An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified February 2026 by Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Information Provided by (Responsible Party)
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Clinicaltrials.gov Identifier
NCT05304767
Other Study ID Numbers:
CN012-0009
First Submitted
March 20, 2022
First Posted
March 30, 2022
Last Update Posted
March 10, 2026
Last Verified
February 2026

ClinicalTrials.gov processed this data on March 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Schizophrenia
Drug: Xanomeline and Trospium Chloride Capsules

Study Design

Study TypeInterventional
Actual Enrollment280 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleAn Open-label Extension Study to Assess the Long-term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
Study Start DateMarch 6, 2022
Actual Primary Completion DateMarch 18, 2026
Actual Study Completion DateMarch 18, 2026

Groups and Cohorts

Group/CohortIntervention/Treatment
Drug: KarXT
Drug: Xanomeline and Trospium Chloride Capsules
KarXT 50 mg/20 mg BID KarXT 75mg/20 mg BID KarXT 100mg/20 mg BID KarXT 125mg/30 mg BID

Outcome Measures

Primary Outcome Measures
  1. Incidence of treatment-emergent adverse events (TEAEs)
Secondary Outcome Measures
  1. Incidence of serious treatment-emergent adverse events (TEAEs)
  2. Incidence of TEAEs leading to discontinuation of study drug

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
1. Subject is aged ≥18 to \<66 years at the time of randomization of Study KAR-012 2. Subject has successfully completed the treatment period of Study KAR-012 3. Subject has been compliant with the procedures in Study KAR-012 (in the Investigator's judgement) 4. Subject has been compliant with their background antipsychotic drug in Study KAR-012 in the opinion of the Investigator and based on subject and informant reporting Note: Subjects are required to remain on the same appropriate approved APD as in Study KAR-012 and should stay on that same dose throughout the study. 5. Subject is capable of providing signed Informed Consent Form before any study assessments will be performed 6. Subject resides in a stable living situation, in the opinion of the Investigator 7. Subject has identified a reliable informant/caregiver willing and able to assist with study activities as needed throughout the subject's participation in the study. The informant can complete the study visits assessments via phone (as per local regulations). In Bulgaria, the informant needs to be physically present at all study visits where the Investigator determines that his/her input would be beneficial. 8. Women of childbearing potential (WOCP), or men whose sexual partners are WOCP, must be able and willing to use at least 1 highly effective method of contraception during the study and for at least 1 menstrual cycle (e.g., 30 days) after the last dose of study drug. Sperm donation is not allowed for 30 days after the final dose of the study drug. A female subject is considered to be a WOCP after menarche and until she is in a postmenopausal state for 12 months or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).
Exclusion Criteria
1. Risk for suicidal behavior during the study as determined by the Investigator's clinical assessment and/or Columbia-Suicide Severity Rating Scale (C-SSRS) as confirmed by the following: 1. Subject answers "Yes" to "suicidal ideation" Item 4 (active suicidal ideation with some intent to act, without a specific plan) or Item 5 (active suicidal ideation with a specific plan and intent) on the C-SSRS 2. Non-suicidal self-injurious behavior is not exclusionary 2. Any clinically significant abnormalities, including any finding(s) from ECG, or laboratory test at Visit 6, and the physical examination, vital signs, at the EOT visit of Study KAR-012 that the Investigator, in consultation with the Medical Monitor are considered to jeopardize the safety of the subject 3. Female subject is pregnant 4. If, in the opinion of the Investigator (and/or Sponsor/ Medical Monitor), subject is unsuitable for enrollment in the study or subject has any finding that, in the view of the Investigator (and/or Sponsor /Medical Monitor), may compromise the safety of the subject or affect their ability to adhere to the protocol visit schedule or study requirements 5. Risk of violent or destructive behavior as per Investigator's judgement 6. Subjects participating in another investigational drug or device trial or planning on participating in another clinical trial during the study 7. History or high risk of urinary retention, gastric retention, or narrow angle glaucoma as evaluated by the Investigator 8. Subject is taking, or plans to take while in the study, any prohibited concomitant medication 9. For all male subjects only, any one of the following: 1. History of bladder stones 2. History of recurrent urinary tract infections 3. Serum prostate specific antigen (PSA) \>10 ng/mL 4. An International Prostate Symptom Score (IPSS) of 5 (almost always) on either item 1, 3, 5, or 6 5. A sum of scores on IPSS items 1, 3, 5, and 6 of ≥9 Note: IPSS will be required only for male subjects ≥ 45 years of age. Subjects already enrolled in the study who do not have available PSA values from Study KAR-012 for baseline value use in Study CN012-0009, will have these assessments at their next clinic visit planned after re-consenting to determine current eligibility.

