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Tildacerfont for Congenital Adrenal Hyperplasia
Study Summary
This trial is testing a possible new treatment for classic CAH, which is a condition that affects the adrenal glands. The trial will last up to 70 weeks, and there is an optional extension period of up to 240 weeks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have been on a stable dose of mineralocorticoid for at least 1 month.I am currently on dexamethasone for CAH or have switched to another stable GC therapy for over a month.I show signs of adrenal insufficiency.I am allergic to Tildacerfont or similar medications.You have had both adrenal glands removed or have a condition called hypopituitarism.I was diagnosed with classic CAH in childhood and am currently treated with specific steroids.I have been on a stable high dose of steroid treatment.I have a form of CAH that is not due to 21 hydroxylase deficiency.I am over 18 years old.
- Group 1: Tildacerfont Group 3
- Group 2: Tildacerfont Group 2
- Group 3: Placebo
- Group 4: Tildacerfont Group 1
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many healthcare centers in this state are administering this trial?
"Forty-two clinical sites across the United States are actively recruiting patients for this trial. These locations span from Boston and Baltimore to Orange, as well as numerous other areas in between - you should select a site closer to your residence so that travel demands remain low if accepted into the study."
Is there still availability for patients to join this experiment?
"According to clinicaltrials.gov, this trial is currently enrolling patients. This study was initially published on August 26th 2020 and has been recently revised November 4th 2022."
What end goal is this investigation attempting to achieve?
"The primary efficacy outcome of this 12-week trial is the alteration in androstenedione. Secondary objectives include a safety analysis, measurement of A4 levels below the upper limit of normal values, as well as assessment of any changes to TART(s) lesion volume for male CAH subjects over up to 12 months."
For whom is enrollment in this research project open?
"This clinical trial is searching for 72 individuals, aged 18 to 55, diagnosed with congenital adrenal hyperplasia. In addition to this criteria, the participants must be of any gender over 18 years old and have a genetic mutation in CYP21A2 or elevated 17-OHP levels which are treated with hormonal corticosteroids at doses between 15 - 60 milligrams per day. Furthermore, those with salt wasting forms require stable mineralocorticoid replacement treatment periods that exceed 1 month before screening begins."
Are individuals aged 25 and over being included in the experimental program?
"The requisite criteria for enrolment in this trial necessitate that participants are aged 18 to 55. Meanwhile, 28 and 105 trials respectively cater to those below 18 or above 65 years of age."
How many participants have registered for this experiment?
"Affirmative. According to clinicaltrials.gov, this research is actively seeking participants; the trial was first published on August 26th 2020 and has been recently updated on November 4th 2022. The study seeks a total of 72 individuals from 42 distinct sites."
How efficacious is Tildacerfont Group 3 for individuals?
"Our team at Power has assigned the safety of Tildacerfont Group 3 a rating of 2, as there is existing evidence that it is harmless yet no data to affirm its efficacy."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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