An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
NCT ID: NCT05304767
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
280 participants
INTERVENTIONAL
2022-03-07
2026-03-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Drug: KarXT
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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. 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.
18 Years
65 Years
ALL
No
Sponsors
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Karuna Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Alea Research
Phoenix, Arizona, United States
Pillar Clinical Research LLC
Little Rock, Arkansas, United States
Woodland International Research Group, LLC
Little Rock, Arkansas, United States
Advanced Research Center, Inc.
Anaheim, California, United States
CITrials - Bellflower
Bellflower, California, United States
Local Institution - 110
Cerritos, California, United States
Local Institution - 167
Culver City, California, United States
Local Institution - 127
Garden Grove, California, United States
Local Institution - 152
La Habra, California, United States
Local Institution - 126
Lafayette, California, United States
Synergy Clinical Research of Escondido
Lemon Grove, California, United States
Local Institution - 141
Los Angeles, California, United States
Excell Research, Inc.
Oceanside, California, United States
NRC Research Institute
Orange, California, United States
CNRI - Los Angeles, LLC
Pico Rivera, California, United States
CITrials, Inc. - Riverside & San Bernardino County
Riverside, California, United States
Local Institution - 193
San Diego, California, United States
Local Institution - 164
Stanford, California, United States
Local Institution - 109
Torrance, California, United States
Prestige Clinical Research Center, Inc.
Coral Gables, Florida, United States
Reliable Clinical Research LLC
Hialeah, Florida, United States
Galiz Research, LLC
Hialeah, Florida, United States
Local Institution - 105
Lauderhill, Florida, United States
Premier Clinical Research Institute, Inc.
Miami, Florida, United States
Local Institution - 171
Miami, Florida, United States
Local Institution - 173
Miami Lakes, Florida, United States
Local Institution - 120
Miami Lakes, Florida, United States
Assertive Research Center
Miami Lakes, Florida, United States
Local Institution - 124
Orange City, Florida, United States
Pines Care Research Center, Inc.
Pembroke Pines, Florida, United States
Interventional Psychiatry of Tampa Bay
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Local Institution - 111
Atlanta, Georgia, United States
CenExel Atlanta Center for Medical Research
Atlanta, Georgia, United States
Local Institution - 135
Augusta, Georgia, United States
CenExel iResearch Atlanta
Decatur, Georgia, United States
Psych Atlanta, P.C.
Marietta, Georgia, United States
Local Institution - 191
Savannah, Georgia, United States
Local Institution - 177
Chicago, Illinois, United States
Local Institution - 142
Chicago, Illinois, United States
Local Institution - 143
Chicago, Illinois, United States
Uptown Research Institute, LLC
Chicago, Illinois, United States
Local Institution - 139
Overland Park, Kansas, United States
Local Institution - 154
Monroe, Louisiana, United States
Local Institution - 166
Gaithersburg, Maryland, United States
Local Institution - 158
Boston, Massachusetts, United States
Boston University - PARENT
Boston, Massachusetts, United States
Local Institution - 269
Boston, Massachusetts, United States
Local Institution - 185
Worcester, Massachusetts, United States
Local Institution - 184
Ann Arbor, Michigan, United States
Local Institution - 149
Grand Rapids, Michigan, United States
Local Institution - 162
Kalamazoo, Michigan, United States
Local Institution - 129
St Louis, Missouri, United States
Arch Clinical Trials LLC
St Louis, Missouri, United States
Omaha Insomnia and Psychiatric Services LLC
Omaha, Nebraska, United States
Local Institution - 147
Las Vegas, Nevada, United States
Local Institution - 148
Las Vegas, Nevada, United States
CenExel HRI Marlton
Berlin, New Jersey, United States
Local Institution - 104
New York, New York, United States
Manhattan Psychiatric Center
New York, New York, United States
Local Institution - 157
New York, New York, United States
Psychiatry and Alzheimer's Care of Rochester. PLLC
Rochester, New York, United States
Richmond Behavioral Associates ERG Clinical Research - New York PLLC
Staten Island, New York, United States
Local Institution - 176
Hickory, North Carolina, United States
Local Institution - 165
Cincinnati, Ohio, United States
Local Institution - 168
Garfield Heights, Ohio, United States
Local Institution - 163
Independence, Ohio, United States
Local Institution - 194
Oklahoma City, Oklahoma, United States
Prevention Science Institute
Eugene, Oregon, United States
Community Clinical Research, Inc.