Contacts and Locations

Sponsors and CollaboratorsKaruna Therapeutics, Inc., a Bristol Myers Squibb company
Locations
Alea Research | Phoenix Arizona, United States, 85012Pillar Clinical Research LLC | Little Rock Arkansas, United States, 72204Woodland International Research Group, LLC | Little Rock Arkansas, United States, 72211Advanced Research Center, Inc. | Anaheim California, United States, 92805CITrials - Bellflower | Bellflower California, United States, 90706Local Institution - 110 | Cerritos California, United States, 90703Local Institution - 167 | Culver City California, United States, 90230Local Institution - 127 | Garden Grove California, United States, 92845Local Institution - 152 | La Habra California, United States, 90631-3842Local Institution - 126 | Lafayette California, United States, 94549Synergy Clinical Research of Escondido | Lemon Grove California, United States, 91945-2956Local Institution - 141 | Los Angeles California, United States, 91403Excell Research, Inc. | Oceanside California, United States, 92056NRC Research Institute | Orange California, United States, 92868CNRI - Los Angeles, LLC | Pico Rivera California, United States, 90660CITrials, Inc. - Riverside & San Bernardino County | Riverside California, United States, 92506Local Institution - 193 | San Diego California, United States, 92123Local Institution - 164 | Stanford California, United States, 94305Local Institution - 109 | Torrance California, United States, 90504Prestige Clinical Research Center, Inc. | Coral Gables Florida, United States, 33134Reliable Clinical Research LLC | Hialeah Florida, United States, 33012Galiz Research, LLC | Hialeah Florida, United States, 33016-1814Local Institution - 105 | Lauderhill Florida, United States, 33319-4985Premier Clinical Research Institute, Inc. | Miami Florida, United States, 33122-1335Local Institution - 171 | Miami Florida, United States, 33166Local Institution - 173 | Miami Lakes Florida, United States, 33014Local Institution - 120 | Miami Lakes Florida, United States, 33016-1553Assertive Research Center | Miami Lakes Florida, United States, 33016Local Institution - 124 | Orange City Florida, United States, 32763-8350Pines Care Research Center, Inc. | Pembroke Pines Florida, United States, 33025Interventional Psychiatry of Tampa Bay | Tampa Florida, United States, 33629Emory University | Atlanta Georgia, United States, 30303-3031Local Institution - 111 | Atlanta Georgia, United States, 30328CenExel Atlanta Center for Medical Research | Atlanta Georgia, United States, 30331Local Institution - 135 | Augusta Georgia, United States, 30912-2613CenExel iResearch Atlanta | Decatur Georgia, United States, 30030Psych Atlanta, P.C. | Marietta Georgia, United States, 30060Local Institution - 191 | Savannah Georgia, United States, 31405Local Institution - 177 | Chicago Illinois, United States, 60611Local Institution - 142 | Chicago Illinois, United States, 60612Local Institution - 143 | Chicago Illinois, United States, 60612Uptown Research Institute, LLC | Chicago Illinois, United States, 60640Local Institution - 139 | Overland Park Kansas, United States, 66210-2670Local Institution - 154 | Monroe Louisiana, United States, 71201Local Institution - 166 | Gaithersburg Maryland, United States, 20877Local Institution - 158 | Boston Massachusetts, United States, 02114Boston University - PARENT | Boston Massachusetts, United States, 02118Local Institution - 269 | Boston Massachusetts, United States, 02118Local Institution - 185 | Worcester Massachusetts, United States, 01655Local Institution - 184 | Ann Arbor Michigan, United States, 48105Local Institution - 149 | Grand Rapids Michigan, United States, 49503Local Institution - 162 | Kalamazoo Michigan, United States, 49001Local