A Study to Assess Efficacy and Safety of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
NCT ID: NCT05145413
Last Updated: 2025-03-28
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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COMPLETED
PHASE3
396 participants
INTERVENTIONAL
2021-11-12
2025-03-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
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
Placebo
Placebo
Placebo Capsules
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
Placebo
Placebo Capsules
Eligibility Criteria
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Inclusion Criteria
2. Subject is capable of providing signed Informed Consent Form before any study assessments will be performed
3. Subject has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 criteria and confirmed by Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorder Studies (MINI) version 7.0.2
4. Subject is currently being treated with stable dosing of monotherapy risperidone, paliperidone, aripiprazole, or their LAIs ziprasidone, lurasidone, or cariprazine and has been taking this treatment with the same dosing regimen for at least 8 weeks at the time of Day 1 (Visit 3)
5. The subject has had at least 1 previous inadequate response to above antipsychotics that was dosed appropriately (within the label) for at least 6 weeks
6. The subject has not required psychiatric hospitalization, incarceration in prison, acute crisis intervention, or other increase in the level of care due to symptom exacerbation within 8 weeks of Screening and is psychiatrically stable in the opinion of the Investigator
7. To be eligible for randomization, subjects need to have detectable levels of background antipsychotic medication (measured at Visit 1)
8. Positive and Negative Syndrome Scale (PANSS) total score ≥ 70 at Screening and randomization
9. Clinical Global Impression-Severity (CGI-S) scale with a score ≥ 4 (moderate) at Screening and randomization
10. PANSS Marder Positive symptom factor ≥ 4 on 2 (or more) items (PANSS items, delusions, hallucinations, grandiosity, suspiciousness and persecution, stereotyped thinking, somatic concern, unusual thought content or lack of judgment and insight), at Screening and randomization
11. Subjects with ≤ 20-point decrease in PANSS Total score between Visit 1 and Visit 3
12. Subject is willing and able to visit the clinic in an outpatient setting for the study duration, follow instructions, and comply with the protocol requirements
13. Body Mass Index (BMI) must be within 18 to 40 kg/m2 (inclusive of both values)
14. Subject resides in a stable living situation in the opinion of the Investigator
15. 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 needs to be physically present at the Baseline visit, but can complete the remaining study visits assessments via phone (as needed and as per local regulations). In Bulgaria, the informant needs to physically present at the Baseline visit and should be physically present at all study visits where the Investigator determines that his/her input would be beneficial.
16. 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
2. The subject has a history of moderate to severe substance use disorder (other than nicotine) within the past 12 months
1. A Screening subject with mild substance use disorder within the 12 months before Screening must be discussed with the Medical Monitor before being allowed into the study
2. Subjects who test positive for cannabis at Screening may be permitted to enroll in consultation with the Medical Monitor if the subject's pattern of use is not indicative of a moderate to severe substance use disorder
3. Subject has a history of treatment-resistant schizophrenia defined as:
a. Failure to minimally respond to 2 adequate courses of antipsychotic drug (APD) pharmacotherapy Note: Failure to minimally respond is defined as persistence symptoms of moderate severity in 2 or more psychotic symptom domains or persistence of severe symptoms in 1 or more psychotic symptom domains despite adequate dose and duration (6 weeks or longer) of APD treatment.
4. History of symptom instability
a. \> 3 psychiatric hospitalizations over the last 12 months or 2 over the last 6 months
5. Current APD is other than aripiprazole, risperidone, paliperidone, or their LAI versions, ziprasidone, lurasidone, or cariprazine
6. Subjects who are diagnosed with schizophreniform disorder or are experiencing their first treated episode of schizophrenia
7. Significant or severe medical conditions including pulmonary, cardiovascular, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the Investigator, could jeopardize the safety of the subject or the validity of the study results
1. eGFR \< 60 mL/min
2. Alanine transaminase or aspartate transaminase (AST) \> 1.5 x upper limit of normal (ULN)
3. Total bilirubin \> 1.5 x ULN (Subjects with Gilbert's syndrome can be included as long as direct bilirubin is ≤ 1.5 x ULN)
8. Subjects with human immunodeficiency virus (HIV), cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections as indicated by medical history, serologies or LFT results
9. History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator
10. History of irritable bowel syndrome (with or without constipation) or any serious constipation requiring treatment within the last 6 months
11. Risk for suicidal behavior during the study as determined by the Investigator's clinical assessment and/or C-SSRS as confirmed by the following:
1. Answers "Yes" on items 4 or 5 (C-SSRS - ideation) with the most recent episode occurring within the 2 months before Screening or,
2. Answers "Yes" to any of the 5 items (C-SSRS behavior) with an episode occurring within the 12 months before Screening
12. Clinically significant abnormal finding on the physical examination, medical history, ECG, or clinical laboratory results at Screening
13. Urine toxicology screen is positive for phencyclidine, amphetamines, opiates, cocaine, or alcohol (clinically significant alcohol use in the opinion of the Investigator)
