Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

An open-label, cross-over, multi-site, prospective, phase IIb study of effects on circadian rhythms and quality of life of modifieddual-release hydrocortisone Efmody™ versus immediate-release hydrocortisone in patients with Addison’s Disease

This research study is for people living with Addison's disease. It aims to compare a newer medication, called Efmody™, with the hydrocortisone treatment many people currently use. The main goal is to find out if Efmody™ helps improve how people feel in their daily lives and helps their body's natural rhythms (like sleep-wake cycles). Participants will try both treatments for a period of time to see which one works better for them. This is an exploratory study, meaning it’s a detailed look into the effects of these treatments. The results will help doctors understand if this newer medication could offer a better way to manage Addison's disease and improve quality of life.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Royal College Of Surgeons In Ireland

Enrolment target

Start

10 Jul 2023

Addison’s Disease

What is this study about?

This study is designed for individuals who have Addison's disease. This condition affects your adrenal glands, making them unable to produce enough of certain important hormones, like cortisol. People with Addison's disease need to take medication, often hydrocortisone, to replace these missing hormones.

The main purpose of this research is to compare a new type of hydrocortisone, called Efmody™, with the standard hydrocortisone tablets that many people currently use. The study is particularly interested in whether Efmody™ can improve two key areas: your general well-being and daily life (often called 'quality of life') and how well your body's natural clock, or 'circadian rhythm', works. This body clock affects things like your sleep patterns, energy levels, and mood throughout the day. Some people with Addison's disease find these aspects challenging to manage.

Researchers want to see if Efmody™, which is designed to release hydrocortisone differently in your body, might match your body's natural cortisol rhythms more closely than current treatments. By carefully comparing both medications, the study hopes to find out if one treatment helps people feel better, more energetic, and more in tune with their natural body rhythms. This information can then help doctors make the best treatment choices for people with Addison's disease in the future.

Key takeaways

Compares a new hydrocortisone (Efmody™) with standard treatment.
Aims to improve daily well-being and body clocks for people with Addison's disease.
Participants will try both treatments for specific periods.
You'll answer questionnaires and have clinic visits.
Safety and well-being are closely monitored by medical staff.

Who may be eligible?

To join this study, you must be at least 18 years old. The study is open to both men and women.

Beyond these basic requirements, there will be specific health checks and medical history questions to ensure the study is safe and suitable for you. This will include making sure your Addison's disease is stable and that you don't have any other health conditions or medications that might interfere with how the study treatments work or make it unsafe for you to participate.

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.

Are you at least 18 years old?
Do you have a diagnosis of Addison's disease?
Are you able to attend regular clinic appointments?
Are you generally in stable health besides your Addison's disease?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will try two different types of hydrocortisone medication: the new Efmody™ and your usual immediate-release hydrocortisone. You won't know which one you're taking at which time, to make sure the results are fair.

Throughout the study, you'll have regular visits to the clinic. These visits will involve answering questionnaires about how you're feeling and how well you’re sleeping. You may also have some blood tests to check hormone levels. Each treatment period will last about 11 weeks, and you'll switch between the two medications. The total duration of your participation will include these treatment periods and follow-up, which a doctor or nurse will explain in detail.

Potential risks and benefits

Participating in this study might offer you the benefit of trying a new medication that could potentially improve your daily life and body rhythms. You'll also receive careful monitoring from medical professionals throughout your involvement. However, as with any medication, there's a possibility of side effects, though the medical team will discuss these with you. You might also experience no change or an improvement that isn't significant. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Ireland

Common questions

What is Addison's disease?

Addison's disease is a rare condition where your body doesn't produce enough of certain important hormones, like cortisol. It needs to be managed with daily medication.

What is Efmody™?

Efmody™ is a newer type of hydrocortisone medication designed to release the hormone more steadily throughout the day, potentially matching your body's natural rhythms better.

What will I have to do in the study?

You'll take two different hydrocortisone medications at different times, fill out questionnaires about your well-being, and attend regular clinic visits for monitoring.

How long will the study last for me?

Each treatment period will last about 11 weeks. The full duration will be explained by the study team, as you will try both medications.

Can I stop participating if I want to?

Yes, absolutely. You can withdraw from the study at any time, for any reason, and it will not affect your medical care.