Institution - 129 | St Louis Missouri, United States, 63128Arch Clinical Trials LLC | St Louis Missouri, United States, 63141Omaha Insomnia and Psychiatric Services LLC | Omaha Nebraska, United States, 68144Local Institution - 147 | Las Vegas Nevada, United States, 89102Local Institution - 148 | Las Vegas Nevada, United States, 89102CenExel HRI Marlton | Berlin New Jersey, United States, 08009Local Institution - 104 | New York New York, United States, 10017Manhattan Psychiatric Center | New York New York, United States, 10035Local Institution - 157 | New York New York, United States, 10036Psychiatry and Alzheimer's Care of Rochester. PLLC | Rochester New York, United States, 14623Richmond Behavioral Associates ERG Clinical Research - New York PLLC | Staten Island New York, United States, 10314-1607Local Institution - 176 | Hickory North Carolina, United States, 28601Local Institution - 165 | Cincinnati Ohio, United States, 45219Local Institution - 168 | Garfield Heights Ohio, United States, 44125Local Institution - 163 | Independence Ohio, United States, 44131Local Institution - 194 | Oklahoma City Oklahoma, United States, 73112Prevention Science Institute | Eugene Oregon, United States, 97403Community Clinical Research, Inc. | Austin Texas, United States, 78754Local Institution - 189 | DeSoto Texas, United States, 75115JPS Health Network | Fort Worth Texas, United States, 76104Local Institution - 183 | Houston Texas, United States, 77030Clinical Trial Network LLC | Houston Texas, United States, 77074Local Institution - 103 | Irving Texas, United States, 75062-2757Pillar Clinical Research, LLC | Richardson Texas, United States, 75080Local Institution - 159 | Richmond Texas, United States, 77407Green Mountain Research Institute | Rutland Vermont, United States, 05701Northwest Clinical Research Center | Bellevue Washington, United States, 98007Center for Mental Health Center - Sofia District EOOD | Sofia Sofia-Grad, Bulgaria, 1202Medical Center Akademika EOOD | Sofia Sofia-Grad, Bulgaria, 1463MHAT Dr. Hristo Stambolski, EOOD | Kazanlak Stara Zagora, Bulgaria, 6100Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Natsov | Cherven Bryag , Bulgaria, 5980Local Institution - 311 | Dupnitsa , Bulgaria, 2600Local Institution - 316 | Kardzhali , Bulgaria, 6600State Psychiatric Hospital 'Sv. Ivan Rilski', Novi Iskar | Novi Iskar , Bulgaria, 1282Local Institution - 315 | Pleven , Bulgaria, 5800Medical Center Medconsult Pleven OOD | Pleven , Bulgaria, 5800UMHAT Sv. Georgi, EAD | Plovdiv , Bulgaria, 4002Local Institution - 321 | Plovdiv , Bulgaria, 4004Local Institution - 313 | Razgrad , Bulgaria, 7200MHAT Dr Ivan Seliminski AD | Sliven , Bulgaria, 8800Medical Center 'Sv.Naum' | Sofia , Bulgaria, 1113DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD | Sofia , Bulgaria, 1408Local Institution - 320 | Sofia , Bulgaria, 1408Medical Center Hera EOOD | Sofia , Bulgaria, 1510Medical Center Intermedica, OOD | Sofia , Bulgaria, 1680Medical Center VAS OOD | Targovishte , Bulgaria, 7700DCC Mladost M - Varna, OOD | Varna , Bulgaria, 9020Mental Health Center-Vratsa EOOD | Vratsa , Bulgaria, 3000Local Institution - 905 | Klecany , Czechia, 25067Local Institution - 903 | Ostrava - Poruba , Czechia, 70868Local Institution - 904 | Pilsen , Czechia, 301 00Local Institution - 906 | Prague , Czechia, 100 00Local Institution - 901 | Prague , Czechia, 11000Local Institution - 902 | Prague , Czechia, 186 00Local Institution - 616 | Guwahati Assam, India, 781032Local Institution - 607 | Ahmedabad Gujarat, India, 380008Local Institution - 604 | Ahmedabad Gujarat, India, 380013Local Institution - 609 | Surat Gujarat, India, 395001Local Institution - 613 | Vadodara Gujarat, India, 390021Local Institution - 617 | Belgavi