Clinical trials: Congenital Adrenal Hyperplasia
Mild Autonomous Cortisol Secretion (MACS)
Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)
To characterize the impact of Isturisa on clinical features and comorbidities associated with MACS. The investigators hypothesize that patients treated with Isturisa will exhibit significantly better metabolic indicators (such as…
- Trial name
- NCT07247058
- Testing
- Osilodrostat (Isturisa)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Johns Hopkins University
Congenital Adrenal Hyperplasia, Classic Congenital Adrenal Hyperplasia
A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia
The purpose of this study is to evaluate the efficacy, safety, PK, and PD of atumelnant in adults with classic CAH due to 21-OHD.
- Trial name
- NCT07144163
- Testing
- Atumelnant
- Where
- 75 sites in United States, Argentina and 13 more
- Volunteers
- 150 people
- Sponsor
- Crinetics Pharmaceuticals Inc.
Congenital Adrenal Hyperplasia, Classic Congenital Adrenal Hyperplasia
A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH)
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of atumelnant treatment in pediatric participants with classic congenital adrenal hyperplasia (CAH).
- Trial name
- NCT07159841
- Testing
- Atumelnant
- Where
- 51 sites in United States, Argentina and 11 more
- Volunteers
- 153 people
- Sponsor
- Crinetics Pharmaceuticals Inc.
Congenital Adrenal Hyperplasia
Development of Healthcare Transition for Patients With Congenital Adrenal Hyperplasia
The purpose of this study is to implement and evaluate the feasibility and acceptability of a structured healthcare transition program for adolescents and young adults with congenital adrenal hyperplasia (CAH).
- Trial name
- NCT07611786
- Testing
- exposure to healthcare transition protocol
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Adrenal Hyperplasia, Congenital
An Extension Trial of Asedebart in Participants With Congenital Adrenal Hyperplasia
The main goal of the trial is to study the long-term safety, how well people can handle the treatment, and how asedebart acts in the body and affects the body when used to treat classic congenital adrenal hyperplasia (CAH).
- Trial name
- NCT07859293
- Testing
- Asedebart
- Volunteers
- 45 people
- Sponsor
- H. Lundbeck A/S
Endocrine Disease, Adrenal Insufficiency
Pilot Study to Characterize and Examine the Pharmacokinetics and Efficacy of Chronocort® in Adults With CAH
The purpose of this study is to gather safety and effectiveness information about a new formulation of Hydrocortisone (Chronocort®) used to treat patients with a disease called congenital adrenal hyperplasia (CAH).
- Conditions
- Endocrine Disease, Adrenal Insufficiency, Congenital Adrenal Hyperplasia
- Trial name
- NCT01735617
- Testing
- Hydrocortisone Modified Release Capsules
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Neurocrine UK Limited
Congenital Adrenal Hyperplasia
Comparison of Chronocort® With Standard Glucocorticoid Therapy in Patients With Congenital Adrenal Hyperplasia
This study is a parallel arm, randomised, open-label study, including dose titration and admissions for four overnight stays for 24-hour endocrine profiles.
- Trial name
- NCT02716818
- Testing
- Chronocort®, standard glucocorticoid therapy
- Where
- United States
- Volunteers
- 122 people
- Sponsor
- Neurocrine UK Limited
Congenital Adrenal Hyperplasia
A Study of the Efficacy, Safety and Tolerability of Chronocort in Treating CAH
Subjects completing study DIUR-005 and those who have already completed study DIUR-003 will be offered the opportunity either to continue Chronocort® therapy or to switch from their current glucocorticoid therapy to Chronocort®…
- Trial name
- NCT03062280
- Testing
- Hydrocortisone
- Where
- United States
- Volunteers
- 91 people
- Sponsor
- Neurocrine UK Limited
Congenital Adrenal Hyperplasia
Comparison of Chronocort Versus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia
This study is a randomized, double-blind, active-controlled, phase III study of Chronocort® compared with immediate-release hydrocortisone replacement therapy in participants aged 16 years and over with Congenital Adrenal…
- Trial name
- CONnECT (NCT05063994)
- Testing
- Chronocort, Cortef
- Where
- 21 sites in United States, France and 1 more
- Volunteers
- 55 people
- Sponsor
- Neurocrine UK Limited
Congenital Adrenal Hyperplasia
Efficacy, Safety, Tolerability, and Pharmacokinetics of NBIP-01435 in Adult Participants With Classic Congenital Adrenal Hyperplasia (CAH)
The main objective of this study is to evaluate the efficacy of different dose levels of NBIP-01435 on reducing elevated androstenedione (A4) levels in adults with classic CAH.
