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Date of registration	Mar. 04, 2026
Last modified on	Mar. 04, 2026
Trial ID	jRCT2011250065

Scientific Title	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)
Public Title	A Phase 3 Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (13 to 17 years of age) (CN012-0020)

Contact for Scientific Queries	Name	Radhakrishnan Rajiv
	Affiliation	Bristol-Myers Squibb
	Address	1-2-1 Otemachi, Chiyoda-ku, Tokyo
	Telephone	+81-120-093-507
	E-mail	mg-jp-clinical_trial@bms.com
Contact for Public Queries	Name	Radhakrishnan Rajiv
	Affiliation	Bristol-Myers Squibb
	Address	1-2-1 Otemachi, Chiyoda-ku, Tokyo
	Telephone	+81-120-093-507
	E-mail	MG-JP-RCO-JRCT@bms.com

Recruitment status	Pending

Anticipated date of first enrollment		Mar. 09, 2026
Target sample size		166
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	-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).
	Exclusion Criteria	-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.
	Age Minimum	13age old over
	Age Maximum	17age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Schizophrenia
Intervention(s)		KarXT (Xanomeline and Trospium Chloride) Capsules (KarXT 50 mg/20 mg BID, KarXT 75mg/20 mg BID and KarXT 100mg/20 mg BID) or Pracebo
Primary Outcome(s)		Change From Baseline in PANSS Total Score at Week 5
Secondary Outcome(s)		-Change from baseline in CGI-S score at Week 5. -Change from baseline in PANSS positive score at Week 5 -Change from baseline in PANSS negative score at Week 5 -Change from baseline in PANSS Negative Marder Factor score at Week 5 -Percentage of PANSS responders (a >= 30% change in PANSS total score) at Week 5 -CGI-I score at Week 5. -Change from baseline in CGAS Score at Week 5.

Primary Sponsor	Bristol-Myers Squibb

Name of Certified Review Board	Goryokai hospital Institutional review board
Address	6-2-3, Shinoro9jo, Sapporo Kita-ku, Hokkaido, Hokkaido
Telephone	+81-11-771-5660
E-Mail	kiminaka@nifty.com
Approval Status	Approval
Date of approval	Dec. 19, 2025

Plan to share IPD	No

Secondary ID(s)	NCT07288567
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	ARGENTINA/COLOMBIA/ROMANIA/UNITED STATES