Study on the Effects of Modified-Release Hydrocortisone vs. Immediate-Release Hydrocortisone for Patients with Addison’s Disease

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Efmody on patients with Addison’s Disease. Addison’s Disease is a condition where the body does not produce enough of certain hormones, which can lead to symptoms like fatigue, muscle weakness, and weight loss. The study will compare the effects of Efmody, a modified-release form of hydrocortisone, with immediate-release hydrocortisone, which is commonly used as a replacement therapy for this condition.

The purpose of the study is to evaluate how switching from immediate-release hydrocortisone to Efmody affects patients’ quality of life, sleep efficiency, and daily stability. The study will also assess changes in the timing of melatonin release, which is a hormone that helps regulate sleep. Participants will take part in a cross-over study, meaning they will receive both treatments at different times during the study. This approach allows researchers to directly compare the effects of the two treatments on the same group of patients.

Throughout the study, participants will be monitored for changes in their quality of life using specific questionnaires designed for people with Addison’s Disease. The study will last for several weeks, with each treatment period lasting 11 weeks. By the end of the study, researchers hope to gain a better understanding of how Efmody can improve the management of Addison’s Disease and enhance the overall well-being of patients.

1 beginning of the trial

Upon joining the study, you will start with a baseline assessment. This involves completing a questionnaire to evaluate your current quality of life. This is known as the Health-related Quality of Life in Addison’s disease (AddiQoL) questionnaire.

You will also complete the 36-Item Short Form Health Survey (SF-36) questionnaire to assess your general health status.

2 initial treatment phase

You will begin taking immediate-release hydrocortisone as part of your treatment. The specific dosage and frequency will be determined by the study team based on your current treatment regimen.

This phase will last for 11 weeks, during which you will continue your regular treatment with immediate-release hydrocortisone.

3 first assessment

At the end of the 11-week period, you will undergo another assessment. This will involve completing the same questionnaires as at the beginning of the trial to measure any changes in your quality of life and general health status.

4 crossover to modified-release treatment

You will switch to taking modified-release hydrocortisone Efmody™. This medication is designed to release the active ingredient over a longer period.

The dosage and frequency will be adjusted by the study team to suit your needs. This phase will also last for 11 weeks.

5 second assessment

After completing the 11-week period with modified-release hydrocortisone, you will undergo a final assessment.

You will complete the same questionnaires to evaluate any changes in your quality of life and general health status compared to the initial treatment phase.

Who Can Join the Study?

Participants must be 18 years or older.
Participants must be able to understand the Patient Information Leaflet and provide signed and dated informed consent.
Participants must have a confirmed diagnosis of Addison’s Disease and currently be treated with immediate-release hydrocortisone as replacement therapy.
Participants must have been on a stable immediate-release hydrocortisone treatment for 4 weeks or more before joining the study.
Participants must have been on a stable dose of fludrocortisone for 4 weeks or more before joining the study.
Women of childbearing potential must use effective contraception and must not be pregnant or breastfeeding. They must agree to follow contraceptive guidance during the study. A woman is considered of childbearing potential from the start of menstruation until menopause, unless permanently sterile.
Participants must be, in the investigator’s opinion, able and willing to comply with all trial requirements.

Who Cannot Join the Study?

Patients who do not have Addison’s Disease cannot participate. Addison’s Disease is a condition where the body doesn’t produce enough of certain hormones.
Patients who are not within the specified age range cannot participate. The age range includes children and adults.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Connolly Hospital	Dublin	Ireland
Beaumont Hospital	Dublin	Ireland

Trial status

Country	Status	Recruitment Start
Ireland	Not recruiting	01.09.2023

Trial locations

Investigated drugs:

Hydrocortisone

Efmody™ is a modified-release form of hydrocortisone. It is designed to help people with Addison’s Disease by releasing the medication slowly over time. This helps to mimic the body’s natural rhythm of cortisol production, which can improve sleep patterns, daily stability, and overall quality of life. The goal of using Efmody™ in the trial is to see if it can better manage symptoms compared to the standard immediate-release hydrocortisone.

Hydrocortisone is a medication that replaces cortisol, a hormone that the body normally produces. In people with Addison’s Disease, the body does not make enough cortisol, which is essential for many bodily functions. The immediate-release form of hydrocortisone is taken to quickly increase cortisol levels in the body. In this trial, it is used as a comparison to see if the modified-release version, Efmody™, offers any benefits in terms of quality of life and sleep efficiency.

Addison’s Disease – Addison’s Disease is a disorder that occurs when the adrenal glands do not produce enough hormones, specifically cortisol and aldosterone. The disease progresses slowly, often over several months or years, and symptoms may be vague and non-specific at first. As the condition advances, individuals may experience fatigue, muscle weakness, weight loss, and low blood pressure. Darkening of the skin, particularly in areas exposed to the sun, is also common. Over time, the lack of hormone production can lead to more severe symptoms, such as abdominal pain, nausea, and vomiting. If left unmanaged, the disease can cause an adrenal crisis, characterized by severe symptoms that require immediate medical attention.

Trial ID:

2023-503584-42-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Modified-Release Hydrocortisone vs. Immediate-Release Hydrocortisone for Patients with Addison’s Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?