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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06951698




Registration number
NCT06951698
Ethics application status
Date submitted
23/04/2025
Date registered
30/04/2025

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
Scientific 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)
Secondary ID [1] 0 0
CN012-0036
Universal Trial Number (UTN)
Trial acronym
BALSAM-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar-I Disorder With Mania or Mania With Mixed Features 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - KarXT
Other interventions - Placebo

Experimental: KarXT - Flexible dosing

Placebo comparator: Placebo -


Treatment: Drugs: KarXT
Specified dose on specified days

Other interventions: Placebo
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in Young Mania Rating Scale (YMRS) score
Timepoint [1] 0 0
At week 3
Secondary outcome [1] 0 0
Change from baseline in Clinical Global Impressions-Bipolar (CGI-BP)
Timepoint [1] 0 0
At week 3
Secondary outcome [2] 0 0
Occurrence of response based on a = 50% decrease from baseline in YMRS score
Timepoint [2] 0 0
At week 3
Secondary outcome [3] 0 0
Occurrence of response based on CGI-BP change from baseline = 1
Timepoint [3] 0 0
At week 3

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
17/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2026
Actual
Sample size
Target
274
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Local Institution - 0117 - St Leonards
Recruitment hospital [2] 0 0
Local Institution - 0106 - Brisbane
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
4005 - Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Argentina
State/province [9] 0 0
Ciudad Autónoma De Buenos Aires
Country [10] 0 0
Argentina
State/province [10] 0 0
Córdoba
Country [11] 0 0
Argentina
State/province [11] 0 0
Mendoza
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Burgas
Country [13] 0 0
Bulgaria
State/province [13] 0 0
Novi Iskar
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Pleven
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Sliven
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Vratsa
Country [17] 0 0
Hungary
State/province [17] 0 0
Gyor-Moson-Sopron
Country [18] 0 0
Hungary
State/province [18] 0 0
Budapest
Country [19] 0 0
Japan
State/province [19] 0 0
Aichi
Country [20] 0 0
Japan
State/province [20] 0 0
Chiba
Country [21] 0 0
Japan
State/province [21] 0 0
Fukuoka
Country [22] 0 0
Japan
State/province [22] 0 0
Hokkaido
Country [23] 0 0
Japan
State/province [23] 0 0
Saga-Ken
Country [24] 0 0
Japan
State/province [24] 0 0
Saitama
Country [25] 0 0
Japan
State/province [25] 0 0
Tokyo
Country [26] 0 0
Japan
State/province [26] 0 0
Miyazaki
Country [27] 0 0
Japan
State/province [27] 0 0
Osaka
Country [28] 0 0
Japan
State/province [28] 0 0
Wakayama
Country [29] 0 0
Japan
State/province [29] 0 0
Yamagata
Country [30] 0 0
New Zealand
State/province [30] 0 0
Auckland
Country [31] 0 0
Poland
State/province [31] 0 0
Mazowieckie
Country [32] 0 0
Poland
State/province [32] 0 0
Podlaskie
Country [33] 0 0
Poland
State/province [33] 0 0
Pomorskie
Country [34] 0 0
Poland
State/province [34] 0 0
Wielkopolskie
Country [35] 0 0
Poland
State/province [35] 0 0
Lódzkie
Country [36] 0 0
Poland
State/province [36] 0 0
Slaskie

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Study Connect www.BMSStudyConnect.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06951698