KarXT for Bipolar Disorder

Recruiting at 89 trial locations

Overseen By BMS Study Connect www.BMSStudyConnect.com

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bristol-Myers Squibb

Must not be taking: Psychotropics

Disqualifiers: BP-II, Major depression, Substance use, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

274 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called KarXT for individuals with Bipolar-I disorder experiencing a severe mood episode, such as intense mania or mixed mood changes. The goal is to determine if KarXT can manage these symptoms more effectively than a placebo (a harmless pill with no active medicine) during a three-week hospital stay. Suitable candidates have Bipolar-I disorder and require hospital care due to a recent severe mood episode. They should discontinue other psychiatric medications before starting the trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for the trial?

Yes, you will need to stop taking all psychotropic medications (drugs that affect mood, perception, or behavior) at least 14 days before starting the trial medication.

Is there any evidence suggesting that KarXT is likely to be safe for humans?

Research has shown that KarXT is generally well-tolerated. In a study on schizophrenia, KarXT proved safe and did not cause unexpected problems. Another study on long-term use also demonstrated positive safety results over time.

Although KarXT is not yet approved for treating bipolar disorder, these studies suggest it is relatively safe based on its use in other conditions. However, every treatment can have side effects, and individual experiences may differ. Always discuss with a doctor what’s best. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for bipolar disorder?

Unlike the standard treatments for bipolar disorder, which mainly involve mood stabilizers and antipsychotic medications, KarXT offers a fresh approach. KarXT is unique because it combines xanomeline, a muscarinic receptor agonist, with trospium, which limits peripheral side effects. This combination targets the brain's cholinergic system, which is different from how most current medications work. Researchers are excited about KarXT because it may reduce symptoms with potentially fewer side effects, offering a new hope for those who struggle with the side effects of existing treatments.

What evidence suggests that KarXT might be an effective treatment for bipolar disorder?

Research shows that KarXT, which participants in this trial may receive, may help improve symptoms of mental health conditions. In an earlier study, individuals taking KarXT experienced nearly a 40% reduction in their total PANSS score, which measures symptoms like delusions and hallucinations, over five weeks. This study focused on schizophrenia, indicating that KarXT can effectively reduce severe symptoms. While specific data for bipolar disorder is still being collected, early results appear promising for treating symptoms of mania. ^{6 7 8 9 10}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for adults with Bipolar-I disorder experiencing a severe manic or mixed episode, requiring hospitalization. They must have specific scores on mania and global impression scales, no other major psychiatric disorders in the past year (except mild anxiety), no recent substance abuse, and not be at risk of suicide.

Inclusion Criteria

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

I have been diagnosed with Bipolar-I disorder by a psychiatrist.

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 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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive KarXT or placebo during a 3-week inpatient period to evaluate efficacy in treating manic episodes

3 weeks

Inpatient stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• KarXT

Trial Overview The study tests KarXT against a placebo over three weeks to see if it's better at treating mania symptoms in Bipolar-I patients. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real drug versus placebo.

How Is the Trial Designed?

Group I: KarXT Experimental Treatment 1 Intervention

Flexible dosing

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06951711

A Study to Evaluate the Efficacy and Safety of KarXT ... The CGI-BP is designed to assess the severity, improvement, and efficacy of treatment in individuals with bipolar disorder. Only section I, illness severity, ...

2. psychiatrist.com psychiatrist.com/news/evaluating-pooled-data-from-the-emergent-study-programs/

Evaluating Pooled Data from the EMERGENT Study ... In the open-label extension EMERGENT-4 trial, KarXT significantly improved symptoms of schizophrenia across all efficacy measures at 52 weeks.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11124398/

The New Horizon of Antipsychotics beyond the Classic ... The NNH values for KarXT, derived from the results of this trial, were 9 for nausea, 23 for vomiting, 8 for constipation, and 13 for dry mouth [71]. According ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2773021225000379

Positive response to adjunctive KarXT (xanomeline ... Overall, our patient saw a 39.53 % decrease in total PANSS score from 86 just prior to the first dose of KarXT to 52 at five weeks on the medication. This ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06951698

NCT06951698 | A Study to Evaluate the Efficacy and ... 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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06951711

NCT06951711 | A Study to Evaluate the Efficacy and ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9719488/

Safety/Tolerability of KarXT in Schizophrenia Study KarXT was generally well tolerated with an AE profile consistent with the activity of xanomeline–trospium at muscarinic receptors.

8. bmsclinicaltrials.com bmsclinicaltrials.com/us/en/clinical-trials/NCT06951698

Trial ID CN012-0036 | NCT06951698 - BMS Clinical Trials The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder.

9. news.bms.com news.bms.com/news/details/2024/Bristol-Myers-Squibb-Presents-New-Pooled-Interim-Long-Term-Safety-and-Metabolic-Outcomes-Data-from-the-EMERGENT-Program-Evaluating-KarXT-in-Schizophrenia-at-the-2024-Annual-Congress-of-the-Schizophrenia-International-Research-Society/default.aspx

KarXT demonstrated a favorable long-term metabolic ... Bristol Myers Squibb Presents New Pooled Interim Long-Term Safety and Metabolic Outcomes Data from the EMERGENT Program Evaluating KarXT in ...

10. bmsstudyconnect.com bmsstudyconnect.com/cz/en/clinical-trials/NCT06929273.html

A Study to Assess the Long-term Safety of KarXT for the ... 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 ...