An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
Study Details
Study Description
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. Additional exploratory objectives assess the efficacy of adjunctive KarXT at scheduled visits.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Drug: KarXT
|
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
|
Outcome Measures
Primary Outcome Measures
- Incidence of treatment-emergent adverse events (TEAEs) [From initial dose to safety follow-up visit (54 weeks) or early termination]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject is aged 18 to 55 years at time of enrollment into the preceding KarXT ARISE study (KAR-012)
-
Subject has successfully completed the treatment period (through Visit 8) of ARISE Study (KAR-012)
-
Subject has been compliant with the procedures in ARISE Study (KAR-012) (in the Principal Investigator's judgement)
-
Subject is capable of providing signed electronic Informed Consent Form (eICF) before any study assessments will be performed. If local regulations do not allow eICF, then paper ICFs are permitted
-
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 needs to be physically present at Visit 1, but can complete the remaining study visits assessments via phone (as needed)
-
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:
-
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 abnormality, including any finding(s) from the physical examination, vital signs, ECG, or laboratory test at the EOT visit of ARISE Study KAR-012 (Visit 8) that the Investigator, in consultation with the Medical Monitor, would consider 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 his/her ability to adhere to the protocol visit schedule or fulfill visit requirements
-
Risk of violent or destructive behavior as per Investigator's judgement that would interfere with subject's participation
-
Subjects participating in another investigational drug or device trial or planning on participating in another clinical trial during the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Innovations Inc. | Bellflower | California | United States | 90706 |
| 2 | Sunwise Clinical Research, LLC | Lafayette | California | United States | 94549 |
| 3 | Galiz Research | Hialeah | Florida | United States | 33016 |
| 4 | Adaptive Clinical Research, Inc. | North Miami | Florida | United States | 33161 |
| 5 | Synexus Clinical Research | Atlanta | Georgia | United States | 30328 |
Sponsors and Collaborators
- Karuna Therapeutics
Investigators
- Study Director: Ronald Marcus, MD, Karuna Therapeutics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KAR-013