An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
Launched by KARUNA THERAPEUTICS · Mar 30, 2022
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is designed to study the long-term safety and tolerability of a medication called KarXT, which combines two drugs, xanomeline and trospium chloride, for people with schizophrenia who are not fully responding to their current treatment. The trial lasts for 52 weeks and is open to individuals aged 18 to 60 years who have previously participated in another study (called the ARISE Study) and completed its treatment phase. Participants will need a reliable caregiver to help them during the study and must continue taking their prescribed antipsychotic medication throughout the trial.
If eligible, participants can expect to take the study medication twice daily and attend regular check-ups to monitor their health and response to the treatment. It is important to note that individuals with certain health risks, such as a history of suicidal thoughts or specific medical conditions, may not be able to join the study. The goal is to gather more information about how safe KarXT is for long-term use in treating schizophrenia, helping to improve future treatment options for patients.
Gender
ALL
Eligibility criteria
- 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.
About Karuna Therapeutics
Karuna Therapeutics is a biopharmaceutical company dedicated to developing innovative treatments for neuropsychiatric diseases. Focused on addressing unmet medical needs in conditions such as schizophrenia and pain, Karuna leverages its proprietary drug development platform to advance novel therapeutic candidates through rigorous clinical trials. With a commitment to scientific excellence and patient-centric solutions, the company aims to transform the treatment landscape and improve the quality of life for individuals affected by complex mental health disorders.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Stanford, California, United States
Irving, Texas, United States
Garden Grove, California, United States
Chicago, Illinois, United States
Austin, Texas, United States
Atlanta, Georgia, United States
New York, New York, United States
Hickory, North Carolina, United States
Saint Louis, Missouri, United States
Little Rock, Arkansas, United States
Austin, Texas, United States
Saint Louis, Missouri, United States
Pleven, , Bulgaria
Little Rock, Arkansas, United States
Chicago, Illinois, United States
Bellevue, Washington, United States
Oceanside, California, United States
Pico Rivera, California, United States
Las Vegas, Nevada, United States
Belgrade, , Serbia
Hialeah, Florida, United States
Orange, California, United States
Hialeah, Florida, United States
Fort Worth, Texas, United States
Culver City, California, United States
Riverside, California, United States
Belgrade, , Serbia
Pleven, , Bulgaria
Kragujevac, , Serbia
Lemon Grove, California, United States
Richardson, Texas, United States
Bellflower, California, United States
Miami, Florida, United States
New York, New York, United States
Sofia, , Bulgaria
Dupnitsa, , Bulgaria
Anaheim, California, United States
Miami Lakes, Florida, United States
Sofia, , Bulgaria
Sofia, , Bulgaria
Vratsa, , Bulgaria
Phoenix, Arizona, United States
Cerritos, California, United States
Torrance, California, United States
Sofia, , Bulgaria
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Rutland, Vermont, United States
New York, New York, United States
Fukuoka, , Japan
Garden Grove, California, United States
Lemon Grove, California, United States
Las Vegas, Nevada, United States
Richardson, Texas, United States
Marietta, Georgia, United States
Rochester, New York, United States
Las Vegas, Nevada, United States
Coral Gables, Florida, United States
North Miami, Florida, United States
Miami Springs, Florida, United States
Miami Lakes, Florida, United States
