2024-510773-20-00招募中3 期
An Open-label Extension Study to Assess the Long-term Safety and Tolerability of Adjunctive KarXT in Subjects with Inadequately Controlled Symptoms of Schizophrenia
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 19
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
To assess the long-term safety and tolerability of adjunctive KarXT in subjects with schizophrenia
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Subject is aged 18 to 65 years (inclusive), at the time of randomization (Visit 3 of Study KAR-012)
- •Subject has successfully completed the treatment period (through Visit 8) of Study KAR-012
- •Subject has been compliant with the procedures in Study KAR-012 (in the Investigator's judgment)
- •Subject has been compliant with their background APD in Study KAR-012 in the opinion of the Investigator and based on subject and informant reporting. Note: Subjects are required to remain on the same appropriate approved APD as in Study KAR-012 and should stay on that same dose throughout the study
- •Subject is capable of providing signed ICF before any study assessments will be performed. Subject must be fluent in the language of the ICF to consent
- •Subject resides in a stable living situation, in the opinion of the Investigator
- •Subject has identified a reliable informant/caregiver willing and able to assist with study activities as needed throughout the subject's participation in the study. The informant does not have to be someone responsible for the subject’s physical or psychiatric well-being. As needed, the informant can complete the study visits assessments via phone (as .per local regulations). In Bulgaria, the informant needs to be physically present at all study visits where the Investigator determines that his/her input would be beneficial
- •Women of childbearing potential (WOCBP), or men whose sexual partners are WOCBP, must be able and willing to use at least 1 highly effective method of contraception during the study and for at least 1 menstrual cycle (e.g., 30 days) after the last dose of study drug. Sperm donation is not allowed for 30 days after the final dose of the study drug. A female subject is considered to be a WOCBP after menarche and until she is in a postmenopausal state for 12 months or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, or bilateral oophorectomy)
排除标准
- •Risk for suicidal behavior during the study as determined by the Investigator's clinical assessment and/or C-SSRS at Visit 8 in Study KAR-012, as confirmed by the following: a. Subject answers "Yes" to "suicidal ideation" Item 4 (active suicidal ideation with some intent to act, without a specific plan) or Item 5 (active suicidal ideation with a specific plan and intent) on the C-SSRS b. Non-suicidal self-injurious behavior is not exclusionary
- •Any clinically significant abnormalities, including any finding(s) from the ECG, or laboratory test at Visit 6, and physical examination, vital signs, at the EOT visit of Study KAR-012 (Visit 8) that the Investigator, in consultation with the Medical Monitor, are considered to jeopardize the safety of the subject
- •Female subject is pregnant
- •If, in the opinion of the Investigator (and/or Sponsor/ Medical Monitor), subject is unsuitable for enrollment in the study or subject has any finding that, in the view of the Investigator (and/or Sponsor /Medical Monitor), may compromise the safety of the subject or affect his/her ability to adhere to the protocol visit schedule or study requirements
- •Risk of violent or destructive behavior as per Investigator's judgment
- •Subjects participating in another investigational drug or device trial or planning on participating in another clinical trial during the study
- •History or high risk of urinary retention, gastric retention, or narrow angle glaucoma as evaluated by the Investigator
- •Subject is taking, or plans to take while in the study, any prohibited concomitant medication as outlined in APPENDIX 4
- •For all male subjects only, any one of the following: a. History of bladder stones b. History of recurrent urinary tract infections c. Serum prostate specific antigen >10 ng/mL d. An International Prostate Symptom Score (IPSS) of 5 (almost always) on either item 1, 3, 5, or 6 e. A sum of scores on IPSS items 1, 3, 5, and 6 of ≥9 Note: IPSS will be required only for male subjects ≥ 45 years of age. An additional prostate-specific antigen (PSA) result prior to enrollment in study KAR-013 is not required; PSA results captured from the KAR-012 study will suffice.
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events (TEAEs)
次要结局
- Incidence of serious TEAEs
- Incidence of TEAEs leading to discontinuation of study drug
研究者
GSM-CT
Scientific
Karuna Therapeutics Inc.
研究点 (19)
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