Austin, Texas, United States
Local Institution - 189
DeSoto, Texas, United States
JPS Health Network
Fort Worth, Texas, United States
Local Institution - 183
Houston, Texas, United States
Clinical Trial Network LLC
Houston, Texas, United States
Local Institution - 103
Irving, Texas, United States
Pillar Clinical Research, LLC
Richardson, Texas, United States
Local Institution - 159
Richmond, Texas, United States
Green Mountain Research Institute
Rutland, Vermont, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Center for Mental Health Center - Sofia District EOOD
Sofia, Sofia-Grad, Bulgaria
Medical Center Akademika EOOD
Sofia, Sofia-Grad, Bulgaria
MHAT Dr. Hristo Stambolski, EOOD
Kazanlak, Stara Zagora, Bulgaria
Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Natsov
Cherven Bryag, , Bulgaria
Local Institution - 311
Dupnitsa, , Bulgaria
Local Institution - 316
Kardzhali, , Bulgaria
State Psychiatric Hospital 'Sv. Ivan Rilski', Novi Iskar
Novi Iskar, , Bulgaria
Medical Center Medconsult Pleven OOD
Pleven, , Bulgaria
UMHAT 'Dr. Georgi Stranski', EAD
Pleven, , Bulgaria
UMHAT Sv. Georgi, EAD
Plovdiv, , Bulgaria
Local Institution - 321
Plovdiv, , Bulgaria
Local Institution - 313
Razgrad, , Bulgaria
MHAT Dr Ivan Seliminski AD
Sliven, , Bulgaria
Medical Center 'Sv.Naum'
Sofia, , Bulgaria
DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
Sofia, , Bulgaria
Local Institution - 320
Sofia, , Bulgaria
Medical Center Hera EOOD
Sofia, , Bulgaria
Medical Center Intermedica, OOD
Sofia, , Bulgaria
Medical Center VAS OOD
Targovishte, , Bulgaria
DCC Mladost M - Varna, OOD
Varna, , Bulgaria
Mental Health Center-Vratsa EOOD
Vratsa, , Bulgaria
Local Institution - 905
Klecany, , Czechia
Local Institution - 903
Ostrava - Poruba, , Czechia
Local Institution - 904
Pilsen, , Czechia
Local Institution - 906
Prague, , Czechia
Local Institution - 901
Prague, , Czechia
Local Institution - 902
Prague, , Czechia
Local Institution - 616
Guwahati, Assam, India
Local Institution - 607
Ahmedabad, Gujarat, India
Local Institution - 604
Ahmedabad, Gujarat, India
Local Institution - 609
Surat, Gujarat, India
Local Institution - 613
Vadodara, Gujarat, India
Local Institution - 617
Belgavi, Karnataka, India
Local Institution - 614
Mangalore, Karnataka, India
Local Institution - 602
Mangalore, Karnataka, India
Local Institution - 601
Mysore, Karnataka, India
Local Institution - 611
Kozhikode, Kerala, India
Local Institution - 610
Aurangabad, Maharashtra, India
Local Institution - 603
Nagpur, Maharashtra, India
Local Institution - 608
Nashik, Maharashtra, India
Local Institution - 605
Nashik, Maharashtra, India
Local Institution - 615
Ajmer, Rajasthan, India
Local Institution - 606
Rajkot, Rajasthan, India
Local Institution - 612
Lucknow, Uttar Pradesh, India
Local Institution - 258
Konan-shi, Aichi-ken, Japan
Local Institution - 250
Toyoake-shi, Aichi-ken, Japan
Local Institution - 255
Fukuoka, Fukuoka, Japan
Local Institution - 257
Shirakawa-shi, Fukushima, Japan
Local Institution - 254
Karatsu-shi, Saga-ken, Japan
Local Institution - 253
Meguro-ku, Tokyo, Japan
Sangenjaya Neurology- Psychosomatic Clinic
Setagaya-ku, Tokyo, Japan
Local Institution - 910
Shibuya-ku, Tokyo, Japan
Local Institution - 256
Shinjuku-ku, Tokyo-To, Japan
Local Institution - 506
Bialystok, , Poland
Local Institution - 507
Gdansk, , Poland
Local Institution - 509
Grudziądz, , Poland
Local Institution - 502
Katowice, , Poland
Local Institution - 501
Kielce, , Poland
Local Institution - 503
Lodz, , Poland
Local Institution - 505
Lublin, , Poland
Local Institution - 508
Suchy Las, , Poland
Local Institution - 504
Tuszyn, , Poland
Local Institution - 803
Brasov, , Romania
Local Institution - 804
Bucharest, , Romania
Local Institution - 810
Bucharest, , Romania
Local Institution - 802
Bucharest, , Romania
Local Institution - 809
Bucharest, , Romania
Local Institution - 807
Bucharest, , Romania
Local Institution - 808
Craiova, , Romania
Local Institution - 801
Galati, , Romania
Local Institution - 806
Iași, , Romania
Local Institution - 805
Sibiu, , Romania
Local Institution - 403
Belgrade, , Serbia
Clinical Center ' Dr Dragisa Misovic Dedinje'
Belgrade, , Serbia
Local Institution - 413
Belgrade, , Serbia
Local Institution - 417
Belgrade, , Serbia
University Clinical Center of Serbia
Belgrade, , Serbia
Local Institution - 411
Gornja Toponica, , Serbia
Special Hospital for Psychiatric Diseases 'Kovin'
Kovin, , Serbia
Local Institution - 404
Kovin, , Serbia
Local Institution - 406
Kragujevac, , Serbia
Local Institution - 408
Kragujevac, , Serbia
University Clinical Center Kragujevac
Kragujevac, , Serbia
University Clinical Center Kragujevac
Kragujevac, , Serbia
Local Institution - 415
Niš, , Serbia
Local Institution - 416
Novi Kneževac, , Serbia
Special Hospital for Psychiatric Diseases 'Sveti Vracevi'
Novi Kneževac, , Serbia
Local Institution - 409
Vršac, , Serbia
Local Institution - 707
Bodmin, Cornwall, United Kingdom
Local Institution - 705
Brighton, East Sussex, United Kingdom
Local Institution - 701
London, Greater London, United Kingdom
Local Institution - 706
Ashton-under-Lyne, Lancashire, United Kingdom
Local Institution - 708
Oxford, Oxfordshire, United Kingdom
Local Institution - 702
Chertsey, Surrey, United Kingdom
Local Institution - 703
Birmingham, West Midlands, United Kingdom
Local Institution - 704
Glasgow, , United Kingdom
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
First line of the email MUST contain the NCT# and Site #.
