An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia

NCT05304767 | Recruiting Phase 3 FDA Drug

• 2 other identifiers: CN012-0009KAR-013
• Study Type: interventional
• Target: 280
• Locations: 9 countries
• Sites: 175

Brief Summary

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

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events (TEAEs)

  From initial dose to safety follow-up visit (54 weeks) or early termination

Secondary Outcomes (2)

• Incidence of serious treatment-emergent adverse events (TEAEs)

  From initial dose to safety follow-up visit (54 weeks) or early termination

• Incidence of TEAEs leading to discontinuation of study drug

  From initial dose to safety follow-up visit (54 weeks) or early termination

Study Arms (1)

Drug: KarXT

EXPERIMENTAL

Drug: Xanomeline and Trospium Chloride Capsules

Interventions

Xanomeline and Trospium Chloride Capsules DRUG

KarXT 50 mg/20 mg BID KarXT 75mg/20 mg BID KarXT 100mg/20 mg BID KarXT 125mg/30 mg BID

Drug: KarXT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is aged ≥18 to \<66 years at the time of randomization of Study KAR-012
• Subject has successfully completed the treatment period of Study KAR-012
• Subject has been compliant with the procedures in Study KAR-012 (in the Investigator's judgement)
• 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.
• Subject is capable of providing signed Informed Consent Form before any study assessments will be performed
• Subject resides in a stable living situation, in the opinion of the Investigator
• 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.
• 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).

You may not qualify if:

• Risk for suicidal behavior during the study as determined by the Investigator's clinical assessment and/or Columbia-Suicide Severity Rating Scale (C-SSRS) as confirmed by the following:
• 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
• 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
• Female subject is pregnant
• 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
• Risk of violent or destructive behavior as per Investigator's judgement
• Subjects participating in another investigational drug or device trial or planning on participating in another clinical trial during the study
• History or high risk of urinary retention, gastric retention, or narrow angle glaucoma as evaluated by the Investigator
• Subject is taking, or plans to take while in the study, any prohibited concomitant medication
• For all male subjects only, any one of the following:
• History of bladder stones
• History of recurrent urinary tract infections
• Serum prostate specific antigen (PSA) \>10 ng/mL
• An International Prostate Symptom Score (IPSS) of 5 (almost always) on either item 1, 3, 5, or 6
• 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.

Sponsors & Collaborators

• Karuna Therapeutics, Inc., a Bristol Myers Squibb company: lead

Study Sites (175)

Alea Research

Phoenix, Arizona, 85012, United States

RECRUITING

Pillar Clinical Research LLC

Little Rock, Arkansas, 72204, United States

RECRUITING

Woodland International Research Group, LLC

Little Rock, Arkansas, 72211, United States

RECRUITING

Advanced Research Center, Inc.

Anaheim, California, 92805, United States

RECRUITING

CITrials - Bellflower

Bellflower, California, 90706, United States

RECRUITING

Local Institution - 110

Cerritos, California, 90703, United States

COMPLETED

Local Institution - 167

Culver City, California, 90230, United States

ACTIVE NOT RECRUITING

Local Institution - 127

Garden Grove, California, 92845, United States

ACTIVE NOT RECRUITING

Local Institution - 152

La Habra, California, 90631-3842, United States

NOT YET RECRUITING

Local Institution - 126

Lafayette, California, 94549, United States

COMPLETED

Synergy Clinical Research of Escondido

Lemon Grove, California, 91945-2956, United States

RECRUITING

Local Institution - 141

Los Angeles, California, 91403, United States

WITHDRAWN

Excell Research, Inc.

