An Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-5)
NCT ID: NCT04820309
Last Updated: 2025-09-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
566 participants
INTERVENTIONAL
2021-06-02
2024-05-24
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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KarXT
Xanomeline and Trospium Chloride Capsules
Oral xanomeline 50 mg/trospium 20 mg BID on days 1-2 followed by xanomeline 100 mg/trospium 20 mg BID on days 3-7. The dose is increased to xanomeline 125 mg/trospium 30 mg BID on days 8-364 unless the subject is experiencing adverse events from the xanomeline 100 mg/ trospium 20 mg dose. Subjects who were increased to xanomeline 125 mg/trospium 30 mg will have the option to return to xanomeline 100 mg/ trospium 20 mg depending on clinical response and tolerability. Re-escalation to 125/30 BID or re-titration in cases in which the subject has been off KarXT for a longer period of time (at least a week) is allowed and will require a discussion between the principal investigator and the medical monitor.
Interventions
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Xanomeline and Trospium Chloride Capsules
Oral xanomeline 50 mg/trospium 20 mg BID on days 1-2 followed by xanomeline 100 mg/trospium 20 mg BID on days 3-7. The dose is increased to xanomeline 125 mg/trospium 30 mg BID on days 8-364 unless the subject is experiencing adverse events from the xanomeline 100 mg/ trospium 20 mg dose. Subjects who were increased to xanomeline 125 mg/trospium 30 mg will have the option to return to xanomeline 100 mg/ trospium 20 mg depending on clinical response and tolerability. Re-escalation to 125/30 BID or re-titration in cases in which the subject has been off KarXT for a longer period of time (at least a week) is allowed and will require a discussion between the principal investigator and the medical monitor.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject is capable of providing informed consent.
1. A signed informed consent form (ICF) must be provided before any study assessments are performed.
2. Subject must be fluent in (oral and written) the language of the ICGF to consent.
3. Subject has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013) criteria and confirmed by Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorder Studies (MINI) version 7.0.2.
4. Subject has not required psychiatric hospitalization, acute crisis intervention, or other increase in level of care due to symptom exacerbation within 8 weeks of screening and is psychiatrically stable in the opinion of the investigator.
5. PANSS total score ≤ 80 at screening and Baseline Visit B (Day 0).
6. Clinical Global Impression - Severity (CGI-S) score of ≤ 4 at screening and Baseline Visit B (Day 0).
7. At the time of screening, or at any time within the 30 days prior to screening, the subject must have received an oral antipsychotic medication daily at a dose and frequency consistent with the drug label.
8. In the opinion of the investigator, it is clinically appropriate for the subject to discontinue current antipsychotic therapy and initiate experimental treatment with KarXT.
9. Subject is willing and able, in the opinion of the investigator, to discontinue all antipsychotic medications prior to baseline visit.
10. Subject has an identified reliable informant willing to be able to address some questions related to certain study visits, if needed. An informant may not be necessary if the subject has been the patient of the investigator for ≥1 year.
11. At Day 0, subject will have been off lithium therapy for at least 2 weeks and must have discontinued all oral antipsychotic medications.
12. Subjects taking a long-acting injectable antipsychotic could not have received a dose of medication for at least 12 weeks (24 weeks for paliperidone palmitate) before Day 0.
13. Body mass index must be ≥ 18 and ≤ 40 kg/m2.
14. Subject resides in a stable living situation and is anticipated to remain in a stable living situation for the duration of study enrollment, in the opinion of the investigator.
15. Women of childbearing potential or men with sexual partners of childbearing potential must be willing and able to use at least 1 highly effective method of contraception during the study and for at least 30 days after the last dose of KarXT. Sperm donation is not allowed for 30 days after the final dose of KarXT.
Exclusion Criteria
2. Subject has a history of moderate to severe alcohol use disorder or a substance (other than nicotine or caffeine) use disorder within the past 12 months or a positive urine drug screen (UDS) for a substance other than cannabis at screening or baseline.
3. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results
4. Subject has human immunodeficiency virus (HIV), cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on either medical history or liver function test results.
5. History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma
6. History of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months
7. Risk for suicidal behavior during the study as determined by the investigator's clinical assessment and Columbia-Suicide Severity Rating Scale (C-SSRS).
8. Clinically significant abnormal finding from the physical examination, medical history, ECG, or clinical laboratory results at screening.
