- What is a clinical study?
Before medicines can be approved for the treatment of a health condition, they must be tested in clinical studies to understand their safety and effectiveness. The studies are reviewed and approved by an independent review board or ethics committee to help protect the rights, privacy, and safety of research subjects. If the studies for a medicine show the medicine is safe and effective, the information about the medicine is reviewed by a government agency (such as the FDA or EMA) for a final decision on whether the medicine can be prescribed to patients.
- What are the benefits of participating in a clinical study?
People choose to enter research studies for various reasons, including gaining access to investigational medications. Also, some people participate due to a desire to help researchers understand if a medicine is a safe and effective treatment.
- What are the benefits of participating in this clinical study?
Levoketoconazole may or may not help improve your condition or help prevent your condition from worsening. LOGICS is designed to provide additional information to researchers and regulators to determine if levoketoconazole is providing a benefit to endogenous Cushing’s syndrome patients and is a safe and effective treatment choice.
- What is the purpose of the study?
The purpose of this study is to compare the effects and safety of levoketoconazole (COR-003) to a placebo (a pill with inactive ingredients) in people with endogenous Cushing’s syndrome. The safety and effectiveness of levoketoconazole for endogenous Cushing’s syndrome have not been established.
- Who can participate?
The study is for adults (18 years or older) with endogenous Cushing’s syndrome. There are eligibility criteria that are best reviewed in a private consultation with a doctor who is participating in the study.
- Can I participate in the LOGICS study if I participated in the SONICS trial and previously took levoketoconazole?
Yes, this study will include subjects who have previously taken levoketoconazole in addition to subjects who have never taken levoketoconazole. If you previously participated in the SONICS study, please contact your study doctor for more details about the study and discuss your interest in participating in the LOGICS study. The information contained on this site primarily pertains to subjects who have never taken levoketoconazole.
- How long is this study?
Participants will be followed for as long as 1 year, but most will be followed for half a year or less. The maximum expected time taking the medication is 38 weeks if you have not been receiving levoketoconazole prior to this study and 19 weeks if you completed SONICS and have been receiving a stable dose of levoketoconazole prior to this study. See more detailed information on study design by clicking here to visit www.clinicaltrials.gov.
- Will everyone in the study receive levoketoconazole?
Yes. The first part of the study, which is only for subjects who haven’t been receiving a stable dose of levoketoconazole prior to entry, is an open-label, dose-finding part, in which everyone will receive levoketoconazole. In part 2, participants have a 50% chance of getting levoketoconazole and a 50% chance of getting placebo (a pill with inactive ingredients) for up to 9 1/2 weeks or before then if your study doctor thinks that you need to have active treatment restarted, per the study instructions. Finally in the third part, everyone will be given both levoketoconazole and placebo.
- What can I expect next if I participate in this study?
If the doctor participating in the study decides that you may be eligible, you will:
- Review and sign an informed consent document if you choose to participate
- Take part in a screening to find out if you are eligible to participate in the study
- Take study medication as directed by your study doctor, if you are eligible to participate in the study
- Be asked to follow all study visits, procedures, and requirements. During the study, you will take part in various medical tests
- Will I have to pay anything to be in the study?
No. All study procedures and study medication will be provided at no cost to you.
- Where will I visit the doctor?
There are doctors around the United States who are participating in the study. Please fill out the “For More Information” form with your information and we will contact you about possible locations.
Want to Volunteer?
The safety and effectiveness of levoketoconazole for endogenous Cushing’s syndrome have not been established.