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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05304767
Other study ID # CN012-0009
Secondary ID CN012-0009KAR-01
Status Enrolling by invitation
Phase Phase 3
First received
Last updated
Start date March 7, 2022
Est. completion date February 28, 2026

Study information

Verified date June 2024
Source Karuna Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 280
Est. completion date February 28, 2026
Est. primary completion date February 28, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 59 Years
Eligibility Inclusion Criteria: 1. Subject is aged =18 to <60 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Bulgaria Local Institution - 318 Cherven Bryag
Bulgaria Local Institution - 311 Dupnitsa
Bulgaria Local Institution - 316 Kardzhali
Bulgaria Local Institution - 302 Kazanlak
Bulgaria Local Institution - 304 Novi Iskar
Bulgaria Local Institution - 301 Pleven
Bulgaria UMHAT 'Dr. Georgi Stranski', EAD Pleven
Bulgaria Local Institution - 314 Plovdiv
Bulgaria Local Institution - 321 Plovdiv
Bulgaria Local Institution - 313 Razgrad
Bulgaria MHAT Dr Ivan Seliminski AD Sliven
Bulgaria Local Institution - 303 Sofia
Bulgaria Local Institution - 305 Sofia
Bulgaria Local Institution - 306 Sofia
Bulgaria Local Institution - 307 Sofia
Bulgaria Local Institution - 309 Sofia
Bulgaria Local Institution - 320 Sofia
Bulgaria Local Institution - 317 Targovishte
Bulgaria DCC Mladost M - Varna, OOD Varna
Bulgaria Local Institution - 310 Vratsa
India Local Institution - 604 Ahmedabad Gujarat
India Local Institution - 607 Ahmedabad Gujarat
India Local Institution - 615 Ajmer Rajasthan
India Local Institution - 610 Aurangabad Maharashtra
India Local Institution - 617 Belgavi Karnataka
India Local Institution - 616 Guwahati Assam
India Local Institution - 611 Kozhikode Kerala
India Local Institution - 612 Lucknow Uttar Pradesh
India Local Institution - 602 Mangalore Karnataka
India Local Institution - 614 Mangalore Karnataka
India Local Institution - 601 Mysore Karnataka
India Local Institution - 603 Nagpur Maharashtra
India Local Institution - 605 Nashik Maharashtra
India Local Institution - 608 Nashik Maharashtra
India Local Institution - 606 Rajkot Rajasthan
India Local Institution - 609 Surat Gujarat
India Local Institution - 613 Vadodara Gujarat
Poland Local Institution - 506 Bialystok
Poland Local Institution - 507 Gdansk
Poland Local Institution - 509 Grudziadz
Poland Local Institution - 501 Kielce
Poland Local Institution - 503 Lodz
Poland Local Institution - 505 Lublin
Poland Local Institution - 502 Siemianowice Slaskie
Poland Local Institution - 508 Suchy Las
Poland Local Institution - 504 Tuszyn
Romania Local Institution - 803 Brasov
Romania Local Institution - 802 Bucuresti
Romania Local Institution - 804 Bucuresti
Romania Local Institution - 807 Bucuresti
Romania Local Institution - 809 Bucuresti
Romania Local Institution - 810 Bucuresti
Romania Local Institution - 808 Craiova
Romania Local Institution - 801 Galati
Romania Local Institution - 806 Iasi
Romania Local Institution - 805 Sibiu
Serbia Local Institution - 402 Belgrade
Serbia Local Institution - 403 Belgrade
Serbia Local Institution - 405 Belgrade
Serbia Local Institution - 413 Belgrade
Serbia Local Institution - 417 Belgrade
Serbia Local Institution - 404 Kovin
Serbia Local Institution - 414 Kovin
Serbia Local Institution - 401 Kragujevac
Serbia Local Institution - 406 Kragujevac
Serbia Local Institution - 408 Kragujevac
Serbia University Clinical Center Kragujevac Kragujevac
Serbia Local Institution - 411 Nis
Serbia Local Institution - 415 Nis
Serbia Local Institution - 410 Novi Knezevac
Serbia Local Institution - 416 Novi Knezevac
Serbia Local Institution - 409 Vrsac
United Kingdom Local Institution - 706 Ashton Under Lyne Lancashire
United Kingdom Local Institution - 703 Birmingham West Midlands
United Kingdom Local Institution - 707 Bodmin Cornwall
United Kingdom Local Institution - 705 Brighton East Sussex
United Kingdom Local Institution - 702 Chertsey Surrey
United Kingdom Local Institution - 701 London Greater London
United Kingdom Local Institution - 708 Oxford Oxfordshire
United Kingdom Local Institution - 704 Paisley Renfrewshire
United States Advanced Research Center, Inc. Anaheim California
United States Local Institution - 184 Ann Arbor Michigan
United States Grady Memorial Hospital Atlanta Georgia
United States Synexus Clinical Research US, Inc. Atlanta Georgia
United States Local Institution - 135 Augusta Georgia
United States Community Clinical Research, Inc. Austin Texas
