Chronocort for Congenital Adrenal Hyperplasia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing Chronocort, a medication for people aged 16 and over with Congenital Adrenal Hyperplasia (CAH). It aims to see if Chronocort can safely and effectively manage their hormone levels. Chronocort works by releasing hormones in a way that mimics the body's natural rhythm. Chronocort is a modified-release formulation of hydrocortisone designed to better mimic the body's natural cortisol circadian rhythm.
Will I have to stop taking my current medications?
The trial requires that participants do not take medications that interfere with glucocorticoid metabolism or regular daily steroids for conditions other than CAH. If you are on such medications, you may need to stop them to participate.
Is Chronocort safe for humans?
Chronocort, a modified-release hydrocortisone, has been studied for congenital adrenal hyperplasia and compared to conventional hydrocortisone. While the study focused on hormonal profiles, it implies that Chronocort is generally safe as it is being evaluated as an alternative to existing treatments.12345
How does the drug Chronocort differ from other treatments for congenital adrenal hyperplasia?
What data supports the effectiveness of the drug Chronocort for congenital adrenal hyperplasia?
Chronocort, a modified-release hydrocortisone, was compared to conventional hydrocortisone in patients with congenital adrenal hyperplasia, suggesting it may offer improved hormonal control. This indicates potential effectiveness in managing the condition by providing a more physiological replacement of glucocorticoids.13478
Who Is on the Research Team?
D Merke
Principal Investigator
National Instiututes of Health Clinical Centre, Bethesda, Maryland, United States, 20892-1932
Are You a Good Fit for This Trial?
This trial is for individuals over 16 with Congenital Adrenal Hyperplasia (CAH) who've completed previous Chronocort studies. They must be able to consent and not have conditions that interfere with the study or glucocorticoid metabolism, no recent participation in other drug trials, not pregnant/lactating, and without severe liver/renal disease.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Open-label Extension
Participants continue or switch to Chronocort treatment for long-term safety and tolerability assessment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Chronocort
Find a Clinic Near You
Who Is Running the Clinical Trial?
Neurocrine UK Limited
Lead Sponsor
Diurnal Limited
Lead Sponsor