RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2022-03-07
Study Completion:2026-02-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05304767

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subject is aged ≥18 to \<66 years at the time of randomization of Study KAR-012
  2. 2. Subject has successfully completed the treatment period of Study KAR-012
  3. 3. Subject has been compliant with the procedures in Study KAR-012 (in the Investigator's judgement)
  4. 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. 5. Subject is capable of providing signed Informed Consent Form before any study assessments will be performed
  6. 6. Subject resides in a stable living situation, in the opinion of the Investigator
  7. 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. 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).
  1. 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:
  2. 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
  3. 2. Non-suicidal self-injurious behavior is not exclusionary
  4. 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
  5. 3. Female subject is pregnant
  6. 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
  7. 5. Risk of violent or destructive behavior as per Investigator's judgement
  8. 6. Subjects participating in another investigational drug or device trial or planning on participating in another clinical trial during the study
  9. 7. History or high risk of urinary retention, gastric retention, or narrow angle glaucoma as evaluated by the Investigator
  10. 8. Subject is taking, or plans to take while in the study, any prohibited concomitant medication
  11. 9. For all male subjects only, any one of the following:
  12. 1. History of bladder stones
  13. 2. History of recurrent urinary tract infections
  14. 3. Serum prostate specific antigen (PSA) \>10 ng/mL
  15. 4. An International Prostate Symptom Score (IPSS) of 5 (almost always) on either item 1, 3, 5, or 6
  16. 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.

Contacts and Locations

Study Contact

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

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 161
Phoenix, Arizona, 85012
United States
Local Institution - 175
Little Rock, Arkansas, 72211
United States
Woodland International Research Group, LLC
Little Rock, Arkansas, 72211
United States
Advanced Research Center, Inc.
Anaheim, California, 92805
United States
CITrials - Bellflower
Bellflower, California, 90706
United States
Synexus Clinical Research US, Inc.
Cerritos, California, 90703
United States
Local Institution - 167
Culver City, California, 90230
United States
Local Institution - 141
Encino, California, 91436
United States
Local Institution - 152
La Habra, California, 90631
United States
Sunwise Clinical Research, LLC.
Lafayette, California, 94549
United States
Synergy Clinical Research of Escondido
Lemon Grove, California, 91945
United States
CenExel Collaborative Neuroscience Research
Los Alamitos, California, 90720
United States
Local Institution - 181
Oceanside, California, 92056
United States
NRC Research Institute
Orange, California, 92868
United States
CNRI - Los Angeles, LLC
Pico Rivera, California, 90660
United States
CITrials, Inc. - Riverside & San Bernardino County
Riverside, California, 92506
United States
Local Institution - 164
Stanford, California, 94305
United States
CenExel Collaborative Neuroscience Research
Torrance, California, 90504
United States
Local Institution - 186
Coral Gables, Florida, 33134
United States
Local Institution - 182
Hialeah, Florida, 33012
United States
Galiz Research, LLC
Hialeah, Florida, 33016
United States
Local Institution - 173
Miami Lakes, Florida, 33014
United States
Assertive Research Center
Miami Lakes, Florida, 33016
United States
Local Institution - 171
Miami Springs, Florida, 33166
United States
Local Institution - 105
Miami, Florida, 33016
United States
Local Institution - 120
Miami, Florida, 33016
United States
Premier Clinical Research Institute, Inc.
Miami, Florida, 33122
United States
Local Institution - 124
Orange City, Florida, 32763
United States
Local Institution - 156
Pembroke Pines, Florida, 33024
United States
Interventional Psychiatry of Tampa Bay
Tampa, Florida, 33629
United States
Grady Memorial Hospital
Atlanta, Georgia, 30303
United States
Synexus Clinical Research US, Inc.
Atlanta, Georgia, 30328
United States
Local Institution - 135
Augusta, Georgia, 30912
United States
CenExel iResearch Atlanta
Decatur, Georgia, 30030
United States
Local Institution - 169
Marietta, Georgia, 30060
United States
Local Institution - 177
Chicago, Illinois, 60611
United States
Local Institution - 142
Chicago, Illinois, 60612
United States
Uptown Research Institute, LLC
Chicago, Illinois, 60640
United States
Local Institution - 139
Overland Park, Kansas, 66210
United States
Local Institution - 154
Monroe, Louisiana, 71201
United States
Local Institution - 166
Gaithersburg, Maryland, 20877
United States
Local Institution - 158
Boston, Massachusetts, 02114
United States
Local Institution - 187
Boston, Massachusetts, 02118
United States
Local Institution - 269
Boston, Massachusetts, 02118
United States
Local Institution - 185
Worcester, Massachusetts, 01655
United States
Local Institution - 184
Ann Arbor, Michigan, 48105
United States
Local Institution - 149
Grand Rapids, Michigan, 49503
United States
Local Institution - 162
Kalamazoo, Michigan, 49001
United States
PsychCare Consultants Research
Saint Louis, Missouri, 63128
United States
Local Institution - 178
Saint Louis, Missouri, 63141
United States
Local Institution - 174
Omaha, Nebraska, 68144
United States
Altea Research Institute, Las Vegas
Las Vegas, Nevada, 89102
United States
Local Institution - 147
Las Vegas, Nevada, 89102
United States
Local Institution - 104
New York, New York, 10017
United States
Local Institution - 160
New York, New York, 10035
United States
Local Institution - 157
New York, New York, 10036
United States
Psychiatry and Alzheimer's Care of Rochester. PLLC
Rochester, New York, 14623
United States
Richmond Behavioral Associates ERG Clinical Research - New York PLLC
Staten Island, New York, 10314
United States
Local Institution - 176
Hickory, North Carolina, 28601
United States
Local Institution - 163
Beachwood, Ohio, 44122
United States
Local Institution - 165
Cincinnati, Ohio, 45219
United States
Local Institution - 168
Garfield Heights, Ohio, 44125
United States
Local Institution - 179
Eugene, Oregon, 97403
United States
Community Clinical Research, Inc.
Austin, Texas, 78754
United States
Local Institution - 183
Houston, Texas, 77030
United States
Local Institution - 180
Houston, Texas, 77074
United States
University Hills Clinical Research - Irving
Irving, Texas, 75062
United States
Pillar Clinical Research, LLC
Richardson, Texas, 75080
United States
At Health Texas
Richmond, Texas, 77407
United States
Green Mountain Research Institute
Rutland, Vermont, 05701
United States
Northwest Clinical Research Center
Bellevue, Washington, 98007
United States

Collaborators and Investigators

Sponsor: Karuna Therapeutics

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-07
Study Completion Date2026-02-27

Study Record Updates

Study Start Date2022-03-07
Study Completion Date2026-02-27

Terms related to this study

Additional Relevant MeSH Terms

  • Schizophrenia