RECRUITING

A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)

Talk to us

Conditions

Bipolar Disorder Type I With ManiaBipolar-I disorderManiaBipolar-I disorder with Mania

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is 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 (BP-I) The primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.

Official 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)

Quick Facts

Study Start:2025-07-18
Study Completion:2028-06-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06929273

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants who participated in double-blind placebo-controlled study (CN0120036 or CN0120037):
  2. * De novo participants who did not participate in double-blind placebo-controlled studies:
  3. 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.
  4. 2. Participants must have Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline.
  5. 3. Participants must have CGI-BP score of ≥ 3 at Screening and at baseline.
  6. 4. Participants does not require hospitalization for acute mania.
  1. * Participants who participated in double-blind placebo-controlled study (CN0120036 or CN0120037):
  2. * De novo participants who did not participate in double-blind placebo-controlled studies:
  3. 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.
  4. 2. Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year).
  5. 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.
  6. 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.
  7. 5. Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
  8. 6. Participants must not have history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.
  9. 7. Other protocol-defined Inclusion/Exclusion criteria apply.

Contacts and Locations

Study Contact

BMS Study Connect Contact Center www.BMSStudyConnect.com
CONTACT
08559073286
Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site #.
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0120
Glendale, Arizona, 85304
United States
Local Institution - 0022
Bentonville, Arkansas, 72712
United States
Local Institution - 0021
Little Rock, Arkansas, 72204
United States
Local Institution - 0038
Little Rock, Arkansas, 72211
United States
Local Institution - 0057
Rogers, Arkansas, 72758
United States
Local Institution - 0027
Anaheim, California, 92805
United States
Local Institution - 0050
Bellflower, California, 90706
United States
Local Institution - 0044
Cerritos, California, 90703
United States
Local Institution - 0037
Culver City, California, 90230
United States
Local Institution - 0085
Garden Grove, California, 92845-2506
United States
Local Institution - 0056
Montclair, California, 91763
United States
Local Institution - 0039
Orange, California, 92868
United States
Local Institution - 0043
Riverside, California, 92506
United States
Local Institution - 0123
Torrance, California, 90502
United States
Local Institution - 0026
Hialeah Gardens, Florida, 33016
United States
Local Institution - 0059
Hollywood, Florida, 33021
United States
Local Institution - 0053
Hollywood, Florida, 33024
United States
Local Institution - 0047
Miami Lakes, Florida, 33016
United States
Local Institution - 0025
Miami Springs, Florida, 33166
United States
Local Institution - 0030
Miami, Florida, 33126
United States
Local Institution - 0028
Miami, Florida, 33135
United States
Local Institution - 0045
Saint Petersburg, Florida, 33713
United States
Health Synergy Clinical Research
Stuart, Florida, 34997
United States
Local Institution - 0052
Atlanta, Georgia, 30328
United States
Local Institution - 0054
Atlanta, Georgia, 30331
United States
Local Institution - 0023
Decatur, Georgia, 30030
United States
Local Institution - 0024
Savannah, Georgia, 31405
United States
Local Institution - 0031
Chicago, Illinois, 60640
United States
Local Institution - 0020
Chicago, Illinois, 60641
United States
Local Institution - 0049
Gaithersburg, Maryland, 20877
United States
Local Institution - 0029
Flowood, Mississippi, 39232
United States
Local Institution - 0042
Saint Louis, Missouri, 63141
United States
Local Institution - 0121
North Las Vegas, Nevada, 89030
United States
Local Institution - 0122
North Las Vegas, Nevada, 89030
United States
Local Institution - 0058
Marlton, New Jersey, 08053
United States
Local Institution - 0130
Marlton, New Jersey, 08053
United States
Local Institution - 0033
Staten Island, New York, 10314
United States
Local Institution - 0124
Charlotte, North Carolina, 28211
United States
Local Institution - 0055
Cincinnati, Ohio, 45219
United States
Local Institution - 0040
North Canton, Ohio, 44720
United States
Local Institution - 0048
DeSoto, Texas, 75115
United States
Local Institution - 0046
Houston, Texas, 77021
United States
Local Institution - 0036
Irving, Texas, 75062
United States
Pillar Clinical Research - Richardson
Richardson, Texas, 75080
United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-18
Study Completion Date2028-06-13

Study Record Updates

Study Start Date2025-07-18
Study Completion Date2028-06-13

Terms related to this study

Keywords Provided by Researchers

  • Bipolar-I disorder
  • Mania
  • Bipolar-I disorder with Mania

Additional Relevant MeSH Terms

  • Bipolar Disorder Type I With Mania