Addison's disease Trials in Disease

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

This trial is focused on comparing two different forms of hydrocortisone treatment for people living with Addison's Disease. The condition occurs when the adrenal glands do not produce enough of certain hormones, which can lead to symptoms like fatigue, muscle weakness, and weight loss. The study aims to understand whether a modified-release version of hydrocortisone called Efmody can provide better results than the standard immediate-release hydrocortisone.

Main inclusion criteria:

• Participants must be 18 years or older
• Must have a confirmed diagnosis of Addison's Disease
• Currently treated with immediate-release hydrocortisone as replacement therapy
• Must have been on a stable dose of immediate-release hydrocortisone for at least 4 weeks before joining
• Must have been on a stable dose of fludrocortisone for at least 4 weeks before joining
• Women of childbearing potential must use effective contraception and must not be pregnant or breastfeeding
• Must be able and willing to follow all trial requirements

Main exclusion criteria:

• Patients who do not have Addison's Disease
• Patients who are not within the specified age range
• Patients who are part of a vulnerable population that may need special protection or care

Focus and goal of the trial:

The trial uses a cross-over design, which means participants will receive both treatments at different times during the study. This allows researchers to directly compare the effects of both medications on the same group of patients. The study lasts for several weeks, with each treatment period lasting 11 weeks.

Participants will start by completing questionnaires about their quality of life and general health. They will then begin an 11-week treatment period with immediate-release hydrocortisone, followed by an assessment. After this, they will switch to Efmody, the modified-release version, for another 11 weeks, followed by a final assessment. Throughout the study, researchers will monitor changes in quality of life, sleep efficiency, and daily stability. The study will also assess changes in the timing of melatonin release, a hormone that helps regulate sleep.

Investigational drugs:

The trial is testing Efmody, a modified-release form of hydrocortisone that releases medication slowly over time. It is designed to mimic the body's natural rhythm of cortisol production, which may improve sleep patterns, daily stability, and overall quality of life. This is being compared to standard immediate-release hydrocortisone, which quickly increases cortisol levels in the body. Both medications work to replace cortisol, a hormone that is essential for many bodily functions but is not produced in sufficient amounts in people with Addison's Disease.

Summary

Currently, there is one active clinical trial investigating treatment options for Addison's Disease. This trial is being conducted in Ireland and focuses on comparing the effectiveness of modified-release hydrocortisone with the standard immediate-release form. The study aims to determine whether the newer formulation can provide better symptom management and improved quality of life for patients. By using a cross-over design, researchers can gain valuable insights into how each treatment affects the same individuals, which may help guide future treatment approaches for this condition.