Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
This ongoing study is designed to check the long-term safety of a medication called relacorilant for people who have Cushing's syndrome. Participants in this study will have already taken part in an earlier study involving relacorilant. Their doctor must also believe that continuing with relacorilant will be helpful for them. The study is "open-label," meaning both you and your doctor will know you are receiving relacorilant. The goal is to allow patients to keep taking this medicine if it's helping them, until it becomes widely available or the study comes to an end. Your doctor will adjust the dose based on your individual needs and how well you're responding.
At a glance
What is this study about?
This study is a continuation for people who have Cushing's syndrome and have already shown improvements while taking a medicine called relacorilant in a previous study. Cushing's syndrome is a condition caused by too much of a hormone called cortisol in the body, which can lead to various health problems. Relacorilant is designed to help block the effects of this excess cortisol.
The main purpose of this study is to see how safe relacorilant is over a longer period of time. If you've been in a previous relacorilant study and your doctor feels you are benefiting from it, this study offers you the chance to keep taking the medication. This allows for continuous treatment if it's helping control your Cushing's syndrome symptoms.
Your doctor will carefully monitor your health and how you respond to the treatment. They can adjust your dose of relacorilant – either keeping it the same, lowering it, or increasing it – to make sure it's working best for you and that you're tolerating it well. The study will continue until relacorilant is generally available or until the study's sponsor decides to stop it.
Key takeaways
- This study offers continued treatment with relacorilant for people with Cushing's syndrome.
- It's for people who found relacorilant helpful in a previous study.
- The main aim is to check the long-term safety of the medication.
- Your doctor will decide if continued treatment is right for you and adjust your dose as needed.
- You can continue treatment for a longer period if it's helping you.
- You can leave the study at any time.
Who may be eligible?
To join this study, you must have already finished taking part in another study sponsored by Corcept that involved relacorilant for Cushing's syndrome. In that previous study, you must have taken your medication at least 80% of the time as instructed.
Crucially, your doctor must also believe that continuing to take relacorilant would be beneficial for your health and help manage your Cushing's syndrome symptoms.
However, you won't be able to join if you stopped your previous relacorilant study early, or if you have certain other health conditions that are not well-controlled, such as serious thyroid problems, high blood pressure, or severe kidney issues.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Have you already completed a previous study with relacorilant for Cushing's syndrome?
- Did you take your study medication at least 80% of the time in that previous study?
- Does your doctor think you would benefit from continuing relacorilant?
- Do you have any serious, uncontrolled health conditions like thyroid problems, high blood pressure, or severe kidney issues?
What does participation involve?
If you join this study, you will continue to take relacorilant once a day. Your doctor will regularly check your health and how you're responding to the medication. This includes reviewing your symptoms, perhaps taking blood samples, and checking your blood pressure and other vital signs. The dose of relacorilant may be adjusted by your doctor based on how you are feeling and how well the treatment is working for you. There is no set end date for your participation; you can continue taking the medication until it's available more widely or the study ends. You will have regular visits with your doctor to monitor your progress and ensure your safety.
Potential risks and benefits
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Common questions
What is an 'extension study'?
An extension study means you get to keep taking a study medicine (like relacorilant) for a longer time after you've finished an initial study, if it's been helpful and your doctor agrees.
What is Cushing's syndrome?
Cushing's syndrome is a health condition caused by too much of a hormone called cortisol in your body, which can lead to various symptoms and health problems.
What does 'open-label' mean?
It means that both you and your doctor will know that you are receiving the study medication, relacorilant, and not a placebo (dummy pill).
How long will I take part in this study?
There isn't a fixed end date for individuals; you can continue as long as the medication is helping, until it's generally available, or until the study itself stops.
What if I feel unwell during the study?
You should always tell your study doctor or nurse immediately if you feel unwell or experience any new or worsening symptoms.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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