14. Subject is currently taking, or plans to take while in the study, any prohibited concomitant medication.
15. Pregnant, lactating, or less than 3 months postpartum
16. 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 his/her ability to adhere to the protocol visit schedule or fulfill visit requirements
17. Positive test for coronavirus (COVID-19) within 2 weeks or at Screening
18. Subjects with extreme concerns relating to global pandemics, such as COVID-19, that would obscure ratings or be expected to disrupt adherence to trial procedures
19. Unable to taper and discontinue a concomitant medication that would preclude participation in the double-blind adjunctive treatment (e.g., cannot stop anticholinergic)
20. Subjects with prior exposure to KarXT
21. Subjects who experienced any adverse effects due to xanomeline or trospium
22. Subjects who received investigational product as part of a clinical trial within 3 months of Screening
23. Risk of violent or destructive behavior as per Investigator's judgment that would interfere with subject's participation
24. Current involuntary hospitalization or incarcerationor on parole/probation
25. 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 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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IMA Clinical Research
Phoenix, Arizona, United States
Local Institution - 147
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
Synexus Clinical Research US, Inc.
Cerritos, California, United States
Clinical Innovations Inc.
Costa Mesa, California, United States
Proscience Research Group
Culver City, California, United States
CenExel Collaborative Neuroscience Research
Garden Grove, California, United States
Omega Clinical Trials
La Habra, California, United States
Sunwise Clinical Research, LLC.
Lafayette, California, United States
Synergy Clinical Research of Escondido
Lemon Grove, California, United States
Encino Hospital Medical Center
Los Angeles, California, United States
Excell Research, Inc.
Oceanside, California, United States
Neuropsychiatric Research Center of Orange County
Orange, California, United States
CNRI - Los Angeles, LLC
Pico Rivera, California, United States
CenExel Clinical Innovations, Inc.
Riverside, California, United States
Cnri-San Diego
San Diego, California, United States
Stanford University School of Medicine
Stanford, California, United States
CenExel Collaborative Neuroscience Research
Torrance, California, United States
Local Institution - 186
Coral Gables, Florida, United States
Reliable Clinical Research LLC
Hialeah, Florida, United States
Galiz Research, LLC
Hialeah, Florida, United States
Adaptive Clinical Research, Inc
Lauderhill, Florida, United States
Behavioral Clinical Research , Inc
Miami, Florida, United States
Premier Clinical Research Institute, Inc.
Miami, Florida, United States
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, United States
Assertive Research Center
Miami Lakes, Florida, United States
Envision Trials LLC
Miami Springs, 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
Grady Memorial Hospital
Atlanta, Georgia, United States
Synexus Clinical Research US, Inc.
Atlanta, Georgia, United States
Local Institution - 192
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
CenExel iResearch, LLC
Savannah, Georgia, United States
Northwestern University
Chicago, Illinois, United States
American Medical Research, Inc.
Chicago, Illinois, United States
Uptown Research Institute, LLC
Chicago, Illinois, United States
Phoenix Medical Research, Inc.
Prairie Village, Kansas, United States
IMA Clinical Research
Monroe, Louisiana, United States
CenExel Center for Behavioral Health
Gaithersburg, Maryland, United States
Local Institution - 158
Boston, Massachusetts, United States
Local Institution - 187
Boston, Massachusetts, United States
Local Institution - 185
Worcester, Massachusetts, United States
Michigan Clinical Research Institute PC
Ann Arbor, Michigan, United States
Cherry Health
Grand Rapids, Michigan, United States
Western Michigan University Homer Stryker M.D. School of Medicine
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
Altea Research Institute, Las Vegas
Las Vegas, Nevada, United States
CenExel Hassman Research Institute
Berlin, New Jersey, United States
Synexus Clinical Research US, Inc.
