Chronocort for Congenital Adrenal Hyperplasia

Recruiting in Palo Alto (17 mi)

+20 other locations

Overseen byD Merke

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Neurocrine UK Limited

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

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.

Eligibility Criteria

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

Participants with Congenital Adrenal Hyperplasia (CAH) who have successfully completed Chronocort study DIUR-006 (sites in France and US only) or study DIUR-014

I can sign and agree to follow the study's rules.

Exclusion Criteria

Participants who routinely work night shifts and so do not sleep during the usual night-time hours

My body weight is 50 kg or less.

Participants with any other significant medical or psychiatric conditions that in the opinion of the Investigator would preclude participation in the study

+9 more

Participant Groups

The trial is testing the long-term safety of a medication called Chronocort for treating CAH. It's an open-label extension study across multiple countries where participants will continue using Chronocort to assess its ongoing safety profile.

1Treatment groups

Experimental Treatment

Group I: Chronocort (hydrocortisone modified-release capsule)Experimental Treatment1 Intervention

Chronocort (hydrocortisone modified-release capsules) supplied as 5 mg and 10 mg per capsule for oral administration.