Actively Recruiting
An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
Led by Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Updated on 2026-03-11
280
Participants Needed
175
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to under 66 years at randomization of Study KAR-012
- Successfully completed the treatment period of Study KAR-012
- Compliant with Study KAR-012 procedures as judged by the Investigator
- Compliant with background antipsychotic medication during Study KAR-012 and willing to continue the same dose
- Able to provide signed informed consent before any study assessments
- Resides in a stable living situation as judged by the Investigator
- Has a reliable informant or caregiver willing and able to assist with study activities throughout participation
- Women of childbearing potential and men with partners who are women of childbearing potential must use at least one highly effective contraception method during the study and for at least one menstrual cycle after the last dose
- Female subjects must be postmenopausal for 12 months or otherwise permanently sterile to be considered not of childbearing potential
You will not qualify if you...
- Risk for suicidal behavior during the study as determined by clinical assessment or Columbia-Suicide Severity Rating Scale
- Clinically significant abnormalities from ECG, lab tests, physical exam, or vital signs at End of Treatment visit in Study KAR-012 that could jeopardize safety
- Female subjects who are pregnant
- Investigator or Medical Monitor judgement of unsuitability for enrollment or safety concerns
- Risk of violent or destructive behavior as judged by Investigator
- Participation in another investigational drug or device trial during this study
- History or high risk of urinary retention, gastric retention, or narrow angle glaucoma
- Use or planned use of prohibited concomitant medications during the study
- For male subjects only: history of bladder stones, recurrent urinary tract infections, prostate specific antigen >10 ng/mL, or high scores on International Prostate Symptom Score items
- IPSS assessment required for males aged 45 or older if baseline PSA values are unavailable from prior study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 175 locations
1
Alea Research
Phoenix, Arizona, United States, 85012
Actively Recruiting
2
Pillar Clinical Research LLC
Little Rock, Arkansas, United States, 72204
Actively Recruiting
3
Woodland International Research Group, LLC
Little Rock, Arkansas, United States, 72211
Actively Recruiting
4
Advanced Research Center, Inc.
Anaheim, California, United States, 92805
Actively Recruiting
5
CITrials - Bellflower
Bellflower, California, United States, 90706
Actively Recruiting
6
Local Institution - 110
Cerritos, California, United States, 90703
Completed
7
Local Institution - 167
Culver City, California, United States, 90230
Active, Not Recruiting
8
Local Institution - 127
Garden Grove, California, United States, 92845
Active, Not Recruiting
9
Local Institution - 152
La Habra, California, United States, 90631-3842
Not Yet Recruiting
10
Local Institution - 126
Lafayette, California, United States, 94549
Completed
11
Synergy Clinical Research of Escondido
Lemon Grove, California, United States, 91945-2956
Actively Recruiting
12
Local Institution - 141
Los Angeles, California, United States, 91403
Withdrawn
13
Excell Research, Inc.
Oceanside, California, United States, 92056
Actively Recruiting
14
NRC Research Institute
Orange, California, United States, 92868
Actively Recruiting
15
CNRI - Los Angeles, LLC
Pico Rivera, California, United States, 90660
Actively Recruiting
16
CITrials, Inc. - Riverside & San Bernardino County
Riverside, California, United States, 92506
Actively Recruiting
17
Local Institution - 193
San Diego, California, United States, 92123
Withdrawn
18
Local Institution - 164
Stanford, California, United States, 94305
Active, Not Recruiting
19
Local Institution - 109
Torrance, California, United States, 90504
Active, Not Recruiting
20
Prestige Clinical Research Center, Inc.
Coral Gables, Florida, United States, 33134
Actively Recruiting
21
Reliable Clinical Research LLC
Hialeah, Florida, United States, 33012
Actively Recruiting
22
Galiz Research, LLC
Hialeah, Florida, United States, 33016-1814
Actively Recruiting
23
Local Institution - 105
Lauderhill, Florida, United States, 33319-4985
Terminated
24
Premier Clinical Research Institute, Inc.
Miami, Florida, United States, 33122-1335
Actively Recruiting
25
Local Institution - 171
Miami, Florida, United States, 33166
Active, Not Recruiting
26
Local Institution - 173
Miami Lakes, Florida, United States, 33014
Active, Not Recruiting
27
Local Institution - 120
Miami Lakes, Florida, United States, 33016-1553
Withdrawn
28
Assertive Research Center
Miami Lakes, Florida, United States, 33016
Actively Recruiting
29
Local Institution - 124
Orange City, Florida, United States, 32763-8350
Withdrawn
30
Pines Care Research Center, Inc.
