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Tests treatment safety and results for Bipolar Disorder Type I With Mania or Mania With Mixed...
Official title A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
ClinicalTrials.gov ID: NCT06951711
What this study is testing
What is KarXT?
KarXT is an investigational medicine, being studied as a potential treatment for bipolar disorder type i with mania or mania with mixed features.
Also referred to as BMS-986510, Xanomeline and trospium chloride.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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.
You likely can't join if
- Participants must not have any primary Diagnostic and Statistical Manual of Mental Disorders (5th Edition, Text Revision) (DSM-5-TR) disorder, other...
- 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...
- Participants must not be at risk for suicidal behavior at screening or the baseline visit as determined by the Investigator's clinical assessment and...
- Participants must not have cirrhosis, liver cancer, clinically significant liver disease based on the liver function test results.
- Other protocol-defined Inclusion/Exclusion criteria apply.
See the full eligibility 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.
- 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...
- 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...
- 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 cirrhosis, liver cancer, clinically significant liver disease based on the liver function test results.
- Other protocol-defined Inclusion/Exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Rogers, Arkansas, United States
- Culver City, California, United States
- Riverside, California, United States
- Torrance, California, United States
- Hialeah Gardens, Florida, United States
- Hollywood, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Miami Springs, Florida, United States
- Tampa, Florida, United States
- West Palm Beach, Florida, United States
- Atlanta, Georgia, United States
- Decatur, Georgia, United States
- Chicago, Illinois, United States
- Gaithersburg, Maryland, United States
- Flowood, Mississippi, United States
- St Louis, Missouri, United States
- North Las Vegas, Nevada, United States
- Marlton, New Jersey, United States
+ 50 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Rogers, Arkansas, United States; Culver City, California, United States; Riverside, California, United States; Torrance, California, United States; Hialeah Gardens, Florida, United States and 64 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.