9. Subjects cannot currently (within 5 half-lives before Day 0) be receiving monoamine oxidase inhibitors, anticonvulsants, tricyclic antidepressants, centrally active anticholinergics, or any other psychoactive medications other than daily antipsychotic maintenance therapy. As-needed anxiolytics and/or sleep aids are permitted. Selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors taken at stable dose may be permitted.
10. Subject has a history of treatment resistance to schizophrenia medications defined as failure to respond to 2 adequate courses of pharmacotherapy (a minimum of 4 weeks at an adequate dose per the label) within the past 12 months or having received clozapine within the past 3 years
11. Pregnant, lactating, or less than 3 months postpartum.
12. If, in the opinion of the investigator (and/or Sponsor), subject is unsuitable for enrollment in the study or subject has any finding that, in the view of the investigator (and/or Sponsor), may compromise the safety of the subject or affect his/her ability to adhere to the protocol visit schedule or fulfill visit requirements.
13. Subjects has tested positive for coronavirus disease 2019 (COVID-19) within 2 weeks of screening.
14. Subject has extreme concerns relating to global pandemics, such as COVID-19, that preclude study participation.
15. Subject has had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 6 months before screening.
16. Subject has prior exposure to KarXT.
17. Risk of violent or destructive behavior.
18. Current involuntary hospitalization or incarceration.
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
Inder Kaul, MD
Role: STUDY_DIRECTOR
Karuna Therapeutics
Locations
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Local Institution - 011-238
Little Rock, Arkansas, United States
Woodland International Research Group
Little Rock, Arkansas, United States
Local Institution - 011-201
Rogers, Arkansas, United States
Woodland Research Northwest
Rogers, Arkansas, United States
Local Institution - 011-240
Anaheim, California, United States
Advanced Research Center, Inc.
Anaheim, California, United States
Clinical Innovations, Inc
Bellflower, California, United States
Local Institution - 011-222
Bellflower, California, United States
Local Institution - 011-263
Bellflower, California, United States
Local Institution - 011-257
Cerritos, California, United States
ATP Clinical Research Inc
Costa Mesa, California, United States
ATP Clinical Research, Inc.
Costa Mesa, California, United States
Local Institution - 011-206
Culver City, California, United States
ProScience Research Group
Culver City, California, United States
Local Institution - 011-253
Garden Grove, California, United States
Local Institution - 011-202
Glendale, California, United States
Behavioral Clinical Research, Inc.
Glendale, California, United States
Omega Clinical Trials
La Habra, California, United States
Omega Clinical Trials
La Habra, California, United States
Alliance for Wellness dba Alliance for Research
Long Beach, California, United States
Alliance for Wellness
Long Beach, California, United States
North County Clinical Research (NCCR)
Oceanside, California, United States
Excell Research Inc
Oceanside, California, United States
Local Institution - 011-229
Oceanside, California, United States
Local Institution - 011-242
Orange, California, United States
NRC Research Institute
Orange, California, United States
CNRI-Los Angeles, LLC
Pico Rivera, California, United States
Local Institution - 011-244
Pico Rivera, California, United States
CITrials
Riverside, California, United States
Local Institution - 011-233
Riverside, California, United States
CITrials
Santa Ana, California, United States
Local Institution - 011-251
Santa Rosa, California, United States
Siyan Clinical Research
Santa Rosa, California, United States
Local Institution - 011-246
Sherman Oaks, California, United States
Schuster Medical Research Institute
Sherman Oaks, California, United States
Collaborative Neuroscience Research
Torrance, California, United States
Local Institution - 011-252
Torrance, California, United States
Local Institution - 011-224
Hallandale, Florida, United States
Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, United States
Local Institution - 011-261
Hollywood, Florida, United States
Homestead Research Institute, Inc.
