Ongoing Clinical Trials
CARES Foundation does not counsel individual patients either for or against participation in any specific research study. Prospective volunteers should always carefully review the study’s informed consent documentation and discuss the pros and cons of their participation with trusted advisers, including their health care providers and family members. For more information on research participation, check out https://www.hhs.gov/ohrp/education-and-outreach/about-research-participation/index.html
- Phase 2, Multiple-dose, Dose Escalation Study to Evaluate the Safety and Efficacy of SPR001 – This study is for an investigational, once-a-day pill for CAH, designed to correct hormone imbalance and potentially reduce the necessary dose of traditional steroid medications. If you are 18 years of age or older, and have been diagnosed with classic CAH, you may qualify to participate. Participants will receive study-related care and medication at no cost, and compensated for your time and travel.If you are interested, CLICK HERE to see if you qualify.
- Adolescent CAH Study– Adolescent volunteers with classic CAH, ages 12-18, needed for a clinical trial of the investigational compound NBI-77860. Neurocrine Biosciences, Inc. is conducting an open-label, single-dose clinical trial to assess the effect of NBI-77860 on safety measures and hormone levels in adolescent patients with classic, 21-hydroxylase deficiency, congenital adrenal hyperplasia (CAH). This study will be conducted in approximately 15 adolescent females with CAH. Three independent dosing groups of NBI-77860 (approximately 5 patients per group) will be evaluated following single-dose administration of the study drug.
- ATR-101 for the Treatment of Classic Congenital Adrenal Hyperplasia (CAH)– An ongoing clinical trial of the investigational compound, ATR-101; Millendo Therapeutics is conducting a single-blind, multiple dose study to assess the effect of ATR-101 on adrenal hormone levels and safety measures in adult patients with classic CAH.
- CAH Volunteers Needed for Natural History Study at NIH – patients of all ages with CAH (both classic and nonclassic). For more information, contact the CARES office at 866-227-3737.
- Classical CAH Adult Volunteers Needed for Chronocort® Study at NIH – Patients at least 18 years of age with Classic CAH due to 21-hydroxylase deficiency for 6-month study that will compare patients’ standard therapy to Chronocort® therapy.
- Infracort – Current hydrocortisone replacement therapy poses significant challenges especially at low doses where no licensed therapies exist for neonates and infants. A study is underway to assess an immediate-release, oral formulation of hydrocortisone which has been designed specifically for children.
- Related Quality of Life of Female Children with Congenital Adrenal Hyperplasia : A Mixed Methods Study – This study aims to learn more about the health of female children with CAH and how CAH affects the child’s life from the perspective of the child and caregiver. Conducted by: University of Tennessee Health Science Center Memphis, TN
- NIH Study of Infertility Disorder – researchers are investigating the role of adrenal hormones in polycystic ovary syndrome (PCOS). This study will be conducted by NIH and studies women aged 16 to 24 with PCOS.
- Noninvasive Prenatal Diagnosis of Congenital Adrenal Hyperplasia – study that will help determine in early pregnancy whether your baby is a boy or a girl and whether he or she has CAH, just by testing the pregnant woman’s blood. Women with CAH or with a family member with CAH thinking of becoming pregnant.
- Parental Management of Adrenal Crisis in Children with Congenital Adrenal Hyperplasia (CAH) – A pilot study to explore parental management of adrenal crisis in children with CAH by describing parents’ perceptions of the sources of information from health care providers related to times of crisis and examining strategies and approaches parents take to educate family members, school personnel, and others in their social network on managing adrenal crises in their children. Louise Fleming. UPDATE: Seeking participants for survey. See Invitation To Participate in CAH Research.
- Participants sought for NIH study of adrenal disorder – Adults who have congenital adrenal hyperplasia, a disorder of the adrenal glands, may be eligible to take part in a study at the National Institutes of Health on the effectiveness of a new pump which delivers missing adrenal hormones in a manner more closely matching their release by the adrenal glands.
- Phase III Chronocort® Study – Study of efficacy, safety and tolerability of Chronocort® compared with a standard three times daily hydrocortisone replacement regimen in the treatment of adults with congenital adrenal hyperplasia. For more information, contact the CARES office at 866-227-3737
- Surgical Outcomes Study– This multi-site study will incorporate parents’ ratings of surgical results along with their ratings of their own psychological outcomes and their satisfaction or regret with their medical decisions in order to evaluate outcomes of modern genitoplasty.