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

March 10, 2026 updated by: Karuna Therapeutics

An Open-label Extension Study to Assess the 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 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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

280

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain the NCT# and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Bulgaria
      • Cherven Bryag, Bulgaria, 5980
        • Recruiting
        • Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Natsov
        • Contact:
          • Ivo Natsov, Site 318
          • Phone Number: 359888704961
      • Dupnitsa, Bulgaria, 2600
        • Active, not recruiting
        • Local Institution - 311
      • Kardzhali, Bulgaria, 6600
        • Completed
        • Local Institution - 316
      • Novi Iskar, Bulgaria, 1282
        • Recruiting
        • State Psychiatric Hospital 'Sv. Ivan Rilski', Novi Iskar
        • Contact:
          • Tsveteslava Galabova, Site 304
          • Phone Number: 3599917215
      • Pleven, Bulgaria, 5800
        • Recruiting
        • Medical center Medconsult Pleven OOD
        • Contact:
          • Mariya Alexandrova-Stoycheva, Site 301
          • Phone Number: 360+11
      • Pleven, Bulgaria, 5800
        • Completed
        • Local Institution - 315
      • Plovdiv, Bulgaria, 4002
        • Recruiting
        • UMHAT Sv. Georgi, EAD
        • Contact:
          • Andriana Kakanakova, Site 314
          • Phone Number: 360+11
      • Plovdiv, Bulgaria, 4004
        • Not yet recruiting
        • Local Institution - 321
        • Contact:
          • Site 321
      • Razgrad, Bulgaria, 7200
        • Active, not recruiting
        • Local Institution - 313
      • Sliven, Bulgaria, 8800
        • Recruiting
        • MHAT Dr Ivan Seliminski AD
        • Contact:
          • Rozalina Petrova, Site 312
          • Phone Number: 00359887801545
      • Sofia, Bulgaria, 1680
        • Recruiting
        • Medical Center Intermedica, OOD
        • Contact:
          • Toni Donchev, Site 303
          • Phone Number: 360+11
      • Sofia, Bulgaria, 1408
        • Recruiting
        • DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
        • Contact:
          • Petya Dimitrova, Site 319
          • Phone Number: 360+11
      • Sofia, Bulgaria, 1510
        • Recruiting
        • Medical Center Hera EOOD
        • Contact:
          • Sibila Dimitrova-Mitova, Site 307
          • Phone Number: +359886046145
      • Sofia, Bulgaria, 1113
        • Recruiting
        • Medical Center 'Sv.Naum'
        • Contact:
          • Assen Karadaliev, Site 305
          • Phone Number: 35929702117
      • Sofia, Bulgaria, 1408
        • Withdrawn
        • Local Institution - 320
      • Targovishte, Bulgaria, 7700
        • Recruiting
        • Medical Center VAS OOD
        • Contact:
          • Veselka Vasileva, Site 317
          • Phone Number: 359888446697
      • Varna, Bulgaria, 9020
        • Recruiting
        • DCC Mladost M - Varna, OOD
        • Contact:
          • Hristo Kozhuharov, Site 308
          • Phone Number: 35952555695
      • Vratsa, Bulgaria, 3000
        • Recruiting
        • Mental Health Center-Vratsa EOOD
        • Contact:
          • Nadya Ivanova, Site 310
          • Phone Number: +359887422440
    • Sofia-Grad
      • Sofia, Sofia-Grad, Bulgaria, 1202
        • Recruiting
        • Center for Mental Health Center - Sofia District EOOD
        • Contact:
          • Emil Grashnov, Site 306
          • Phone Number: 360+11
      • Sofia, Sofia-Grad, Bulgaria, 1463
        • Recruiting
        • Medical Center Akademika EOOD
        • Contact:
          • Vihra Milanova, Site 309
          • Phone Number: 359888941451
    • Stara Zagora
      • Kazanlak, Stara Zagora, Bulgaria, 6100
        • Recruiting
        • MHAT Dr. Hristo Stambolski, EOOD
        • Contact:
          • Ivan Dimitrov, Site 302
          • Phone Number: 360+11
  • Czechia
      • Klecany, Czechia, 25067
        • Withdrawn
        • Local Institution - 905
      • Ostrava - Poruba, Czechia, 70868
        • Withdrawn
        • Local Institution - 903
      • Pilsen, Czechia, 301 00