Homestead, Florida, United States
Local Institution - 011-231
Homestead, Florida, United States
Local Institution - 011-203
Miami, Florida, United States
Premier Clinical Research Institute
Miami, Florida, United States
Central Miami Medical Institute
Miami, Florida, United States
Local Institution - 011-215
Miami, Florida, United States
Local Institution - 011-220
Miami, Florida, United States
Phoenix Medical Research
Miami, Florida, United States
Innovative Clinical Research
Miami Lakes, Florida, United States
Local Institution - 011-234
Miami Lakes, Florida, United States
Research Centers of America at Fort Lauderdale Behavioral Health Center
Oakland Park, Florida, United States
Health Synergy Clinical Research
Okeechobee, Florida, United States
Local Institution - 011-216
Okeechobee, Florida, United States
Local Institution - 011-219
Pembroke Pines, Florida, United States
Pines Care Research Center
Pembroke Pines, Florida, United States
Local Institution - 011-262
West Palm Beach, Florida, United States
Neuroscience Research Institute
West Palm Beach, Florida, United States
Local Institution - 011-259
Atlanta, Georgia, United States
Synexus Clinical Research US, Inc.
Atlanta, Georgia, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Local Institution - 011-237
Atlanta, Georgia, United States
Local Institution - 011-235
Decatur, Georgia, United States
Local Institution - 011-204
Chicago, Illinois, United States
Uptown Research Institute
Chicago, Illinois, United States
Local Institution - 011-223
Wichita, Kansas, United States
Ascension Via Christi Research
Wichita, Kansas, United States
Local Institution - 011-205
Shreveport, Louisiana, United States
Louisiana Clinical Research
Shreveport, Louisiana, United States
CBH Health, LLC
Gaithersburg, Maryland, United States
Local Institution - 011-211
Gaithersburg, Maryland, United States
Local Institution - 011-232
Ann Arbor, Michigan, United States
Michigan Clinical Research Institute PC
Ann Arbor, Michigan, United States
Local Institution - 011-226
Flowood, Mississippi, United States
Precise Research Centers
Flowood, Mississippi, United States
Local Institution - 011-227
Saint Charles, Missouri, United States
Midwest Research Group - St. Charles Psychiatric Associates
Saint Charles, Missouri, United States
St. Charles Psychiatric Associates/Midwest Research Group
Saint Charles, Missouri, United States
Arch Clinical Trials
St Louis, Missouri, United States
Local Institution - 011-241
St Louis, Missouri, United States
Altea Research Institute
Las Vegas, Nevada, United States
Local Institution - 011-239
Las Vegas, Nevada, United States
Hassman Research Institute
Berlin, New Jersey, United States
Local Institution - 011-230
Berlin, New Jersey, United States
Hassman Research Institute
Marlton, New Jersey, United States
Local Institution - 011-249
Marlton, New Jersey, United States
Local Institution - 011-256
New York, New York, United States
Manhattan Behavioral Medicine, PLLC
New York, New York, United States
Local Institution - 011-210
New York, New York, United States
The Medical Research Network, LLC
New York, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Local Institution - 011-250
Rochester, New York, United States
Clinical Trials of America
Hickory, North Carolina, United States
Local Institution - 011-218
Dayton, Ohio, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Local Institution - 011-248
North Canton, Ohio, United States
Neuro-Behavioral Clinical Research, Inc
North Canton, Ohio, United States
Cincy Science
West Chester, Ohio, United States
Local Institution - 011-221
West Chester, Ohio, United States
SP Research PLLC
Oklahoma City, Oklahoma, United States
Suburban Research Associates
Media, Pennsylvania, United States
Global Medical Institutes LLC Scranton Medical Institute
Moosic, Pennsylvania, United States
Local Institution - 011-207
West Chester, Pennsylvania, United States
Psychiatric Consultants
Franklin, Tennessee, United States
Community Clinical Research
Austin, Texas, United States
Local Institution - 011-243
Austin, Texas, United States
BioBehavioral Research of Austin P.C.
Austin, Texas, United States
BioBehavioral Research of Austin
Austin, Texas, United States
InSite Clinical Research, LLC
DeSoto, Texas, United States
Local Institution - 011-236
DeSoto, Texas, United States
Local Institution - 011-258
Fort Worth, Texas, United States
Core Clinical Research
Richmond, Texas, United States
healthTx
Richmond, Texas, United States
Cedar Clinical Research
Draper, Utah, United States
Local Institution - 011-209
Bellevue, Washington, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Local Institution - 011-260
Everett, Washington, United States
INSPIRA Clinical Research
San Juan, PR, Puerto Rico
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
FDA Safety Alerts and Recalls
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CN012-0007
Identifier Type: OTHER
Identifier Source: secondary_id
KAR-011
Identifier Type: OTHER
Identifier Source: secondary_id
CN012-0007
Identifier Type: -
Identifier Source: org_study_id
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