Trials / Recruiting
RecruitingNCT06882785
A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia
A Phase 3, Randomized, Two-part Study With a 5-week Double-blind Part (Randomized, Parallelgroup, Placebo-controlled) Followed by a 52-week Open-label Extension Part to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Patients With Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) Schizophrenia
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 250 (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 KarXT in acutely psychotic Japanese adult participants with schizophrenia
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KarXT | Specified dose on specified days |
| OTHER | Placebo | Specified dose on specified days |
Timeline
- Start date
- 2025-06-10
- Primary completion
- 2028-09-23
- Completion
- 2029-08-23
- First posted
- 2025-03-19
- Last updated
- 2026-03-17
Locations
55 sites across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06882785. Inclusion in this directory is not an endorsement.