        • Withdrawn
        • Local Institution - 904
      • Prague, Czechia, 100 00
        • Withdrawn
        • Local Institution - 906
      • Prague, Czechia, 11000
        • Withdrawn
        • Local Institution - 901
      • Prague, Czechia, 186 00
        • Withdrawn
        • Local Institution - 902
  • India
    • Assam
      • Guwahati, Assam, India, 781032
        • Withdrawn
        • Local Institution - 616
    • Gujarat
      • Ahmedabad, Gujarat, India, 380008
        • Withdrawn
        • Local Institution - 607
      • Ahmedabad, Gujarat, India, 380013
        • Withdrawn
        • Local Institution - 604
      • Surat, Gujarat, India, 395001
        • Withdrawn
        • Local Institution - 609
      • Vadodara, Gujarat, India, 390021
        • Withdrawn
        • Local Institution - 613
    • Karnataka
      • Belgavi, Karnataka, India, 590002
        • Withdrawn
        • Local Institution - 617
      • Mangalore, Karnataka, India, 575003
        • Withdrawn
        • Local Institution - 614
      • Mangalore, Karnataka, India, 575018
        • Withdrawn
        • Local Institution - 602
      • Mysore, Karnataka, India, 570001
        • Withdrawn
        • Local Institution - 601
    • Kerala
      • Kozhikode, Kerala, India, 673009
        • Withdrawn
        • Local Institution - 611
    • Maharashtra
      • Aurangabad, Maharashtra, India, 431005
        • Withdrawn
        • Local Institution - 610
      • Nagpur, Maharashtra, India, 440010
        • Withdrawn
        • Local Institution - 603
      • Nashik, Maharashtra, India, 422001
        • Withdrawn
        • Local Institution - 608
      • Nashik, Maharashtra, India, 422005
        • Withdrawn
        • Local Institution - 605
    • Rajasthan
      • Ajmer, Rajasthan, India, 305001
        • Withdrawn
        • Local Institution - 615
      • Rajkot, Rajasthan, India, 360001
        • Withdrawn
        • Local Institution - 606
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226003
        • Withdrawn
        • Local Institution - 612
  • Japan
    • Aichi-ken
      • Konan-shi, Aichi-ken, Japan, 483-8248
        • Withdrawn
        • Local Institution - 258
      • Toyoake-shi, Aichi-ken, Japan, 470-1168
        • Active, not recruiting
        • Local Institution - 250
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 819-0037
        • Completed
        • Local Institution - 255
    • Fukushima
      • Shirakawa-shi, Fukushima, Japan, 961-0021
        • Active, not recruiting
        • Local Institution - 257
    • Saga-ken
      • Karatsu-shi, Saga-ken, Japan, 847-0031
        • Active, not recruiting
        • Local Institution - 254
    • Tokyo
      • Meguro-ku, Tokyo, Japan, 1540012
        • Not yet recruiting
        • Local Institution - 253
        • Contact:
          • Site 253
      • Setagaya-ku, Tokyo, Japan, 1540004
        • Recruiting
        • Sangenjaya Neurology- Psychosomatic Clinic
        • Contact:
          • Kenji Shigemori, Site 252
      • Shibuya-ku, Tokyo, Japan, 1510053
        • Withdrawn
        • Local Institution - 910
    • Tokyo-To
      • Shinjuku-ku, Tokyo-To, Japan, 162-0843
        • Active, not recruiting
        • Local Institution - 256
  • Poland
      • Bialystok, Poland, 15-404
        • Withdrawn
        • Local Institution - 506
      • Gdansk, Poland, 80-546
        • Withdrawn
        • Local Institution - 507
      • Grudziądz, Poland, 86-300
        • Withdrawn
        • Local Institution - 509
      • Katowice, Poland, 40-146
        • Withdrawn
        • Local Institution - 502
      • Kielce, Poland, 25-411
        • Withdrawn
        • Local Institution - 501
      • Lodz, Poland, 93-118
        • Withdrawn
        • Local Institution - 503
      • Lublin, Poland, 20-109
        • Withdrawn
        • Local Institution - 505
      • Suchy Las, Poland, 62-002
        • Withdrawn
        • Local Institution - 508
      • Tuszyn, Poland, 95-080
        • Withdrawn
        • Local Institution - 504
  • Romania
      • Brasov, Romania, 500123
        • Withdrawn
        • Local Institution - 803
      • Bucharest, Romania, 010825
        • Withdrawn
        • Local Institution - 804