Role: CONTACT
Facility Contacts
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Payam Sadr, Site 161
Role: primary
Leslie Smith, Site 175
Role: primary
George Konis, Site 112
Role: primary
Steven Macina, Site 146
Role: primary
Gerald Maguire, Site 130
Role: primary
Site 152
Role: primary
Charmaine Semeniuk, Site 131
Role: primary
Sherry Soefje, Site 181
Role: primary
Tony Ortiz, Site 150
Role: primary
Mohamed El-Gabalawy, Site 170
Role: primary
Evagelos Coskinas, Site 144
Role: primary
Patricia Junquera, Site 186
Role: primary
Gilberto Cruz, Site 182
Role: primary
Jose Gamez, Site 133
Role: primary
Niveditha Bhaskarla, Site 145
Role: primary
Bashar Mohsen, Site 153
Role: primary
Jaynier Moya, Site 156
Role: primary
Jamie Winderbaum Fernandez, Site 155
Role: primary
Robert Cotes, Site 136
Role: primary
Elyssa Barron, Site 192
Role: primary
Saundra Maass Robinson, Site 138
Role: primary
Michael Banov, Site 169
Role: primary
John Sonnenberg, Site 151
Role: primary
Hannah Brown, Site 187
Role: primary
Junaid Syed, Site 178
Role: primary
Vithya Selvaraj, Site 174
Role: primary
Cassie Blanchard, Site 188
Role: primary
Jean-Pierre Lindenmayer, Site 160
Role: primary
M. Saleem Ismail, Site 108
Role: primary
Waqar Siddiqui, Site 113
Role: primary
Fred Sabb, Site 179
Role: primary
David Brown, Site 128
Role: primary
Dustin Demoss, Site 190
Role: primary
Manjeshwar Prabhu, Site 180
Role: primary
Scott Bartley, Site 172
Role: primary
Lesley Brodie, Site 140
Role: primary
Arifulla Khan, Site 101
Role: primary
Emil Grashnov, Site 306
Role: primary
Vihra Milanova, Site 309
Role: primary
Ivan Dimitrov, Site 302
Role: primary
Ivo Natsov, Site 318
Role: primary
Tsveteslava Galabova, Site 304
Role: primary
Mariya Alexandrova-Stoycheva, Site 301
Role: primary
Maya Stoimenova-Popova, Site 315
Role: primary
Andriana Kakanakova, Site 314
Role: primary
Site 321
Role: primary
Rozalina Petrova, Site 312
Role: primary
Assen Karadaliev, Site 305
Role: primary
Petya Dimitrova, Site 319
Role: primary
Sibila Dimitrova-Mitova, Site 307
Role: primary
Toni Donchev, Site 303
Role: primary
Veselka Vasileva, Site 317
Role: primary
Hristo Kozhuharov, Site 308
Role: primary
Nadya Ivanova, Site 310
Role: primary
Site 253
Role: primary
Kenji Shigemori, Site 252
Role: primary
Vladimir Diligenski, Site 405
Role: primary
Maja Ivkovic, Site 402
Role: primary
Snezana Djordjevic, Site 414
Role: primary
Site 404
Role: primary
Site 408
Role: primary
Dragana Ristic, Site 401
Role: primary
Mirjana Jovanovic, Site 407
Role: primary
Suzana Stijovic, Site 410
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CN012-0009
Identifier Type: OTHER
Identifier Source: secondary_id
KAR-013
Identifier Type: OTHER
Identifier Source: secondary_id
CN012-0009
Identifier Type: -
Identifier Source: org_study_id
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