Bellflower, California, United States
Lafayette, California, United States
Hialeah, Florida, United States
Staten Island, New York, United States
Cerritos, California, United States
Tamarac, Florida, United States
Staten Island, New York, United States
Decatur, Georgia, United States
Lafayette, California, United States
Houston, Texas, United States
Kragujevac, , Serbia
New York, New York, United States
Atlanta, Georgia, United States
Hialeah, Florida, United States
Decatur, Georgia, United States
Sofia, , Bulgaria
Varna, , Bulgaria
Tampa, Florida, United States
Sofia, , Bulgaria
Kragujevac, , Serbia
Kazanlak, , Bulgaria
Torrance, California, United States
Belgrade, , Serbia
Anaheim, California, United States
Lafayette, California, United States
Lemon Grove, California, United States
Kragujevac, , Serbia
Miami Lakes, Florida, United States
Chicago, Illinois, United States
Miami Lakes, Florida, United States
Gaithersburg, Maryland, United States
Richmond, Texas, United States
Kardzhali, , Bulgaria
Little Rock, Arkansas, United States
Bellflower, California, United States
Cerritos, California, United States
Torrance, California, United States
Atlanta, Georgia, United States
Saint Louis, Missouri, United States
Austin, Texas, United States
Irving, Texas, United States
Bellevue, Washington, United States
Varna, , Bulgaria
Tamarac, Florida, United States
Kazanlak, , Bulgaria
Fort Worth, Texas, United States
Sliven, , Bulgaria
Orange, California, United States
Pico Rivera, California, United States
Miami Springs, Florida, United States
Dupnitsa, , Bulgaria
Pleven, , Bulgaria
Vratsa, , Bulgaria
Saint Louis, Missouri, United States
Bellevue, Washington, United States
Phoenix, Arizona, United States
Stanford, California, United States
Torrance, California, United States
Miami, Florida, United States
Orange City, Florida, United States
Augusta, Georgia, United States
Decatur, Georgia, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
Ann Arbor, Michigan, United States
Omaha, Nebraska, United States
Rochester, New York, United States
Staten Island, New York, United States
Hickory, North Carolina, United States
Garfield Heights, Ohio, United States
Eugene, Oregon, United States
Houston, Texas, United States
Houston, Texas, United States
Irving, Texas, United States
Cherven Bryag, , Bulgaria
Novi Iskar, , Bulgaria
Plovdiv, , Bulgaria
Plovdiv, , Bulgaria
Razgrad, , Bulgaria
Sliven, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Targovishte, , Bulgaria
Varna, , Bulgaria
Guwahati, Assam, India
Ahmedabad, Gujarat, India
Ahmedabad, Gujarat, India
Surat, Gujarat, India
Vadodara, Gujarat, India
Belgavi, Karnataka, India
Mangalore, Karnataka, India
Mangalore, Karnataka, India
Mysore, Karnataka, India
Kozhikode, Kerala, India
Aurangabad, Maharashtra, India
Nagpur, Maharashtra, India
Nashik, Maharashtra, India
Nashik, Maharashtra, India
Ajmer, Rajasthan, India
Rajkot, Rajasthan, India
Lucknow, Uttar Pradesh, India
Bialystok, , Poland
Gdansk, , Poland
Grudziadz, , Poland
Kielce, , Poland
Lodz, , Poland
Lublin, , Poland
Siemianowice śląskie, , Poland
Suchy Las, , Poland
Tuszyn, , Poland
Brasov, , Romania
Bucuresti, , Romania
Bucuresti, , Romania
Bucuresti, , Romania
Bucuresti, , Romania
Bucuresti, , Romania
Craiova, , Romania
Galati, , Romania
Iasi, , Romania
Sibiu, , Romania
Belgrade, , Serbia
Belgrade, , Serbia
Kovin, , Serbia
Nis, , Serbia
Novi Knezevac, , Serbia
Brighton, East Sussex, United Kingdom
London, Greater London, United Kingdom
Oxford, Oxfordshire, United Kingdom
Chertsey, Surrey, United Kingdom
Birmingham, West Midlands, United Kingdom
Little Rock, Arkansas, United States
Culver City, California, United States
Encino, California, United States
La Habra, California, United States
Los Alamitos, California, United States
Oceanside, California, United States
Coral Gables, Florida, United States
Hialeah, Florida, United States
Miami Lakes, Florida, United States
