A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Adjunctive KarXT in Subjects with Inadequately Controlled Symptoms of Schizophrenia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-510770-25-00

Acronym

KAR-012

Enrollment

Registered

2024-06-14

Start date

2023-03-22

Completion date

2025-02-24

Last updated

2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Brief summary

Change from Baseline in PANSS total score at Week 6

Detailed description

Change from Baseline in PSP at Week 6, Change from Baseline in CGI-S at Week 6, Change from Baseline in PANSS M-Pos Symptom Factor score at Week 6, Change from Baseline in PANSS M-Neg symptom factor score at Week 6, Categorical response defined as the proportion of subjects achieving a ≥ 30% improvement in PANSS total score at Week 6, POM at Week 6

Interventions

DRUGKarXT Matching Placebo

DRUGKarXT

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from Baseline in PANSS total score at Week 6	—

Secondary

Measure	Time frame
Change from Baseline in PSP at Week 6, Change from Baseline in CGI-S at Week 6, Change from Baseline in PANSS M-Pos Symptom Factor score at Week 6, Change from Baseline in PANSS M-Neg symptom factor score at Week 6, Categorical response defined as the proportion of subjects achieving a ≥ 30% improvement in PANSS total score at Week 6, POM at Week 6	—

Countries

Bulgaria

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026