New York, New York, United States
Manhattan Psychiatric Center
New York, New York, United States
Manhattan Behavioral Medicine, PLLC
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
Clinical Trials of America - Psychiatry
Hickory, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Local Institution - 168
Garfield Heights, Ohio, United States
Insight Clinical Trials LLC
Independence, Ohio, United States
The Rivus Wellness & Research Institute
Oklahoma City, Oklahoma, United States
Prevention Science Institute
Eugene, Oregon, United States
Community Clinical Research, Inc.
Austin, Texas, United States
InSite Clinical Research; LLC
DeSoto, Texas, United States
JPS Health Network
Fort Worth, Texas, United States
Ben Taub Hospital
Houston, Texas, United States
Clinical Trial Network LLC
Houston, Texas, United States
University Hills Clinical Research - Irving
Irving, Texas, United States
Pillar Clinical Research, LLC
Richardson, Texas, United States
At Health Texas
Richmond, Texas, United States
Perceptive Pharma Research
Richmond, Texas, United States
Green Mountain Research Institute
Rutland, Vermont, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
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
Medical Centre 'Asklepii', OOD
Dupnitsa, , Bulgaria
Medical Center Lifemed
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
MHC - Sofia, EOOD
Sofia, , Bulgaria
Local Institution - 320
Sofia, , Bulgaria
DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
Sofia, , Bulgaria
Medical Center Akademika EOOD
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 - 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 - 619
Mumbai, 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 - 618
Bikaner, Rajasthan, India
Local Institution - 606
Rajkot, Rajasthan, India
Local Institution - 612
Lucknow, Uttar Pradesh, India
Local Institution - 258
Kōnan, Aichi-ken, Japan
Local Institution - 250
Toyoake-shi, Aichi-ken, Japan
Local Institution - 257
Shirakawa, Fukushima, Japan
Local Institution - 254
Karatsu-shi, Saga-ken, Japan
Local Institution - 255
Fukuoka, , Japan
Local Institution - 256
Tokyo, , Japan
Local Institution - 506
Bialystok, , Poland
Local Institution - 507
Gdansk, , Poland
Local Institution - 509
Grudziądz, , Poland
Local Institution - 501
Kielce, , Poland
Local Institution - 503
Lodz, , Poland
Local Institution - 505
Lublin, , Poland
Local Institution - 502
Siemianowice Śląskie, , Poland
Local Institution - 508
Suchy Las, , Poland
Local Institution - 504
Tuszyn, , Poland
Local Institution - 803
Brasov, , Romania
Local Institution - 809
Bucharest, , Romania
Local Institution - 804
Bucharest, , Romania
Local Institution - 810
Bucharest, , Romania
Local Institution - 802
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
Clinical Center ' Dr Dragisa Misovic Dedinje'
Belgrade, , Serbia
Institute of Mental Health
Belgrade, , Serbia
Local Institution - 413
Belgrade, , Serbia
Local Institution - 417
Belgrade, , Serbia
University Clinical Center of Serbia
Belgrade, , Serbia
"Special Hospital for Psychiatric Diseases ""Kovin"""
Kovin, , Serbia
Special Hospital for Psychiatric Diseases 'Kovin'
Kovin, , Serbia
University Clinical Center Kragujevac
Kragujevac, , Serbia
University Clinical Center Nis
Niš, , Serbia
Special Hospital for Psychiatric Diseases 'Gornja Toponica'
Niš, , Serbia
Special Hospital for Psychiatric Diseases 'Sveti Vracevi'
Novi Kneževac, , Serbia
Special Hospital for Psychiatric Disease 'Dr Slavoljub Bakalovic'
Vršac, , Serbia
Local Institution - 707
Pool, Reruth, 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, Greater Manchester, United Kingdom
Local Institution - 710
Manchester, Greater Manchester, United Kingdom
Local Institution - 709
Maidstone, Kent, United Kingdom
Local Institution - 708
Oxford, Oxfordshire, United Kingdom
Local Institution - 704
Glasgow, Strathclyde, United Kingdom
Local Institution - 702
Chertsey, Surrey, United Kingdom
Local Institution - 703
Birmingham, West Midlands, United Kingdom
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CN012-0008
Identifier Type: OTHER
Identifier Source: secondary_id
KAR-012
Identifier Type: OTHER
Identifier Source: secondary_id
CN012-0008
Identifier Type: -
Identifier Source: org_study_id
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