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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06929273




Registration number
NCT06929273
Ethics application status
Date submitted
14/04/2025
Date registered
16/04/2025
Date last updated
25/06/2025

Titles & IDs
Public title
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
Scientific title
A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)
Secondary ID [1] 0 0
2024-520259-26-00
Secondary ID [2] 0 0
CN012-0038
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

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

Experimental: KarXT -


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

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment emergent adverse events (TEAEs)
Timepoint [1] 0 0
Up to week 54
Secondary outcome [1] 0 0
Number of participants with AEs of special interest (AESIs)
Timepoint [1] 0 0
Up to week 54
Secondary outcome [2] 0 0
Number of participants with serious AEs (SAEs)
Timepoint [2] 0 0
Up to week 54
Secondary outcome [3] 0 0
Number of participants with TEAEs leading to treatment discontinuation
Timepoint [3] 0 0
Up to week 54
Secondary outcome [4] 0 0
Number of participants with change in suicidal ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Timepoint [4] 0 0
Up to week 54
Secondary outcome [5] 0 0
Change from baseline in Barnes Akathisia Rating Scale (BARS) score
Timepoint [5] 0 0
Up to week 54
Secondary outcome [6] 0 0
Change from baseline in Simpson Angus Scale (SAS) score
Timepoint [6] 0 0
Up to week 54
Secondary outcome [7] 0 0
Chnage from baseline in Abnormal Involuntary Movement Scale (AIMS) score
Timepoint [7] 0 0
Up to week 54
Secondary outcome [8] 0 0
Change from baseline in International Prostate Symptom Score (IPSS)
Timepoint [8] 0 0
Up to week 54

Eligibility
Key inclusion criteria
* Participants who participated in double-blind placebo-controlled study (CN0120036 or CN0120037):

a. Participants must have completed treatment period of parent study.
* De novo participants who did not participate in double-blind placebo-controlled studies:

1. Participants must have primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI, v7.0.2), with symptoms of mania or mixed mania.
2. Participants must have Young Mania Rating Scale (YMRS) score of = 14 at Screening and at baseline.
3. Participants must have CGI-BP score of = 3 at Screening and at baseline.
4. Participants does not require hospitalization for acute mania.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants who participated in double-blind placebo-controlled study (CN0120036 or CN0120037):

a. Discontinuation from any KarXT parent studies.
* De novo participants who did not participate in double-blind placebo-controlled studies:

1. All participants with a risk for suicidal behavior at baseline as determined by Investigator's clinical assessment or history of suicidal behavior as assessed on C-SSRS.
2. Participants must not have primary diagnosis of BP-I with rapid cycling (ie, = 4 distinct mood episodes in one year).
3. Participants must not have any primary DSM-5-TR disorder other than BP-I with mania or mania with mixed features within 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), including BP-I with depression, (previous 3 months only), Bipolar-II disorder, major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.
4. 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 at Screening), or current use as determined by urine toxicology screen or alcohol test.
5. Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
6. Participants must not have history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.
7. Other protocol-defined Inclusion/Exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
22/07/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/06/2028
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Local Institution - 0105 - St Leonards
Recruitment hospital [2] 0 0
Local Institution - 0087 - 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
Arizona
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United States of America
State/province [2] 0 0
Arkansas
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United States of America
State/province [3] 0 0
California
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United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
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United States of America
State/province [6] 0 0
Illinois
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United States of America
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Maryland
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United States of America
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Mississippi
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United States of America
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Missouri
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Nevada
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New Jersey
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New York
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North Carolina
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United States of America
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Ohio
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United States of America
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Texas
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Argentina
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Ciudad Autónoma De Buenos Aires
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Argentina
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Córdoba
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Argentina
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Mendoza
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Bulgaria
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Burgas
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Bulgaria
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Novi Iskar
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Bulgaria
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Pleven
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Bulgaria
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Sliven
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Bulgaria
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Vratsa
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Croatia
State/province [24] 0 0
Grad Zagreb
Country [25] 0 0
Croatia
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Zagreb
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Hungary
State/province [26] 0 0
Gyor-Moson-Sopron
Country [27] 0 0
Hungary
State/province [27] 0 0
Budapest
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India
State/province [28] 0 0
Gujarat
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India
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Kerala
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India
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Telangana
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India
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West Bengal
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India
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Ludhiana
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Israel
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HaMerkaz
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Israel
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Southern
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Israel
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Jerusalem
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Italy
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Lombardia
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Italy
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Toscana
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Italy
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Ancona
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Italy
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Genova
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Fukuoka
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Japan
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Hokkaido
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Japan
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Osaka
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Japan
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Saga-Ken
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Japan
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Saitama
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Japan
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Tokyo
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Japan
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Miyazaki
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Japan
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Wakayama
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Japan
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Yamagata
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New Zealand
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Auckland
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Poland
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Mazowieckie
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Poland
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Podlaskie
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Pomorskie
Country [55] 0 0
Poland
State/province [55] 0 0
Wielkopolskie
Country [56] 0 0
Poland
State/province [56] 0 0
Lódzkie
Country [57] 0 0
Poland
State/province [57] 0 0
Slaskie
Country [58] 0 0
Romania
State/province [58] 0 0
Bucure?ti
Country [59] 0 0
Romania
State/province [59] 0 0
Ia?i
Country [60] 0 0
Romania
State/province [60] 0 0
Sanpetru /Brasov
Country [61] 0 0
Slovakia
State/province [61] 0 0
Košický Kraj
Country [62] 0 0
Slovakia
State/province [62] 0 0
Prešovský Kraj
Country [63] 0 0
Spain
State/province [63] 0 0
Barcelona [Barcelona]
Country [64] 0 0
Spain
State/province [64] 0 0
Catalunya [Cataluña]
Country [65] 0 0
Spain
State/province [65] 0 0
País Vasco
Country [66] 0 0
Sweden
State/province [66] 0 0
Stockholms Län [se-01]
Country [67] 0 0
Sweden
State/province [67] 0 0
Uppsala Län [se-03]
Country [68] 0 0
Sweden
State/province [68] 0 0
Västra Götalands Län [se-14]

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 Contact Center www.BMSStudyConnect.com
Address 0 0
Country 0 0
Phone 0 0
08559073286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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/disclosurecommitment.html

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
See plan description
Available to whom?
See plan description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html


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/NCT06929273