- Trial name
- NCT07850739
- Testing
- NBIP-01435
- Volunteers
- 36 people
- Sponsor
- Neurocrine Biosciences
Autonomous Cortisol Secretion, Mild Autonomous Cortisol Secretion (MACS)
Metyrapone for Mild Autonomous Cortisol Secretion (MACS)
The purpose of this study is to find out whether the study drug, metyrapone, is safe and effective in treating participants with Mild Autonomous Cortisol Secretion (MACS).
- Trial name
- NCT06106295
- Testing
- Metyrapone
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Mayo Clinic
Mild Autonomous Cortisol Secretion (MACS), Autonomous Cortisol Secretion (ACS)
Metyrapone Study for Patients Diagnosed With Mild Autonomous Cortisol Secretion - MACS
single-center, randomized, double-blind, placebo-controlled Phase 2 study to evaluate safety and efficacy of overnight metyrapone in patients with MACS.
- Trial name
- NCT07138274
- Testing
- Metyrapone 250 mg Oral Tablets
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Mayo Clinic
Congenital Adrenal Hyperplasia
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Crinecerfont in Participants With Classic Congenital Adrenal Hyperplasia (CAH) Who Are Less Than 4 Years Old
The main objective of this study is to assess the safety and tolerability of crinecerfont in pediatric participants 3 months to <4 years of age with CAH.
- Trial name
- NCT07536269
- Testing
- Crinecerfont
- Where
- 11 sites in United States
- Volunteers
- 20 people
- Sponsor
- Neurocrine Switzerland GmbH
Congenital Adrenal Hyperplasia, Adrenal Insufficiency
An Open Label Study in Healthy Volunteers to Compare Chronocort® to Hydrocortisone
This was an open label, randomized, single dose, three period crossover pharmacokinetic study of Chronocort® in 30 healthy male volunteers. The study was conducted in smaller sub groups (Group 1, n=18 and Group 2, n=12).
- Trial name
- NCT03019614
- Testing
- Hydrocortisone, Chronocort
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Neurocrine UK Limited
Adrenal Insufficiency, Congenital Adrenal Hyperplasia
A Two-part, Study to Compare the Pharmacokinetics and Dose Proportionality of up to 6 Chronocort Formulations
This was an open label, randomised, single dose study, comprising Part A (undertaken in two separate three-period crossover cohorts denoted as A1 and A2) and Part B (undertaken in one four-period crossover cohort), to evaluate…
- Trial name
- NCT03051893
- Testing
- Chronocort
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Neurocrine UK Limited
Congenital Adrenal Hyperplasia
Open-label Comparison of Chronocort® Versus Standard Glucocorticoid Replacement Therapy
This study is an open-label, randomised, titration-blinded, parallel arm, multicenter study to compare twice daily Chronocort® with standard care in participants with Congenital Adrenal Hyperplasia (CAH).
- Trial name
- RESTORE (NCT03532022)
- Testing
- Chronocort®, Standard Care
- Where
- United States
- Sponsor
- Neurocrine UK Limited
Congenital Adrenal Hyperplasia, Classic Congenital Adrenal Hyperplasia
Evaluate the Safety, Efficacy, and Pharmacokinetics of CRN04894 in Participants With Congenital Adrenal Hyperplasia (TouCAHn)
The purpose of this Phase 2, open-label, sequential dose cohort study is to evaluate the safety, efficacy, and pharmacokinetics (PK) of atumelnant (CRN04894) in participants with classic congenital adrenal hyperplasia (CAH)…
- Trial name
- NCT05907291
- Testing
- atumelnant (CRN04894)
- Where
- 27 sites in United States, Argentina and 5 more
- Volunteers
- 38 people
- Sponsor
- Crinetics Pharmaceuticals Inc.
Congenital Adrenal Hyperplasia (CAH)
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of OMS1620
The goal of this study is to explore the safety, drug concentrations and effects on adrenal gland hormones after a single dose or multiple doses of OMS1620 in healthy participants.
- Trial name
- NCT07811089
- Testing
- OMS1620
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- OMass Therapeutics Australia Proprietary Ltd
Congenital Adrenal Hyperplasia (CAH), Familial Male-Limited Precocious Puberty (FMPP)
Natural History Study of Patients With Excess Androgen
This study will evaluate and gather information in patients with genetic causes of too much androgen (male-like hormone) in order to better understand the effects of too much androgen and describe problems associated with it.
- Trial name
- NCT00250159
- Where
- 2 sites in United States
- Volunteers
- 3,000 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CAH - 21-Hydroxylase Deficiency
Parenting and CAH - 21-hydroxylase Deficiency
Congenital adrenal hyperplasia (CAH) is a genetic disease with autosomal recessive transmission, which is defined by a deficiency of one of the steroidogenesis enzymes.
- Trial name
- PARENT-HCS (NCT06900153)
- Testing
- phone questionnaire
- Where
- 7 sites in France
- Volunteers
- 200 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris