It Starts With YOU!
Join the Research Effort for
Endogenous cushing’s syndrome Consider the LOGICS Study.

Now enrolling volunteers to participate in a clinical study for an investigational drug, levoketoconazole.

The safety and effectiveness of levoketoconazole for endogenous Cushing’s syndrome have not been established.

About the Study

OBJECTIVE:

The purpose of this study is to compare the effects and safety of levoketoconazole (previously known as 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.

STUDY DESIGN:

This study will include subjects who have previously taken levoketoconazole as well as 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 to discuss your interest in participating in the LOGICS study.

 

The following information pertains to subjects who have never taken levoketoconazole ONLY.

 

  • After signing an Informed Consent, the study will begin with a screening period.
  • This study includes three parts. In part one, eligible participants who are not taking levoketoconazole will start taking levoketoconazole. Your study doctor will increase the dose slowly and see how well you respond. This part of the study is open-label, which means that both you and your study doctor are aware of the treatment being given.
  • In part two of the study, you will be assigned to a study group by chance (like a coin flip) rather than by a medical decision made by the researchers. During this part of the study, there is a 50% chance that you will continue taking levoketoconazole and a 50% chance that you will receive a placebo. Neither you nor your study doctor will know what you will receive.
  • In the third part of the study, both groups will receive levoketoconazole and placebo at the same time. If you were receiving placebo during the second part of the study, you would start taking levoketoconazole again in addition to the placebo. If you were receiving levoketoconazole during the second part of the study, you would also start taking placebo.
  • Levoketoconazole and placebo will be taken by mouth in tablet form.
  • Throughout the study, you can expect to meet regularly with a study doctor and take part in a variety of medical tests. Your study doctor will test how well the medication is working — and make adjustments if necessary — primarily by measuring the cortisol levels in urine and secondarily by recording changes over time in other measures of health status that include a variety of tests using samples of your blood, saliva and urine, physical examinations and your responses to questions about your health.
  • This study is being conducted to learn more about possible side effects, so you will need to let your study doctor know about changes in your usual health.
  • Your study doctor will carefully check your condition and, if your condition worsens, may change the dose of study medication or withdraw you from the study.

See if you may be eligible for this clinical study. By giving your contact information, you will receive more information about the study and your eligibility.

Eligibility for the Study

The study is for adults (18 years or older) with a diagnosis of endogenous Cushing’s syndrome confirmed by your doctor. There are eligibility criteria that are best reviewed in a private consultation with a doctor who is participating in this study. The doctor can discuss with you whether you are eligible. Please visit www.clinicaltrials.gov for the details on eligibility.

If you would like to be considered for the study, please provide us with your contact information and we will follow up with you.

What is Endogenous Cushing’s Syndrome?

Endogenous Cushing’s syndrome occurs when the body produces too much cortisol. Most forms of endogenous Cushing’s syndrome are caused by tumors in the pituitary gland, others by tumors in the adrenal glands, or in other places throughout the body (ectopic tumors). Signs and symptoms of endogenous Cushing’s syndrome often include upper body obesity with thin arms and legs, weak muscles or bones, and depression. Individuals with Cushing’s syndrome are also more likely to develop diabetes, obesity, or high blood pressure.

Want to Volunteer?

The safety and effectiveness of levoketoconazole for endogenous Cushing’s syndrome have not been established.