臨床研究等提出・公開システム

Date of registration	Jan. 26, 2026
Last modified on	Jan. 26, 2026
Trial ID	jRCT2041250170

Scientific Title	A Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Individuals with Bipolar-I Disorder TakingLithium, Valproate, or Lamotrigine
Public Title	A Phase 3 Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features,in Bipolar-I Disorder TakingLithium, Valproate, or Lamotrigine (CN0120046)

Contact for Scientific Queries	Name	Galati Steven
	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	Galati Steven
	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	Recruiting

Anticipated date of first enrollment		Feb. 06, 2026
Target sample size		27
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	Participant must be 18 to 65 years of age, inclusive, at the time of signing the ICF. Individuals have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on the DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI)version 7.0.2 Standard with Borderline Personality Disorder version. Individual is experiencing an acute exacerbation or relapse of manic episode, with or without mixed features (=< 3 weeks). The individual requires hospitalization for the acute exacerbation or relapse of mania. Bodymass index >= 18 and =< 40 kg/m2 Currently experiencing an acute episode of mania or mania with mixed featureswitha therapeutic dose of lithium, valproate, or lamotrigine.The dose of the mood stabilizer must have remained stable for at least two weeks prior to screening. Additionally, participants on valproate must have been receiving treatment with valproate for a minimum of seven months. YMRS Total Score of >= 18 at Screening and at Baseline, and < 20% reduction in YMRS from screening to baseline. Clinical Global Impression Severity scale (CGI-BP) >= 4
	Exclusion Criteria	Any primary DSM-5-TR disorder other than BP-I within 12 months before screening (confirmed using MINI version 7.0.2 Standard with Borderline PersonalityDisorderversion at screening) including BP-Idepression, BP-Iwith rapid cycling, first manic episode, BP-II, borderline personality disorder, and major depressive disorder. Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening (confirmed using MINI version 7.0.2 Standard with Borderline Personality Disorder version at screening), or current use as determined by urine toxicology screen or alcohol test. Risk for suicidal behavior atscreening as determined by the investigator's clinical assessment and the C-SSRS with an answer "Yes" to item 4 or 5 within 6months before screeningor between screening and baseline, or suicide attempt within 12 months beforescreening, or between screening and baseline History of irritable bowel syndrome (with or without constipation) or any serious constipation requiring treatment within the last 6 months. History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma. Participants with HIV, cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on either medical history or the LFT results. Elevations in hepatic transaminases at screening >= 2 x ULN for ALT and AST and/or bilirubin > 1.5x ULN, unless in the context of Gilbert's syndrome. All grades of hepatic impairment (mild [Child-Pugh Class A], moderate [Child-Pugh Class B], and severe [Child-Pugh Class C]).
	Age Minimum	18age old over
	Age Maximum	65age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Bipolar-I Disorder
Intervention(s)		KarXT group: xanomeline/trospium chloride 50 mg/20 mg or 75 mg/20 mg or 100 mg/20 mg or 125 mg/30 mg capsule BID Placebo group: placebo capsule BID
Primary Outcome(s)		Change from baseline in Young Mania Rating Scale (YMRS) scoreat Week 5.
Secondary Outcome(s)		Change from baseline in CGI-BP at Week 5.

Primary Sponsor	Bristol-Myers Squibb

Name of Certified Review Board	Okehazama Hospital IRB
Address	3-879 Minamiyakata Sakae-cho, Toyoake, Aichi, Aichi
Telephone	+81-532-96-1361
Approval Status	Approval
Date of approval	Dec. 03, 2025

Plan to share IPD	Yes
Plan description	BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

Secondary ID(s)	NCT07140913
Issuing Authority	CT.gov

Countries of Recruitment（Except Japan）	Argentina/Bulgaria/Denmark/France/India/Israel/Italy/Poland/Romania/United States/China/Ukraine