Pembroke Pines, Florida, United States, 33025
Actively Recruiting
31
Interventional Psychiatry of Tampa Bay
Tampa, Florida, United States, 33629
Actively Recruiting
32
Emory University
Atlanta, Georgia, United States, 30303-3031
Actively Recruiting
33
Local Institution - 111
Atlanta, Georgia, United States, 30328
Active, Not Recruiting
34
CenExel Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
Actively Recruiting
35
Local Institution - 135
Augusta, Georgia, United States, 30912-2613
Withdrawn
36
CenExel iResearch Atlanta
Decatur, Georgia, United States, 30030
Actively Recruiting
37
Psych Atlanta, P.C.
Marietta, Georgia, United States, 30060
Actively Recruiting
38
Local Institution - 191
Savannah, Georgia, United States, 31405
Withdrawn
39
Local Institution - 177
Chicago, Illinois, United States, 60611
Withdrawn
40
Local Institution - 142
Chicago, Illinois, United States, 60612
Withdrawn
41
Local Institution - 143
Chicago, Illinois, United States, 60612
Withdrawn
42
Uptown Research Institute, LLC
Chicago, Illinois, United States, 60640
Actively Recruiting
43
Local Institution - 139
Overland Park, Kansas, United States, 66210-2670
Withdrawn
44
Local Institution - 154
Monroe, Louisiana, United States, 71201
Withdrawn
45
Local Institution - 166
Gaithersburg, Maryland, United States, 20877
Active, Not Recruiting
46
Local Institution - 158
Boston, Massachusetts, United States, 02114
Withdrawn
47
Boston University - PARENT
Boston, Massachusetts, United States, 02118
Actively Recruiting
48
Local Institution - 269
Boston, Massachusetts, United States, 02118
Withdrawn
49
Local Institution - 185
Worcester, Massachusetts, United States, 01655
Withdrawn
50
Local Institution - 184
Ann Arbor, Michigan, United States, 48105
Withdrawn
51
Local Institution - 149
Grand Rapids, Michigan, United States, 49503
Withdrawn
52
Local Institution - 162
Kalamazoo, Michigan, United States, 49001
Withdrawn
53
Local Institution - 129
St Louis, Missouri, United States, 63128
Completed
54
Arch Clinical Trials LLC
St Louis, Missouri, United States, 63141
Actively Recruiting
55
Omaha Insomnia and Psychiatric Services LLC
Omaha, Nebraska, United States, 68144
Actively Recruiting
56
Local Institution - 147
Las Vegas, Nevada, United States, 89102
Withdrawn
57
Local Institution - 148
Las Vegas, Nevada, United States, 89102
Completed
58
CenExel HRI Marlton
Berlin, New Jersey, United States, 08009
Actively Recruiting
59
Local Institution - 104
New York, New York, United States, 10017
Terminated
60
Manhattan Psychiatric Center
New York, New York, United States, 10035
Actively Recruiting
61
Local Institution - 157
New York, New York, United States, 10036
Active, Not Recruiting
62
Psychiatry and Alzheimer's Care of Rochester. PLLC
Rochester, New York, United States, 14623
Actively Recruiting
63
Richmond Behavioral Associates ERG Clinical Research - New York PLLC
Staten Island, New York, United States, 10314-1607
Actively Recruiting
64
Local Institution - 176
Hickory, North Carolina, United States, 28601
Active, Not Recruiting
65
Local Institution - 165
Cincinnati, Ohio, United States, 45219
Withdrawn
66
Local Institution - 168
Garfield Heights, Ohio, United States, 44125
Withdrawn
67
Local Institution - 163
Independence, Ohio, United States, 44131
Completed
68
Local Institution - 194
Oklahoma City, Oklahoma, United States, 73112
Withdrawn
69
Prevention Science Institute
Eugene, Oregon, United States, 97403
Actively Recruiting
70
Community Clinical Research, Inc.
