KarXT for Bipolar Disorder

Recruiting at 201 trial locations

Overseen By BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bristol-Myers Squibb

Disqualifiers: Suicidal behavior, Rapid cycling, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the long-term safety of KarXT, a treatment for individuals with Bipolar-I disorder who experience mania (intense excitement or euphoria) or mixed features (a combination of mania and depression). The goal is to assess how well patients tolerate KarXT over time. Individuals diagnosed with Bipolar-I who frequently experience manic episodes may be suitable candidates for this study. As a Phase 3 trial, this study serves as the final step before FDA approval, providing participants an opportunity to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Previous studies have shown promising safety results for KarXT. Research indicates that KarXT is generally well-tolerated, with most side effects reported as mild to moderate. The most common side effects include dry mouth, constipation, and nausea. Serious side effects were rare and occurred in only a small number of participants.

KarXT is already approved by the FDA for another condition, suggesting its safety. This trial aims to confirm these findings over a longer period for individuals with Bipolar-I disorder. For those considering joining the trial, existing data supports that KarXT is generally safe with manageable side effects.

Why do researchers think this study treatment might be promising for Bipolar Disorder?

KarXT is unique because it targets muscarinic receptors in the brain, which is different from most current treatments for bipolar disorder that typically focus on neurotransmitters like serotonin or dopamine. This novel mechanism of action could potentially offer a new way to manage symptoms with possibly fewer side effects. Researchers are excited about KarXT because it represents a fresh approach, providing hope for more effective and tolerable treatment options for those living with bipolar disorder.

What evidence suggests that KarXT might be an effective treatment for Bipolar-I disorder?

Research shows that KarXT, which participants in this trial may receive, may help treat symptoms of bipolar disorder, especially mania and mixed episodes. In earlier studies, patients taking KarXT showed a noticeable decrease in mania symptoms compared to those taking a placebo. This treatment affects certain parts of the brain, helping to balance mood and reduce feelings of excitement and irritability. Early results suggest that KarXT could effectively manage manic episodes linked to bipolar disorder. Experts are increasingly optimistic about its potential due to these positive findings.

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 individuals with Bipolar-I Disorder who experience manic or mixed episodes. Participants must have completed a prior study of KarXT to join this extension study, ensuring they are familiar with the treatment and its effects.

Inclusion Criteria

Participants who participated in double-blind placebo-controlled study (CN0120036 or CN0120037) must have completed treatment period of parent study.

De novo participants who did not participate in double-blind placebo-controlled studies 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.

De novo participants who did not participate in double-blind placebo-controlled studies must have Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline.

Exclusion Criteria

Participants who participated in double-blind placebo-controlled study (CN0120036 or CN0120037) and discontinued from any KarXT parent studies.

De novo participants who did not participate in double-blind placebo-controlled studies must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year).

De novo participants who did not participate in double-blind placebo-controlled studies 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label extension

Participants receive KarXT to assess long-term safety and tolerability for the treatment of mania or mania with mixed features in Bipolar-I disorder

54 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• KarXT

Trial Overview The focus of this phase 3 trial is on the long-term safety of a medication called KarXT specifically for treating mania in people with Bipolar-I Disorder. It's an open-label extension, meaning everyone knows they're getting KarXT and there's no placebo.

How Is the Trial Designed?

Group I: KarXT or Adjuvant KarXT Experimental Treatment 4 Interventions

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