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Corticosteroid

Chronocort for Congenital Adrenal Hyperplasia

Phase 3
Waitlist Available
Led By D Merke
Research Sponsored by Diurnal Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must not have
Participants with a body weight of 50 kg or less
Participants with a history of bilateral adrenalectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 32 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 60 Other Conditions
No Placebo-Only Group
Pivotal Trial

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, typical concerns may include potential impacts on organ function like liver or kidneys due to long-term medication use. Participants' health will be closely monitored for any adverse reactions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My body weight is 50 kg or less.
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I have had both of my adrenal glands removed.
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My kidney or liver tests show they are not working well.
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I use steroids daily for reasons other than adrenal gland disorders.
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I am not pregnant or breastfeeding.
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I take daily medication that affects how my body uses steroids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 32 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 32 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Signs and symptoms of over-treatment [Safety and Tolerability] throughout the study.
Signs and symptoms of under-treatment [Safety and Tolerability] throughout the study.
To measure signs or symptoms of under treatment [Safety and Tolerability] in terms of incidence of adrenal crises throughout the study.
+5 more
Secondary study objectives
To assess the impact of treatment on 17-Hydroxyprogesterone (17-OHP) levels - Change from pre-Chronocort baseline
To assess the impact of treatment on Androstenedione (A4) levels - Change from pre-Chronocort baseline
To assess the impact of treatment on body weight - Change from pre-Chronocort baseline
+5 more
Other study objectives
To assess the impact of treatment on 17-Hydroxyprogesterone (17-OHP) levels - Change from initial study baseline
To assess the impact of treatment on Androstenedione (A4) levels - Change from initial study baseline
To assess the impact of treatment on body weight - Change from initial study baseline
+7 more

Side effects data

From 2009 Phase 1 & 2 trial • 20 Patients • NCT00519818
21%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cortef
Chronocort

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydrocortisone
FDA approved

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Congenital Adrenal Hyperplasia (CAH) involve glucocorticoid therapy, which aims to replace deficient cortisol and suppress excess adrenal androgen production. Modified-release hydrocortisone, such as Chronocort, mimics the natural circadian rhythm of cortisol secretion, providing more physiological hormone levels throughout the day. This approach helps to better control symptoms, reduce the risk of adrenal crises, and minimize side effects associated with traditional glucocorticoid regimens. For CAH patients, maintaining a stable and natural cortisol rhythm is crucial for overall health, growth, and development.

Find a Location

Who is running the clinical trial?

Diurnal LimitedLead Sponsor
18 Previous Clinical Trials
631 Total Patients Enrolled
D MerkePrincipal InvestigatorNational Instiututes of Health Clinical Centre, Bethesda, Maryland, United States, 20892-1932
1 Previous Clinical Trials
55 Total Patients Enrolled

Media Library

Chronocort (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05299554 — Phase 3
Congenital Adrenal Hyperplasia Research Study Groups: Chronocort (hydrocortisone modified-release capsule)
Congenital Adrenal Hyperplasia Clinical Trial 2023: Chronocort Highlights & Side Effects. Trial Name: NCT05299554 — Phase 3
Chronocort (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05299554 — Phase 3
~5 spots leftby Dec 2024