United States Local Institution - 163 Beachwood Ohio
United States Northwest Clinical Research Center Bellevue Washington
United States CITrials - Bellflower Bellflower California
United States Local Institution - 158 Boston Massachusetts
United States Local Institution - 187 Boston Massachusetts
United States Synexus Clinical Research US, Inc. Cerritos California
United States Local Institution - 142 Chicago Illinois
United States Local Institution - 177 Chicago Illinois
United States Uptown Research Institute, LLC Chicago Illinois
United States Local Institution - 165 Cincinnati Ohio
United States Local Institution - 186 Coral Gables Florida
United States Local Institution - 167 Culver City California
United States CenExel iResearch Atlanta Decatur Georgia
United States Local Institution - 141 Encino California
United States Local Institution - 179 Eugene Oregon
United States Local Institution - 166 Gaithersburg Maryland
United States Local Institution - 168 Garfield Heights Ohio
United States Local Institution - 149 Grand Rapids Michigan
United States Galiz Research, LLC Hialeah Florida
United States Local Institution - 182 Hialeah Florida
United States Local Institution - 176 Hickory North Carolina
United States Local Institution - 180 Houston Texas
United States Local Institution - 183 Houston Texas
United States University Hills Clinical Research - Irving Irving Texas
United States Local Institution - 162 Kalamazoo Michigan
United States Local Institution - 152 La Habra California
United States Sunwise Clinical Research, LLC. Lafayette California
United States Altea Research Institute, Las Vegas Las Vegas Nevada
United States Local Institution - 147 Las Vegas Nevada
United States Synergy Clinical Research of Escondido Lemon Grove California
United States Local Institution - 175 Little Rock Arkansas
United States Woodland International Research Group, LLC Little Rock Arkansas
United States CenExel Collaborative Neuroscience Research Los Alamitos California
United States Local Institution - 169 Marietta Georgia
United States Local Institution - 105 Miami Florida
United States Local Institution - 120 Miami Florida
United States Premier Clinical Research Institute, Inc. Miami Florida
United States Assertive Research Center Miami Lakes Florida
United States Local Institution - 173 Miami Lakes Florida
United States Local Institution - 171 Miami Springs Florida
United States Local Institution - 154 Monroe Louisiana
United States Local Institution - 104 New York New York
United States Local Institution - 157 New York New York
United States Local Institution - 160 New York New York
United States Local Institution - 181 Oceanside California
United States Local Institution - 174 Omaha Nebraska
United States NRC Research Institute Orange California
United States Local Institution - 124 Orange City Florida
United States Local Institution - 139 Overland Park Kansas
United States Local Institution - 156 Pembroke Pines Florida
United States Local Institution - 161 Phoenix Arizona
United States CNRI - Los Angeles, LLC Pico Rivera California
United States Pillar Clinical Research, LLC Richardson Texas
United States At Health Texas Richmond Texas
United States CITrials, Inc. - Riverside & San Bernardino County Riverside California
United States Psychiatry and Alzheimer's Care of Rochester. PLLC Rochester New York
United States Green Mountain Research Institute Rutland Vermont
United States Local Institution - 178 Saint Louis Missouri
United States PsychCare Consultants Research Saint Louis Missouri
United States Local Institution - 164 Stanford California
United States Richmond Behavioral Associates ERG Clinical Research - New York PLLC Staten Island New York
United States Interventional Psychiatry of Tampa Bay Tampa Florida
United States CenExel Collaborative Neuroscience Research Torrance California
United States Local Institution - 185 Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Karuna Therapeutics

Countries where clinical trial is conducted

United States,  Bulgaria,  India,  Poland,  Romania,  Serbia,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of treatment-emergent adverse events (TEAEs) From initial dose to safety follow-up visit (54 weeks) or early termination
Secondary Incidence of serious treatment-emergent adverse events (TEAEs) From initial dose to safety follow-up visit (54 weeks) or early termination
Secondary Incidence of TEAEs leading to discontinuation of study drug From initial dose to safety follow-up visit (54 weeks) or early termination
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