Trials / Recruiting
RecruitingNCT07140913
A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
A Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Individuals With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 424 (estimated)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of adjunctive KarXT for the treatment of mania in participants with Bipolar-I Disorder.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Xanomeline/Trospium Chloride | Specified dose on specified days |
| DRUG | Placebo | Specified dose on specified days |
Timeline
- Start date
- 2025-10-08
- Primary completion
- 2027-06-28
- Completion
- 2027-06-28
- First posted
- 2025-08-26
- Last updated
- 2026-04-01
Locations
103 sites across 13 countries: United States, Argentina, Bulgaria, China, Denmark, France, India, Israel, Italy, Japan, Poland, Romania, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07140913. Inclusion in this directory is not an endorsement.