      • Bucharest, Romania, 040874
        • Withdrawn
        • Local Institution - 810
      • Bucharest, Romania, 041914
        • Withdrawn
        • Local Institution - 802
      • Bucharest, Romania, 041914
        • Withdrawn
        • Local Institution - 809
      • Bucharest, Romania, 60222
        • Withdrawn
        • Local Institution - 807
      • Craiova, Romania, 200157
        • Withdrawn
        • Local Institution - 808
      • Galati, Romania, 800179
        • Withdrawn
        • Local Institution - 801
      • Iași, Romania, 700282
        • Withdrawn
        • Local Institution - 806
      • Sibiu, Romania, 550281
        • Withdrawn
        • Local Institution - 805
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • University Clinical Center of Serbia
        • Contact:
          • Maja Ivkovic, Site 402
          • Phone Number: 381112685662
      • Belgrade, Serbia, 11000
        • Recruiting
        • Clinical Center ' Dr Dragisa Misovic Dedinje'
        • Contact:
          • Vladimir Diligenski, Site 405
          • Phone Number: +381637708765
      • Belgrade, Serbia, 101421
        • Active, not recruiting
        • Local Institution - 403
      • Belgrade, Serbia, 11000
        • Withdrawn
        • Local Institution - 413
      • Belgrade, Serbia, 11000
        • Withdrawn
        • Local Institution - 417
      • Gornja Toponica, Serbia, 705631
        • Active, not recruiting
        • Local Institution - 411
      • Kovin, Serbia, 26220
        • Recruiting
        • Special Hospital for Psychiatric Diseases 'Kovin'
        • Contact:
          • Snezana Djordjevic, Site 414
          • Phone Number: 382+11
      • Kovin, Serbia, 306041
        • Not yet recruiting
        • Local Institution - 404
        • Contact:
          • Site 404
      • Kragujevac, Serbia, 34 000
        • Recruiting
        • University Clinical Center Kragujevac
        • Contact:
          • Mirjana Jovanovic, Site 407
          • Phone Number: 38134370208
      • Kragujevac, Serbia, 34 000
        • Not yet recruiting
        • Local Institution - 408
        • Contact:
          • Site 408
      • Kragujevac, Serbia, 34 000
        • Active, not recruiting
        • Local Institution - 406
      • Niš, Serbia, 18000
        • Withdrawn
        • Local Institution - 415
      • Novi Kneževac, Serbia, 23330
        • Recruiting
        • Special Hospital for Psychiatric Diseases 'Sveti Vracevi'
        • Contact:
          • Suzana Stijovic, Site 410
          • Phone Number: 38163529049
      • Novi Kneževac, Serbia, 23330
        • Withdrawn
        • Local Institution - 416
      • Vršac, Serbia, 26300
        • Withdrawn
        • Local Institution - 409
  • United Kingdom
      • Glasgow, United Kingdom, G51 4TF
        • Withdrawn
        • Local Institution - 704
    • Cornwall
      • Bodmin, Cornwall, United Kingdom, PL31 2QN
        • Withdrawn
        • Local Institution - 707
    • East Sussex
      • Brighton, East Sussex, United Kingdom, BN1 9RY
        • Withdrawn
        • Local Institution - 705
    • Greater London
      • London, Greater London, United Kingdom, SE5 8AF
        • Withdrawn
        • Local Institution - 701
    • Lancashire
      • Ashton-under-Lyne, Lancashire, United Kingdom, OL6 7SR
        • Withdrawn
        • Local Institution - 706
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7JX
        • Withdrawn
        • Local Institution - 708
    • Surrey
      • Chertsey, Surrey, United Kingdom, KT16 9AU
        • Withdrawn
        • Local Institution - 702
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B4 6NH
        • Withdrawn
        • Local Institution - 703
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Recruiting
        • Alea Research
        • Contact:
          • Payam Sadr, Site 161
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Woodland International Research Group, LLC
        • Contact:
          • George Konis, Site 112
          • Phone Number: 501-221-8681
      • Little Rock, Arkansas, United States, 72204
        • Recruiting
        • Pillar Clinical Research LLC
        • Contact:
          • Leslie Smith, Site 175
          • Phone Number: 501-350-3285
    • California
      • Anaheim, California, United States, 92805
        • Recruiting
        • Advanced Research Center, Inc.
        • Contact:
          • Steven Macina, Site 146
          • Phone Number: 714-999-6688
      • Bellflower, California, United States, 90706
        • Recruiting
        • CITrials - Bellflower
        • Contact:
          • Gerald Maguire, Site 130
          • Phone Number: 714-547-4100
      • Cerritos, California, United States, 90703
        • Completed
        • Local Institution - 110
      • Culver City, California, United States, 90230
        • Active, not recruiting
        • Local Institution - 167
      • Garden Grove, California, United States, 92845
        • Active, not recruiting
        • Local Institution - 127
      • La Habra, California, United States, 90631-3842
        • Not yet recruiting
        • Local Institution - 152
        • Contact:
          • Site 152
      • Lafayette, California, United States, 94549
        • Completed
        • Local Institution - 126
      • Lemon Grove, California, United States, 91945-2956
        • Recruiting
        • Synergy Clinical Research of Escondido
        • Contact:
          • Charmaine Semeniuk, Site 131
          • Phone Number: 619-303-6130
      • Los Angeles, California, United States, 91403
        • Withdrawn
        • Local Institution - 141
      • Oceanside, California, United States, 92056
        • Recruiting
        • Excell Research, Inc.
        • Contact:
          • Sherry Soefje, Site 181
          • Phone Number: 760-758-2222
      • Orange, California, United States, 92868
        • Recruiting
        • NRC Research Institute
        • Contact:
          • Tony Ortiz, Site 150
          • Phone Number: 714-289-1100
      • Pico Rivera, California, United States, 90660
        • Recruiting
        • CNRI - Los Angeles, LLC
        • Contact:
          • Mohamed El-Gabalawy, Site 170
      • Riverside, California, United States, 92506
        • Recruiting
        • CITrials, Inc. - Riverside & San Bernardino County
        • Contact:
          • Evagelos Coskinas, Site 144
          • Phone Number: 951300492
      • San Diego, California, United States, 92123
        • Withdrawn
        • Local Institution - 193
      • Stanford, California, United States, 94305
        • Active, not recruiting
        • Local Institution - 164
      • Torrance, California, United States, 90504
        • Active, not recruiting
        • Local Institution - 109
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Recruiting
        • Prestige Clinical Research Center, Inc.
        • Contact:
          • Patricia Junquera, Site 186
          • Phone Number: 305-907-6960
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • Reliable Clinical Research LLC
        • Contact:
          • Gilberto Cruz, Site 182
          • Phone Number: 786-536-4177
      • Hialeah, Florida, United States, 33016-1814
        • Recruiting
        • Galiz Research, LLC
        • Contact:
          • Jose Gamez, Site 133
          • Phone Number: 305-805-0921
      • Lauderhill, Florida, United States, 33319-4985
        • Terminated
        • Local Institution - 105
      • Miami, Florida, United States, 33122-1335
        • Recruiting
        • Premier Clinical Research Institute, Inc.
        • Contact:
          • Niveditha Bhaskarla, Site 145
      • Miami, Florida, United States, 33166
        • Active, not recruiting
        • Local Institution - 171
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Assertive Research Center
        • Contact:
          • Bashar Mohsen, Site 153
          • Phone Number: 305-698-4000
      • Miami Lakes, Florida, United States, 33014
        • Active, not recruiting
        • Local Institution - 173
      • Miami Lakes, Florida, United States, 33016-1553
        • Withdrawn
        • Local Institution - 120
      • Orange City, Florida, United States, 32763-8350
        • Withdrawn
        • Local Institution - 124
      • Pembroke Pines, Florida, United States, 33025
        • Recruiting
        • Pines Care Research Center, Inc.
        • Contact:
          • Jaynier Moya, Site 156
          • Phone Number: 954-239-7486
