What this study is
The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia
What's being tested
- Xanomeline/Trospium Chloride
Intervention · DRUG
- Placebo
Intervention · DRUG
Both interventions
Specified dose on specified days
Study details
- Official title
- A Phase 3 Double-blind, Placebo-controlled Randomized Withdrawal Maintenance Trial of KarXT Treatment in Participants With Schizophrenia
- Sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
- Conditions
- Schizophrenia
- Enrolling
- 472 people
- Starts
- 2026-08-20
- Est. completion
- 2029-03-03
- Design
- Quadruple-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 65 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Participant must have a primary diagnosis of schizophrenia for at least 1 year established by a comprehensive psychiatric evaluation based on the DSM-5-TR (American Psychiatric Association 2022) criteria and confirmed by MINI for Psychotic Disorder Studies version 7.0.2 at screening.
- Participant must have experienced hospitalization for schizophrenia within 1 year from the screening date.
- Participant must be experiencing residual schizophrenia symptoms and have a PANSS total score ≥70 to ≤ 110 at screening and Day -1.
- Participant much have a PANSS Score of ≥ 4 (moderate or greater) on ≥ 2 of the following Positive Scale (P) items at screening and Day -1:; Item 1 (P1; delusions); Item 2 (P2; conceptual disorganization); Item 3 (P3; hallucinatory behavior); Item 6 (P6; suspiciousness/persecution)
- Participant must have a CGI-S score of ≥ 4 at screening and Day -1
- Participant must have a BMI ≥ 18 and ≤ 40 kg/m2.
You can't join if
- Participant must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening
- Participants must not have a newly diagnosed or are experiencing their first treated episode of psychosis or schizophrenia.
- Participant must not have a risk of suicidal behavior as determined by the Investigator's clinical assessment and/or Columbia-suicide Severity Rating Scale (C-SSRS).
- Participant must not have had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 6 months before screening.
- Participant must not have a history of treatment resistance to schizophrenia medications
- Participant must not have decrease in PANSS total score (floor adjusted) between screening and Day -1 of more than 20%.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (54)
49 openContact for 38 of 49 open sites
- Site 0021 · Contact
Pillar Clinical Research - Bentonville
Bentonville, Arkansas, United States
- Fayz Hudefi, Site 0154 · Contact479-367-2688
RecruitingPillar Clinical Research- Little Rock
Little Rock, Arkansas, United States
- Leslie Smith, Site 0139 · Contact501-350-3285
RecruitingLocal Institution - 0021
Little Rock, Arkansas, United States
Not yet recruitingLocal Institution - 0153
Rogers, Arkansas, United States
Not yet recruitingLocal Institution - 0190
Anaheim, California, United States
Not yet recruitingClinical Innovations, Inc. dba CITrials
Bellflower, California, United States
- Gerald Maguire, Site 0040 · Contact562-249-6956
RecruitingLocal Institution - 0032
Culver City, California, United States
Not yet recruitingCollaborative Neuroscience Research, LLC
Garden Grove, California, United States
- David Walling, Site 0037 · Contact714-799-7799
RecruitingLocal Institution - 0068
La Habra, California, United States
Not yet recruitingLocal Institution - 0128
Lemon Grove, California, United States
Not yet recruitingLocal Institution - 0187
Montclair, California, United States
Not yet recruiting- Recruiting
Local Institution - 0030
Pico Rivera, California, United States
Not yet recruitingLocal Institution - 0185
Redlands, California, United States
Not yet recruitingLocal Institution - 0186
Riverside, California, United States
Not yet recruitingLocal Institution - 0193
Torrance, California, United States
Not yet recruitingHealth Synergy Clinical Research
Boynton Beach, Florida, United States
- Mohammad Nisar, Site 0044 · Contact786-831-7303
RecruitingResearch Centers of America ( Hollywood )
Hollywood, Florida, United States
- Edwin Gomez, Site 0145 · Contact954-604-3900
RecruitingLocal Institution - 0195
Oakland Park, Florida, United States
Not yet recruitingAtlanta Center for Medical Research
Atlanta, Georgia, United States
- Elyssa Barron, Site 0166 · Contact404-881-5800
RecruitingLocal Institution - 0070
Sandy Springs, Georgia, United States
Not yet recruitingLocal Institution - 0189
Savannah, Georgia, United States
Not yet recruitingLocal Institution - 0067
Chicago, Illinois, United States
Not yet recruitingPillar Clinical Research -Chicago
Chicago, Illinois, United States
- Roueen Rafeyan, Site 0056 · Contact312-865-6336
RecruitingLocal Institution - 0192
Gaithersburg, Maryland, United States
Not yet recruitingLocal Institution - 0183
Cincinnati, Ohio, United States
Not yet recruitingLocal Institution - 0047
Oklahoma City, Oklahoma, United States
Not yet recruitingLocal Institution - 0049
Austin, Texas, United States
Not yet recruitingPillar Clinical Research - Richardson
Richardson, Texas, United States
- Scott Bartley, Site 0133 · Contact214-396-4844
RecruitingLocal Institution - 0075
Miami, Florida, United States
WithdrawnLocal Institution - 0054
Miami Lakes, Florida, United States
WithdrawnLocal Institution - 0134
Miami Springs, Florida, United States
Withdrawn
22 sites outside the US
Local Institution - 0002
Córdoba, Argentina
Not yet recruitingLocal Institution - 0197
Córdoba, Argentina
Not yet recruiting- Recruiting
Local Institution - 0191
Novi Iskar, Bulgaria
Not yet recruitingLocal Institution - 0162
Brno, Czechia
Not yet recruitingLocal Institution - 0014
Klecany, Czechia
Not yet recruitingLocal Institution - 0123
Warsaw, Masovian Voivodeship, Poland
Not yet recruitingLocal Institution - 0122
Bialystok, Podlaskie Voivodeship, Poland
Not yet recruitingLocal Institution - 0001
Poznan, Poland
Not yet recruitingLocal Institution - 0104
Brașov, Brăila County, Romania
Not yet recruitingLocal Institution - 0103
Bucharest, Bucharest, Romania
Not yet recruitingLocal Institution - 0105
Bucharest, Bucharest, Romania
Not yet recruitingLocal Institution - 0107
Bucharest, Bucharest, Romania
Not yet recruitingLocal Institution - 0110
Bucharest, Bucharest, Romania
Not yet recruitingLocal Institution - 0174
Bucharest, Romania
Not yet recruitingLocal Institution - 0106
Bucharest, Romania
Not yet recruitingLocal Institution - 0109
Bucharest, Romania
Not yet recruitingLocal Institution - 0112
Barcelona, Barcelona [Barcelona], Spain
Not yet recruitingLocal Institution - 0167
Valladolid, Spain
Not yet recruitingLocal Institution - 0181
Zamora, Spain
Not yet recruitingLocal Institution - 0175
Río Cuarto, Córdoba Province, Argentina
WithdrawnLocal Institution - 0143
Buenos Aires, Argentina
Withdrawn
Study team
Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Study ID CN012-0006
Study director
Bristol-Myers Squibb
Bristol-Myers Squibb
CONTACT
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain NCT # and Site #.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.