Miami Springs, Florida, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Overland Park, Kansas, United States
Monroe, Louisiana, United States
Gaithersburg, Maryland, United States
Grand Rapids, Michigan, United States
Kalamazoo, Michigan, United States
Saint Louis, Missouri, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Hickory, North Carolina, United States
Beachwood, Ohio, United States
Cincinnati, Ohio, United States
Cherven Bryag, , Bulgaria
Dupnitsa, , Bulgaria
Kardzhali, , Bulgaria
Kazanlak, , Bulgaria
Novi Iskar, , Bulgaria
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Targovishte, , Bulgaria
Vratsa, , Bulgaria
Lodz, , Poland
Belgrade, , Serbia
Belgrade, , Serbia
Belgrade, , Serbia
Kovin, , Serbia
Kragujevac, , Serbia
Kragujevac, , Serbia
Kragujevac, , Serbia
Nis, , Serbia
Novi Knezevac, , Serbia
Vrsac, , Serbia
Bodmin, Cornwall, United Kingdom
London, Greater London, United Kingdom
Ashton Under Lyne, Lancashire, United Kingdom
Paisley, Renfrewshire, United Kingdom
Tampa, Florida, United States
Belgrade, , Serbia
Toyoake, Aichi, Japan
Eugene, Oregon, United States
Kazanlak, , Bulgaria
Shibuya Ku, Tokyo, Japan
Meguro Ku, Tokyo, Japan
Setagaya Ku, Tokyo, Japan
Boston, Massachusetts, United States
Toyoake, Aichi, Japan
Berlin, New Jersey, United States
Fukuoka Shi, Fukuoka Ken, Japan
Independence, Ohio, United States
Konan Shi, Aichi, Japan
Toyoake, Aichi, Japan
Fukuoka, , Japan
Saint Louis, Missouri, United States
Razgrad, , Bulgaria
Klecany, , Czechia
Ostrava Poruba, , Czechia
Plzen, , Czechia
Praha 10, , Czechia
Praha 1, , Czechia
Praha 8, , Czechia
Shirakawa, Fukushima, Japan
Karatsu, Saga, Japan
Setagaya Ku, Tokyo, Japan
Shinjuku Ku, Tokyo, Japan
Bucuresti, , Romania
Bucuresti, , Romania
Little Rock, Arkansas, United States
Miami Springs, Florida, United States
Oklahoma City, Oklahoma, United States
Irving, Texas, United States
Dupnitsa, , Bulgaria
Novi Iskar, , Bulgaria
Sofia, , Bulgaria
Katowice, , Poland
Kovin, , Serbia
Nis, , Serbia
Novi Knezevac, , Serbia
Toyoake Shi, Aichi Ken, Japan
Hialeah, Florida, United States
Decatur, Georgia, United States
Kazanlak, Stara Zagora, Bulgaria
Toyoake Shi, Aichi Ken, Japan
Karatsu Shi, Saga Ken, Japan
Tokyo, , Japan
Little Rock, Arkansas, United States
Cerritos, California, United States
Garden Grove, California, United States
La Habra, California, United States
Lemon Grove, California, United States
Riverside, California, United States
Torrance, California, United States
Miami Lakes, Florida, United States
Miami, Florida, United States
Orange City, Florida, United States
Pembroke Pines, Florida, United States
Tamarac, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Overland Park, Kansas, United States
Saint Louis, Missouri, United States
Las Vegas, Nevada, United States
New York, New York, United States
Staten Island, New York, United States
Eugene, Oregon, United States
Austin, Texas, United States
Irving, Texas, United States
Sofia, Sofia Grad, Bulgaria
Sofia, Sofia Grad, Bulgaria
Sofia, Sofia Grad, Bulgaria
Sofia, , Bulgaria
Konan Shi, Aichi Ken, Japan
Toyoake Shi, Aichi Ken, Japan
Shirakawa Shi, Fukushima Ken, Japan
Karatsu Shi, Saga Ken, Japan
Beograd, Belgrade, Serbia
Beograd, , Serbia
Gornja Toponica, , Serbia
Kovin, , Serbia
Kragujevac, , Serbia
Glasgow, , United Kingdom
Oxford, , United Kingdom
Garden Grove, California, United States
Lauderhill, Florida, United States
Belgavi, Karnataka, India
Savannah, Georgia, United States
Boston, Massachusetts, United States
Desoto, Texas, United States
Fukuoka Shi, Fukuoka Ken, Japan
Shinjuku Ku, Tokyo To, Japan
Pembroke Pines, Florida, United States
Bucuresti, , Romania
Los Angeles, California, United States
Berlin, New Jersey, United States
San Diego, California, United States
Chicago, Illinois, United States
Bucuresti, , Romania
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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