An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
Public ClinicalTrials.gov record NCT05304767. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-label Extension Study to Assess the Long-term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05304767
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 290 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 7, 2022 (Actual)
- Primary completion
- Mar 25, 2026 (Actual)
- Completion
- Mar 25, 2026 (Actual)
- Last update posted
- Jul 31, 2026
2022 – 2026
United States locations
- U.S. sites
- 56
- U.S. states
- 19
- U.S. cities
- 47
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Local Institution - 161 | Phoenix | Arizona | 85012 | — |
| Local Institution - 175 | Little Rock | Arkansas | 72204 | — |
| Local Institution - 112 | Little Rock | Arkansas | 72211 | — |
| Local Institution - 146 | Anaheim | California | 92805 | — |
| Local Institution - 130 | Bellflower | California | 90706 | — |
| Local Institution - 110 | Cerritos | California | 90703 | — |
| Local Institution - 167 | Culver City | California | 90230 | — |
| Local Institution - 127 | Garden Grove | California | 92845 | — |
| Local Institution - 152 | La Habra | California | 90631-3842 | — |
| Local Institution - 126 | Lafayette | California | 94549 | — |
| Local Institution - 131 | Lemon Grove | California | 91945-2956 | — |
| Local Institution - 181 | Oceanside | California | 92056 | — |
| Local Institution - 150 | Orange | California | 92868 | — |
| Local Institution - 170 | Pico Rivera | California | 90660 | — |
| Local Institution - 144 | Riverside | California | 92506 | — |
| Local Institution - 164 | Stanford | California | 94305 | — |
| Local Institution - 109 | Torrance | California | 90504 | — |
| Local Institution - 186 | Coral Gables | Florida | 33134 | — |
| Local Institution - 182 | Hialeah | Florida | 33012 | — |
| Local Institution - 133 | Hialeah | Florida | 33016-1814 | — |
| Local Institution - 105 | Lauderhill | Florida | 33319-4985 | — |
| Local Institution - 145 | Miami | Florida | 33122-1335 | — |
| Local Institution - 171 | Miami | Florida | 33166 | — |
| Local Institution - 173 | Miami Lakes | Florida | 33014 | — |
| Local Institution - 153 | Miami Lakes | Florida | 33016 | — |
| Local Institution - 156 | Pembroke Pines | Florida | 33025 | — |
| Local Institution - 155 | Tampa | Florida | 33629 | — |
| Local Institution - 136 | Atlanta | Georgia | 30303-3031 | — |
| Local Institution - 111 | Atlanta | Georgia | 30328 | — |
| Local Institution - 192 | Atlanta | Georgia | 30331 | — |
| Local Institution - 138 | Decatur | Georgia | 30030 | — |
| Local Institution - 169 | Marietta | Georgia | 30060 | — |
| Local Institution - 151 | Chicago | Illinois | 60640 | — |
| Local Institution - 166 | Gaithersburg | Maryland | 20877 | — |
| Local Institution - 187 | Boston | Massachusetts | 02118 | — |
| Local Institution - 129 | St Louis | Missouri | 63128 | — |
| Local Institution - 178 | St Louis | Missouri | 63141 | — |
| Local Institution - 174 | Omaha | Nebraska | 68144 | — |
| Local Institution - 148 | Las Vegas | Nevada | 89102 | — |
| Local Institution - 188 | Berlin | New Jersey | 08009 | — |
| Local Institution - 104 | New York | New York | 10017 | — |
| Local Institution - 160 | New York | New York | 10035 | — |
| Local Institution - 157 | New York | New York | 10036 | — |
| Local Institution - 108 | Rochester | New York | 14623 | — |
| Local Institution - 113 | Staten Island | New York | 10314-1607 | — |
| Local Institution - 176 | Hickory | North Carolina | 28601 | — |
| Local Institution - 163 | Independence | Ohio | 44131 | — |
| Local Institution - 179 | Eugene | Oregon | 97403 | — |
| Local Institution - 128 | Austin | Texas | 78754 | — |
| Local Institution - 190 | Fort Worth | Texas | 76104 | — |
| Local Institution - 180 | Houston | Texas | 77074 | — |
| Local Institution - 103 | Irving | Texas | 75062-2757 | — |
| Local Institution - 172 | Richardson | Texas | 75080 | — |
| Local Institution - 159 | Richmond | Texas | 77407 | — |
| Local Institution - 140 | Rutland | Vermont | 05701 | — |
| Local Institution - 101 | Bellevue | Washington | 98007 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 38 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05304767, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 31, 2026 · Synced Oct 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05304767 live on ClinicalTrials.gov.