Austin, Texas, United States, 78754
Actively Recruiting
71
Local Institution - 189
DeSoto, Texas, United States, 75115
Withdrawn
72
JPS Health Network
Fort Worth, Texas, United States, 76104
Actively Recruiting
73
Local Institution - 183
Houston, Texas, United States, 77030
Withdrawn
74
Clinical Trial Network LLC
Houston, Texas, United States, 77074
Actively Recruiting
75
Local Institution - 103
Irving, Texas, United States, 75062-2757
Completed
76
Pillar Clinical Research, LLC
Richardson, Texas, United States, 75080
Actively Recruiting
77
Local Institution - 159
Richmond, Texas, United States, 77407
Active, Not Recruiting
78
Green Mountain Research Institute
Rutland, Vermont, United States, 05701
Actively Recruiting
79
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Actively Recruiting
80
Center for Mental Health Center - Sofia District EOOD
Sofia, Sofia-Grad, Bulgaria, 1202
Actively Recruiting
81
Medical Center Akademika EOOD
Sofia, Sofia-Grad, Bulgaria, 1463
Actively Recruiting
82
MHAT Dr. Hristo Stambolski, EOOD
Kazanlak, Stara Zagora, Bulgaria, 6100
Actively Recruiting
83
Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Natsov
Cherven Bryag, Bulgaria, 5980
Actively Recruiting
84
Local Institution - 311
Dupnitsa, Bulgaria, 2600
Active, Not Recruiting
85
Local Institution - 316
Kardzhali, Bulgaria, 6600
Completed
86
State Psychiatric Hospital 'Sv. Ivan Rilski', Novi Iskar
Novi Iskar, Bulgaria, 1282
Actively Recruiting
87
Local Institution - 315
Pleven, Bulgaria, 5800
Completed
88
Medical Center Medconsult Pleven OOD
Pleven, Bulgaria, 5800
Actively Recruiting
89
UMHAT Sv. Georgi, EAD
Plovdiv, Bulgaria, 4002
Actively Recruiting
90
Local Institution - 321
Plovdiv, Bulgaria, 4004
Not Yet Recruiting
91
Local Institution - 313
Razgrad, Bulgaria, 7200
Active, Not Recruiting
92
MHAT Dr Ivan Seliminski AD
Sliven, Bulgaria, 8800
Actively Recruiting
93
Medical Center 'Sv.Naum'
Sofia, Bulgaria, 1113
Actively Recruiting
94
DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
Sofia, Bulgaria, 1408
Actively Recruiting
95
Local Institution - 320
Sofia, Bulgaria, 1408
Withdrawn
96
Medical Center Hera EOOD
Sofia, Bulgaria, 1510
Actively Recruiting
97
Medical Center Intermedica, OOD
Sofia, Bulgaria, 1680
Actively Recruiting
98
Medical Center VAS OOD
Targovishte, Bulgaria, 7700
Actively Recruiting
99
DCC Mladost M - Varna, OOD
Varna, Bulgaria, 9020
Actively Recruiting
100
Mental Health Center-Vratsa EOOD
Vratsa, Bulgaria, 3000
Actively Recruiting
101
Local Institution - 905
Klecany, Czechia, 25067
Withdrawn
102
Local Institution - 903
Ostrava - Poruba, Czechia, 70868
Withdrawn
103
Local Institution - 904
Pilsen, Czechia, 301 00
Withdrawn
104
Local Institution - 906
Prague, Czechia, 100 00
Withdrawn
105
Local Institution - 901
Prague, Czechia, 11000
Withdrawn
106
Local Institution - 902
Prague, Czechia, 186 00
Withdrawn
107
Local Institution - 616
Guwahati, Assam, India, 781032
Withdrawn
108
Local Institution - 607
Ahmedabad, Gujarat, India, 380008
Withdrawn
109
Local Institution - 604
Ahmedabad, Gujarat, India, 380013
Withdrawn
110
Local Institution - 609
Surat, Gujarat, India, 395001
Withdrawn
111
Local Institution - 613
Vadodara, Gujarat, India, 390021
Withdrawn
112
Local Institution - 617
Belgavi, Karnataka, India, 590002
Withdrawn
113
Local Institution - 614
Mangalore, Karnataka, India, 575003
Withdrawn
114
Local Institution - 602
Mangalore, Karnataka, India, 575018
Withdrawn
115
Local Institution - 601
Mysore, Karnataka, India, 570001
Withdrawn
116
Local Institution - 611
Kozhikode, Kerala, India, 673009
Withdrawn
117
Local Institution - 610
Aurangabad, Maharashtra, India, 431005
Withdrawn
118
Local Institution - 603
Nagpur, Maharashtra, India, 440010
Withdrawn
119
Local Institution - 608
Nashik, Maharashtra, India, 422001
Withdrawn
120
Local Institution - 605
Nashik, Maharashtra, India, 422005
Withdrawn
121
Local Institution - 615
Ajmer, Rajasthan, India, 305001
Withdrawn
122
Local Institution - 606
Rajkot, Rajasthan, India, 360001
Withdrawn
123
Local Institution - 612
Lucknow, Uttar Pradesh, India, 226003
Withdrawn
