KarXT for Bipolar Disorder

Recruiting at 122 trial locations

Overseen By BMS Study Connect Contact Center www.BMSStudyConnect.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

300 Participants Needed

Trial Summary

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.

How is the drug KarXT different from other treatments for bipolar disorder?

KarXT is unique because it combines two components, xanomeline and trospium, which target different pathways in the brain, potentially offering a novel approach to treating bipolar disorder compared to traditional mood stabilizers like lithium and valproate. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: KarXT Experimental Treatment 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

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Neuroprotective and antioxidant effects of curcumin in a ketamine-induced model of mania in rats. [2014]

2. Germany pubmed.ncbi.nlm.nih.gov

The Neurobiology of Bipolar Disorder. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Na+, K+-ATPase α Isoforms and Endogenous Cardiac Steroids in Prefrontal Cortex of Bipolar Patients and Controls. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Evaluation of behavioral and neurochemical changes induced by ketamine in rats: implications as an animal model of mania. [2019]

5. England pubmed.ncbi.nlm.nih.gov

The Bipolar Illness Onset study: research protocol for the BIO cohort study. [2022]