      • Tampa, Florida, United States, 33629
        • Recruiting
        • Interventional Psychiatry of Tampa Bay
        • Contact:
          • Jamie Winderbaum Fernandez, Site 155
          • Phone Number: 813-251-1800
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Recruiting
        • CenExel Atlanta Center for Medical Research
        • Contact:
          • Elyssa Barron, Site 192
          • Phone Number: 404-881-5800
      • Atlanta, Georgia, United States, 30303-3031
        • Recruiting
        • Emory University
        • Contact:
          • Robert Cotes, Site 136
          • Phone Number: 404-616-4752
      • Atlanta, Georgia, United States, 30328
        • Active, not recruiting
        • Local Institution - 111
      • Augusta, Georgia, United States, 30912-2613
        • Withdrawn
        • Local Institution - 135
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • CenExel iResearch Atlanta
        • Contact:
          • Saundra Maass Robinson, Site 138
          • Phone Number: 404-537-1281
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Psych Atlanta, P.C.
        • Contact:
          • Michael Banov, Site 169
          • Phone Number: 770-422-2846
      • Savannah, Georgia, United States, 31405
        • Withdrawn
        • Local Institution - 191
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Recruiting
        • Uptown Research Institute, LLC
        • Contact:
          • John Sonnenberg, Site 151
          • Phone Number: 773-989-9692
      • Chicago, Illinois, United States, 60611
        • Withdrawn
        • Local Institution - 177
      • Chicago, Illinois, United States, 60612
        • Withdrawn
        • Local Institution - 142
      • Chicago, Illinois, United States, 60612
        • Withdrawn
        • Local Institution - 143
    • Kansas
      • Overland Park, Kansas, United States, 66210-2670
        • Withdrawn
        • Local Institution - 139
    • Louisiana
      • Monroe, Louisiana, United States, 71201
        • Withdrawn
        • Local Institution - 154
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • Active, not recruiting
        • Local Institution - 166
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston University - PARENT
        • Contact:
          • Hannah Brown, Site 187
          • Phone Number: 617-638-8141
      • Boston, Massachusetts, United States, 02114
        • Withdrawn
        • Local Institution - 158
      • Boston, Massachusetts, United States, 02118
        • Withdrawn
        • Local Institution - 269
      • Worcester, Massachusetts, United States, 01655
        • Withdrawn
        • Local Institution - 185
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Withdrawn
        • Local Institution - 184
      • Grand Rapids, Michigan, United States, 49503
        • Withdrawn
        • Local Institution - 149
      • Kalamazoo, Michigan, United States, 49001
        • Withdrawn
        • Local Institution - 162
    • Missouri
      • St Louis, Missouri, United States, 63128
        • Completed
        • Local Institution - 129
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Arch Clinical Trials LLC
        • Contact:
          • Junaid Syed, Site 178
          • Phone Number: 314-498-9799
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Recruiting
        • Omaha Insomnia and Psychiatric Services LLC
        • Contact:
          • Vithya Selvaraj, Site 174
          • Phone Number: 402-991-9630
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Completed
        • Local Institution - 148
      • Las Vegas, Nevada, United States, 89102
        • Withdrawn
        • Local Institution - 147
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Recruiting
        • CenExel HRI Marlton
        • Contact:
          • Cassie Blanchard, Site 188
          • Phone Number: 856-753-7335
    • New York
      • New York, New York, United States, 10035
        • Recruiting
        • Manhattan Psychiatric Center
        • Contact:
          • Jean-Pierre Lindenmayer, Site 160
          • Phone Number: 646-766-5004
      • New York, New York, United States, 10017
        • Terminated
        • Local Institution - 104
      • New York, New York, United States, 10036
        • Active, not recruiting