124
Local Institution - 258
Konan-shi, Aichi-ken, Japan, 483-8248
Withdrawn
125
Local Institution - 250
Toyoake-shi, Aichi-ken, Japan, 470-1168
Active, Not Recruiting
126
Local Institution - 255
Fukuoka, Fukuoka, Japan, 819-0037
Completed
127
Local Institution - 257
Shirakawa-shi, Fukushima, Japan, 961-0021
Active, Not Recruiting
128
Local Institution - 254
Karatsu-shi, Saga-ken, Japan, 847-0031
Active, Not Recruiting
129
Local Institution - 253
Meguro-ku, Tokyo, Japan, 1540012
Not Yet Recruiting
130
Sangenjaya Neurology- Psychosomatic Clinic
Setagaya-ku, Tokyo, Japan, 1540004
Actively Recruiting
131
Local Institution - 910
Shibuya-ku, Tokyo, Japan, 1510053
Withdrawn
132
Local Institution - 256
Shinjuku-ku, Tokyo-To, Japan, 162-0843
Active, Not Recruiting
133
Local Institution - 506
Bialystok, Poland, 15-404
Withdrawn
134
Local Institution - 507
Gdansk, Poland, 80-546
Withdrawn
135
Local Institution - 509
Grudziądz, Poland, 86-300
Withdrawn
136
Local Institution - 502
Katowice, Poland, 40-146
Withdrawn
137
Local Institution - 501
Kielce, Poland, 25-411
Withdrawn
138
Local Institution - 503
Lodz, Poland, 93-118
Withdrawn
139
Local Institution - 505
Lublin, Poland, 20-109
Withdrawn
140
Local Institution - 508
Suchy Las, Poland, 62-002
Withdrawn
141
Local Institution - 504
Tuszyn, Poland, 95-080
Withdrawn
142
Local Institution - 803
Brasov, Romania, 500123
Withdrawn
143
Local Institution - 804
Bucharest, Romania, 010825
Withdrawn
144
Local Institution - 810
Bucharest, Romania, 040874
Withdrawn
145
Local Institution - 802
Bucharest, Romania, 041914
Withdrawn
146
Local Institution - 809
Bucharest, Romania, 041914
Withdrawn
147
Local Institution - 807
Bucharest, Romania, 60222
Withdrawn
148
Local Institution - 808
Craiova, Romania, 200157
Withdrawn
149
Local Institution - 801
Galati, Romania, 800179
Withdrawn
150
Local Institution - 806
Iași, Romania, 700282
Withdrawn
151
Local Institution - 805
Sibiu, Romania, 550281
Withdrawn
152
Local Institution - 403
Belgrade, Serbia, 101421
Active, Not Recruiting
153
Clinical Center ' Dr Dragisa Misovic Dedinje'
Belgrade, Serbia, 11000
Actively Recruiting
154
Local Institution - 413
Belgrade, Serbia, 11000
Withdrawn
155
Local Institution - 417
Belgrade, Serbia, 11000
Withdrawn
156
University Clinical Center of Serbia
Belgrade, Serbia, 11000
Actively Recruiting
157
Local Institution - 411
Gornja Toponica, Serbia, 705631
Active, Not Recruiting
158
Special Hospital for Psychiatric Diseases 'Kovin'
Kovin, Serbia, 26220
Actively Recruiting
159
Local Institution - 404
Kovin, Serbia, 306041
Not Yet Recruiting
160
Local Institution - 406
Kragujevac, Serbia, 34 000
Active, Not Recruiting
161
Local Institution - 408
Kragujevac, Serbia, 34 000
Not Yet Recruiting
162
University Clinical Center Kragujevac
Kragujevac, Serbia, 34 000
Actively Recruiting
163
University Clinical Center Kragujevac
Kragujevac, Serbia, 34 000
Actively Recruiting
164
Local Institution - 415
Niš, Serbia, 18000
Withdrawn
165
Local Institution - 416
Novi Kneževac, Serbia, 23330
Withdrawn
166
Special Hospital for Psychiatric Diseases 'Sveti Vracevi'
Novi Kneževac, Serbia, 23330
Actively Recruiting
167
Local Institution - 409
Vršac, Serbia, 26300
Withdrawn
168
Local Institution - 707
Bodmin, Cornwall, United Kingdom, PL31 2QN
Withdrawn
169
Local Institution - 705
Brighton, East Sussex, United Kingdom, BN1 9RY
Withdrawn
170
Local Institution - 701
London, Greater London, United Kingdom, SE5 8AF
Withdrawn
171
Local Institution - 706
Ashton-under-Lyne, Lancashire, United Kingdom, OL6 7SR
Withdrawn
172
Local Institution - 708
Oxford, Oxfordshire, United Kingdom, OX3 7JX
Withdrawn
173
Local Institution - 702
Chertsey, Surrey, United Kingdom, KT16 9AU
Withdrawn
174
Local Institution - 703
Birmingham, West Midlands, United Kingdom, B4 6NH
Withdrawn
175
Local Institution - 704
Glasgow, United Kingdom, G51 4TF
Withdrawn
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
F
First line of the email MUST contain the NCT# and Site #.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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