Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT05304767

PHASE3

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

Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company

View on ClinicalTrials.gov

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.

Official title: An Open-label Extension Study to Assess the Long-term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

280

Start Date

2022-03-07

Completion Date

2026-03-19

Last Updated

2026-03-11

Healthy Volunteers

Conditions

Schizophrenia

Interventions

DRUG

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

Inclusion Criteria: 1. Subject is aged ≥18 to \<66 years at the time of randomization of Study KAR-012 2. Subject has successfully completed the treatment period of Study KAR-012 3. Subject has been compliant with the procedures in Study KAR-012 (in the Investigator's judgement) 4. 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. 5. Subject is capable of providing signed Informed Consent Form before any study assessments will be performed 6. Subject resides in a stable living situation, in the opinion of the Investigator 7. 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. 8. 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: 1. 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: 1. 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 2. Non-suicidal self-injurious behavior is not exclusionary 2. 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 3. Female subject is pregnant 4. 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 5. Risk of violent or destructive behavior as per Investigator's judgement 6. Subjects participating in another investigational drug or device trial or planning on participating in another clinical trial during the study 7. History or high risk of urinary retention, gastric retention, or narrow angle glaucoma as evaluated by the Investigator 8. Subject is taking, or plans to take while in the study, any prohibited concomitant medication 9. 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 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.

Locations (175)

Alea Research

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

Local Institution - 110

Cerritos, California, United States

Local Institution - 167

Culver City, California, United States

Local Institution - 127

Garden Grove, California, United States

Local Institution - 152

La Habra, California, United States

Local Institution - 126

Lafayette, California, United States

Synergy Clinical Research of Escondido

Lemon Grove, California, United States

Local Institution - 141

Los Angeles, California, United States

Excell Research, Inc.

Oceanside, California, United States

NRC Research Institute

Orange, California, United States

CNRI - Los Angeles, LLC

Pico Rivera, California, United States

CITrials, Inc. - Riverside & San Bernardino County

Riverside, California, United States

Local Institution - 193

San Diego, California, United States

Local Institution - 164

Stanford, California, United States

Local Institution - 109

Torrance, California, United States

Prestige Clinical Research Center, Inc.

Coral Gables, Florida, United States

Reliable Clinical Research LLC

Hialeah, Florida, United States

Galiz Research, LLC

Hialeah, Florida, United States

Local Institution - 105

Lauderhill, Florida, United States

Premier Clinical Research Institute, Inc.

Miami, Florida, United States

Local Institution - 171

Miami, Florida, United States

Local Institution - 173

Miami Lakes, Florida, United States

Local Institution - 120

Miami Lakes, Florida, United States

Assertive Research Center

Miami Lakes, 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

Emory University

Atlanta, Georgia, United States

Local Institution - 111

Atlanta, Georgia, United States

CenExel Atlanta Center for Medical Research

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

Local Institution - 191

Savannah, Georgia, United States

Local Institution - 177

Chicago, Illinois, United States

Local Institution - 142

Chicago, Illinois, United States

Local Institution - 143

Chicago, Illinois, United States

Uptown Research Institute, LLC

Chicago, Illinois, United States

Local Institution - 139

Overland Park, Kansas, United States

Local Institution - 154

Monroe, Louisiana, United States

Local Institution - 166

Gaithersburg, Maryland, United States

Local Institution - 158

Boston, Massachusetts, United States

Boston University - PARENT

Boston, Massachusetts, United States

Local Institution - 269

Boston, Massachusetts, United States

Local Institution - 185

Worcester, Massachusetts, United States

Local Institution - 184

Ann Arbor, Michigan, United States

Local Institution - 149

Grand Rapids, Michigan, United States

Local Institution - 162

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

Local Institution - 147

Las Vegas, Nevada, United States

Local Institution - 148

Las Vegas, Nevada, United States

CenExel HRI Marlton

Berlin, New Jersey, United States

Local Institution - 104

New York, New York, United States

Manhattan Psychiatric Center

New York, New York, United States

Local Institution - 157

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

Local Institution - 176

Hickory, North Carolina, United States

Local Institution - 165

Cincinnati, Ohio, United States

Local Institution - 168

Garfield Heights, Ohio, United States

Local Institution - 163

Independence, Ohio, United States

Local Institution - 194

Oklahoma City, Oklahoma, United States

Prevention Science Institute

Eugene, Oregon, United States

Community Clinical Research, Inc.