        • Local Institution - 157
      • Rochester, New York, United States, 14623
        • Recruiting
        • Psychiatry and Alzheimer's Care of Rochester. PLLC
        • Contact:
          • M. Saleem Ismail, Site 108
          • Phone Number: 585-241-9670
      • Staten Island, New York, United States, 10314-1607
        • Recruiting
        • Richmond Behavioral Associates ERG Clinical Research - New York PLLC
        • Contact:
          • Waqar Siddiqui, Site 113
          • Phone Number: 718-317-5522
    • North Carolina
      • Hickory, North Carolina, United States, 28601
        • Active, not recruiting
        • Local Institution - 176
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Withdrawn
        • Local Institution - 165
      • Garfield Heights, Ohio, United States, 44125
        • Withdrawn
        • Local Institution - 168
      • Independence, Ohio, United States, 44131
        • Completed
        • Local Institution - 163
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Withdrawn
        • Local Institution - 194
    • Oregon
      • Eugene, Oregon, United States, 97403
        • Recruiting
        • Prevention Science Institute
        • Contact:
          • Fred Sabb, Site 179
          • Phone Number: 310-844-6458
    • Texas
      • Austin, Texas, United States, 78754
        • Recruiting
        • Community Clinical Research, Inc.
        • Contact:
          • David Brown, Site 128
          • Phone Number: 512-323-2622
      • DeSoto, Texas, United States, 75115
        • Withdrawn
        • Local Institution - 189
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • JPS Health Network
        • Contact:
          • Dustin Demoss, Site 190
      • Houston, Texas, United States, 77074
        • Recruiting
        • Clinical Trial Network LLC
        • Contact:
          • Manjeshwar Prabhu, Site 180
          • Phone Number: 832-325-7080
      • Houston, Texas, United States, 77030
        • Withdrawn
        • Local Institution - 183
      • Irving, Texas, United States, 75062-2757
        • Completed
        • Local Institution - 103
      • Richardson, Texas, United States, 75080
        • Recruiting
        • Pillar Clinical Research, LLC
        • Contact:
          • Scott Bartley, Site 172
          • Phone Number: 214-396-4844
      • Richmond, Texas, United States, 77407
        • Active, not recruiting
        • Local Institution - 159
    • Vermont
      • Rutland, Vermont, United States, 05701
        • Recruiting
        • Green Mountain Research Institute
        • Contact:
          • Lesley Brodie, Site 140
          • Phone Number: 802-855-8368
    • Washington
      • Bellevue, Washington, United States, 98007
        • Recruiting
        • Northwest Clinical Research Center
        • Contact:
          • Arifulla Khan, Site 101
          • Phone Number: 425-453-0404

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: From initial dose to safety follow-up visit (54 weeks) or early termination
From initial dose to safety follow-up visit (54 weeks) or early termination

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of serious treatment-emergent adverse events (TEAEs)
Time Frame: From initial dose to safety follow-up visit (54 weeks) or early termination
From initial dose to safety follow-up visit (54 weeks) or early termination
Incidence of TEAEs leading to discontinuation of study drug
Time Frame: From initial dose to safety follow-up visit (54 weeks) or early termination
From initial dose to safety follow-up visit (54 weeks) or early termination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karuna Therapeutics

Collaborators

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2022

Primary Completion (Estimated)

March 19, 2026

Study Completion (Estimated)

March 19, 2026

Study Registration Dates

First Submitted

March 21, 2022

First Submitted That Met QC Criteria

March 30, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN012-0009 (Other Identifier: Bristol-Myers Squibb Protocol ID)
  • KAR-013 (Other Identifier: Karuna Pharmaceuticals Protocol ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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