and G10 ≤4 at screening.
- •Stable dose of oral antipsychotic medication(s) for at least 4 weeks prior to Screening. Participants should be on monotherapy oral AP for baseline visit.
- •Have a SCIP total below
- •Test negative for pregnancy at the screening visit and must be using a highly effective contraceptive method during the study and 30 days after the study, if being a female of childbearing potential.
排除标准
- •Be pregnant, lactating, or less than 3 months postpartum.
- •Currently meet DSM-5 criteria for a manic episode or major depressive disorder as confirmed by the MINI.
- •Currently meeting DSM-5 criteria for severe substance and/or alcohol use disorder as confirmed by the MINI (≥6 on module K for alcohol use disorder and/or ≥6 on module J for substance use disorder, unless being in early or sustained remission).
- •Have a positive urine toxicology for phencyclidine, amphetamines, opiates (unless participant has a valid prescription for short-term use), cocaine, or alcohol (clinically significant alcohol use in the opinion of the Investigator). Nicotine and caffeine use is allowed. Stimulants and cannabis is allowed when used sporadically and recreationally as per the judgement of the clinician.
- •Present with an intellectual disability, drug-induced psychosis, or history of clinically significant brain trauma as per the judgement of the clinician.
- •Have current or past use of clozapine (used for at least 6 weeks in an effective dose range) and/or current use of a long-acting injectable antipsychotic, or anticholinergic treatment that cannot be discontinued before the baseline visit.
- •Be expected to require more than the allowed psychotropic concomitant medication during the study (from baseline on). This is defined as: needing benzodiazepines of more than 2 mg lorazepam equivalent (daily), quetiapine, antidepressants. If these treatments are used at the screening visit, they must be tapered down before the baseline visit. NB. Stable use of mood stabilizers is allowed during the study. This is defined as being on the stable dosage for at least 4 weeks prior to baseline.
- •Having a known allergy to xanomeline, trospium chloride or any of the ingredients of XT.
- •Have clinically significant abnormal finding on the physical examination, medical history, ECG (at screening), or clinically significant laboratory results at screening.
- •Participated in any cognitive remediation/training program or completed the BACS within 4 weeks of Screening.
- •Have current presence of clinically significant cardiovascular, pulmonary, renal, hematologic, gastrointestinal (e.g., obstructive disorders [including conditions that may decrease GI motility, such as ulcerative colitis, intestinal atony, and myasthenia gravis], endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results. This includes: a. Have history or high risk of urinary retention. b. All grades of hepatic impairment (mild [Child-Pugh Class A], moderate [Child-Pugh Class B], and severe [Child-Pugh Class C]). c. Elevations in hepatic transaminases at screening ≥ 2× ULN for ALT and AST and/or bilirubin > 2 × ULN, unless in the context of Gilbert’s syndrome. d. Have a history or high risk for narrow-angle glaucoma. e. Active biliary disease (e.g., symptomatic gallstones). Participants with other biliary histories are eligible and should be discussed with the sponsor. f. Participants with a history of bladder stones. g. Participants with a history of recurrent urinary tract infections. h. For all male participants, serum prostate-specific antigen >10 ng/mL at screening. i. For male participants ≥ 45 years of age, an IPSS score of 5 (i.e, “almost always”) on items 1, 3, 5, or 6, and/or for male participants ≥ 45 years of age, an IPSS score ≥ 9 for the sum of items 1, 3, 5, and
- •j. An eGFR of < 60 mL/min (which indicates renal dysfunction). k. History of unstable hypertension or tachycardia as evidenced by a blood pressure of ≥ 160/100 mmHg at screening and/or a heart rate of ≥ 110 bpm at screening.
- •Be at significant risk of committing suicide. This is defined as: participants with active suicidal ideation with some intent to act, without specific plan (“Yes” to question 4 of the Columbia-Suicide Severity Rating Scale (C-SSRS) or active suicidal ideation with specific plan and intent (“Yes” to question 5 of the C-SSRS), followed by an assessment by the treating clinician who determines it is not safe for the participant to participate in the study.
研究组 & 干预措施
KarXT
Test
干预措施: KarXT (Drug)
结局指标
主要结局
Change from baseline to week 24 in the BACS composite cognitive score.
Change from baseline to week 24 in the BACS composite cognitive score.
次要结局
- Change from baseline to week 24 in the PANSS negative subscale.
研究者
Dr. Inge Winter
Scientific
European Group for Research in Schizophrenia Stichting
研究点 (15)
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