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NCT05304767 · ClinicalTrials.gov registry record · Phase 3
An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
A Phase 3 study of Schizophrenia, sponsored by Karuna Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 280
- Enrollment target
- 20
- Study locations
NCT05304767: Recruiting Phase 3 study of Schizophrenia, sponsored by Karuna Therapeutics.
NCT05304767 is a Phase 3 study of Schizophrenia that is actively recruiting participants, run by Karuna Therapeutics. The registered enrollment target is 280 participants, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (28% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05304767, a Phase 3 study of Schizophrenia, is actively recruiting participants, sponsored by Karuna Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 280 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 3, multicenter, 52-week, outpatient, open-label extension (OLE) study to evaluate the long-term safety and tolerability of adjunctive KarXT in subjects with schizophrenia with an inadequate response to their current antipsychotic treatment who previously completed the treatment period (Visit 8/Day 42 ± 3) of ARISE Study (KAR-012). The primary objective of the study is to assess the long-term safety and tolerability of adjunctive KarXT (a fixed dose combination of xanomeline and trospium chloride twice daily \[BID\]) in subjects with schizophrenia.
Conditions Studied
Interventions
- DRUG Xanomeline and Trospium Chloride Capsules
Study Locations (20)
California
- Advanced Research Center, Inc. - Anaheim
- CITrials - Bellflower - Bellflower
- Local Institution - 110 - Cerritos
- Local Institution - 167 - Culver City
- Local Institution - 127 - Garden Grove
- Local Institution - 152 - La Habra
- Local Institution - 126 - Lafayette
- Synergy Clinical Research of Escondido - Lemon Grove
- Local Institution - 141 - Los Angeles
- Excell Research, Inc. - Oceanside
- NRC Research Institute - Orange
- CNRI - Los Angeles, LLC - Pico Rivera
- CITrials, Inc. - Riverside & San Bernardino County - Riverside
- Local Institution - 193 - San Diego
- Local Institution - 164 - Stanford
- Local Institution - 109 - Torrance
Arkansas
- Pillar Clinical Research LLC - Little Rock
- Woodland International Research Group, LLC - Little Rock
Arizona
- Alea Research - Phoenix
Florida
- Prestige Clinical Research Center, Inc. - Coral Gables
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2022-03-07 |
| Est. Completion | 2026-03-19 |
| Phase | Phase 3 |
What NCT05304767 shows while recruiting
NCT05304767 is an interventional study that assigns participants to a tested intervention. The registered 280 participants enrollment target is mid-sized for trials with a published cap, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (28% higher).
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 1 intervention - of which Xanomeline and Trospium Chloride Capsules is the first listed.
NCT05304767 names 20 study sites across 4 states, led by California, Arkansas, Arizona.
Frequently Asked Questions
What is clinical trial NCT05304767 about?
NCT05304767 is a clinical study titled "An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia". This is a Phase 3, multicenter, 52-week, outpatient, open-label extension (OLE) study to evaluate the long-term safety and tolerability of adjunctive KarXT in subjects with schizophrenia with an inadequate response to their current antipsychotic treatment who previously completed the treatment perio...
What is the current status of trial NCT05304767?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 280 participants. The study started on 2022-03-07. Estimated completion is 2026-03-19.
What conditions does trial NCT05304767 study?
This clinical trial studies the following conditions: Schizophrenia.
What interventions are being tested in trial NCT05304767?
The interventions under investigation include: Xanomeline and Trospium Chloride Capsules (DRUG).
Who is sponsoring clinical trial NCT05304767?
This trial is sponsored by Karuna Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05304767 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Schizophrenia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05304767's enrollment target sits among peer trials
280 71st of 315 higher than 244 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With Schizophrenia
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A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (EMERGENT TEEN)
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A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
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