Oceanside, California, 92056, United States

RECRUITING

NRC Research Institute

Orange, California, 92868, United States

RECRUITING

CNRI - Los Angeles, LLC

Pico Rivera, California, 90660, United States

RECRUITING

CITrials, Inc. - Riverside & San Bernardino County

Riverside, California, 92506, United States

RECRUITING

Local Institution - 193

San Diego, California, 92123, United States

WITHDRAWN

Local Institution - 164

Stanford, California, 94305, United States

ACTIVE NOT RECRUITING

Local Institution - 109

Torrance, California, 90504, United States

ACTIVE NOT RECRUITING

Prestige Clinical Research Center, Inc.

Coral Gables, Florida, 33134, United States

RECRUITING

Reliable Clinical Research LLC

Hialeah, Florida, 33012, United States

RECRUITING

Galiz Research, LLC

Hialeah, Florida, 33016-1814, United States

RECRUITING

Local Institution - 105

Lauderhill, Florida, 33319-4985, United States

TERMINATED

Premier Clinical Research Institute, Inc.

Miami, Florida, 33122-1335, United States

RECRUITING

Local Institution - 171

Miami, Florida, 33166, United States

ACTIVE NOT RECRUITING

Local Institution - 173

Miami Lakes, Florida, 33014, United States

ACTIVE NOT RECRUITING

Local Institution - 120

Miami Lakes, Florida, 33016-1553, United States

WITHDRAWN

Assertive Research Center

Miami Lakes, Florida, 33016, United States

RECRUITING

Local Institution - 124

Orange City, Florida, 32763-8350, United States

WITHDRAWN

Pines Care Research Center, Inc.

Pembroke Pines, Florida, 33025, United States

RECRUITING

Interventional Psychiatry of Tampa Bay

Tampa, Florida, 33629, United States

RECRUITING

Emory University

Atlanta, Georgia, 30303-3031, United States

RECRUITING

Local Institution - 111

Atlanta, Georgia, 30328, United States

ACTIVE NOT RECRUITING

CenExel Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

RECRUITING

Local Institution - 135

Augusta, Georgia, 30912-2613, United States

WITHDRAWN

CenExel iResearch Atlanta

Decatur, Georgia, 30030, United States

RECRUITING

Psych Atlanta, P.C.