Austin, Texas, United States

Local Institution - 189

DeSoto, Texas, United States

JPS Health Network

Fort Worth, Texas, United States

Local Institution - 183

Houston, Texas, United States

Clinical Trial Network LLC

Houston, Texas, United States

Local Institution - 103

Irving, Texas, United States

Pillar Clinical Research, LLC

Richardson, Texas, United States

Local Institution - 159

Richmond, Texas, United States

Green Mountain Research Institute

Rutland, Vermont, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Center for Mental Health Center - Sofia District EOOD

Sofia, Sofia-Grad, Bulgaria

Medical Center Akademika EOOD

Sofia, Sofia-Grad, Bulgaria

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

Local Institution - 311

Dupnitsa, Bulgaria

Local Institution - 316

Kardzhali, Bulgaria

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

Novi Iskar, Bulgaria

Local Institution - 315

Pleven, Bulgaria

Medical Center Medconsult Pleven OOD

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

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

Sofia, Bulgaria

Local Institution - 320

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 - 905

Klecany, Czechia

Local Institution - 903

Ostrava - Poruba, Czechia

Local Institution - 904

Pilsen, Czechia

Local Institution - 906

Prague, Czechia

Local Institution - 901

Prague, Czechia

Local Institution - 902

Prague, Czechia

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 - 603

Nagpur, Maharashtra, India

Local Institution - 608

Nashik, Maharashtra, India

Local Institution - 605

Nashik, Maharashtra, India

Local Institution - 615

Ajmer, Rajasthan, India

Local Institution - 606

Rajkot, Rajasthan, India

Local Institution - 612

Lucknow, Uttar Pradesh, India

Local Institution - 258

Konan-shi, Aichi-ken, Japan

Local Institution - 250

Toyoake-shi, Aichi-ken, Japan

Local Institution - 255

Fukuoka, Fukuoka, Japan

Local Institution - 257

Shirakawa-shi, Fukushima, Japan

Local Institution - 254

Karatsu-shi, Saga-ken, Japan

Local Institution - 253

Meguro-ku, Tokyo, Japan

Sangenjaya Neurology- Psychosomatic Clinic

Setagaya-ku, Tokyo, Japan

Local Institution - 910

Shibuya-ku, Tokyo, Japan

Local Institution - 256

Shinjuku-ku, Tokyo-To, Japan

Local Institution - 506

Bialystok, Poland

Local Institution - 507

Gdansk, Poland

Local Institution - 509

Grudziądz, Poland

Local Institution - 502

Katowice, Poland

Local Institution - 501

Kielce, Poland

Local Institution - 503

Lodz, Poland

Local Institution - 505

Lublin, Poland

Local Institution - 508

Suchy Las, Poland

Local Institution - 504

Tuszyn, Poland

Local Institution - 803

Brasov, Romania

Local Institution - 804

Bucharest, Romania

Local Institution - 810

Bucharest, Romania

Local Institution - 802

Bucharest, Romania

Local Institution - 809

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

Local Institution - 403

Belgrade, Serbia

Clinical Center ' Dr Dragisa Misovic Dedinje'

Belgrade, Serbia

Local Institution - 413

Belgrade, Serbia

Local Institution - 417

Belgrade, Serbia

University Clinical Center of Serbia

Belgrade, Serbia

Local Institution - 411

Gornja Toponica, Serbia

Special Hospital for Psychiatric Diseases 'Kovin'

Kovin, Serbia

Local Institution - 404

Kovin, Serbia

Local Institution - 406

Kragujevac, Serbia

Local Institution - 408

Kragujevac, Serbia

University Clinical Center Kragujevac

Kragujevac, Serbia

University Clinical Center Kragujevac

Kragujevac, Serbia

Local Institution - 415

Niš, Serbia

Local Institution - 416

Novi Kneževac, Serbia

Special Hospital for Psychiatric Diseases 'Sveti Vracevi'

Novi Kneževac, Serbia

Local Institution - 409

Vršac, Serbia

Local Institution - 707

Bodmin, 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, Lancashire, United Kingdom

Local Institution - 708

Oxford, Oxfordshire, United Kingdom

Local Institution - 702

Chertsey, Surrey, United Kingdom

Local Institution - 703

Birmingham, West Midlands, United Kingdom

Local Institution - 704

Glasgow, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (175)