Adults with schizophrenia may face many challenges with their emotions and thoughts as well as their treatment. Not only does their condition affect their personal relationships and feelings, but they may also have side effects from treatment or may not take medication as directed for many reasons. Because of these challenges, there is a need for additional research for treatment of this condition. Researchers continue to explore schizophrenia relapses (or episodes) and possible study drugs for these patients.
This study is testing an investigational drug for adults with schizophrenia. Pharmaceutical companies use clinical research studies like this one to learn more about investigational drugs before they are made available to the public. Study volunteers can help us in this important research. Thank you for considering participation in this study.
You may qualify for this study if:
There are additional eligibility requirements to enroll in this study. Your doctor will review the study requirements and discuss your eligibility with you.
Clinical studies (also called clinical trials) are important for medical advances. Current treatments for diseases are only available because of research study volunteers.Your participation is voluntary, and you may choose to withdraw from the study at any time.
This study is investigating the long-term safety, tolerability, and effectiveness of the study drug (KarXT) in adults with schizophrenia. A study drug (or investigational drug) is one that is not approved for use by the general public.
This study will last up to 56 weeks (just over 1 year), including a 52-week study treatment period and a 7-day follow-up/end-of-study period.
If you are eligible to enroll in this study, you have been diagnosed with schizophrenia without any relapse of psychotic symptoms within the past 8 weeks. You will take KarXT capsules twice per day for up to 52 weeks and your drug dosage may vary based on your tolerability.
Interim visits will occur remotely and approximately once every 4 weeks by utilizing video conferencing tools between you and the study doctor. A safety follow-up visit will be performed for all subjects after the last dose of KarXT.
Lab tests, physical exams, and other assessments and questionnaires will be conducted as part of this study.
Enrolled patients will receive all study-related procedures, medications, and laboratory services at no cost.
There are possible risks involved with any clinical study. Your study doctor will review the risks with you, and you will be closely monitored throughout the study.
In a clinical study, participants are assigned to one or more investigational drugs to answer questions about the treatment to see if it works, works better than other treatments, and has side effects.
An investigational drug is a substance that is being tested in clinical studies. It has been reviewed by an ethics committee for testing in people and may or may not be approved by the government health agency for treatment for this condition.