At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 173 enrolled / 173 target
Drug / intervention
KarXTdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3b, Open-label, Multicenter, Two-Period, Slow-titration and Food Effect Study to Assess the Safety and Efficacy of KarXT in Participants With DSM-5 Schizophrenia
Karuna Therapeutics, Inc., a Bristol Myers Squibb company·interventional·Posted Aug 27, 2024·Updated Jun 22, 2026
In Brief
A Phase 3 clinical trial evaluating KarXT for Schizophrenia. Completed, enrolled 173 participants across 6 sites.
Detailed Summary
The purpose of this study is to assess the safety and efficacy of slowly increasing dose and food effect of KarXT in adult participants with schizophrenia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20252026
First PostedAug 2024
Enrollment StartOct 2024
Primary CompletionMar 2025
TodayJul 2026
First PostedAug 27, 2024
Enrollment StartOct 28, 2024
Primary CompletionMar 13, 2025
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 1.8 years ago
Arms & Interventions
KarXT on empty stomach and with foodexperimental
Drug: KarXT
Interventions
KarXTdrug
Specified dose on specified days