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)

未提供0 个研究点目标入组 166 人开始时间: 待定

适应症

试验速览

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•Diagnosis of schizophrenia as defined by the DSM-5-TR criteria, confirmed by the K-SADSPL and experiencing symptoms of psychosis at screening (Visit 1).
•PANSS total score of at least 70 at screening (Visit 1) and randomization (Visit 2).
•CGI-S score of >= 4 at screening (Visit 1) and randomization (Visit 2).

•Any primary DSM-5-TR disorder other than schizophrenia within 12 months before screening.
•History or presence of clinically significant cardiovascular, pulmonary, hepatic impairment,renal, hematologic, GI, 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.
•All grades of hepatic impairment (mild [Child-Pugh Class A], moderate [Child-Pugh Class B], and severe [Child-Pugh Class C]).
•Participants with known intellectual disability defined as an IQ less than 70; or, either clinical evidence or known social or school history indicative of intellectual disability.
•Any neurological disorder, except for Tourette's Syndrome.
•Participants who have either a sBP or dBP meeting criteria for stage 2 HTN, regardless of the presence or absence of symptoms.

发起方

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