Karnataka, India, 590002Local Institution - 614 | Mangalore Karnataka, India, 575003Local Institution - 602 | Mangalore Karnataka, India, 575018Local Institution - 601 | Mysore Karnataka, India, 570001Local Institution - 611 | Kozhikode Kerala, India, 673009Local Institution - 610 | Aurangabad Maharashtra, India, 431005Local Institution - 603 | Nagpur Maharashtra, India, 440010Local Institution - 608 | Nashik Maharashtra, India, 422001Local Institution - 605 | Nashik Maharashtra, India, 422005Local Institution - 615 | Ajmer Rajasthan, India, 305001Local Institution - 606 | Rajkot Rajasthan, India, 360001Local Institution - 612 | Lucknow Uttar Pradesh, India, 226003Local Institution - 258 | Konan-shi Aichi-ken, Japan, 483-8248Local Institution - 250 | Toyoake-shi Aichi-ken, Japan, 470-1168Local Institution - 255 | Fukuoka Fukuoka, Japan, 819-0037Local Institution - 257 | Shirakawa-shi Fukushima, Japan, 961-0021Local Institution - 254 | Karatsu-shi Saga-ken, Japan, 847-0031Local Institution - 253 | Meguro-ku Tokyo, Japan, 1540012Sangenjaya Neurology- Psychosomatic Clinic | Setagaya-ku Tokyo, Japan, 1540004Local Institution - 910 | Shibuya-ku Tokyo, Japan, 1510053Local Institution - 256 | Shinjuku-ku Tokyo-To, Japan, 162-0843Local Institution - 506 | Bialystok , Poland, 15-404Local Institution - 507 | Gdansk , Poland, 80-546Local Institution - 509 | Grudziądz , Poland, 86-300Local Institution - 502 | Katowice , Poland, 40-146Local Institution - 501 | Kielce , Poland, 25-411Local Institution - 503 | Lodz , Poland, 93-118Local Institution - 505 | Lublin , Poland, 20-109Local Institution - 508 | Suchy Las , Poland, 62-002Local Institution - 504 | Tuszyn , Poland, 95-080Local Institution - 803 | Brasov , Romania, 500123Local Institution - 804 | Bucharest , Romania, 010825Local Institution - 810 | Bucharest , Romania, 040874Local Institution - 802 | Bucharest , Romania, 041914Local Institution - 809 | Bucharest , Romania, 041914Local Institution - 807 | Bucharest , Romania, 60222Local Institution - 808 | Craiova , Romania, 200157Local Institution - 801 | Galati , Romania, 800179Local Institution - 806 | Iași , Romania, 700282Local Institution - 805 | Sibiu , Romania, 550281Local Institution - 403 | Belgrade , Serbia, 101421Clinical Center ' Dr Dragisa Misovic Dedinje' | Belgrade , Serbia, 11000Local Institution - 413 | Belgrade , Serbia, 11000Local Institution - 417 | Belgrade , Serbia, 11000University Clinical Center of Serbia | Belgrade , Serbia, 11000Local Institution - 411 | Gornja Toponica , Serbia, 705631Special Hospital for Psychiatric Diseases 'Kovin' | Kovin , Serbia, 26220Local Institution - 404 | Kovin , Serbia, 306041Local Institution - 406 | Kragujevac , Serbia, 34 000Local Institution - 408 | Kragujevac , Serbia, 34 000University Clinical Center Kragujevac | Kragujevac , Serbia, 34 000University Clinical Center Kragujevac | Kragujevac , Serbia, 34 000Local Institution - 415 | Niš , Serbia, 18000Local Institution - 416 | Novi Kneževac , Serbia, 23330Special Hospital for Psychiatric Diseases 'Sveti Vracevi' | Novi Kneževac , Serbia, 23330Local Institution - 409 | Vršac , Serbia, 26300Local Institution - 707 | Bodmin Cornwall, United Kingdom, PL31 2QNLocal Institution - 705 | Brighton East Sussex, United Kingdom, BN1 9RYLocal Institution - 701 | London Greater London, United Kingdom, SE5 8AFLocal Institution - 706 | Ashton-under-Lyne Lancashire, United Kingdom, OL6 7SRLocal Institution - 708 | Oxford Oxfordshire, United Kingdom, OX3 7JXLocal Institution - 702 | Chertsey Surrey, United Kingdom, KT16 9AULocal Institution - 703 | Birmingham West Midlands, United Kingdom, B4 6NHLocal Institution - 704 | Glasgow , United Kingdom, G51 4TF
Investigators
Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb