An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
- Conditions
- Schizophrenia
- Interventions
- Registration Number
- NCT05304767
- Lead Sponsor
- Karuna Therapeutics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 280
- 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).
-
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
- Non-suicidal self-injurious behavior is not exclusionary
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Drug: KarXT Xanomeline and Trospium Chloride Capsules -
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events (TEAEs) From initial dose to safety follow-up visit (54 weeks) or early termination
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (169)
Local Institution - 509
🇵🇱Grudziadz, Poland
San Marcus Research Clinic, Inc.
🇺🇸Miami Lakes, Florida, United States
Local Institution - 320
🇧🇬Sofia, Bulgaria
Medical Center Hera EOOD
🇧🇬Sofia, Bulgaria
MHAT Dr. Hristo Stambolski, EOOD
🇧🇬Kazanlak, Stara Zagora, Bulgaria
Local Institution - 507
🇵🇱Gdansk, Poland
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
Synexus Clinical Research US, Inc.
🇺🇸Atlanta, Georgia, United States
Proscience Research Group
🇺🇸Culver City, California, United States
CenExel Collaborative Neuroscience Research
🇺🇸Torrance, California, United States
Local Institution - 152
🇺🇸La Habra, California, United States
Sunwise Clinical Research, LLC.
🇺🇸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
Stanford University School of Medicine
🇺🇸Stanford, 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
Local Institution - 120
🇺🇸Miami Lakes, Florida, United States
Assertive Research Center
🇺🇸Miami Lakes, Florida, United States
South Florida Research Phase I-IV, Inc.
🇺🇸Miami Springs, Florida, United States
Premier Clinical Research Institute, Inc.
🇺🇸Miami, 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
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
Uptown Research Institute, LLC
🇺🇸Chicago, Illinois, United States
Local Institution - 139
🇺🇸Overland Park, Kansas, United States
Local Institution - 154
🇺🇸Monroe, Louisiana, United States
CenExel Center for Behavioral Health
🇺🇸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
🇺🇸Saint Louis, Missouri, United States
Arch Clinical Trials LLC
🇺🇸Saint Louis, Missouri, United States
Omaha Insomnia and Psychiatric Services LLC
🇺🇸Omaha, Nebraska, United States
Altea Research Institute, Las Vegas
🇺🇸Las Vegas, Nevada, United States
Local Institution - 147
🇺🇸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
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
IMA Clinical Research Hickory
🇺🇸Hickory, North Carolina, United States
Local Institution - 165
🇺🇸Cincinnati, Ohio, United States
Local Institution - 168
🇺🇸Garfield Heights, Ohio, United States
Insight Clinical Trials LLC
🇺🇸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
University Hills Clinical Research - Irving
🇺🇸Irving, Texas, United States
Pillar Clinical Research, LLC
🇺🇸Richardson, Texas, United States
At Health Texas
🇺🇸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
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
MHAT Sveti Ivan Rilski - Razgrad AD
🇧🇬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
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
🇨🇿Plzen, Czechia
Local Institution - 906
🇨🇿Praha 10, Czechia
Local Institution - 901
🇨🇿Praha 1, Czechia
Local Institution - 902
🇨🇿Praha 8, 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-shi, Fukuoka-Ken, Japan
Local Institution - 257
🇯🇵Shirakawa-shi, Fukushima-Ken, Japan
Local Institution - 254
🇯🇵Karatsu-shi, Saga-Ken, Japan
Local Institution - 256
🇯🇵Shinjuku-ku, Tokyo-To, 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 - 506
🇵🇱Bialystok, 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
🇷🇴Bucuresti, Romania
Local Institution - 810
🇷🇴Bucuresti, Romania
Local Institution - 809
🇷🇴Bucuresti, Romania
Local Institution - 802
🇷🇴Bucuresti, Romania
Local Institution - 807
🇷🇴Bucuresti, Romania
Local Institution - 808
🇷🇴Craiova, Romania
Local Institution - 801
🇷🇴Galati, Romania
Local Institution - 806
🇷🇴Iasi, Romania
Local Institution - 805
🇷🇴Sibiu, Romania
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
Institute of Mental Health
🇷🇸Beograd, Serbia
Special Hospital for Psychiatric Diseases 'Gornja Toponica'
🇷🇸Gornja Toponica, Serbia
Special Hospital for Psychiatric Diseases 'Kovin'
🇷🇸Kovin, Serbia
Local Institution - 404
🇷🇸Kovin, Serbia
Local Institution - 408
🇷🇸Kragujevac, Serbia
University Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
Local Institution - 415
🇷🇸Nis, Serbia
Local Institution - 416
🇷🇸Novi Knezevac, Serbia
Special Hospital for Psychiatric Diseases 'Sveti Vracevi'
🇷🇸Novi Knezevac, Serbia
Local Institution - 409
🇷🇸Vrsac, 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