Marietta, Georgia, 30060, United States

RECRUITING

Local Institution - 191

Savannah, Georgia, 31405, United States

WITHDRAWN

Local Institution - 177

Chicago, Illinois, 60611, United States

WITHDRAWN

Local Institution - 142

Chicago, Illinois, 60612, United States

WITHDRAWN

Local Institution - 143

Chicago, Illinois, 60612, United States

WITHDRAWN

Uptown Research Institute, LLC

Chicago, Illinois, 60640, United States

RECRUITING

Local Institution - 139

Overland Park, Kansas, 66210-2670, United States

WITHDRAWN

Local Institution - 154

Monroe, Louisiana, 71201, United States

WITHDRAWN

Local Institution - 166

Gaithersburg, Maryland, 20877, United States

ACTIVE NOT RECRUITING

Local Institution - 158

Boston, Massachusetts, 02114, United States

WITHDRAWN

Boston University - PARENT

Boston, Massachusetts, 02118, United States

RECRUITING

Local Institution - 269

Boston, Massachusetts, 02118, United States

WITHDRAWN

Local Institution - 185

Worcester, Massachusetts, 01655, United States

WITHDRAWN

Local Institution - 184

Ann Arbor, Michigan, 48105, United States

WITHDRAWN

Local Institution - 149

Grand Rapids, Michigan, 49503, United States

WITHDRAWN

Local Institution - 162

Kalamazoo, Michigan, 49001, United States

WITHDRAWN

Local Institution - 129

St Louis, Missouri, 63128, United States

COMPLETED

Arch Clinical Trials LLC

St Louis, Missouri, 63141, United States

RECRUITING

Omaha Insomnia and Psychiatric Services LLC

Omaha, Nebraska, 68144, United States

RECRUITING

Local Institution - 147

Las Vegas, Nevada, 89102, United States

WITHDRAWN

Local Institution - 148

Las Vegas, Nevada, 89102, United States

COMPLETED

CenExel HRI Marlton

Berlin, New Jersey, 08009, United States

RECRUITING

Local Institution - 104

New York, New York, 10017, United States

TERMINATED

Manhattan Psychiatric Center

New York, New York, 10035, United States

RECRUITING

Local Institution - 157

New York, New York, 10036, United States

ACTIVE NOT RECRUITING

Psychiatry and Alzheimer's Care of Rochester. PLLC

Rochester, New York, 14623, United States

RECRUITING

Richmond Behavioral Associates ERG Clinical Research - New York PLLC

Staten Island, New York, 10314-1607, United States

RECRUITING

Local Institution - 176

Hickory, North Carolina, 28601, United States

ACTIVE NOT RECRUITING

Local Institution - 165

Cincinnati, Ohio, 45219, United States

WITHDRAWN

Local Institution - 168

Garfield Heights, Ohio, 44125, United States

WITHDRAWN

Local Institution - 163

Independence, Ohio, 44131, United States

COMPLETED

Local Institution - 194

Oklahoma City, Oklahoma, 73112, United States

WITHDRAWN

Prevention Science Institute

Eugene, Oregon, 97403, United States

RECRUITING

Community Clinical Research, Inc.

Austin, Texas, 78754, United States

RECRUITING

Local Institution - 189

DeSoto, Texas, 75115, United States

WITHDRAWN

JPS Health Network

Fort Worth, Texas, 76104, United States

RECRUITING

Local Institution - 183

Houston, Texas, 77030, United States

WITHDRAWN

Clinical Trial Network LLC

Houston, Texas, 77074, United States

RECRUITING

Local Institution - 103

Irving, Texas, 75062-2757, United States

COMPLETED

Pillar Clinical Research, LLC

Richardson, Texas, 75080, United States

RECRUITING

Local Institution - 159

Richmond, Texas, 77407, United States

ACTIVE NOT RECRUITING

Green Mountain Research Institute

Rutland, Vermont, 05701, United States

RECRUITING

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

RECRUITING

Center for Mental Health Center - Sofia District EOOD

Sofia, Sofia-Grad, 1202, Bulgaria

RECRUITING

Medical Center Akademika EOOD

Sofia, Sofia-Grad, 1463, Bulgaria

RECRUITING

MHAT Dr. Hristo Stambolski, EOOD

Kazanlak, Stara Zagora, 6100, Bulgaria

RECRUITING

Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Natsov

Cherven Bryag, 5980, Bulgaria

RECRUITING

Local Institution - 311

Dupnitsa, 2600, Bulgaria

ACTIVE NOT RECRUITING

Local Institution - 316

Kardzhali, 6600, Bulgaria

COMPLETED

State Psychiatric Hospital 'Sv. Ivan Rilski', Novi Iskar

Novi Iskar, 1282, Bulgaria

RECRUITING

Local Institution - 315

Pleven, 5800, Bulgaria

COMPLETED

Medical Center Medconsult Pleven OOD

Pleven, 5800, Bulgaria

RECRUITING

UMHAT Sv. Georgi, EAD

Plovdiv, 4002, Bulgaria

RECRUITING

Local Institution - 321

Plovdiv, 4004, Bulgaria

NOT YET RECRUITING

Local Institution - 313

Razgrad, 7200, Bulgaria

ACTIVE NOT RECRUITING

MHAT Dr Ivan Seliminski AD

Sliven, 8800, Bulgaria

RECRUITING

Medical Center 'Sv.Naum'

Sofia, 1113, Bulgaria

RECRUITING

DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD

Sofia, 1408, Bulgaria

RECRUITING

Local Institution - 320

Sofia, 1408, Bulgaria

WITHDRAWN

Medical Center Hera EOOD

Sofia, 1510, Bulgaria

RECRUITING

Medical Center Intermedica, OOD

Sofia, 1680, Bulgaria

RECRUITING

Medical Center VAS OOD

Targovishte, 7700, Bulgaria

RECRUITING

DCC Mladost M - Varna, OOD

Varna, 9020, Bulgaria

RECRUITING

Mental Health Center-Vratsa EOOD

Vratsa, 3000, Bulgaria

RECRUITING

Local Institution - 905

Klecany, 25067, Czechia

WITHDRAWN

Local Institution - 903

Ostrava - Poruba, 70868, Czechia

WITHDRAWN

Local Institution - 904

Pilsen, 301 00, Czechia

WITHDRAWN

Local Institution - 906

Prague, 100 00, Czechia

WITHDRAWN

Local Institution - 901

Prague, 11000, Czechia

WITHDRAWN

Local Institution - 902

Prague, 186 00, Czechia

WITHDRAWN

Local Institution - 616

Guwahati, Assam, 781032, India

WITHDRAWN

Local Institution - 607

Ahmedabad, Gujarat, 380008, India

WITHDRAWN

Local Institution - 604

Ahmedabad, Gujarat, 380013, India

WITHDRAWN

Local Institution - 609

Surat, Gujarat, 395001, India

WITHDRAWN

Local Institution - 613

Vadodara, Gujarat, 390021, India

WITHDRAWN

Local Institution - 617

Belgavi, Karnataka, 590002, India

WITHDRAWN

Local Institution - 614

Mangalore, Karnataka, 575003, India

WITHDRAWN

Local Institution - 602

Mangalore, Karnataka, 575018, India

WITHDRAWN

Local Institution - 601

Mysore, Karnataka, 570001, India

WITHDRAWN

Local Institution - 611

Kozhikode, Kerala, 673009, India

WITHDRAWN

Local Institution - 610

Aurangabad, Maharashtra, 431005, India

WITHDRAWN

Local Institution - 603

Nagpur, Maharashtra, 440010, India

WITHDRAWN

Local Institution - 608

Nashik, Maharashtra, 422001, India

WITHDRAWN

Local Institution - 605

Nashik, Maharashtra, 422005, India

WITHDRAWN

Local Institution - 615

Ajmer, Rajasthan, 305001, India

WITHDRAWN

Local Institution - 606

Rajkot, Rajasthan, 360001, India

WITHDRAWN

Local Institution - 612

Lucknow, Uttar Pradesh, 226003, India

WITHDRAWN

Local Institution - 258

Konan-shi, Aichi-ken, 483-8248, Japan

WITHDRAWN

Local Institution - 250

Toyoake-shi, Aichi-ken, 470-1168, Japan

ACTIVE NOT RECRUITING

Local Institution - 255

Fukuoka, Fukuoka, 819-0037, Japan

COMPLETED

Local Institution - 257

Shirakawa-shi, Fukushima, 961-0021, Japan

ACTIVE NOT RECRUITING

Local Institution - 254

Karatsu-shi, Saga-ken, 847-0031, Japan

ACTIVE NOT RECRUITING

Local Institution - 253

Meguro-ku, Tokyo, 1540012, Japan

NOT YET RECRUITING

Sangenjaya Neurology- Psychosomatic Clinic

Setagaya-ku, Tokyo, 1540004, Japan

RECRUITING

Local Institution - 910

Shibuya-ku, Tokyo, 1510053, Japan

WITHDRAWN

Local Institution - 256

Shinjuku-ku, Tokyo-To, 162-0843, Japan

ACTIVE NOT RECRUITING

Local Institution - 506

Bialystok, 15-404, Poland

WITHDRAWN

Local Institution - 507

Gdansk, 80-546, Poland

WITHDRAWN

Local Institution - 509

Grudziądz, 86-300, Poland

WITHDRAWN

Local Institution - 502

Katowice, 40-146, Poland

WITHDRAWN

Local Institution - 501

Kielce, 25-411, Poland

WITHDRAWN

Local Institution - 503

Lodz, 93-118, Poland

WITHDRAWN

Local Institution - 505

Lublin, 20-109, Poland

WITHDRAWN

Local Institution - 508

Suchy Las, 62-002, Poland

WITHDRAWN

Local Institution - 504

Tuszyn, 95-080, Poland

WITHDRAWN

Local Institution - 803

Brasov, 500123, Romania

WITHDRAWN

Local Institution - 804

Bucharest, 010825, Romania

WITHDRAWN

Local Institution - 810

Bucharest, 040874, Romania

WITHDRAWN

Local Institution - 802

Bucharest, 041914, Romania

WITHDRAWN

Local Institution - 809

Bucharest, 041914, Romania

WITHDRAWN

Local Institution - 807

Bucharest, 60222, Romania

WITHDRAWN

Local Institution - 808

Craiova, 200157, Romania

WITHDRAWN

Local Institution - 801

Galati, 800179, Romania

WITHDRAWN

Local Institution - 806

Iași, 700282, Romania

WITHDRAWN

Local Institution - 805

Sibiu, 550281, Romania

WITHDRAWN

Local Institution - 403

Belgrade, 101421, Serbia

ACTIVE NOT RECRUITING

Clinical Center ' Dr Dragisa Misovic Dedinje'

Belgrade, 11000, Serbia

RECRUITING

Local Institution - 413

Belgrade, 11000, Serbia

WITHDRAWN

Local Institution - 417

Belgrade, 11000, Serbia

WITHDRAWN

University Clinical Center of Serbia

Belgrade, 11000, Serbia

RECRUITING

Local Institution - 411

Gornja Toponica, 705631, Serbia

ACTIVE NOT RECRUITING

Special Hospital for Psychiatric Diseases 'Kovin'

Kovin, 26220, Serbia

RECRUITING

Local Institution - 404

Kovin, 306041, Serbia

NOT YET RECRUITING

Local Institution - 406

Kragujevac, 34 000, Serbia

ACTIVE NOT RECRUITING

Local Institution - 408

Kragujevac, 34 000, Serbia

NOT YET RECRUITING

University Clinical Center Kragujevac

Kragujevac, 34 000, Serbia

RECRUITING

University Clinical Center Kragujevac

Kragujevac, 34 000, Serbia

RECRUITING

Local Institution - 415

Niš, 18000, Serbia

WITHDRAWN

Local Institution - 416

Novi Kneževac, 23330, Serbia

WITHDRAWN

Special Hospital for Psychiatric Diseases 'Sveti Vracevi'

Novi Kneževac, 23330, Serbia

RECRUITING

Local Institution - 409

Vršac, 26300, Serbia

WITHDRAWN

Local Institution - 707

Bodmin, Cornwall, PL31 2QN, United Kingdom

WITHDRAWN

Local Institution - 705

Brighton, East Sussex, BN1 9RY, United Kingdom

WITHDRAWN

Local Institution - 701

London, Greater London, SE5 8AF, United Kingdom

WITHDRAWN

Local Institution - 706

Ashton-under-Lyne, Lancashire, OL6 7SR, United Kingdom

WITHDRAWN

Local Institution - 708

Oxford, Oxfordshire, OX3 7JX, United Kingdom

WITHDRAWN

Local Institution - 702

Chertsey, Surrey, KT16 9AU, United Kingdom

WITHDRAWN

Local Institution - 703

Birmingham, West Midlands, B4 6NH, United Kingdom

WITHDRAWN

Local Institution - 704

Glasgow, G51 4TF, United Kingdom

WITHDRAWN

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Schizophrenia

Interventions

xanomeline; trospium chloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain the NCT# and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: March 31, 2022
• Study Start: March 7, 2022
• Primary Completion: March 19, 2026
• Study Completion: March 19, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (9); IN (17); RO (10); JP (9); US (79); SE (16); CZ (6); BU (21); GB (8)