Clinical trials: Congenital Adrenal Hyperplasia
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, 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
Congenital Adrenal Hyperplasia
A Trial of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia
This trial will evaluate the effects of different doses of Lu AG13909 in adult participants with congenital adrenal hyperplasia, also called CAH.
- Trial name
- NCT05669950
- Testing
- Lu AG13909
- Where
- 17 sites in United States, Denmark and 7 more
- Volunteers
- 42 people
- Sponsor
- H. Lundbeck A/S
Hypercortisolism
A Study of the Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas
This is a Phase 3, randomized, double-blind, placebo-controlled study to assess the efficacy, and safety of relacorilant to treat hypercortisolism in patients with cortisol-secreting adrenal adenoma or hyperplasia associated with…
- Trial name
- GRADIENT (NCT04308590)
- Testing
- Relacorilant
- Where
- 45 sites in United States, Austria and 7 more
- Volunteers
- 137 people
- Sponsor
- Corcept Therapeutics
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
Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia
This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 24 weeks in approximately 165 adult participants with classic CAH due to 21-hydroxylase deficiency.
- Trial name
- CAHtalyst (NCT04490915)
- Testing
- Crinecerfont
- Where
- 70 sites in United States, Austria and 16 more
- Volunteers
- 182 people
- Sponsor
- Neurocrine Biosciences
Congenital Adrenal Hyperplasia, 21-OHD
A Phase 2 Study to Evaluate the Safety, Efficacy and PK of Tildacerfont in Children Aged 2-17 Years With CAH
An investigation of the safety and efficacy of tildacerfont in participants with CAH.
- Trial name
- NCT05128942
- Testing
- Tildacerfont
- Where
- 13 sites in United States
- Volunteers
- 67 people
- Sponsor
- Spruce Biosciences
Adrenal Hyperplasia, Congenital, Congenital Hypothyroidism
Clinical Evaluation of NeoPlex4 Assay and NeoPlex System
The purpose of this study is to assess the agreement of clinical performance between the proposed NeoPlex 4 assay and NeoPlex System and the comparator devices in clinical use in newborn screening programs for detection of T4…
- Conditions
- Adrenal Hyperplasia, Congenital, Congenital Hypothyroidism, Cystic Fibrosis
- Trial name
- NCT01488721
- Where
- 3 sites in United States
- Volunteers
- 7,462 people, healthy volunteers welcome
- Sponsor
- Luminex Corporation
Congenital Adrenal Hyperplasia
Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)
This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 28 weeks in approximately 81 pediatric participants with classic congenital adrenal hyperplasia (CAH) due…
- Trial name
- NCT04806451
- Testing
- Crinecerfont
- Where
- 46 sites in United States, Belgium and 8 more
- Volunteers
- 103 people
- Sponsor
- Neurocrine Biosciences
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
- 81 sites in United States, Argentina and 13 more
- Volunteers
- 150 people
- Sponsor
- Crinetics Pharmaceuticals Inc.
Congenital Adrenal Hyperplasia
A Ph2b to Evaluate Clinical Efficacy and Safety of Tildacerfont in Adult CAH
An investigation of the efficacy and safety of up to 70 weeks of treatment with Tildacerfont in subjects with classic CAH who have elevated biomarkers at baseline on their current GC regimen.
- Trial name
- NCT04457336
- Where
- 65 sites in United States, Australia and 18 more
- Volunteers
- 96 people
- Sponsor
- Spruce Biosciences
Cushing's Syndrome, Ectopic Corticotropin Syndrome
Study of Efficacy and Safety of Osilodrostat in Cushing's Syndrome
The study aim was to investigate the efficacy and safety of Osilodrostat in patients with Cushing's syndrome due to causes other than Cushing's disease in Japan.
- Conditions
- Cushing's Syndrome, Ectopic Corticotropin Syndrome, Adrenal Adenoma, Adrenal Carcinoma
- Trial name
- NCT02468193
- Testing
- Osilodrostat
- Where
- 4 sites in Japan
- Volunteers
- 9 people
- Sponsor
- Novartis Pharmaceuticals
21-hydroxylase Deficiency
A Study Examining Doses of Abiraterone Acetate in Adult Women With 21-Hydroxylase Deficiency
The purpose of this study is to determine the minimum dose of abiraterone acetate needed to decrease serum androstenedione to age-appropriate levels in premenopausal women on steroid replacement for classic 21-hydroxylase…
- Trial name
- NCT01495910
- Testing
- Abiraterone acetate
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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
Adrenal Insufficiency
Extension Study for Patients Entered Into Study Infacort 003
A Phase 3, open-label, single-group, non-randomised, observational study of the safety and biochemical disease control of Infacort® in neonates, infants and children with adrenal insufficiency and congenital adrenal hyperplasia…
- Trial name
- NCT02733367
- Testing
- Infacort®
- Where
- Germany
- Volunteers
- 18 people
- Sponsor
- Neurocrine UK Limited
Congenital Adrenal Hyperplasia
A Ph2b to Evaluate Tildacerfont in the Reduction of Glucocorticoid Steroid Doses in Adult CAH
An investigation of the ability of Tildacerfont to reduce supraphysiologic glucocorticoid dosing in classic Congenital adrenal hyperplasia (CAH) subjects up to 76 weeks of treatment. Optional open label extension up to 240 weeks.
- Trial name
- NCT04544410
- Where
- 43 sites in United States, Australia and 14 more
- Volunteers
- 100 people
- Sponsor
- Spruce Biosciences
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
Long-term Safety Study of Chronocort in the Treatment of Participants With Congenital Adrenal Hyperplasia
This phase III study is an open-label extension study to be conducted at approximately 21 investigational sites across 3 countries.
- Trial name
- NCT05299554
- Testing
- Chronocort
- Where
- 21 sites in United States, France and 1 more
- Volunteers
- 76 people
- Sponsor
- Immedica Pharma AB
Autonomous Cortisol Secretion (ACS), ACTH-Independent Cushing Syndrome
SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor
This is study with SPI-62 to evaluate the efficacy, safety, and pharmacological effect of SPI-62 in subjects with hypercortisolism related to a benign adrenal tumor. Each subject will receive 2mg of SPI-62 daily.
- Conditions
- Autonomous Cortisol Secretion (ACS), ACTH-Independent Cushing Syndrome, ACTH-Independent Adrenal Cushing Syndrome, Somatic
- Trial name
- ACSPIRE (NCT05436639)
- Testing
- SPI-62 dose
- Where
- 5 sites in United States, Romania and 1 more
- Volunteers
- 30 people
- Sponsor
- Sparrow Pharmaceuticals
Congenital Adrenal Hyperplasia
A Study of Gene Therapy for Classic Congenital Adrenal Hyperplasia (CAH)
This study is designed to evaluate the safety, tolerability, and efficacy of AAV5 based BBP-631 in adult participants diagnosed with classic congenital adrenal hyperplasia.
- Trial name
- NCT04783181
- Testing
- AAV BBP-631
- Where
- 5 sites in United States
- Volunteers
- 8 people
- Sponsor
- Adrenas Therapeutics Inc