Clinical trial NCT06951698: A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-1)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Bipolar-I Disorder With Mania or Mania With Mixed Features
Keywords: Bipolar-I
Mania
Mixed
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2025-04-30
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder

Detailed description: This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in subjects with bipolar disorder experiencing an acute episode of mania or mania with mixed features.

The primary objective of the study is to evaluate the efficacy of KarXT compared to placebo in treating symptoms of mania during a 3-week inpatient period. The duration of the study including screening, the double-blind inpatient treatment period and safety-follow-up is no more than seven weeks.

Eligibility criteria: Inclusion Criteria

* Participants must have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation.
* Participants must be experiencing an acute episode or relapse of mania or mania with mixed features (≤ 3 weeks).
* Participants must require hospitalization for the acute exacerbation or relapse of mania.
* Participants must have all psychotropic medications washed out in no more than 14 days prior to the first dose of the study drug.
* Participants must have a Young Mania Rating Scale (YMRS) score of ≥ 20 at Screening and at Baseline.
* Participants must have a Clinical Global Impressions-Bipolar (CGI-BP) ≥ 4 at Screening and at Baseline.

Exclusion Criteria:

* Participants must not have any primary Diagnostic and Statistical Manual of Mental Disorders (5th Edition, Text Revision) (DSM-5-TR) disorder, other than BP-I with mania or mania with mixed features within 12 months before screening, including BP-I with depression (for previous 3 months only), BP-II disorder, major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.
* Participants must not have a primary diagnosis of BP-I with rapid cycling (≥ 4 distinct mood episodes in one year).
* Participants must not have a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening, or current use as determined by urine toxicology screen or alcohol test.
* Participants must not be at risk for suicidal behavior at screening or the baseline visit as determined by the Investigator's clinical assessment and the Columbia-Suicide Severity Rating Scale (C-SSRS).
* Participants must not have a history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
* Participants must not have a history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcomes:
measure: Change from baseline in Young Mania Rating Scale (YMRS) score
timeFrame: At week 3
Secondary outcomes:
measure: Change from baseline in Clinical Global Impressions-Bipolar (CGI-BP)
timeFrame: At week 3
measure: Occurrence of response based on a ≥ 50% decrease from baseline in YMRS score
timeFrame: At week 3
measure: Occurrence of response based on CGI-BP change from baseline ≥ 1
timeFrame: At week 3
Other outcomes:
Locations:
city: Bentonville
country: United States
facility: Local Institution - 0058
state: Arkansas
city: Little Rock
country: United States
facility: Local Institution - 0011
state: Arkansas
city: Anaheim
country: United States
facility: Local Institution - 0005
state: California
city: Bellflower
country: United States
facility: Local Institution - 0008
state: California
city: Cerritos
country: United States
facility: Local Institution - 0014
state: California
city: Long Beach
country: United States
facility: Local Institution - 0059
state: California
city: Montclair
country: United States
facility: Local Institution - 0072
state: California
city: Orange
country: United States
facility: Local Institution - 0053
state: California
city: Lauderhill
country: United States
facility: Local Institution - 0054
state: Florida
city: Miami Lakes
country: United States
facility: Local Institution - 0015
state: Florida
city: Miami Springs
country: United States
facility: Local Institution - 0069
state: Florida
city: Miami
country: United States
facility: Local Institution - 0020
state: Florida
city: Stuart
country: United States
facility: Local Institution - 0023
state: Florida
city: Atlanta
country: United States
facility: Local Institution - 0009
state: Georgia
city: Savannah
country: United States
facility: Local Institution - 0057
state: Georgia
city: Chicago
country: United States
facility: Local Institution - 0047
state: Illinois
city: Staten Island
country: United States
facility: Local Institution - 0030
state: New York
city: North Canton
country: United States
facility: Local Institution - 0013
state: Ohio
city: Irving
country: United States
facility: Local Institution - 0029
state: Texas
city: Richardson
country: United States
facility: Local Institution - 0044
state: Texas
city: ABB
country: Argentina
facility: Local Institution - 0110
state: Ciudad Autónoma De Buenos Aires
city: Córdoba
country: Argentina
facility: Local Institution - 0115
city: Mendoza
country: Argentina
facility: Local Institution - 0108
city: Mendoza
country: Argentina
facility: Local Institution - 0109
city: St Leonards
country: Australia
facility: Local Institution - 0117
state: New South Wales
city: Brisbane
country: Australia
facility: Local Institution - 0106
state: Queensland
city: Burgas
country: Bulgaria
facility: Local Institution - 0113
city: Novi Iskar
country: Bulgaria
facility: Local Institution - 0119
city: Pleven
country: Bulgaria
facility: Local Institution - 0112
city: Sliven
country: Bulgaria
facility: Local Institution - 0120
city: Vratsa
country: Bulgaria
facility: Local Institution - 0121
city: Győr
country: Hungary
facility: Local Institution - 0116
state: Győr-Moson-Sopron
city: Budapest
country: Hungary
facility: Local Institution - 0114
city: Budapest
country: Hungary
facility: Local Institution - 0118
city: Konan
country: Japan
facility: Local Institution - 0082
state: Aichi
city: Toyoake
country: Japan
facility: Local Institution - 0079
state: Aichi
city: Ichikawa
country: Japan
facility: Local Institution - 0078
state: Chiba
city: Kitakyushu
country: Japan
facility: Local Institution - 0100
state: Fukuoka
city: Obihiro
country: Japan
facility: Local Institution - 0090
state: Hokkaido
city: Sapporo
country: Japan
facility: Local Institution - 0080
state: Hokkaido
city: Karatsu-shi
country: Japan
facility: Local Institution - 0087
state: Saga-Ken
city: Iruma
country: Japan
facility: Local Institution - 0081
state: Saitama
city: Kumagaya
country: Japan
facility: Local Institution - 0092
state: Saitama
city: Itabashi City
country: Japan
facility: Local Institution - 0085
state: Tokyo
city: Kodaira
country: Japan
facility: Local Institution - 0105
state: Tokyo
city: Fukuoka
country: Japan
facility: Local Institution - 0083
city: Miyazaki
country: Japan
facility: Local Institution - 0077
city: Osaka
country: Japan
facility: Local Institution - 0086
city: Osaka
country: Japan
facility: Local Institution - 0089
city: Osaka
country: Japan
facility: Local Institution - 0084
city: Tokyo
country: Japan
facility: Local Institution - 0104
city: Wakayama
country: Japan
facility: Local Institution - 0076
city: Yamagata
country: Japan
facility: Local Institution - 0088
city: Auckland
country: New Zealand
facility: Local Institution - 0055
city: Warsaw
country: Poland
facility: Local Institution - 0107
state: Mazowieckie
city: Bialystok
country: Poland
facility: Local Institution - 0094
state: Podlaskie
city: Gdańsk
country: Poland
facility: Local Institution - 0111
state: Pomorskie
city: Poznań
country: Poland
facility: Local Institution - 0095
state: Wielkopolskie
city: Tuszyn
country: Poland
facility: Local Institution - 0096
state: Łódzkie
city: Chorzów
country: Poland
facility: Local Institution - 0103
state: Śląskie
city: Sosnowiec
country: Poland
facility: Local Institution - 0102
state: Śląskie
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: